Implementierungsleitfaden

Profil
Anmerkungen zu Must-Support Elementen

ISiKLaboruntersuchung (Observation)

ISiKLaboruntersuchung (Observation)

ISiKLaboruntersuchung

Dieses Profil ermöglicht die Abbildung von Informationen zur Laboruntersuchungen eines Patienten in ISiK Szenarien. Es dient primär als Vorlage, von der spezifische Laboruntersuchungs-Profile abgeleitet werden, kann aber grundsätzlich auch zur Repräsentation von nicht weiter ausspezifizierten Laboruntersuchungen genutzt werden.

Viele medizinischen Entscheidungen benötigen Informationen zu den Laboruntersuchungen eines Patienten. Hierzu gehören z.B. aktuelle Nierenfunktionswerte, Leberwerte, Blutbildwerte oder Hormone aus Schilddrüse. Jede dieser Untersuchungen wird durch bestimmte [[https://loinc.org/ LOINC]] oder [[http://snomed.info/sct SNOMED CT]] Codes bezeichnet. Der angegebene Wert ist durch genaue Einheitenangaben in [[http://unitsofmeasure.org UCUM]] zu konkretitiseren. Motivierender Use-Case zur Einführung dieser Profile ist die Arzneitmitteltherapiesicherheit im Krankenhaus - AMTS.

In FHIR werden Untersuchungen, bzw. Beobachtungen als Observation-Ressource repräsentiert. Zugehörige Codes und Einheiten sind den entsprechenden Valuessets zu entnehmen.

Metadaten

Canonical	https://gematik.de/fhir/isik/StructureDefinition/ISiKLaboruntersuchung
Status	active
Version	5.0.0
Basis	http://hl7.org/fhir/StructureDefinition/Observation

Inhalt

ISiKLaboruntersuchung (Observation)	I		Observation	There are no (further) constraints on this element Element id Observation Short description Measurements and simple assertions Alternate names Vital Signs, Measurement, Results, Tests Definition Measurements and simple assertions made about a patient, device or other subject. 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. Data type Observation Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.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-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-5: If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` dom-6: A resource should have narrative for robust management text.`div`.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()` Mappings rim: Entity. Role, or Act workflow: Event sct-concept: < 363787002 \|Observable entity\| v2: OBX rim: Observation[classCode=OBS, moodCode=EVN]
id	Σ	0..1	string	There are no (further) constraints on this element Element id Observation.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. 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. Data type string
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id Observation.meta Short description Metadata about the resource 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. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id Observation.implicitRules Short description A set of rules under which this content was created 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. 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. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
language		0..1	codeBinding	There are no (further) constraints on this element Element id Observation.language Short description Language of the resource content Definition The base language in which the resource is written. 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). Data type code Binding A human language. CommonLanguages (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
text		0..1	Narrative	There are no (further) constraints on this element Element id Observation.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display 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. 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. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: Act.text?
contained		0..*	Resource	There are no (further) constraints on this element Element id Observation.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources 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. 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. Data type Resource Mappings rim: N/A
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Constraints ele-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()` Mappings rim: N/A
modifierExtension	?! I	0..*	Extension	There are no (further) constraints on this element Element id Observation.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content 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). 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. 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. Data type Extension Constraints ele-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()` Mappings rim: N/A
identifier	Σ	0..*	Identifier	There are no (further) constraints on this element Element id Observation.identifier Short description Business Identifier for observation Definition A unique identifier assigned to this observation. Requirements Allows observations to be distinguished and referenced. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Event.identifier w5: FiveWs.identifier v2: OBX.21 For OBX segments from systems without OBX-21 support a combination of ORC/OBR and OBX must be negotiated between trading partners to uniquely identify the OBX segment. Depending on how V2 has been implemented each of these may be an option: 1) OBR-3 + OBX-3 + OBX-4 or 2) OBR-3 + OBR-4 + OBX-3 + OBX-4 or 2) some other way to uniquely ID the OBR/ORC + OBX-3 + OBX-4. rim: id
basedOn	Σ	0..*	Reference(CarePlan \| DeviceRequest \| ImmunizationRecommendation \| MedicationRequest \| NutritionOrder \| ServiceRequest)	There are no (further) constraints on this element Element id Observation.basedOn Short description Fulfills plan, proposal or order Alternate names Fulfills 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. Requirements Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon. Data type Reference(CarePlan \| DeviceRequest \| ImmunizationRecommendation \| MedicationRequest \| NutritionOrder \| ServiceRequest) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Event.basedOn v2: ORC rim: .inboundRelationship[typeCode=COMP].source[moodCode=EVN]
partOf	Σ	0..*	Reference(MedicationAdministration \| MedicationDispense \| MedicationStatement \| Procedure \| Immunization \| ImagingStudy)	There are no (further) constraints on this element Element id Observation.partOf Short description Part of referenced event Alternate names Container Definition A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure. Comments To link an Observation to an Encounter use `encounter`. See the Notes below for guidance on referencing another Observation. Data type Reference(MedicationAdministration \| MedicationDispense \| MedicationStatement \| Procedure \| Immunization \| ImagingStudy) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Event.partOf v2: Varies by domain rim: .outboundRelationship[typeCode=FLFS].target
status	S Σ ?!	1..1	codeBinding	Element id Observation.status Short description Status der Laboruntersuchung Definition The status of the result value. Requirements Need to track the status of individual results. Some results are finalized before the whole report is finalized. Comments Begründung MS: Der Status ist unerlässlich für die korrekte Interpretation einer Untersuchung. WICHTIGER Hinweis für Implementierer: Alle server-seitigen Implementierungen MÜSSEN in der Lage sein, die systemintern möglichen Statuswerte korrekt in FHIR abzubilden, mindestens jedoch die Werte `final` und `unknown`. Alle client-seitigen Implementierungen MÜSSEN in der Lage sein, sämtliche Status-Codes zu interpretieren und dem Anwender in angemessener Form darstellen zu können, beispielsweise durch Ausblenden/Durchstreichen von Prozeduren mit dem status `entered-in-error` und Ausgrauen von Untersuchungen, die noch nicht stattgefunden haben, o.ä. Data type code Binding Codes providing the status of an observation. ObservationStatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Event.status w5: FiveWs.status sct-concept: < 445584004 \|Report by finality status\| v2: OBX-11 rim: status Amended & Final are differentiated by whether it is the subject of a ControlAct event with a type of "revise"
category	S	1..*	CodeableConceptBindingPattern	Element id Observation.category Short description Kategorie der Laboruntersuchung Definition A code that classifies the general type of observation being made. Requirements Used for filtering what observations are retrieved and displayed. Comments Begründung MS: Ermöglicht das Filtern, Sortieren und Gruppieren von Befunden. Für Laboruntersuchungen ist die Kategorie zwingend mit dem entsprechenden Code (z. B. LOINC-Kategorie „laboratory“) zu befüllen. Data type CodeableConcept Binding Codes for high level observation categories. ObservationCategoryCodes (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Pattern { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/observation-category", "code": "laboratory" } ] } Mappings w5: FiveWs.class rim: .outboundRelationship[typeCode="COMP].target[classCode="LIST", moodCode="EVN"].code
code	S Σ	1..1	CodeableConcept	Element id Observation.code Short description Gegenstand der Untersuchung (Laborparameter) Alternate names Name Definition Describes what was observed. Sometimes this is called the observation "name". Requirements Knowing what kind of observation is being made is essential to understanding the observation. Comments Begründung MS: Der Code identifiziert, was gemessen wurde, und ist damit das zentrale Element der Observation. Ohne .code ist kein eindeutiger sowie maschinell auswertbarer klinischer Kontext dokumentiert. Data type CodeableConcept Binding Codes identifying names of simple observations. LOINCCodes (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Event.code w5: FiveWs.what[x] sct-concept: < 363787002 \|Observable entity\| OR < 386053000 \|Evaluation procedure\| v2: OBX-3 rim: code sct-attr: 116680003 \|Is a\|
id		0..1	string	There are no (further) constraints on this element Element id Observation.code.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.code.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-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()` Mappings rim: n/a
coding	S Σ	1..*	Coding	Element id Observation.code.coding Short description Kodierung des Laborparameters Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. 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. Data type Coding Sliced: Unordered, Open, by $this(Pattern) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
(All Slices)				There are no (further) constraints on this element
id		0..1	string	There are no (further) constraints on this element Element id Observation.code.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.code.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-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()` Mappings rim: n/a
system	S Σ	1..1	uri	Element id Observation.code.coding.system Short description System, aus dem der Code für den Laborparameter stammt (z. B. LOINC) Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. 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. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id Observation.code.coding.version Short description Version of the system - if relevant 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. 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. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	S Σ	1..1	code	Element id Observation.code.coding.code Short description Code des Laborparameters entsprechend dem verwendeten System 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). Requirements Need to refer to a particular code in the system. Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	S Σ	0..1	string	Element id Observation.code.coding.display Short description Anzeige-/Bezeichnungstext für den Laborparameter-Code Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id Observation.code.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). 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. 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. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
loinc	S Σ	1..*	CodingPattern	Element id Observation.code.coding:loinc Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. 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. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Pattern { "system": "http://loinc.org" } Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
text	S Σ	0..1	string	There are no (further) constraints on this element Element id Observation.code.text Short description Plain text representation of the concept 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. 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. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
subject	S Σ	1..1	Reference(Patient)	Element id Observation.subject Short description Referenz auf den Patienten 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. Requirements Observations have no value if you don't know who or what they're about. Comments Begründung MS: Die Verknüpfung zur Patientin oder zum Patienten ist zwingend notwendig für jegliche klinische Verwertbarkeit. Data type Reference(Patient) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Event.subject w5: FiveWs.subject[x] v2: PID-3 rim: participation[typeCode=RTGT] w5: FiveWs.subject
focus	Σ	0..*	Reference(Resource)	There are no (further) constraints on this element Element id Observation.focus Short description What the observation is about, when it is not about the subject of record 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. 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. Data type Reference(Resource) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.subject[x] v2: OBX-3 rim: participation[typeCode=SBJ] w5: FiveWs.subject
encounter	S Σ	0..1	Reference(Encounter)	Element id Observation.encounter Short description Referenz auf den Abteilungskontakt Alternate names Context Definition The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made. Requirements For some observations it may be important to know the link between an observation and a particular encounter. Comments Begründung MS: Dient der Einordnung in den klinischen Verlauf und ermöglicht Kontextinformationen wie Aufnahmediagnose oder behandelnde Abteilung. Data type Reference(Encounter) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Event.context w5: FiveWs.context v2: PV1 rim: inboundRelationship[typeCode=COMP].source[classCode=ENC, moodCode=EVN]
effective[x]	S Σ	0..1		Element id Observation.effective[x] Short description Zeitpunkt der Untersuchung Alternate names Occurrence Definition The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself. Requirements Knowing when an observation was deemed true is important to its relevance as well as determining trends. Comments Begründung Must Support: Das Element effective[x] ist zentral, um die Beobachtung - insbesondere bei Laborbefunden - zeitlich korrekt einzuordnen. Es stellt sicher, dass Systeme erkennen können, wann eine Untersuchung durchgeführt oder ein Zustand beobachtet wurde. Dies ist entscheidend für: die klinische Relevanz des Ergebnisses (z.B. aktueller vs. älterer Befund), Verlaufsauswertungen und Trendanalysen, zeitlich abhängige Entscheidungsunterstützung, eine valide Anzeige im zeitlichen Kontext des Patientenaufenthalts. Sliced: Unordered, Open, by $this(Type) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Event.occurrence[x] w5: FiveWs.done[x] v2: OBX-14, and/or OBX-19 after v2.4 (depends on who observation made) rim: effectiveTime
(All Slices)				There are no (further) constraints on this element
effectivePeriod			Period	There are no (further) constraints on this element Data type Period
effectiveTiming			Timing	There are no (further) constraints on this element Data type Timing
effectiveInstant			instant	There are no (further) constraints on this element Data type instant
effectiveDateTime	S Σ	0..1	dateTime	Element id Observation.effective[x]:effectiveDateTime Short description Clinically relevant time/time-period for observation Alternate names Occurrence Definition The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself. Requirements Knowing when an observation was deemed true is important to its relevance as well as determining trends. 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. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Event.occurrence[x] w5: FiveWs.done[x] v2: OBX-14, and/or OBX-19 after v2.4 (depends on who observation made) rim: effectiveTime
issued	S Σ	0..1	instant	Element id Observation.issued Short description Zeitpunkt der Verfügbarkeit des Untersuchungsergebnisses Definition The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified. Comments Begründung MS: Relevant zur Nachvollziehbarkeit und Validierung von Befunden, z.B. wann eine Entscheidung darauf basierte. Data type instant Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.recorded v2: OBR.22 (or MSH.7), or perhaps OBX-19 (depends on who observation made) rim: participation[typeCode=AUT].time
performer	Σ	0..*	Reference(Practitioner \| PractitionerRole \| Organization \| CareTeam \| Patient \| RelatedPerson)	There are no (further) constraints on this element Element id Observation.performer Short description Who is responsible for the observation Definition Who was responsible for asserting the observed value as "true". Requirements May give a degree of confidence in the observation and also indicates where follow-up questions should be directed. Data type Reference(Practitioner \| PractitionerRole \| Organization \| CareTeam \| Patient \| RelatedPerson) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Event.performer.actor w5: FiveWs.actor v2: OBX.15 / (Practitioner) OBX-16, PRT-5:PRT-4='RO' / (Device) OBX-18 , PRT-10:PRT-4='EQUIP' / (Organization) OBX-23, PRT-8:PRT-4='PO' rim: participation[typeCode=PRF]
value[x]	S Σ I	0..1		Element id Observation.value[x] Short description Festgestellter (Mess)Wert für den Laborparameter Definition The information determined as a result of making the observation, if the information has a simple value. 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. Comments Begründung MS: Der gemessene Wert stellt die zentrale Aussage der Observation dar. Ohne value besitzt die Observation keine medizinische Relevanz. Sliced: Unordered, Open, by $this(Type) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings sct-concept: < 441742003 \|Evaluation finding\| v2: OBX.2, OBX.5, OBX.6 rim: value sct-attr: 363714003 \|Interprets\|
(All Slices)				There are no (further) constraints on this element
valueCodeableConcept			CodeableConcept	There are no (further) constraints on this element Data type CodeableConcept
valueString			string	There are no (further) constraints on this element Data type string
valueBoolean			boolean	There are no (further) constraints on this element Data type boolean
valueInteger			integer	There are no (further) constraints on this element Data type integer
valueRange			Range	There are no (further) constraints on this element Data type Range
valueRatio			Ratio	There are no (further) constraints on this element Data type Ratio
valueSampledData			SampledData	There are no (further) constraints on this element Data type SampledData
valueTime			time	There are no (further) constraints on this element Data type time
valueDateTime			dateTime	There are no (further) constraints on this element Data type dateTime
valuePeriod			Period	There are no (further) constraints on this element Data type Period
valueQuantity	S Σ I	0..1	Quantity	Element id Observation.value[x]:valueQuantity Short description Messwert in quantitativer Form Definition The information determined as a result of making the observation, if the information has a simple value. 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. Comments Begründung MS: Standardisierte, codierte Einheiten sind für Vergleichbarkeit, Umrechnung und automatische Plausibilisierung erforderlich. Data type Quantity Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings sct-concept: < 441742003 \|Evaluation finding\| v2: OBX.2, OBX.5, OBX.6 rim: value sct-attr: 363714003 \|Interprets\|
id		0..1	string	There are no (further) constraints on this element Element id Observation.value[x]:valueQuantity.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.value[x]:valueQuantity.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-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()` Mappings rim: n/a
value	S Σ	1..1	decimal	Element id Observation.value[x]:valueQuantity.value Short description Der numerische Messwert Definition The value of the measured amount. The value includes an implicit precision in the presentation of the value. Requirements Precision is handled implicitly in almost all cases of measurement. 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). Data type decimal Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: SN.2 / CQ - N/A rim: PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
comparator	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element id Observation.value[x]:valueQuantity.comparator Short description < \| <= \| >= \| > - how to understand the value 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. Requirements Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology. Meaning when missing If there is no comparator, then there is no modification of the value Data type code Binding How the Quantity should be understood and represented. QuantityComparator (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: SN.1 / CQ.1 rim: IVL properties
unit	S Σ	0..1	string	Element id Observation.value[x]:valueQuantity.unit Short description Einheit des Messwertes (z. B. mg/dL) Definition A human-readable form of the unit. Requirements There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: (see OBX.6 etc.) / CQ.2 rim: PQ.unit
system	S Σ I	1..1	uriPattern	Element id Observation.value[x]:valueQuantity.system Short description Kodiersystem für die Einheit (UCUM) Definition The identification of the system that provides the coded form of the unit. Requirements Need to know the system that defines the coded form of the unit. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Pattern http://unitsofmeasure.org Mappings v2: (see OBX.6 etc.) / CQ.2 rim: CO.codeSystem, PQ.translation.codeSystem
code	S Σ	1..1	code	Element id Observation.value[x]:valueQuantity.code Short description UCUM-Code der Einheit Definition A computer processable form of the unit in some unit representation system. 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. Comments 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. Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: (see OBX.6 etc.) / CQ.2 rim: PQ.code, MO.currency, PQ.translation.code
dataAbsentReason	S I	0..1	CodeableConceptBinding	Element id Observation.dataAbsentReason Short description Angabe eines Grundes weshalb kein Ergebniss der Laboruntersuchung vorliegt Definition Provides a reason why the expected value in the element Observation.value[x] is missing. Requirements For many results it is necessary to handle exceptional values in measurements. Comments Begründung Must Support: Nicht alle geplanten oder dokumentierten Untersuchungen liefern auch tatsächlich ein Ergebnis. In solchen Fällen ist es wichtig, nicht nur auf das Fehlen eines Wertes zu reagieren, sondern den Grund strukturiert anzugeben. dataAbsentReason ermöglicht diese präzise Aussage und verhindert Fehlinterpretationen Data type CodeableConcept Binding Codes specifying why the result (`Observation.value[x]`) is missing. DataAbsentReason (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: value.nullFlavor
interpretation	S	0..*	CodeableConceptBinding	Element id Observation.interpretation Short description Interpretation oder Bewertung des Messergebnisses (z.B. „hoch“, „niedrig“, „normal“) Alternate names Abnormal Flag Definition A categorical assessment of an observation value. For example, high, low, normal. Requirements For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. Comments Begründung MS: Unterstützt die klinische Interpretation, insbesondere bei komplexen Parametern und automatisierten Auswertungen. Data type CodeableConcept Binding Codes identifying interpretations of observations. ObservationInterpretationCodes (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings sct-concept: < 260245000 \|Findings values\| v2: OBX-8 rim: interpretationCode sct-attr: 363713009 \|Has interpretation\|
note	S	0..*	Annotation	Element id Observation.note Short description Freitextnotiz oder Kommentar zur Beobachtung (z. B. Hinweise des Labors) Definition Comments about the observation or the results. Requirements Need to be able to provide free text additional information. Comments Begründung MS: Dient zur Dokumentation abweichender Umstände, Freitextbefundung oder ergänzender Laborkommentare. Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: NTE.3 (partner NTE to OBX, or sometimes another (child?) OBX) rim: subjectOf.observationEvent[code="annotation"].value
bodySite		0..1	CodeableConcept	There are no (further) constraints on this element Element id Observation.bodySite Short description Observed body part Definition Indicates the site on the subject's body where the observation was made (i.e. the target site). 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. Data type CodeableConcept Binding Codes describing anatomical locations. May include laterality. SNOMEDCTBodyStructures (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings sct-concept: < 123037004 \|Body structure\| v2: OBX-20 rim: targetSiteCode sct-attr: 718497002 \|Inherent location\|
method	S	0..1	CodeableConcept	Element id Observation.method Short description How it was done Definition Indicates the mechanism used to perform the observation. Requirements In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results. Comments Einschränkung der übergreifenden MS-Definition: Verfügt ein bestätigungsrelevantes System nicht über die Datenstruktur zur Hinterlegung der zugrundeliegenden Methode, so MUSS dieses System die Information NICHT abbilden. Motivation zum eingeschränkten MS: Die Untersuchungsmethode einer Laboruntersuchung ist eine relevante medizinische Information: Unterschiedliche Methoden können unterschiedliche Resultate liefern. Die Methode ist daher für Transparenz und Vergleichbarkeit entscheidend. Da diese Information aktuell häufig nicht übergeben wird, wird das MS eingeschränkt. Es ist dennoch wünschenswert, dass die Probe in der Zukunft übergeben wird. Data type CodeableConcept Binding Methods for simple observations. ObservationMethods (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: OBX-17 rim: methodCode
specimen	S	0..1	Reference(Specimen)	Element id Observation.specimen Short description Specimen used for this observation Definition The specimen that was used when this observation was made. Comments Einschränkung der übergreifenden MS-Definition: Verfügt ein bestätigungsrelevantes System nicht über die Datenstruktur zur Hinterlegung der Laboruntersuchung zugrundeliegenden Probe, so MUSS dieses System die Information NICHT abbilden. Motivation zum eingeschränkten MS: Die Probe (z. B. Serum, Urin) ist zentral für die korrekte Bewertung des Ergebnisses. Die Unterscheidung von Materialtypen ist oft diagnostisch ausschlaggebend. Da die Information aktuell jedoch häufig nicht übergeben wird, wird das MS eingeschränkt. Es ist dennoch wünschenswert, dass die Probe in der Zukunft übergeben wird Data type Reference(Specimen) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings sct-concept: < 123038009 \|Specimen\| v2: SPM segment rim: participation[typeCode=SPC].specimen sct-attr: 704319004 \|Inherent in\|
id		0..1	string	There are no (further) constraints on this element Element id Observation.specimen.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.specimen.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-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()` Mappings rim: n/a
reference	S Σ I	0..1	string	There are no (further) constraints on this element Element id Observation.specimen.reference Short description Literal reference, Relative, internal or absolute URL 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. 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. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A
type	Σ	0..1	uriBinding	There are no (further) constraints on this element Element id Observation.specimen.type Short description Type the reference refers to (e.g. "Patient") 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). 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. Data type uri Binding Aa resource (or, for logical models, the URI of the logical model). ResourceType (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A
identifier	S Σ	0..1	Identifier	There are no (further) constraints on this element Element id Observation.specimen.identifier Short description Logical reference, when literal reference is not known 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. 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). Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: .identifier
id		0..1	string	There are no (further) constraints on this element Element id Observation.specimen.identifier.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.specimen.identifier.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-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()` Mappings rim: n/a
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element id Observation.specimen.identifier.use Short description usual \| official \| temp \| secondary \| old (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data type code Binding Identifies the purpose for this identifier, if known . IdentifierUse (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: Role.code or implied by context
type	Σ	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id Observation.specimen.identifier.type Short description Description of identifier Definition A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Requirements Allows users to make use of identifiers when the identifier system is not known. 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. Data type CodeableConcept Binding A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Identifier Type Codes (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.5 rim: Role.code or implied by context
system	S Σ	1..1	uri	There are no (further) constraints on this element Element id Observation.specimen.identifier.system Short description The namespace for the identifier value Definition Establishes the namespace for the value - that is, a URL that describes a set values that are unique. 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. Comments Identifier.system is always case sensitive. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General http://www.acme.com/identifiers/patient Mappings v2: CX.4 / EI-2-4 rim: II.root or Role.id.root servd: ./IdentifierType
value	S Σ	1..1	string	There are no (further) constraints on this element Element id Observation.specimen.identifier.value Short description The value that is unique Definition The portion of the identifier typically relevant to the user and which is unique within the context of the system. 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. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General 123456 Mappings v2: CX.1 / EI.1 rim: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) servd: ./Value
period	Σ	0..1	Period	There are no (further) constraints on this element Element id Observation.specimen.identifier.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.7 + CX.8 rim: Role.effectiveTime or implied by context servd: ./StartDate and ./EndDate
assigner	Σ	0..1	Reference(Organization)	There are no (further) constraints on this element Element id Observation.specimen.identifier.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. 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. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.4 / (CX.4,CX.9,CX.10) rim: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper servd: ./IdentifierIssuingAuthority
display	Σ	0..1	string	There are no (further) constraints on this element Element id Observation.specimen.display Short description Text alternative for the resource Definition Plain text narrative that identifies the resource in addition to the resource reference. 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. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A
device	S	0..1	Reference(Device \| DeviceMetric)	Element id Observation.device Short description Verwendetes Gerät oder Instrument zur Durchführung der Untersuchung Definition The device used to generate the observation data. Comments Begründung Must Support: Das verwendete Mess- oder Analysegerät kann einen entscheidenden Einfluss auf die Genauigkeit, Validität und Vergleichbarkeit von Untersuchungsergebnissen haben. Data type Reference(Device \| DeviceMetric) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings sct-concept: < 49062001 \|Device\| v2: OBX-17 / PRT -10 rim: participation[typeCode=DEV] sct-attr: 424226004 \|Using device\|
referenceRange	S I	0..*	BackboneElement	Element id Observation.referenceRange Short description Referenzbereich zur Interpretation des Messergebnisses (z. B. Normalwerte) Definition Guidance on how to interpret the value by comparison to a normal or recommended range. Multiple reference ranges are interpreted as an "OR". In other words, to represent two distinct target populations, two `referenceRange` elements would be used. 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. Comments Begründung MS: Referenzbereiche erlauben die sofortige klinische Bewertung eines Wertes Data type BackboneElement Constraints ele-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()` Mappings v2: OBX.7 rim: outboundRelationship[typeCode=REFV]/target[classCode=OBS, moodCode=EVN]
id		0..1	string	There are no (further) constraints on this element Element id Observation.referenceRange.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.referenceRange.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Constraints ele-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()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Observation.referenceRange.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers 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). 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. 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. Data type Extension Constraints ele-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()` Mappings rim: N/A
low	S I	0..1	SimpleQuantity	Element id Observation.referenceRange.low Short description Untergrenze des Referenzbereichs 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). Data type SimpleQuantity Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: OBX-7 rim: value:IVL_PQ.low
id		0..1	string	There are no (further) constraints on this element Element id Observation.referenceRange.low.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.referenceRange.low.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-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()` Mappings rim: n/a
value	S Σ	1..1	decimal	There are no (further) constraints on this element Element id Observation.referenceRange.low.value Short description Numerical value (with implicit precision) Definition The value of the measured amount. The value includes an implicit precision in the presentation of the value. Requirements Precision is handled implicitly in almost all cases of measurement. 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). Data type decimal Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: SN.2 / CQ - N/A rim: PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
comparator	Σ ?!	0..0	codeBinding	There are no (further) constraints on this element Element id Observation.referenceRange.low.comparator Short description < \| <= \| >= \| > - how to understand the value Definition Not allowed to be used in this context Requirements Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology. Meaning when missing If there is no comparator, then there is no modification of the value Data type code Binding How the Quantity should be understood and represented. QuantityComparator (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: SN.1 / CQ.1 rim: IVL properties
unit	S Σ	0..1	string	There are no (further) constraints on this element Element id Observation.referenceRange.low.unit Short description Unit representation Definition A human-readable form of the unit. Requirements There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: (see OBX.6 etc.) / CQ.2 rim: PQ.unit
system	S Σ I	1..1	uriPattern	Element id Observation.referenceRange.low.system Short description System that defines coded unit form Definition The identification of the system that provides the coded form of the unit. Requirements Need to know the system that defines the coded form of the unit. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Pattern http://unitsofmeasure.org Mappings v2: (see OBX.6 etc.) / CQ.2 rim: CO.codeSystem, PQ.translation.codeSystem
code	S Σ	1..1	code	There are no (further) constraints on this element Element id Observation.referenceRange.low.code Short description Coded form of the unit Definition A computer processable form of the unit in some unit representation system. 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. Comments 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. Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: (see OBX.6 etc.) / CQ.2 rim: PQ.code, MO.currency, PQ.translation.code
high	S I	0..1	SimpleQuantity	Element id Observation.referenceRange.high Short description Obergrenze des Referenzbereichs 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). Data type SimpleQuantity Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: OBX-7 rim: value:IVL_PQ.high
id		0..1	string	There are no (further) constraints on this element Element id Observation.referenceRange.high.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.referenceRange.high.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-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()` Mappings rim: n/a
value	S Σ	1..1	decimal	There are no (further) constraints on this element Element id Observation.referenceRange.high.value Short description Numerical value (with implicit precision) Definition The value of the measured amount. The value includes an implicit precision in the presentation of the value. Requirements Precision is handled implicitly in almost all cases of measurement. 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). Data type decimal Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: SN.2 / CQ - N/A rim: PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
comparator	Σ ?!	0..0	codeBinding	There are no (further) constraints on this element Element id Observation.referenceRange.high.comparator Short description < \| <= \| >= \| > - how to understand the value Definition Not allowed to be used in this context Requirements Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology. Meaning when missing If there is no comparator, then there is no modification of the value Data type code Binding How the Quantity should be understood and represented. QuantityComparator (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: SN.1 / CQ.1 rim: IVL properties
unit	S Σ	0..1	string	There are no (further) constraints on this element Element id Observation.referenceRange.high.unit Short description Unit representation Definition A human-readable form of the unit. Requirements There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: (see OBX.6 etc.) / CQ.2 rim: PQ.unit
system	S Σ I	1..1	uriPattern	Element id Observation.referenceRange.high.system Short description System that defines coded unit form Definition The identification of the system that provides the coded form of the unit. Requirements Need to know the system that defines the coded form of the unit. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Pattern http://unitsofmeasure.org Mappings v2: (see OBX.6 etc.) / CQ.2 rim: CO.codeSystem, PQ.translation.codeSystem
code	S Σ	1..1	code	There are no (further) constraints on this element Element id Observation.referenceRange.high.code Short description Coded form of the unit Definition A computer processable form of the unit in some unit representation system. 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. Comments 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. Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: (see OBX.6 etc.) / CQ.2 rim: PQ.code, MO.currency, PQ.translation.code
type	S	0..1	CodeableConceptBinding	Element id Observation.referenceRange.type Short description Art des Referenzbereichs (z. B. normal, kritisch) Definition Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range. Requirements Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation. Comments This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed. Data type CodeableConcept Binding Code for the meaning of a reference range. ObservationReferenceRangeMeaningCodes (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings sct-concept: < 260245000 \|Findings values\| OR < 365860008 \|General clinical state finding\| OR < 250171008 \|Clinical history or observation findings\| OR < 415229000 \|Racial group\| OR < 365400002 \|Finding of puberty stage\| OR < 443938003 \|Procedure carried out on subject\| v2: OBX-10 rim: interpretationCode
id		0..1	string	There are no (further) constraints on this element Element id Observation.referenceRange.type.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.referenceRange.type.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-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()` Mappings rim: n/a
coding	S Σ	0..*	Coding	There are no (further) constraints on this element Element id Observation.referenceRange.type.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. 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. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id Observation.referenceRange.type.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.referenceRange.type.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-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()` Mappings rim: n/a
system	S Σ	1..1	uri	There are no (further) constraints on this element Element id Observation.referenceRange.type.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. 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. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id Observation.referenceRange.type.coding.version Short description Version of the system - if relevant 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. 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. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	S Σ	1..1	code	There are no (further) constraints on this element Element id Observation.referenceRange.type.coding.code Short description Symbol in syntax defined by the system 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). Requirements Need to refer to a particular code in the system. Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	S Σ	0..1	string	There are no (further) constraints on this element Element id Observation.referenceRange.type.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id Observation.referenceRange.type.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). 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. 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. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	S Σ	0..1	string	There are no (further) constraints on this element Element id Observation.referenceRange.type.text Short description Plain text representation of the concept 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. 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. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
appliesTo	S	0..*	CodeableConcept	Element id Observation.referenceRange.appliesTo Short description Für wen der Referenzbereich gilt (z. B. Geschlecht, Alter) 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. Requirements Need to be able to identify the target population for proper interpretation. Comments This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed. Data type CodeableConcept Binding Codes identifying the population the reference range applies to. ObservationReferenceRangeAppliesToCodes (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings sct-concept: < 260245000 \|Findings values\| OR < 365860008 \|General clinical state finding\| OR < 250171008 \|Clinical history or observation findings\| OR < 415229000 \|Racial group\| OR < 365400002 \|Finding of puberty stage\| OR < 443938003 \|Procedure carried out on subject\| v2: OBX-10 rim: interpretationCode
id		0..1	string	There are no (further) constraints on this element Element id Observation.referenceRange.appliesTo.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.referenceRange.appliesTo.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-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()` Mappings rim: n/a
coding	S Σ	0..*	Coding	Element id Observation.referenceRange.appliesTo.coding Short description Kodierte Angabe zur Zielgruppe Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. 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. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id Observation.referenceRange.appliesTo.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.referenceRange.appliesTo.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-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()` Mappings rim: n/a
system	S Σ	1..1	uri	There are no (further) constraints on this element Element id Observation.referenceRange.appliesTo.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. 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. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id Observation.referenceRange.appliesTo.coding.version Short description Version of the system - if relevant 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. 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. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	S Σ	1..1	code	There are no (further) constraints on this element Element id Observation.referenceRange.appliesTo.coding.code Short description Symbol in syntax defined by the system 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). Requirements Need to refer to a particular code in the system. Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	S Σ	0..1	string	There are no (further) constraints on this element Element id Observation.referenceRange.appliesTo.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id Observation.referenceRange.appliesTo.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). 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. 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. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	S Σ	0..1	string	There are no (further) constraints on this element Element id Observation.referenceRange.appliesTo.text Short description Plain text representation of the concept 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. 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. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
age	S	0..1	Range	Element id Observation.referenceRange.age Short description Altersbereich, für den der Referenzbereich gilt 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. Requirements Some analytes vary greatly over age. Data type Range Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: outboundRelationship[typeCode=PRCN].targetObservationCriterion[code="age"].value
id		0..1	string	There are no (further) constraints on this element Element id Observation.referenceRange.age.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.referenceRange.age.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-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()` Mappings rim: n/a
low	S Σ	0..1	SimpleQuantity	There are no (further) constraints on this element Element id Observation.referenceRange.age.low Short description Low limit Definition The low limit. The boundary is inclusive. Comments If the low element is missing, the low boundary is not known. Data type SimpleQuantity Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: NR.1 rim: ./low
high	S Σ	0..1	SimpleQuantity	There are no (further) constraints on this element Element id Observation.referenceRange.age.high Short description High limit Definition The high limit. The boundary is inclusive. Comments If the high element is missing, the high boundary is not known. Data type SimpleQuantity Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: NR.2 rim: ./high
text	S	0..1	string	Element id Observation.referenceRange.text Short description Freitextbeschreibung des Referenzbereichs 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". Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: OBX-7 rim: value:ST
hasMember	Σ	0..*	Reference(Observation \| QuestionnaireResponse \| MolecularSequence)	There are no (further) constraints on this element Element id Observation.hasMember Short description Related resource that belongs to the Observation group 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. 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. Data type Reference(Observation \| QuestionnaireResponse \| MolecularSequence) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: Relationships established by OBX-4 usage rim: outBoundRelationship
derivedFrom	Σ	0..*	Reference(DocumentReference \| ImagingStudy \| Media \| QuestionnaireResponse \| Observation \| MolecularSequence)	There are no (further) constraints on this element Element id Observation.derivedFrom Short description Related measurements the observation is made from 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. 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. Data type Reference(DocumentReference \| ImagingStudy \| Media \| QuestionnaireResponse \| Observation \| MolecularSequence) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: Relationships established by OBX-4 usage rim: .targetObservation
component	Σ	0..*	BackboneElement	There are no (further) constraints on this element Element id Observation.component Short description Component results 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. 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. Comments For a discussion on the ways Observations can be assembled in groups together see Notes below. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: containment by OBX-4? rim: outBoundRelationship[typeCode=COMP]
id		0..1	string	There are no (further) constraints on this element Element id Observation.component.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.component.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Constraints ele-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()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Observation.component.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers 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). 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. 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. Data type Extension Constraints ele-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()` Mappings rim: N/A
code	Σ	1..1	CodeableConcept	There are no (further) constraints on this element Element id Observation.component.code Short description Type of component observation (code / type) Definition Describes what was observed. Sometimes this is called the observation "code". Requirements Knowing what kind of observation is being made is essential to understanding the observation. Comments All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation. Data type CodeableConcept Binding Codes identifying names of simple observations. LOINCCodes (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.what[x] sct-concept: < 363787002 \|Observable entity\| OR < 386053000 \|Evaluation procedure\| v2: OBX-3 rim: code
value[x]	Σ	0..1		There are no (further) constraints on this element Element id Observation.component.value[x] Short description Actual component result Definition The information determined as a result of making the observation, if the information has a simple value. 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. 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. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings sct-concept: 363714003 \|Interprets\| < 441742003 \|Evaluation finding\| v2: OBX.2, OBX.5, OBX.6 rim: value sct-attr: 363714003 \|Interprets\|
valueQuantity			Quantity	There are no (further) constraints on this element Data type Quantity
valueCodeableConcept			CodeableConcept	There are no (further) constraints on this element Data type CodeableConcept
valueString			string	There are no (further) constraints on this element Data type string
valueBoolean			boolean	There are no (further) constraints on this element Data type boolean
valueInteger			integer	There are no (further) constraints on this element Data type integer
valueRange			Range	There are no (further) constraints on this element Data type Range
valueRatio			Ratio	There are no (further) constraints on this element Data type Ratio
valueSampledData			SampledData	There are no (further) constraints on this element Data type SampledData
valueTime			time	There are no (further) constraints on this element Data type time
valueDateTime			dateTime	There are no (further) constraints on this element Data type dateTime
valuePeriod			Period	There are no (further) constraints on this element Data type Period
dataAbsentReason	I	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id Observation.component.dataAbsentReason Short description Why the component result is missing Definition Provides a reason why the expected value in the element Observation.component.value[x] is missing. Requirements For many results it is necessary to handle exceptional values in measurements. 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. Data type CodeableConcept Binding Codes specifying why the result (`Observation.value[x]`) is missing. DataAbsentReason (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: value.nullFlavor
interpretation		0..*	CodeableConceptBinding	There are no (further) constraints on this element Element id Observation.component.interpretation Short description High, low, normal, etc. Alternate names Abnormal Flag Definition A categorical assessment of an observation value. For example, high, low, normal. Requirements For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. 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. Data type CodeableConcept Binding Codes identifying interpretations of observations. ObservationInterpretationCodes (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings sct-concept: < 260245000 \|Findings values\| v2: OBX-8 rim: interpretationCode sct-attr: 363713009 \|Has interpretation\|
referenceRange		0..*	see (referenceRange)	There are no (further) constraints on this element Element id Observation.component.referenceRange Short description Provides guide for interpretation of component result Definition Guidance on how to interpret the value by comparison to a normal or recommended range. 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. 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. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: OBX.7 rim: outboundRelationship[typeCode=REFV]/target[classCode=OBS, moodCode=EVN]

<StructureDefinition xmlns="http://hl7.org/fhir">
    <id value="ISiKLaboruntersuchung" />
    <url value="https://gematik.de/fhir/isik/StructureDefinition/ISiKLaboruntersuchung" />
    <version value="5.0.0" />
    <name value="ISiKLaboruntersuchung" />
    <status value="active" />
    <experimental value="false" />
    <date value="2025-06-26" />
    <publisher value="gematik GmbH" />
    <description value="Dieses Profil erm&#246;glicht die Abbildung von Informationen zur Laboruntersuchungen eines Patienten in ISiK Szenarien. Es dient prim&#228;r als Vorlage, von der spezifische Laboruntersuchungs-Profile abgeleitet werden, kann aber grunds&#228;tzlich auch zur Repr&#228;sentation von nicht weiter ausspezifizierten Laboruntersuchungen genutzt werden.\n\nViele medizinischen Entscheidungen ben&#246;tigen Informationen zu den Laboruntersuchungen eines Patienten. Hierzu geh&#246;ren z.B. aktuelle Nierenfunktionswerte, Leberwerte, Blutbildwerte oder Hormone aus Schilddr&#252;se.\nJede dieser Untersuchungen wird durch bestimmte [[https://loinc.org/ LOINC]] oder [[http://snomed.info/sct SNOMED CT]] Codes bezeichnet. Der angegebene Wert ist durch genaue Einheitenangaben in [[http://unitsofmeasure.org UCUM]] zu konkretitiseren.\nMotivierender Use-Case zur Einf&#252;hrung dieser Profile ist die [Arzneitmitteltherapiesicherheit im Krankenhaus - AMTS](https://simplifier.net/guide/isik-medikation-v4/ImplementationGuide-markdown-UseCases-AMTS?version=current).\n\nIn FHIR werden Untersuchungen, bzw. Beobachtungen als [`Observation`](https://hl7.org/fhir/R4/observation.html)-Ressource repr&#228;sentiert. Zugeh&#246;rige Codes und Einheiten sind den entsprechenden Valuessets zu entnehmen." />
    <fhirVersion value="4.0.1" />
    <kind value="resource" />
    <abstract value="false" />
    <type value="Observation" />
    <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Observation" />
    <derivation value="constraint" />
    <differential>
        <element id="Observation.status">
            <path value="Observation.status" />
            <short value="Status der Laboruntersuchung" />
            <comment value="**Begr&#252;ndung MS**: Der Status ist unerl&#228;sslich f&#252;r die korrekte Interpretation einer Untersuchung. **WICHTIGER Hinweis f&#252;r Implementierer**:  \n  * Alle server-seitigen Implementierungen M&#220;SSEN in der Lage sein, \n  die systemintern m&#246;glichen Statuswerte korrekt in FHIR abzubilden, mindestens jedoch die Werte `final` und `unknown`.\n  * Alle client-seitigen Implementierungen M&#220;SSEN in der Lage sein, s&#228;mtliche Status-Codes zu interpretieren und dem Anwender in angemessener Form darstellen zu k&#246;nnen, \n  beispielsweise durch Ausblenden/Durchstreichen von Prozeduren mit dem status `entered-in-error` und Ausgrauen von Untersuchungen, die noch nicht stattgefunden haben, o.&#228;." />
            <mustSupport value="true" />
        </element>
        <element id="Observation.category">
            <path value="Observation.category" />
            <short value="Kategorie der Laboruntersuchung" />
            <comment value="**Begr&#252;ndung MS**: Erm&#246;glicht das Filtern, Sortieren und Gruppieren von Befunden. F&#252;r Laboruntersuchungen ist die Kategorie zwingend mit dem entsprechenden Code (z. B. LOINC-Kategorie „laboratory“) zu bef&#252;llen." />
            <min value="1" />
            <patternCodeableConcept>
                <coding>
                    <system value="http://terminology.hl7.org/CodeSystem/observation-category" />
                    <code value="laboratory" />
                </coding>
            </patternCodeableConcept>
            <mustSupport value="true" />
        </element>
        <element id="Observation.code">
            <path value="Observation.code" />
            <short value="Gegenstand der Untersuchung (Laborparameter)" />
            <comment value="**Begr&#252;ndung MS**: Der Code identifiziert, was gemessen wurde, und ist damit das zentrale Element der Observation. Ohne .code ist kein eindeutiger sowie maschinell auswertbarer klinischer Kontext  dokumentiert." />
            <mustSupport value="true" />
        </element>
        <element id="Observation.code.coding">
            <path value="Observation.code.coding" />
            <slicing>
                <discriminator>
                    <type value="pattern" />
                    <path value="$this" />
                </discriminator>
                <rules value="open" />
            </slicing>
            <short value="Kodierung des Laborparameters" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.code.coding.system">
            <path value="Observation.code.coding.system" />
            <short value="System, aus dem der Code f&#252;r den Laborparameter stammt (z. B. LOINC)" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.code.coding.code">
            <path value="Observation.code.coding.code" />
            <short value="Code des Laborparameters entsprechend dem verwendeten System" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.code.coding.display">
            <path value="Observation.code.coding.display" />
            <short value="Anzeige-/Bezeichnungstext f&#252;r den Laborparameter-Code" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.code.coding:loinc">
            <path value="Observation.code.coding" />
            <sliceName value="loinc" />
            <min value="1" />
            <max value="*" />
            <patternCoding>
                <system value="http://loinc.org" />
            </patternCoding>
            <mustSupport value="true" />
        </element>
        <element id="Observation.code.text">
            <path value="Observation.code.text" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.subject">
            <path value="Observation.subject" />
            <short value="Referenz auf den Patienten" />
            <comment value="**Begr&#252;ndung MS**: Die Verkn&#252;pfung zur Patientin oder zum Patienten ist zwingend notwendig f&#252;r jegliche klinische Verwertbarkeit." />
            <min value="1" />
            <type>
                <code value="Reference" />
                <targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient" />
            </type>
            <mustSupport value="true" />
        </element>
        <element id="Observation.encounter">
            <path value="Observation.encounter" />
            <short value="Referenz auf den Abteilungskontakt" />
            <comment value="**Begr&#252;ndung MS**: Dient der Einordnung in den klinischen Verlauf und erm&#246;glicht Kontextinformationen wie Aufnahmediagnose oder behandelnde Abteilung." />
            <mustSupport value="true" />
        </element>
        <element id="Observation.effective[x]">
            <path value="Observation.effective[x]" />
            <slicing>
                <discriminator>
                    <type value="type" />
                    <path value="$this" />
                </discriminator>
                <ordered value="false" />
                <rules value="open" />
            </slicing>
            <short value="Zeitpunkt der Untersuchung" />
            <comment value="**Begr&#252;ndung Must Support**:\nDas Element effective[x] ist zentral, um die Beobachtung - insbesondere bei Laborbefunden - zeitlich korrekt einzuordnen. Es stellt sicher, dass Systeme erkennen k&#246;nnen, wann eine Untersuchung durchgef&#252;hrt oder ein Zustand beobachtet wurde. Dies ist entscheidend f&#252;r:\n\n* die klinische Relevanz des Ergebnisses (z.B. aktueller vs. &#228;lterer Befund),\n* Verlaufsauswertungen und Trendanalysen,\n* zeitlich abh&#228;ngige Entscheidungsunterst&#252;tzung,\n* eine valide Anzeige im zeitlichen Kontext des Patientenaufenthalts." />
            <mustSupport value="true" />
        </element>
        <element id="Observation.effective[x]:effectiveDateTime">
            <path value="Observation.effective[x]" />
            <sliceName value="effectiveDateTime" />
            <min value="0" />
            <max value="1" />
            <type>
                <code value="dateTime" />
            </type>
            <mustSupport value="true" />
        </element>
        <element id="Observation.issued">
            <path value="Observation.issued" />
            <short value="Zeitpunkt der Verf&#252;gbarkeit des Untersuchungsergebnisses" />
            <comment value="**Begr&#252;ndung MS**: Relevant zur Nachvollziehbarkeit und Validierung von Befunden, z.B. wann eine Entscheidung darauf basierte." />
            <mustSupport value="true" />
        </element>
        <element id="Observation.value[x]">
            <path value="Observation.value[x]" />
            <slicing>
                <discriminator>
                    <type value="type" />
                    <path value="$this" />
                </discriminator>
                <ordered value="false" />
                <rules value="open" />
            </slicing>
            <short value="Festgestellter (Mess)Wert f&#252;r den Laborparameter" />
            <comment value="**Begr&#252;ndung MS**: Der gemessene Wert stellt die zentrale Aussage der Observation dar. Ohne value besitzt die Observation keine medizinische Relevanz." />
            <mustSupport value="true" />
        </element>
        <element id="Observation.value[x]:valueQuantity">
            <path value="Observation.value[x]" />
            <sliceName value="valueQuantity" />
            <short value="Messwert in quantitativer Form" />
            <comment value="**Begr&#252;ndung MS**: Standardisierte, codierte Einheiten sind f&#252;r Vergleichbarkeit, Umrechnung und automatische Plausibilisierung erforderlich." />
            <min value="0" />
            <max value="1" />
            <type>
                <code value="Quantity" />
            </type>
            <mustSupport value="true" />
        </element>
        <element id="Observation.value[x]:valueQuantity.value">
            <path value="Observation.value[x].value" />
            <short value="Der numerische Messwert" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.value[x]:valueQuantity.unit">
            <path value="Observation.value[x].unit" />
            <short value="Einheit des Messwertes (z. B. mg/dL)" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.value[x]:valueQuantity.system">
            <path value="Observation.value[x].system" />
            <short value="Kodiersystem f&#252;r die Einheit (UCUM)" />
            <min value="1" />
            <patternUri value="http://unitsofmeasure.org" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.value[x]:valueQuantity.code">
            <path value="Observation.value[x].code" />
            <short value="UCUM-Code der Einheit" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.dataAbsentReason">
            <path value="Observation.dataAbsentReason" />
            <short value="Angabe eines Grundes weshalb kein Ergebniss der Laboruntersuchung vorliegt" />
            <comment value="**Begr&#252;ndung Must Support**:\nNicht alle geplanten oder dokumentierten Untersuchungen liefern auch tats&#228;chlich ein Ergebnis. In solchen F&#228;llen ist es wichtig, nicht nur auf das Fehlen eines Wertes zu reagieren, sondern den Grund strukturiert anzugeben. dataAbsentReason erm&#246;glicht diese pr&#228;zise Aussage und verhindert Fehlinterpretationen" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.interpretation">
            <path value="Observation.interpretation" />
            <short value="Interpretation oder Bewertung des Messergebnisses (z.B. „hoch“, „niedrig“, „normal“)" />
            <comment value="Begr&#252;ndung MS: Unterst&#252;tzt die klinische Interpretation, insbesondere bei komplexen Parametern und automatisierten Auswertungen." />
            <mustSupport value="true" />
        </element>
        <element id="Observation.note">
            <path value="Observation.note" />
            <short value="Freitextnotiz oder Kommentar zur Beobachtung (z. B. Hinweise des Labors)" />
            <comment value="**Begr&#252;ndung MS**: Dient zur Dokumentation abweichender Umst&#228;nde, Freitextbefundung oder erg&#228;nzender Laborkommentare." />
            <mustSupport value="true" />
        </element>
        <element id="Observation.method">
            <path value="Observation.method" />
            <comment value="**Einschr&#228;nkung der &#252;bergreifenden MS-Definition:** \n  Verf&#252;gt ein best&#228;tigungsrelevantes System nicht &#252;ber die Datenstruktur zur Hinterlegung der zugrundeliegenden Methode, so MUSS dieses System\n   die Information NICHT abbilden. \n   \n   Motivation zum eingeschr&#228;nkten MS: Die Untersuchungsmethode einer Laboruntersuchung ist eine relevante medizinische Information: Unterschiedliche Methoden k&#246;nnen unterschiedliche Resultate liefern. Die Methode ist daher f&#252;r Transparenz und Vergleichbarkeit entscheidend.\n   Da diese Information aktuell h&#228;ufig nicht &#252;bergeben wird, wird das MS eingeschr&#228;nkt. Es ist dennoch w&#252;nschenswert, dass die Probe in der Zukunft &#252;bergeben wird." />
            <mustSupport value="true" />
        </element>
        <element id="Observation.specimen">
            <path value="Observation.specimen" />
            <comment value="**Einschr&#228;nkung der &#252;bergreifenden MS-Definition:** \n  Verf&#252;gt ein best&#228;tigungsrelevantes System nicht &#252;ber die Datenstruktur zur Hinterlegung der Laboruntersuchung zugrundeliegenden Probe, so MUSS dieses System\n   die Information NICHT abbilden. \n   \n   Motivation zum eingeschr&#228;nkten MS: Die Probe (z. B. Serum, Urin) ist zentral f&#252;r die korrekte Bewertung des Ergebnisses. Die Unterscheidung von Materialtypen ist oft diagnostisch ausschlaggebend.\n   Da die Information aktuell jedoch h&#228;ufig nicht &#252;bergeben wird, wird das MS eingeschr&#228;nkt. Es ist dennoch w&#252;nschenswert, dass die Probe in der Zukunft &#252;bergeben wird" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.specimen.reference">
            <path value="Observation.specimen.reference" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.specimen.identifier">
            <path value="Observation.specimen.identifier" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.specimen.identifier.system">
            <path value="Observation.specimen.identifier.system" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.specimen.identifier.value">
            <path value="Observation.specimen.identifier.value" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.device">
            <path value="Observation.device" />
            <short value="Verwendetes Ger&#228;t oder Instrument zur Durchf&#252;hrung der Untersuchung" />
            <comment value="**Begr&#252;ndung Must Support**:\nDas verwendete Mess- oder Analyseger&#228;t kann einen entscheidenden Einfluss auf die Genauigkeit, Validit&#228;t und Vergleichbarkeit von Untersuchungsergebnissen haben." />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange">
            <path value="Observation.referenceRange" />
            <short value="Referenzbereich zur Interpretation des Messergebnisses (z. B. Normalwerte)" />
            <comment value="**Begr&#252;ndung MS**: Referenzbereiche erlauben die sofortige klinische Bewertung eines Wertes" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.low">
            <path value="Observation.referenceRange.low" />
            <short value="Untergrenze des Referenzbereichs" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.low.value">
            <path value="Observation.referenceRange.low.value" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.low.unit">
            <path value="Observation.referenceRange.low.unit" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.low.system">
            <path value="Observation.referenceRange.low.system" />
            <min value="1" />
            <patternUri value="http://unitsofmeasure.org" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.low.code">
            <path value="Observation.referenceRange.low.code" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.high">
            <path value="Observation.referenceRange.high" />
            <short value="Obergrenze des Referenzbereichs" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.high.value">
            <path value="Observation.referenceRange.high.value" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.high.unit">
            <path value="Observation.referenceRange.high.unit" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.high.system">
            <path value="Observation.referenceRange.high.system" />
            <min value="1" />
            <patternUri value="http://unitsofmeasure.org" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.high.code">
            <path value="Observation.referenceRange.high.code" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.type">
            <path value="Observation.referenceRange.type" />
            <short value="Art des Referenzbereichs (z. B. normal, kritisch)" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.type.coding">
            <path value="Observation.referenceRange.type.coding" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.type.coding.system">
            <path value="Observation.referenceRange.type.coding.system" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.type.coding.code">
            <path value="Observation.referenceRange.type.coding.code" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.type.coding.display">
            <path value="Observation.referenceRange.type.coding.display" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.type.text">
            <path value="Observation.referenceRange.type.text" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.appliesTo">
            <path value="Observation.referenceRange.appliesTo" />
            <short value="F&#252;r wen der Referenzbereich gilt (z. B. Geschlecht, Alter)" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.appliesTo.coding">
            <path value="Observation.referenceRange.appliesTo.coding" />
            <short value="Kodierte Angabe zur Zielgruppe" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.appliesTo.coding.system">
            <path value="Observation.referenceRange.appliesTo.coding.system" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.appliesTo.coding.code">
            <path value="Observation.referenceRange.appliesTo.coding.code" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.appliesTo.coding.display">
            <path value="Observation.referenceRange.appliesTo.coding.display" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.appliesTo.text">
            <path value="Observation.referenceRange.appliesTo.text" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.age">
            <path value="Observation.referenceRange.age" />
            <short value="Altersbereich, f&#252;r den der Referenzbereich gilt" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.age.low">
            <path value="Observation.referenceRange.age.low" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.age.high">
            <path value="Observation.referenceRange.age.high" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange.text">
            <path value="Observation.referenceRange.text" />
            <short value="Freitextbeschreibung des Referenzbereichs" />
            <mustSupport value="true" />
        </element>
    </differential>
</StructureDefinition>

{
    "resourceType": "StructureDefinition",
    "id": "ISiKLaboruntersuchung",
    "url": "https://gematik.de/fhir/isik/StructureDefinition/ISiKLaboruntersuchung",
    "version": "5.0.0",
    "name": "ISiKLaboruntersuchung",
    "status": "active",
    "experimental": false,
    "date": "2025-06-26",
    "publisher": "gematik GmbH",
    "description": "Dieses Profil ermöglicht die Abbildung von Informationen zur Laboruntersuchungen eines Patienten in ISiK Szenarien. Es dient primär als Vorlage, von der spezifische Laboruntersuchungs-Profile abgeleitet werden, kann aber grundsätzlich auch zur Repräsentation von nicht weiter ausspezifizierten Laboruntersuchungen genutzt werden.\n\nViele medizinischen Entscheidungen benötigen Informationen zu den Laboruntersuchungen eines Patienten. Hierzu gehören z.B. aktuelle Nierenfunktionswerte, Leberwerte, Blutbildwerte oder Hormone aus Schilddrüse.\nJede dieser Untersuchungen wird durch bestimmte [[https://loinc.org/ LOINC]] oder [[http://snomed.info/sct SNOMED CT]] Codes bezeichnet. Der angegebene Wert ist durch genaue Einheitenangaben in [[http://unitsofmeasure.org UCUM]] zu konkretitiseren.\nMotivierender Use-Case zur Einführung dieser Profile ist die [Arzneitmitteltherapiesicherheit im Krankenhaus - AMTS](https://simplifier.net/guide/isik-medikation-v4/ImplementationGuide-markdown-UseCases-AMTS?version=current).\n\nIn FHIR werden Untersuchungen, bzw. Beobachtungen als [`Observation`](https://hl7.org/fhir/R4/observation.html)-Ressource repräsentiert. Zugehörige Codes und Einheiten sind den entsprechenden Valuessets zu entnehmen.",
    "fhirVersion": "4.0.1",
    "kind": "resource",
    "abstract": false,
    "type": "Observation",
    "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Observation",
    "derivation": "constraint",
    "differential": {
        "element":  [
            {
                "id": "Observation.status",
                "path": "Observation.status",
                "short": "Status der Laboruntersuchung",
                "comment": "**Begründung MS**: Der Status ist unerlässlich für die korrekte Interpretation einer Untersuchung. **WICHTIGER Hinweis für Implementierer**:  \n  * Alle server-seitigen Implementierungen MÜSSEN in der Lage sein, \n  die systemintern möglichen Statuswerte korrekt in FHIR abzubilden, mindestens jedoch die Werte `final` und `unknown`.\n  * Alle client-seitigen Implementierungen MÜSSEN in der Lage sein, sämtliche Status-Codes zu interpretieren und dem Anwender in angemessener Form darstellen zu können, \n  beispielsweise durch Ausblenden/Durchstreichen von Prozeduren mit dem status `entered-in-error` und Ausgrauen von Untersuchungen, die noch nicht stattgefunden haben, o.ä.",
                "mustSupport": true
            },
            {
                "id": "Observation.category",
                "path": "Observation.category",
                "short": "Kategorie der Laboruntersuchung",
                "comment": "**Begründung MS**: Ermöglicht das Filtern, Sortieren und Gruppieren von Befunden. Für Laboruntersuchungen ist die Kategorie zwingend mit dem entsprechenden Code (z. B. LOINC-Kategorie „laboratory“) zu befüllen.",
                "min": 1,
                "patternCodeableConcept": {
                    "coding":  [
                        {
                            "code": "laboratory",
                            "system": "http://terminology.hl7.org/CodeSystem/observation-category"
                        }
                    ]
                },
                "mustSupport": true
            },
            {
                "id": "Observation.code",
                "path": "Observation.code",
                "short": "Gegenstand der Untersuchung (Laborparameter)",
                "comment": "**Begründung MS**: Der Code identifiziert, was gemessen wurde, und ist damit das zentrale Element der Observation. Ohne .code ist kein eindeutiger sowie maschinell auswertbarer klinischer Kontext  dokumentiert.",
                "mustSupport": true
            },
            {
                "id": "Observation.code.coding",
                "path": "Observation.code.coding",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "pattern",
                            "path": "$this"
                        }
                    ],
                    "rules": "open"
                },
                "short": "Kodierung des Laborparameters",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.code.coding.system",
                "path": "Observation.code.coding.system",
                "short": "System, aus dem der Code für den Laborparameter stammt (z. B. LOINC)",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.code.coding.code",
                "path": "Observation.code.coding.code",
                "short": "Code des Laborparameters entsprechend dem verwendeten System",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.code.coding.display",
                "path": "Observation.code.coding.display",
                "short": "Anzeige-/Bezeichnungstext für den Laborparameter-Code",
                "mustSupport": true
            },
            {
                "id": "Observation.code.coding:loinc",
                "path": "Observation.code.coding",
                "sliceName": "loinc",
                "min": 1,
                "max": "*",
                "patternCoding": {
                    "system": "http://loinc.org"
                },
                "mustSupport": true
            },
            {
                "id": "Observation.code.text",
                "path": "Observation.code.text",
                "mustSupport": true
            },
            {
                "id": "Observation.subject",
                "path": "Observation.subject",
                "short": "Referenz auf den Patienten",
                "comment": "**Begründung MS**: Die Verknüpfung zur Patientin oder zum Patienten ist zwingend notwendig für jegliche klinische Verwertbarkeit.",
                "min": 1,
                "type":  [
                    {
                        "code": "Reference",
                        "targetProfile":  [
                            "http://hl7.org/fhir/StructureDefinition/Patient"
                        ]
                    }
                ],
                "mustSupport": true
            },
            {
                "id": "Observation.encounter",
                "path": "Observation.encounter",
                "short": "Referenz auf den Abteilungskontakt",
                "comment": "**Begründung MS**: Dient der Einordnung in den klinischen Verlauf und ermöglicht Kontextinformationen wie Aufnahmediagnose oder behandelnde Abteilung.",
                "mustSupport": true
            },
            {
                "id": "Observation.effective[x]",
                "path": "Observation.effective[x]",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "type",
                            "path": "$this"
                        }
                    ],
                    "ordered": false,
                    "rules": "open"
                },
                "short": "Zeitpunkt der Untersuchung",
                "comment": "**Begründung Must Support**:\nDas Element effective[x] ist zentral, um die Beobachtung - insbesondere bei Laborbefunden - zeitlich korrekt einzuordnen. Es stellt sicher, dass Systeme erkennen können, wann eine Untersuchung durchgeführt oder ein Zustand beobachtet wurde. Dies ist entscheidend für:\n\n* die klinische Relevanz des Ergebnisses (z.B. aktueller vs. älterer Befund),\n* Verlaufsauswertungen und Trendanalysen,\n* zeitlich abhängige Entscheidungsunterstützung,\n* eine valide Anzeige im zeitlichen Kontext des Patientenaufenthalts.",
                "mustSupport": true
            },
            {
                "id": "Observation.effective[x]:effectiveDateTime",
                "path": "Observation.effective[x]",
                "sliceName": "effectiveDateTime",
                "min": 0,
                "max": "1",
                "type":  [
                    {
                        "code": "dateTime"
                    }
                ],
                "mustSupport": true
            },
            {
                "id": "Observation.issued",
                "path": "Observation.issued",
                "short": "Zeitpunkt der Verfügbarkeit des Untersuchungsergebnisses",
                "comment": "**Begründung MS**: Relevant zur Nachvollziehbarkeit und Validierung von Befunden, z.B. wann eine Entscheidung darauf basierte.",
                "mustSupport": true
            },
            {
                "id": "Observation.value[x]",
                "path": "Observation.value[x]",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "type",
                            "path": "$this"
                        }
                    ],
                    "ordered": false,
                    "rules": "open"
                },
                "short": "Festgestellter (Mess)Wert für den Laborparameter",
                "comment": "**Begründung MS**: Der gemessene Wert stellt die zentrale Aussage der Observation dar. Ohne value besitzt die Observation keine medizinische Relevanz.",
                "mustSupport": true
            },
            {
                "id": "Observation.value[x]:valueQuantity",
                "path": "Observation.value[x]",
                "sliceName": "valueQuantity",
                "short": "Messwert in quantitativer Form",
                "comment": "**Begründung MS**: Standardisierte, codierte Einheiten sind für Vergleichbarkeit, Umrechnung und automatische Plausibilisierung erforderlich.",
                "min": 0,
                "max": "1",
                "type":  [
                    {
                        "code": "Quantity"
                    }
                ],
                "mustSupport": true
            },
            {
                "id": "Observation.value[x]:valueQuantity.value",
                "path": "Observation.value[x].value",
                "short": "Der numerische Messwert",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.value[x]:valueQuantity.unit",
                "path": "Observation.value[x].unit",
                "short": "Einheit des Messwertes (z. B. mg/dL)",
                "mustSupport": true
            },
            {
                "id": "Observation.value[x]:valueQuantity.system",
                "path": "Observation.value[x].system",
                "short": "Kodiersystem für die Einheit (UCUM)",
                "min": 1,
                "patternUri": "http://unitsofmeasure.org",
                "mustSupport": true
            },
            {
                "id": "Observation.value[x]:valueQuantity.code",
                "path": "Observation.value[x].code",
                "short": "UCUM-Code der Einheit",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.dataAbsentReason",
                "path": "Observation.dataAbsentReason",
                "short": "Angabe eines Grundes weshalb kein Ergebniss der Laboruntersuchung vorliegt",
                "comment": "**Begründung Must Support**:\nNicht alle geplanten oder dokumentierten Untersuchungen liefern auch tatsächlich ein Ergebnis. In solchen Fällen ist es wichtig, nicht nur auf das Fehlen eines Wertes zu reagieren, sondern den Grund strukturiert anzugeben. dataAbsentReason ermöglicht diese präzise Aussage und verhindert Fehlinterpretationen",
                "mustSupport": true
            },
            {
                "id": "Observation.interpretation",
                "path": "Observation.interpretation",
                "short": "Interpretation oder Bewertung des Messergebnisses (z.B. „hoch“, „niedrig“, „normal“)",
                "comment": "Begründung MS: Unterstützt die klinische Interpretation, insbesondere bei komplexen Parametern und automatisierten Auswertungen.",
                "mustSupport": true
            },
            {
                "id": "Observation.note",
                "path": "Observation.note",
                "short": "Freitextnotiz oder Kommentar zur Beobachtung (z. B. Hinweise des Labors)",
                "comment": "**Begründung MS**: Dient zur Dokumentation abweichender Umstände, Freitextbefundung oder ergänzender Laborkommentare.",
                "mustSupport": true
            },
            {
                "id": "Observation.method",
                "path": "Observation.method",
                "comment": "**Einschränkung der übergreifenden MS-Definition:** \n  Verfügt ein bestätigungsrelevantes System nicht über die Datenstruktur zur Hinterlegung der zugrundeliegenden Methode, so MUSS dieses System\n   die Information NICHT abbilden. \n   \n   Motivation zum eingeschränkten MS: Die Untersuchungsmethode einer Laboruntersuchung ist eine relevante medizinische Information: Unterschiedliche Methoden können unterschiedliche Resultate liefern. Die Methode ist daher für Transparenz und Vergleichbarkeit entscheidend.\n   Da diese Information aktuell häufig nicht übergeben wird, wird das MS eingeschränkt. Es ist dennoch wünschenswert, dass die Probe in der Zukunft übergeben wird.",
                "mustSupport": true
            },
            {
                "id": "Observation.specimen",
                "path": "Observation.specimen",
                "comment": "**Einschränkung der übergreifenden MS-Definition:** \n  Verfügt ein bestätigungsrelevantes System nicht über die Datenstruktur zur Hinterlegung der Laboruntersuchung zugrundeliegenden Probe, so MUSS dieses System\n   die Information NICHT abbilden. \n   \n   Motivation zum eingeschränkten MS: Die Probe (z. B. Serum, Urin) ist zentral für die korrekte Bewertung des Ergebnisses. Die Unterscheidung von Materialtypen ist oft diagnostisch ausschlaggebend.\n   Da die Information aktuell jedoch häufig nicht übergeben wird, wird das MS eingeschränkt. Es ist dennoch wünschenswert, dass die Probe in der Zukunft übergeben wird",
                "mustSupport": true
            },
            {
                "id": "Observation.specimen.reference",
                "path": "Observation.specimen.reference",
                "mustSupport": true
            },
            {
                "id": "Observation.specimen.identifier",
                "path": "Observation.specimen.identifier",
                "mustSupport": true
            },
            {
                "id": "Observation.specimen.identifier.system",
                "path": "Observation.specimen.identifier.system",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.specimen.identifier.value",
                "path": "Observation.specimen.identifier.value",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.device",
                "path": "Observation.device",
                "short": "Verwendetes Gerät oder Instrument zur Durchführung der Untersuchung",
                "comment": "**Begründung Must Support**:\nDas verwendete Mess- oder Analysegerät kann einen entscheidenden Einfluss auf die Genauigkeit, Validität und Vergleichbarkeit von Untersuchungsergebnissen haben.",
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange",
                "path": "Observation.referenceRange",
                "short": "Referenzbereich zur Interpretation des Messergebnisses (z. B. Normalwerte)",
                "comment": "**Begründung MS**: Referenzbereiche erlauben die sofortige klinische Bewertung eines Wertes",
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.low",
                "path": "Observation.referenceRange.low",
                "short": "Untergrenze des Referenzbereichs",
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.low.value",
                "path": "Observation.referenceRange.low.value",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.low.unit",
                "path": "Observation.referenceRange.low.unit",
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.low.system",
                "path": "Observation.referenceRange.low.system",
                "min": 1,
                "patternUri": "http://unitsofmeasure.org",
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.low.code",
                "path": "Observation.referenceRange.low.code",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.high",
                "path": "Observation.referenceRange.high",
                "short": "Obergrenze des Referenzbereichs",
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.high.value",
                "path": "Observation.referenceRange.high.value",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.high.unit",
                "path": "Observation.referenceRange.high.unit",
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.high.system",
                "path": "Observation.referenceRange.high.system",
                "min": 1,
                "patternUri": "http://unitsofmeasure.org",
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.high.code",
                "path": "Observation.referenceRange.high.code",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.type",
                "path": "Observation.referenceRange.type",
                "short": "Art des Referenzbereichs (z. B. normal, kritisch)",
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.type.coding",
                "path": "Observation.referenceRange.type.coding",
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.type.coding.system",
                "path": "Observation.referenceRange.type.coding.system",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.type.coding.code",
                "path": "Observation.referenceRange.type.coding.code",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.type.coding.display",
                "path": "Observation.referenceRange.type.coding.display",
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.type.text",
                "path": "Observation.referenceRange.type.text",
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.appliesTo",
                "path": "Observation.referenceRange.appliesTo",
                "short": "Für wen der Referenzbereich gilt (z. B. Geschlecht, Alter)",
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.appliesTo.coding",
                "path": "Observation.referenceRange.appliesTo.coding",
                "short": "Kodierte Angabe zur Zielgruppe",
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.appliesTo.coding.system",
                "path": "Observation.referenceRange.appliesTo.coding.system",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.appliesTo.coding.code",
                "path": "Observation.referenceRange.appliesTo.coding.code",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.appliesTo.coding.display",
                "path": "Observation.referenceRange.appliesTo.coding.display",
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.appliesTo.text",
                "path": "Observation.referenceRange.appliesTo.text",
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.age",
                "path": "Observation.referenceRange.age",
                "short": "Altersbereich, für den der Referenzbereich gilt",
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.age.low",
                "path": "Observation.referenceRange.age.low",
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.age.high",
                "path": "Observation.referenceRange.age.high",
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange.text",
                "path": "Observation.referenceRange.text",
                "short": "Freitextbeschreibung des Referenzbereichs",
                "mustSupport": true
            }
        ]
    }
}

ISiKLaboruntersuchung

Constraints/Invarianten

Terminology-Bindings

Anmerkungen zu Must-Support-Feldern

Feldname	Kurzbeschreibung	Hinweise
Observation.status	Status der Laboruntersuchung	Begründung MS: Der Status ist unerlässlich für die korrekte Interpretation einer Untersuchung. WICHTIGER Hinweis für Implementierer: Alle server-seitigen Implementierungen MÜSSEN in der Lage sein, die systemintern möglichen Statuswerte korrekt in FHIR abzubilden, mindestens jedoch die Werte `final` und `unknown`. Alle client-seitigen Implementierungen MÜSSEN in der Lage sein, sämtliche Status-Codes zu interpretieren und dem Anwender in angemessener Form darstellen zu können, beispielsweise durch Ausblenden/Durchstreichen von Prozeduren mit dem status `entered-in-error` und Ausgrauen von Untersuchungen, die noch nicht stattgefunden haben, o.ä.
Observation.category	Kategorie der Laboruntersuchung	Begründung MS: Ermöglicht das Filtern, Sortieren und Gruppieren von Befunden. Für Laboruntersuchungen ist die Kategorie zwingend mit dem entsprechenden Code (z. B. LOINC-Kategorie „laboratory“) zu befüllen.
Observation.code	Gegenstand der Untersuchung (Laborparameter)	Begründung MS: Der Code identifiziert, was gemessen wurde, und ist damit das zentrale Element der Observation. Ohne .code ist kein eindeutiger sowie maschinell auswertbarer klinischer Kontext dokumentiert.
Observation.code.coding	Kodierung des Laborparameters
Observation.code.coding.system	System, aus dem der Code für den Laborparameter stammt (z. B. LOINC)
Observation.code.coding.code	Code des Laborparameters entsprechend dem verwendeten System
Observation.code.coding.display	Anzeige-/Bezeichnungstext für den Laborparameter-Code
Observation.code.coding:loinc
Observation.code.text
Observation.subject	Referenz auf den Patienten	Begründung MS: Die Verknüpfung zur Patientin oder zum Patienten ist zwingend notwendig für jegliche klinische Verwertbarkeit.
Observation.encounter	Referenz auf den Abteilungskontakt	Begründung MS: Dient der Einordnung in den klinischen Verlauf und ermöglicht Kontextinformationen wie Aufnahmediagnose oder behandelnde Abteilung.
Observation.effective[x]	Zeitpunkt der Untersuchung	Begründung Must Support: Das Element effective[x] ist zentral, um die Beobachtung - insbesondere bei Laborbefunden - zeitlich korrekt einzuordnen. Es stellt sicher, dass Systeme erkennen können, wann eine Untersuchung durchgeführt oder ein Zustand beobachtet wurde. Dies ist entscheidend für: die klinische Relevanz des Ergebnisses (z.B. aktueller vs. älterer Befund), Verlaufsauswertungen und Trendanalysen, zeitlich abhängige Entscheidungsunterstützung, eine valide Anzeige im zeitlichen Kontext des Patientenaufenthalts.
Observation.effective[x]:effectiveDateTime
Observation.issued	Zeitpunkt der Verfügbarkeit des Untersuchungsergebnisses	Begründung MS: Relevant zur Nachvollziehbarkeit und Validierung von Befunden, z.B. wann eine Entscheidung darauf basierte.
Observation.value[x]	Festgestellter (Mess)Wert für den Laborparameter	Begründung MS: Der gemessene Wert stellt die zentrale Aussage der Observation dar. Ohne value besitzt die Observation keine medizinische Relevanz.
Observation.value[x]:valueQuantity	Messwert in quantitativer Form	Begründung MS: Standardisierte, codierte Einheiten sind für Vergleichbarkeit, Umrechnung und automatische Plausibilisierung erforderlich.
Observation.value[x]:valueQuantity.value	Der numerische Messwert
Observation.value[x]:valueQuantity.unit	Einheit des Messwertes (z. B. mg/dL)
Observation.value[x]:valueQuantity.system	Kodiersystem für die Einheit (UCUM)
Observation.value[x]:valueQuantity.code	UCUM-Code der Einheit
Observation.dataAbsentReason	Angabe eines Grundes weshalb kein Ergebniss der Laboruntersuchung vorliegt	Begründung Must Support: Nicht alle geplanten oder dokumentierten Untersuchungen liefern auch tatsächlich ein Ergebnis. In solchen Fällen ist es wichtig, nicht nur auf das Fehlen eines Wertes zu reagieren, sondern den Grund strukturiert anzugeben. dataAbsentReason ermöglicht diese präzise Aussage und verhindert Fehlinterpretationen
Observation.interpretation	Interpretation oder Bewertung des Messergebnisses (z.B. „hoch“, „niedrig“, „normal“)	Begründung MS: Unterstützt die klinische Interpretation, insbesondere bei komplexen Parametern und automatisierten Auswertungen.
Observation.note	Freitextnotiz oder Kommentar zur Beobachtung (z. B. Hinweise des Labors)	Begründung MS: Dient zur Dokumentation abweichender Umstände, Freitextbefundung oder ergänzender Laborkommentare.
Observation.method		Einschränkung der übergreifenden MS-Definition: Verfügt ein bestätigungsrelevantes System nicht über die Datenstruktur zur Hinterlegung der zugrundeliegenden Methode, so MUSS dieses System die Information NICHT abbilden. Motivation zum eingeschränkten MS: Die Untersuchungsmethode einer Laboruntersuchung ist eine relevante medizinische Information: Unterschiedliche Methoden können unterschiedliche Resultate liefern. Die Methode ist daher für Transparenz und Vergleichbarkeit entscheidend. Da diese Information aktuell häufig nicht übergeben wird, wird das MS eingeschränkt. Es ist dennoch wünschenswert, dass die Probe in der Zukunft übergeben wird.
Observation.specimen		Einschränkung der übergreifenden MS-Definition: Verfügt ein bestätigungsrelevantes System nicht über die Datenstruktur zur Hinterlegung der Laboruntersuchung zugrundeliegenden Probe, so MUSS dieses System die Information NICHT abbilden. Motivation zum eingeschränkten MS: Die Probe (z. B. Serum, Urin) ist zentral für die korrekte Bewertung des Ergebnisses. Die Unterscheidung von Materialtypen ist oft diagnostisch ausschlaggebend. Da die Information aktuell jedoch häufig nicht übergeben wird, wird das MS eingeschränkt. Es ist dennoch wünschenswert, dass die Probe in der Zukunft übergeben wird
Observation.specimen.reference
Observation.specimen.identifier
Observation.specimen.identifier.system
Observation.specimen.identifier.value
Observation.device	Verwendetes Gerät oder Instrument zur Durchführung der Untersuchung	Begründung Must Support: Das verwendete Mess- oder Analysegerät kann einen entscheidenden Einfluss auf die Genauigkeit, Validität und Vergleichbarkeit von Untersuchungsergebnissen haben.
Observation.referenceRange	Referenzbereich zur Interpretation des Messergebnisses (z. B. Normalwerte)	Begründung MS: Referenzbereiche erlauben die sofortige klinische Bewertung eines Wertes
Observation.referenceRange.low	Untergrenze des Referenzbereichs
Observation.referenceRange.low.value
Observation.referenceRange.low.unit
Observation.referenceRange.low.system
Observation.referenceRange.low.code
Observation.referenceRange.high	Obergrenze des Referenzbereichs
Observation.referenceRange.high.value
Observation.referenceRange.high.unit
Observation.referenceRange.high.system
Observation.referenceRange.high.code
Observation.referenceRange.type	Art des Referenzbereichs (z. B. normal, kritisch)
Observation.referenceRange.type.coding
Observation.referenceRange.type.coding.system
Observation.referenceRange.type.coding.code
Observation.referenceRange.type.coding.display
Observation.referenceRange.type.text
Observation.referenceRange.appliesTo	Für wen der Referenzbereich gilt (z. B. Geschlecht, Alter)
Observation.referenceRange.appliesTo.coding	Kodierte Angabe zur Zielgruppe
Observation.referenceRange.appliesTo.coding.system
Observation.referenceRange.appliesTo.coding.code
Observation.referenceRange.appliesTo.coding.display
Observation.referenceRange.appliesTo.text
Observation.referenceRange.age	Altersbereich, für den der Referenzbereich gilt
Observation.referenceRange.age.low
Observation.referenceRange.age.high
Observation.referenceRange.text	Freitextbeschreibung des Referenzbereichs