ENRICH-mHealth FHIR Implementation Guide
0.1.0 - ci-build

ENRICH-mHealth FHIR Implementation Guide - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: ENRICHKreatinin - Detailed Descriptions

Draft as of 2026-07-16

Definitions for the mii-kreatinin 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())
mii-lab-2: Falls kein Laborwert verfügbar ist, muss eine dataAbsentReason angegeben werden (hasMember.exists() xor value.exists().not() implies dataAbsentReason.exists())
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.

ShortLogical id of this artifact
Comments

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.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
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. 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.


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
This element is affected by the following invariants: ele-1
Typeuri
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()))
8. 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.


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..*
This element is affected by the following invariants: ele-1
Typecanonical(StructureDefinition, StructureDefinition)
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()))
10. 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.

ShortA set of rules under which this content was created
Comments

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..1
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()))
12. 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
Standard StatusNormative (from Normative)
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
  • 14. Observation.identifier
    Definition

    Identifier/s by which this laboratory test is known.


    A unique identifier assigned to this observation.

    ShortIdentifikatorBusiness Identifier for observation
    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control10..*
    This element is affected by the following invariants: ele-1
    TypeIdentifier
    Is Modifierfalse
    Must Supporttrue
    Standard StatusNormative (from Normative)
    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()))
    SlicingThis element introduces a set of slices on Observation.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • pattern @ type
    • 16. Observation.identifier:analyseBefundCode
      Slice NameanalyseBefundCode
      Definition

      A unique identifier assigned to this observation.

      ShortBusiness Identifier for observation
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control10..1*
      This element is affected by the following invariants: ele-1
      TypeIdentifier
      Is Modifierfalse
      Must Supporttrue
      Standard StatusNormative (from Normative)
      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()))
      18. Observation.identifier:analyseBefundCode.use
      Definition

      The purpose of this identifier.

      Shortusual | official | temp | secondary | old (If known)
      Comments

      Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

      Control0..1
      This element is affected by the following invariants: ele-1
      BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1
      (required to http://hl7.org/fhir/ValueSet/identifier-use|4.0.1)

      Identifies the purpose for this identifier, if known .

      Typecode
      Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      20. Observation.identifier:analyseBefundCode.type
      Definition

      A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

      ShortDescription of identifier
      Comments

      This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

      Control10..1
      This element is affected by the following invariants: ele-1
      BindingUnless not suitable, these codes SHALL be taken from MII VS Labor Identifier Type Codeshttp://hl7.org/fhir/ValueSet/identifier-type|4.0.1
      (extensible to https://www.medizininformatik-initiative.de/fhir/core/modul-labor/ValueSet/mii-vs-labor-identifier-type-codes)

      A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Standard StatusNormative (from Normative)
      Summarytrue
      Requirements

      Allows users to make use of identifiers when the identifier system is not known.

      Pattern Value{
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
          "code" : "OBI"
        }]
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      22. Observation.identifier:analyseBefundCode.type.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
      Standard StatusNormative (from Normative)
      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.identifier.type.coding. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ system
      • 24. Observation.identifier:analyseBefundCode.type.coding:observationInstanceV2
        Slice NameobservationInstanceV2
        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..1*
        This element is affected by the following invariants: ele-1
        TypeCoding
        Is Modifierfalse
        Must Supporttrue
        Standard StatusNormative (from Normative)
        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()))
        26. Observation.identifier:analyseBefundCode.type.coding:observationInstanceV2.system
        Definition

        The identification of the code system that defines the meaning of the symbol in the code.

        ShortIdentity of the terminology system
        Comments

        The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

        Control10..1
        This element is affected by the following invariants: ele-1
        Typeuri
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        Need to be unambiguous about the source of the definition of the symbol.

        Fixed Valuehttp://terminology.hl7.org/CodeSystem/v2-0203
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        28. Observation.identifier:analyseBefundCode.type.coding:observationInstanceV2.code
        Definition

        A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

        ShortSymbol in syntax defined by the system
        Comments

        Note that FHIR strings SHALL NOT exceed 1MB in size

        Control10..1
        This element is affected by the following invariants: ele-1
        Typecode
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        Need to refer to a particular code in the system.

        Fixed ValueOBI
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        30. Observation.identifier:analyseBefundCode.system
        Definition

        Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

        ShortThe namespace for the identifier value
        Comments

        Identifier.system is always case sensitive.

        Control10..1
        This element is affected by the following invariants: ele-1
        Typeuri
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

        ExampleGeneral: http://www.acme.com/identifiers/patient
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        32. Observation.identifier:analyseBefundCode.value
        Definition

        The portion of the identifier typically relevant to the user and which is unique within the context of the system.

        ShortThe value that is unique
        Comments

        If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

        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
        Summarytrue
        ExampleGeneral: 123456
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        34. Observation.identifier:analyseBefundCode.assigner
        Definition

        Organization that issued/manages the identifier.

        ShortOrganization that issued id (may be just text)
        Comments

        The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

        Control10..1
        This element is affected by the following invariants: ele-1
        TypeReference(Organization, Organization)
        Is Modifierfalse
        Must Supporttrue
        Standard StatusNormative (from Normative)
        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')))
        36. Observation.status
        Definition

        completed


        The status of the result value.

        ShortStatusregistered | preliminary | final | amended +
        Comments

        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()))
        38. Observation.category
        Definition

        Classification of the laboratory test in the diagnostic service section and laboratory group


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

        ShortKategorieClassification of type of observation
        Comments

        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()))
        40. 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.

        Control20..*
        This element is affected by the following invariants: ele-1
        TypeCoding
        Is Modifierfalse
        Must Supporttrue
        Standard StatusNormative (from Normative)
        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.category.coding. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • pattern @ $this
        • 42. Observation.category.coding:loinc-observation
          Slice Nameloinc-observation
          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..1*
          This element is affected by the following invariants: ele-1
          TypeCoding
          Is Modifierfalse
          Must Supporttrue
          Standard StatusNormative (from Normative)
          Summarytrue
          Requirements

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

          Pattern Value{
            "system" : "http://loinc.org",
            "code" : "26436-6"
          }
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          44. Observation.category.coding:observation-category
          Slice Nameobservation-category
          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..1*
          This element is affected by the following invariants: ele-1
          TypeCoding
          Is Modifierfalse
          Must Supporttrue
          Standard StatusNormative (from Normative)
          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" : "laboratory"
          }
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          46. Observation.code
          Definition

          A LOINC code identifying the laboratory test that was performed.


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

          ShortCodeType of observation (code / type)
          Comments

          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
          BindingThe codes SHOULD be taken from For example codes, see Results Laboratory Observation - IPShttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
          (preferred to http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips)
          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()))
          48. 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.

          ShortWho and/or what the observation is about
          Comments

          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')))
          50. Observation.encounter
          Definition

          Encounter during which the laboratory test was performed.


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

          ShortFall oder KontaktHealthcare event during which this observation is made
          Comments

          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')))
          52. Observation.effective[x]
          Definition

          The time at which the observation was made


          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.

          ShortUntersuchungszeitpunktClinically relevant time/time-period for observation
          Comments

          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()))
          mii-lab-1: Datetime must be at least to day (($this as dateTime).hasValue() implies ($this as dateTime).toString().length() >= 8)
          54. Observation.effective[x].extension:QuelleKlinischesBezugsdatum
          Slice NameQuelleKlinischesBezugsdatum
          Definition

          Specimen collection date | Date sample received in laboratory

          ShortQuelle klinisches Bezugsdatum
          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..1
          This element is affected by the following invariants: ele-1
          TypeExtension(MII EX Labor Quelle Klinisches Bezugsdatum) (Extension Type: Coding)
          Must Supporttrue
          Standard StatusNormative (from Normative)
          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())
          56. Observation.issued
          Definition

          The point in time when the laboratory result was documented


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

          ShortDokumentationsdatumDate/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
          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()))
          58. Observation.value[x]
          Definition

          Value of the analysis


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

          ShortMesswertActual 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..1
          This element is affected by the following invariants: ele-1, obs-7
          TypeChoice of: Quantity, CodeableConcept, Range, Ratio, dateTime, boolean, string, SampledData, Period, integer, time
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          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()))
          SlicingThis element introduces a set of slices on Observation.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
          • type @ $this
          • 60. Observation.value[x]:valueQuantity
            Slice NamevalueQuantity
            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..1
            This element is affected by the following invariants: ele-1, obs-7
            TypeQuantity, dateTime, boolean, string, SampledData, 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.value[x]:valueQuantity.extension:pqTranslation
            Slice NamepqTranslation
            Definition

            An alternative representation of the same physical quantity expressed in a different unit from a different unit code system and possibly with a different value.

            ShortSame quantity with different units
            Comments

            It is not necessary for information processing entities to check and enforce that the translations are valid translations of the base unit, but they are allowed to do so, and to reject instances where the translations are not valid. NOTE Translations are allowed to contain other representations in UCUM units, but there is generally no point to this as it is possible to convert from one UCUM form to another.

            Control0..*
            This element is affected by the following invariants: ele-1
            TypeExtension(PQ Translation) (Extension Type: Quantity)
            Standard StatusDraft (from Normative)
            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())
            64. Observation.value[x]:valueQuantity.value
            Definition

            The value of the measured amount. The value includes an implicit precision in the presentation of the value.

            ShortNumerical value (with implicit precision)
            Comments

            The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

            Control10..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
            Requirements

            Precision is handled implicitly in almost all cases of measurement.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            66. Observation.value[x]:valueQuantity.value.extension:quantityPrecision
            Slice NamequantityPrecision
            Definition

            Explicit precision of the number. This is the number of significant decimal places after the decimal point, irrespective of how many are actually present in the explicitly represented decimal.

            ShortExplicit precision (number of significant decimal places)
            Comments

            The presence of this extension does not change conformance expectations with regard to rendering and calculations that use the number - these are still based on the raw decimal value. Applications that perform calculations SHALL ensure that this extension is removed or updated to the correct precision value if the number is changed. Applications should consider using the exponential form (e.g. 2.10e3) on the raw decimal to manage significant figures, but should be mindful of human display when doing so.

            Control0..1
            This element is affected by the following invariants: ele-1
            TypeExtension(Precision) (Extension Type: integer)
            Must Supporttrue
            Standard StatusDraft (from Normative)
            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())
            68. Observation.value[x]:valueQuantity.comparator
            Definition

            How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

            Short< | <= | >= | > - how to understand the value
            Comments

            Note that FHIR strings SHALL NOT exceed 1MB in size

            Control0..1
            This element is affected by the following invariants: ele-1
            BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
            (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

            How the Quantity should be understood and represented.

            Typecode
            Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Requirements

            Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

            Meaning if MissingIf there is no comparator, then there is no modification of the value
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            70. Observation.value[x]:valueQuantity.unit
            Definition

            A human-readable form of the unit.

            ShortUnit representation
            Comments

            Note that FHIR strings SHALL NOT exceed 1MB in size

            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
            Summarytrue
            Requirements

            There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

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

            The identification of the system that provides the coded form of the unit.

            ShortSystem that defines coded unit form
            Comments

            see http://en.wikipedia.org/wiki/Uniform_resource_identifier

            Control10..1
            This element is affected by the following invariants: ele-1, qty-3
            Typeuri
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Requirements

            Need to know the system that defines the coded form of the unit.

            Fixed Valuehttp://unitsofmeasure.org
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            74. Observation.value[x]:valueQuantity.code
            Definition

            A computer processable form of the unit in some unit representation system.

            ShortCoded form of the unit
            Comments

            The mandatory system is UCUM.


            The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

            Control10..1
            This element is affected by the following invariants: ele-1
            Typecode
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Requirements

            Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            76. Observation.value[x]:valueCodeableConcept
            Slice NamevalueCodeableConcept
            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..1
            This element is affected by the following invariants: ele-1, obs-7
            TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
            [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()))
            78. Observation.value[x]:valueCodeableConcept.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.value[x]:valueCodeableConcept.coding.system
            Definition

            The identification of the code system that defines the meaning of the symbol in the code.

            ShortIdentity of the terminology system
            Comments

            The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

            Control10..1
            This element is affected by the following invariants: ele-1
            Typeuri
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Requirements

            Need to be unambiguous about the source of the definition of the symbol.

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

            A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

            ShortSymbol in syntax defined by the system
            Comments

            Note that FHIR strings SHALL NOT exceed 1MB in size

            Control10..1
            This element is affected by the following invariants: ele-1
            Typecode
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Requirements

            Need to refer to a particular code in the system.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            84. Observation.value[x]:valueRange
            Slice NamevalueRange
            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..1
            This element is affected by the following invariants: ele-1, obs-7
            TypeRange, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, 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()))
            86. Observation.value[x]:valueRatio
            Slice NamevalueRatio
            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..1
            This element is affected by the following invariants: ele-1, obs-7
            TypeRatio, dateTime, boolean, string, SampledData, Quantity, Period, 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()))
            88. Observation.dataAbsentReason
            Definition

            unknown | masked | not-applicable | error | not-performed


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

            ShortGrund für fehlende DatenWhy the 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 "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()))
            90. Observation.interpretation
            Definition

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


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

            ShortInterpretationHigh, 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 ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretation|4.0.1
            (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

            Codes identifying interpretations of observations.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supporttrue
            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()))
            92. Observation.note
            Definition

            Additional information about the laboratory test as free text.


            Comments about the observation or the results.

            ShortHinweisComments 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
            Is Modifierfalse
            Must Supporttrue
            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()))
            94. 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..01
            This element is affected by the following invariants: ele-1
            BindingFor example codes, see SNOMEDCTBodyStructureshttp://hl7.org/fhir/ValueSet/body-site|4.0.1
            (example to http://hl7.org/fhir/ValueSet/body-site)

            Codes describing anatomical locations. May include laterality.

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

            Specific examination method, if the LOINC code for the laboratory test does not contain a method


            Indicates the mechanism used to perform the observation.

            ShortUntersuchungsmethodeHow it was done
            Comments

            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()))
            98. Observation.specimen
            Definition

            Specimen on which the laboratory tests are performed


            The specimen that was used when this observation was made.

            ShortProbenmaterialSpecimen 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, Specimen)
            Is Modifierfalse
            Must Supporttrue
            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')))
            100. Observation.specimen.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.

            ShortLiteral reference, Relative, internal or absolute URL
            Comments

            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.

            Control0..1
            This element is affected by the following invariants: ele-1, 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()))
            102. Observation.specimen.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
            This element is affected by the following invariants: ele-1
            TypeIdentifier
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            104. Observation.device
            Definition

            The device used to generate the test data.


            The device used to generate the observation data.

            ShortGerät(Measurement) Device
            Comments

            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')))
            106. Observation.referenceRange
            Definition

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


            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.

            ShortReferenzbereichProvides 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
            Is Modifierfalse
            Must Supporttrue
            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())
            obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
            108. 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())
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            110. 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, 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())
            112. 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, 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())

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

            0. Observation
            2. Observation.code
            BindingThe codes SHOULD be taken from Results Laboratory Observation - IPS
            (preferred to http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips)
            4. Observation.value[x]:valueQuantity
            Slice NamevalueQuantity
            TypeQuantity
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            6. Observation.value[x]:valueQuantity.extension:pqTranslation
            Slice NamepqTranslation
            Standard StatusDraft (from Draft)
            8. Observation.value[x]:valueQuantity.value
            10. Observation.value[x]:valueQuantity.value.extension:quantityPrecision
            Slice NamequantityPrecision
            Standard StatusDraft (from Draft)

            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())
            mii-lab-2: Falls kein Laborwert verfügbar ist, muss eine dataAbsentReason angegeben werden (hasMember.exists() xor value.exists().not() implies dataAbsentReason.exists())
            2. Observation.id
            Definition

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

            ShortLogical id of this artifact
            Comments

            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
            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
            Must Supporttrue
            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
            XML FormatIn the XML format, this property is represented as an attribute.
            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..*
            This element is affected by the following invariants: ele-1
            TypeExtension
            Standard StatusNormative (from Normative)
            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.

              ShortVersion specific identifier
              Comments

              The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

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

              ShortWhen the resource version last changed
              Comments

              This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

              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()))
              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
              This element is affected by the following invariants: ele-1
              Typeuri
              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()))
              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..*
              This element is affected by the following invariants: ele-1
              Typecanonical(StructureDefinition)
              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()))
              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..*
              This element is affected by the following invariants: ele-1
              BindingUnless not suitable, these codes SHALL be taken from All Security Labels
              (extensible to http://hl7.org/fhir/ValueSet/security-labels)

              Security Labels from the Healthcare Privacy and Security Classification System.

              TypeCoding
              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..*
              This element is affected by the following invariants: ele-1
              BindingFor example codes, see CommonTags
              (example to http://hl7.org/fhir/ValueSet/common-tags)

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

              TypeCoding
              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.

              ShortA set of rules under which this content was created
              Comments

              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..1
              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
              Standard StatusNormative (from Normative)
              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
                Standard StatusNormative (from Normative)
                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

                  Identifier/s by which this laboratory test is known.

                  ShortIdentifikator
                  NoteThis is a business identifier, not a resource identifier (see discussion)
                  Control1..*
                  This element is affected by the following invariants: ele-1
                  TypeIdentifier
                  Must Supporttrue
                  Standard StatusNormative (from Normative)
                  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()))
                  SlicingThis element introduces a set of slices on Observation.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • pattern @ type
                  • 36. Observation.identifier:analyseBefundCode
                    Slice NameanalyseBefundCode
                    Definition

                    A unique identifier assigned to this observation.

                    ShortBusiness Identifier for observation
                    NoteThis is a business identifier, not a resource identifier (see discussion)
                    Control1..1
                    This element is affected by the following invariants: ele-1
                    TypeIdentifier
                    Must Supporttrue
                    Standard StatusNormative (from Normative)
                    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()))
                    38. Observation.identifier:analyseBefundCode.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.
                    40. Observation.identifier:analyseBefundCode.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
                    Standard StatusNormative (from Normative)
                    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.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 42. Observation.identifier:analyseBefundCode.use
                      Definition

                      The purpose of this identifier.

                      Shortusual | official | temp | secondary | old (If known)
                      Comments

                      Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

                      Control0..1
                      This element is affected by the following invariants: ele-1
                      BindingThe codes SHALL be taken from IdentifierUse
                      (required to http://hl7.org/fhir/ValueSet/identifier-use|4.0.1)

                      Identifies the purpose for this identifier, if known .

                      Typecode
                      Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Summarytrue
                      Requirements

                      Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

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

                      A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

                      ShortDescription of identifier
                      Comments

                      This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

                      Control1..1
                      This element is affected by the following invariants: ele-1
                      BindingUnless not suitable, these codes SHALL be taken from MII VS Labor Identifier Type Codes
                      (extensible to https://www.medizininformatik-initiative.de/fhir/core/modul-labor/ValueSet/mii-vs-labor-identifier-type-codes)

                      A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

                      TypeCodeableConcept
                      Must Supporttrue
                      Standard StatusNormative (from Normative)
                      Summarytrue
                      Requirements

                      Allows users to make use of identifiers when the identifier system is not known.

                      Pattern Value{
                        "coding" : [{
                          "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
                          "code" : "OBI"
                        }]
                      }
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      46. Observation.identifier:analyseBefundCode.type.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.
                      48. Observation.identifier:analyseBefundCode.type.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
                      Standard StatusNormative (from Normative)
                      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.identifier.type.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ url
                      • 50. Observation.identifier:analyseBefundCode.type.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
                        Standard StatusNormative (from Normative)
                        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.identifier.type.coding. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • value @ system
                        • 52. Observation.identifier:analyseBefundCode.type.coding:observationInstanceV2
                          Slice NameobservationInstanceV2
                          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..1
                          This element is affected by the following invariants: ele-1
                          TypeCoding
                          Must Supporttrue
                          Standard StatusNormative (from Normative)
                          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()))
                          54. Observation.identifier:analyseBefundCode.type.coding:observationInstanceV2.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.identifier:analyseBefundCode.type.coding:observationInstanceV2.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
                          Standard StatusNormative (from Normative)
                          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.identifier.type.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                          • value @ url
                          • 58. Observation.identifier:analyseBefundCode.type.coding:observationInstanceV2.system
                            Definition

                            The identification of the code system that defines the meaning of the symbol in the code.

                            ShortIdentity of the terminology system
                            Comments

                            The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

                            Control1..1
                            This element is affected by the following invariants: ele-1
                            Typeuri
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Must Supporttrue
                            Summarytrue
                            Requirements

                            Need to be unambiguous about the source of the definition of the symbol.

                            Fixed Valuehttp://terminology.hl7.org/CodeSystem/v2-0203
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            60. Observation.identifier:analyseBefundCode.type.coding:observationInstanceV2.version
                            Definition

                            The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                            ShortVersion of the system - if relevant
                            Comments

                            Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                            NoteThis is a business version Id, not a resource version Id (see discussion)
                            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
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            62. Observation.identifier:analyseBefundCode.type.coding:observationInstanceV2.code
                            Definition

                            A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                            ShortSymbol in syntax defined by the system
                            Comments

                            Note that FHIR strings SHALL NOT exceed 1MB in size

                            Control1..1
                            This element is affected by the following invariants: ele-1
                            Typecode
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Must Supporttrue
                            Summarytrue
                            Requirements

                            Need to refer to a particular code in the system.

                            Fixed ValueOBI
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            64. Observation.identifier:analyseBefundCode.type.coding:observationInstanceV2.display
                            Definition

                            A representation of the meaning of the code in the system, following the rules of the system.

                            ShortRepresentation defined by the system
                            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
                            Summarytrue
                            Requirements

                            Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            66. Observation.identifier:analyseBefundCode.type.coding:observationInstanceV2.userSelected
                            Definition

                            Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                            ShortIf this coding was chosen directly by the user
                            Comments

                            Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

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

                            This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            68. Observation.identifier:analyseBefundCode.type.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()))
                            70. Observation.identifier:analyseBefundCode.system
                            Definition

                            Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

                            ShortThe namespace for the identifier value
                            Comments

                            Identifier.system is always case sensitive.

                            Control1..1
                            This element is affected by the following invariants: ele-1
                            Typeuri
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Must Supporttrue
                            Summarytrue
                            Requirements

                            There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

                            ExampleGeneral: http://www.acme.com/identifiers/patient
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            72. Observation.identifier:analyseBefundCode.value
                            Definition

                            The portion of the identifier typically relevant to the user and which is unique within the context of the system.

                            ShortThe value that is unique
                            Comments

                            If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

                            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
                            Summarytrue
                            ExampleGeneral: 123456
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            74. Observation.identifier:analyseBefundCode.period
                            Definition

                            Time period during which identifier is/was valid for use.

                            ShortTime period when id is/was valid for use
                            Comments

                            A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times").

                            Period is not used for a duration (a measure of elapsed time). See Duration.

                            Control0..1
                            This element is affected by the following invariants: ele-1
                            TypePeriod
                            Standard StatusNormative (from Normative)
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            per-1: If present, start SHALL have a lower value than end (start.hasValue().not() or end.hasValue().not() or (start <= end))
                            76. Observation.identifier:analyseBefundCode.assigner
                            Definition

                            Organization that issued/manages the identifier.

                            ShortOrganization that issued id (may be just text)
                            Comments

                            The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

                            Control1..1
                            This element is affected by the following invariants: ele-1
                            TypeReference(Organization)
                            Must Supporttrue
                            Standard StatusNormative (from Normative)
                            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')))
                            78. 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')))
                            80. 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')))
                            82. Observation.status
                            Definition

                            completed

                            ShortStatus
                            Comments

                            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 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()))
                            84. Observation.category
                            Definition

                            Classification of the laboratory test in the diagnostic service section and laboratory group

                            ShortKategorie
                            Comments

                            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.

                            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()))
                            86. 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.
                            88. 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
                            Standard StatusNormative (from Normative)
                            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
                            • 90. 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.

                              Control2..*
                              This element is affected by the following invariants: ele-1
                              TypeCoding
                              Must Supporttrue
                              Standard StatusNormative (from Normative)
                              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.category.coding. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                              • pattern @ $this
                              • 92. Observation.category.coding:loinc-observation
                                Slice Nameloinc-observation
                                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..1
                                This element is affected by the following invariants: ele-1
                                TypeCoding
                                Must Supporttrue
                                Standard StatusNormative (from Normative)
                                Summarytrue
                                Requirements

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

                                Pattern Value{
                                  "system" : "http://loinc.org",
                                  "code" : "26436-6"
                                }
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                94. Observation.category.coding:observation-category
                                Slice Nameobservation-category
                                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..1
                                This element is affected by the following invariants: ele-1
                                TypeCoding
                                Must Supporttrue
                                Standard StatusNormative (from Normative)
                                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" : "laboratory"
                                }
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                96. 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()))
                                98. Observation.code
                                Definition

                                A LOINC code identifying the laboratory test that was performed.

                                ShortCode
                                Comments

                                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
                                BindingThe codes SHOULD be taken from Results Laboratory Observation - IPS
                                (preferred to http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips)
                                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()))
                                100. 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.

                                ShortWho and/or what the observation is about
                                Comments

                                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.

                                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')))
                                102. 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')))
                                104. Observation.encounter
                                Definition

                                Encounter during which the laboratory test was performed.

                                ShortFall oder Kontakt
                                Comments

                                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)
                                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')))
                                106. Observation.effective[x]
                                Definition

                                The time at which the observation was made

                                ShortUntersuchungszeitpunkt
                                Comments

                                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.

                                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()))
                                mii-lab-1: Datetime must be at least to day (($this as dateTime).hasValue() implies ($this as dateTime).toString().length() >= 8)
                                108. Observation.effective[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.
                                110. Observation.effective[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
                                Standard StatusNormative (from Normative)
                                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.effective[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                • value @ url
                                • 112. Observation.effective[x].extension:QuelleKlinischesBezugsdatum
                                  Slice NameQuelleKlinischesBezugsdatum
                                  Definition

                                  Specimen collection date | Date sample received in laboratory

                                  ShortQuelle klinisches Bezugsdatum
                                  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..1
                                  This element is affected by the following invariants: ele-1
                                  TypeExtension(MII EX Labor Quelle Klinisches Bezugsdatum) (Extension Type: Coding)
                                  Must Supporttrue
                                  Standard StatusNormative (from Normative)
                                  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())
                                  114. Observation.effective[x].value
                                  Definition

                                  Primitive value for dateTime

                                  ShortPrimitive value for dateTime
                                  Control0..1
                                  TypedateTime
                                  XML FormatIn the XML format, this property is represented as an attribute.
                                  116. Observation.issued
                                  Definition

                                  The point in time when the laboratory result was documented

                                  ShortDokumentationsdatum
                                  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
                                  Must Supporttrue
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  118. Observation.performer
                                  Definition

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

                                  ShortWho is responsible for the observation
                                  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(Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson)
                                  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')))
                                  120. Observation.value[x]
                                  Definition

                                  Value of the analysis

                                  ShortMesswert
                                  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..1
                                  This element is affected by the following invariants: ele-1, obs-7
                                  TypeChoice of: Quantity, CodeableConcept, Range, Ratio
                                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                  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()))
                                  SlicingThis element introduces a set of slices on Observation.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                                  • type @ $this
                                  • 122. Observation.value[x]:valueQuantity
                                    Slice NamevalueQuantity
                                    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..1
                                    This element is affected by the following invariants: ele-1, obs-7
                                    TypeQuantity
                                    [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()))
                                    124. Observation.value[x]:valueQuantity.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.
                                    126. Observation.value[x]:valueQuantity.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
                                    Standard StatusNormative (from Normative)
                                    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.value[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                    • value @ url
                                    • 128. Observation.value[x]:valueQuantity.extension:pqTranslation
                                      Slice NamepqTranslation
                                      Definition

                                      An alternative representation of the same physical quantity expressed in a different unit from a different unit code system and possibly with a different value.

                                      ShortSame quantity with different units
                                      Comments

                                      It is not necessary for information processing entities to check and enforce that the translations are valid translations of the base unit, but they are allowed to do so, and to reject instances where the translations are not valid. NOTE Translations are allowed to contain other representations in UCUM units, but there is generally no point to this as it is possible to convert from one UCUM form to another.

                                      Control0..*
                                      This element is affected by the following invariants: ele-1
                                      TypeExtension(PQ Translation) (Extension Type: Quantity)
                                      Standard StatusDraft (from Normative)
                                      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())
                                      130. Observation.value[x]:valueQuantity.value
                                      Definition

                                      The value of the measured amount. The value includes an implicit precision in the presentation of the value.

                                      ShortNumerical value (with implicit precision)
                                      Comments

                                      The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

                                      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
                                      Requirements

                                      Precision is handled implicitly in almost all cases of measurement.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      132. Observation.value[x]:valueQuantity.value.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.value[x]:valueQuantity.value.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
                                      Standard StatusNormative (from Normative)
                                      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.value[x].value.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                      • value @ url
                                      • 136. Observation.value[x]:valueQuantity.value.extension:quantityPrecision
                                        Slice NamequantityPrecision
                                        Definition

                                        Explicit precision of the number. This is the number of significant decimal places after the decimal point, irrespective of how many are actually present in the explicitly represented decimal.

                                        ShortExplicit precision (number of significant decimal places)
                                        Comments

                                        The presence of this extension does not change conformance expectations with regard to rendering and calculations that use the number - these are still based on the raw decimal value. Applications that perform calculations SHALL ensure that this extension is removed or updated to the correct precision value if the number is changed. Applications should consider using the exponential form (e.g. 2.10e3) on the raw decimal to manage significant figures, but should be mindful of human display when doing so.

                                        Control0..1
                                        This element is affected by the following invariants: ele-1
                                        TypeExtension(Precision) (Extension Type: integer)
                                        Must Supporttrue
                                        Standard StatusDraft (from Normative)
                                        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.value[x]:valueQuantity.value.value
                                        Definition

                                        Primitive value for decimal

                                        ShortPrimitive value for decimal
                                        Control0..1
                                        Typedecimal
                                        XML FormatIn the XML format, this property is represented as an attribute.
                                        140. Observation.value[x]:valueQuantity.comparator
                                        Definition

                                        How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

                                        Short< | <= | >= | > - how to understand the value
                                        Comments

                                        Note that FHIR strings SHALL NOT exceed 1MB in size

                                        Control0..1
                                        This element is affected by the following invariants: ele-1
                                        BindingThe codes SHALL be taken from QuantityComparator
                                        (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

                                        How the Quantity should be understood and represented.

                                        Typecode
                                        Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                        Summarytrue
                                        Requirements

                                        Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

                                        Meaning if MissingIf there is no comparator, then there is no modification of the value
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        142. Observation.value[x]:valueQuantity.unit
                                        Definition

                                        A human-readable form of the unit.

                                        ShortUnit representation
                                        Comments

                                        Note that FHIR strings SHALL NOT exceed 1MB in size

                                        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
                                        Summarytrue
                                        Requirements

                                        There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

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

                                        The identification of the system that provides the coded form of the unit.

                                        ShortSystem that defines coded unit form
                                        Comments

                                        see http://en.wikipedia.org/wiki/Uniform_resource_identifier

                                        Control1..1
                                        This element is affected by the following invariants: ele-1, qty-3
                                        Typeuri
                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                        Must Supporttrue
                                        Summarytrue
                                        Requirements

                                        Need to know the system that defines the coded form of the unit.

                                        Fixed Valuehttp://unitsofmeasure.org
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        146. Observation.value[x]:valueQuantity.code
                                        Definition

                                        A computer processable form of the unit in some unit representation system.

                                        ShortCoded form of the unit
                                        Comments

                                        The mandatory system is UCUM.

                                        Control1..1
                                        This element is affected by the following invariants: ele-1
                                        Typecode
                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                        Must Supporttrue
                                        Summarytrue
                                        Requirements

                                        Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        148. Observation.value[x]:valueCodeableConcept
                                        Slice NamevalueCodeableConcept
                                        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..1
                                        This element is affected by the following invariants: ele-1, obs-7
                                        TypeCodeableConcept
                                        [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()))
                                        150. Observation.value[x]:valueCodeableConcept.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.
                                        152. Observation.value[x]:valueCodeableConcept.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
                                        Standard StatusNormative (from Normative)
                                        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.value[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                        • value @ url
                                        • 154. Observation.value[x]:valueCodeableConcept.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()))
                                          156. Observation.value[x]:valueCodeableConcept.coding.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.
                                          158. Observation.value[x]:valueCodeableConcept.coding.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
                                          Standard StatusNormative (from Normative)
                                          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.value[x].coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                          • value @ url
                                          • 160. Observation.value[x]:valueCodeableConcept.coding.system
                                            Definition

                                            The identification of the code system that defines the meaning of the symbol in the code.

                                            ShortIdentity of the terminology system
                                            Comments

                                            The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

                                            Control1..1
                                            This element is affected by the following invariants: ele-1
                                            Typeuri
                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                            Must Supporttrue
                                            Summarytrue
                                            Requirements

                                            Need to be unambiguous about the source of the definition of the symbol.

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

                                            The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                                            ShortVersion of the system - if relevant
                                            Comments

                                            Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                                            NoteThis is a business version Id, not a resource version Id (see discussion)
                                            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
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            164. Observation.value[x]:valueCodeableConcept.coding.code
                                            Definition

                                            A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                                            ShortSymbol in syntax defined by the system
                                            Comments

                                            Note that FHIR strings SHALL NOT exceed 1MB in size

                                            Control1..1
                                            This element is affected by the following invariants: ele-1
                                            Typecode
                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                            Must Supporttrue
                                            Summarytrue
                                            Requirements

                                            Need to refer to a particular code in the system.

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

                                            A representation of the meaning of the code in the system, following the rules of the system.

                                            ShortRepresentation defined by the system
                                            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
                                            Summarytrue
                                            Requirements

                                            Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

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

                                            Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                                            ShortIf this coding was chosen directly by the user
                                            Comments

                                            Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

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

                                            This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            170. Observation.value[x]:valueCodeableConcept.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()))
                                            172. Observation.value[x]:valueRange
                                            Slice NamevalueRange
                                            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..1
                                            This element is affected by the following invariants: ele-1, obs-7
                                            TypeRange
                                            [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()))
                                            174. Observation.value[x]:valueRatio
                                            Slice NamevalueRatio
                                            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..1
                                            This element is affected by the following invariants: ele-1, obs-7
                                            TypeRatio
                                            [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.dataAbsentReason
                                            Definition

                                            unknown | masked | not-applicable | error | not-performed

                                            ShortGrund für fehlende Daten
                                            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 "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 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()))
                                            178. Observation.interpretation
                                            Definition

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

                                            ShortInterpretation
                                            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
                                            Must Supporttrue
                                            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()))
                                            180. Observation.note
                                            Definition

                                            Additional information about the laboratory test as free text.

                                            ShortHinweis
                                            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
                                            Must Supporttrue
                                            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()))
                                            182. 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..0
                                            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()))
                                            184. Observation.method
                                            Definition

                                            Specific examination method, if the LOINC code for the laboratory test does not contain a method

                                            ShortUntersuchungsmethode
                                            Comments

                                            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 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()))
                                            186. Observation.specimen
                                            Definition

                                            Specimen on which the laboratory tests are performed

                                            ShortProbenmaterial
                                            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)
                                            Must Supporttrue
                                            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')))
                                            188. Observation.specimen.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.
                                            190. Observation.specimen.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
                                            Standard StatusNormative (from Normative)
                                            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.specimen.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                            • value @ url
                                            • 192. Observation.specimen.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.

                                              ShortLiteral reference, Relative, internal or absolute URL
                                              Comments

                                              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.

                                              Control0..1
                                              This element is affected by the following invariants: ele-1, ref-1
                                              Typestring
                                              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()))
                                              194. Observation.specimen.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
                                              This element is affected by the following invariants: ele-1
                                              BindingUnless not suitable, these codes SHALL be taken from ResourceType
                                              (extensible to http://hl7.org/fhir/ValueSet/resource-types)

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

                                              Typeuri
                                              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()))
                                              196. Observation.specimen.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
                                              This element is affected by the following invariants: ele-1
                                              TypeIdentifier
                                              Must Supporttrue
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              198. Observation.specimen.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
                                              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
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              200. Observation.device
                                              Definition

                                              The device used to generate the test data.

                                              ShortGerät
                                              Comments

                                              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)
                                              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')))
                                              202. Observation.referenceRange
                                              Definition

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

                                              ShortReferenzbereich
                                              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
                                              Must Supporttrue
                                              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())
                                              204. 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.
                                              206. 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
                                              Standard StatusNormative (from Normative)
                                              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
                                              • 208. 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())
                                                210. 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())
                                                212. 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())
                                                214. 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()))
                                                216. 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()))
                                                218. 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))
                                                220. 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()))
                                                222. 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')))
                                                224. 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')))
                                                226. 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.

                                                ShortComponent results
                                                Comments

                                                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
                                                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()))
                                                228. 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.
                                                230. 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
                                                Standard StatusNormative (from Normative)
                                                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
                                                • 232. 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())
                                                  234. Observation.component.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
                                                  BindingFor example codes, see LOINCCodes
                                                  (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                  Codes identifying names of simple observations.

                                                  TypeCodeableConcept
                                                  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()))
                                                  236. Observation.component.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.

                                                  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
                                                  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()))
                                                  238. 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()))
                                                  240. 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()))
                                                  242. 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.