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Resource Profile: ISiKLaboruntersuchungSerumnatrium

Dieses Profil ermöglicht die Abbildung der Laboruntersuchung Serumnatrium eines Patienten in ISiK Szenarien. Das Profil wird u. A. im Use Case zur Unterstützung von Transplantationsbeauftragten bei der Organspendeerkennung eingesetzt; besonders in diesem Kontext muss es auch Werte abbilden, die im Rahmen von Messungen mittels Point-of-Care-Testing erhoben wurden. Das Profil ist auch geeignet, um Serumnatrium Werte abzubilden, die mittels Laboruntersuchung erhoben wurden.

Eine eindeutige Kennzeichnung für die Differenzierung hinsichtlich der Erhebungsmethode ist derzeit über dieses Profil nicht vorgesehen. Es kann jedoch das Element .method verwendet werden. Die Differenzierung aufgrund der Methode kann unter Umständen sinnvoll sein, wenn im Falle einer Laboruntersuchung ein Arzt die Werte zuerst sichten und bestätigen müsste, bevor sie im PDMS als ‘final’ für den Patienten hinterlegt werden.

Usages:

• Examples for this Profile: Observation/ExampleISiKLaboruntersuchungSerumnatrium1, Observation/ExampleOrganSerumNatrium202003110104, Observation/ExampleOrganSerumNatrium202003110159 and Observation/ExampleOrganSerumNatrium202003110306
• CapabilityStatements using this Profile: ISiK CapabilityStatement Labor Minimal Rolle (Expanded) and ISiK CapabilityStatement Labor Minimal Rolle

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

• Key Elements Table
• Differential Table
• Snapshot Table
• Statistics/References
• All

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	ISiKLaboruntersuchung	Measurements and simple assertions Constraints: obs-6, obs-7, isik-obs-1, isik-obs-2
id	SΣ	0..1	id	serverseitige, interne ID des Datensatzes
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	SΣ	0..*	Identifier	Analyse-Befund-Code Slice: Unordered, Open by pattern:$this
identifier:All Slices				Content/Rules for all slices
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	SΣ	1..1	CodeableConcept	Art des Identifiers Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
coding	SΣ	1..*	Coding	Kodierung des Identifier-Typs
system	SΣ	1..1	uri	Namensraum des Identifiers Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	Der eigentliche Identifier-Wert Example General: 123456
identifier:analyseBefundCode	SΣ	0..1	Identifier	Business Identifier for observation Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
period		0..1	Period	Time period when id is/was valid for use
assigner		0..1	Reference(Organization)	Organization that issued id (may be just text)
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	SΣ	1..1	CodeableConcept	Art des Identifiers Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
text		0..1	string	Plain text representation of the concept
coding	SΣ	1..*	Coding	Kodierung des Identifier-Typs Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: OBI
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
system	SΣ	1..1	uri	Namensraum des Identifiers Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	Der eigentliche Identifier-Wert Example General: 123456
status	?!SΣ	1..1	code	Status der Laboruntersuchung Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category	S	1..*	CodeableConcept	Kategorie der Laboruntersuchung Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:observation-category	S	1..1	CodeableConcept	Festlegung der Kategorie 'laboratory' Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
category:laborbereich		0..1	CodeableConcept	​Fachlicher Laborbereich Binding: https://gematik.de/fhir/isik/ValueSet/ISiKLaborbereichVS (required)
code	SΣ	1..1	CodeableConcept	Gegenstand der Untersuchung (Laborparameter) Binding: LOINCCodes (example): Codes identifying names of simple observations.
Slices for coding	SΣ	1..*	Coding	Kodierung des Laborparameters Slice: Unordered, Open by pattern:$this
coding:loinc	SΣ	1..*	​?pkp-2?	Code defined by a terminology system Binding: ObservationCodesSerumnatrium (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
version		0..1	string	Version of the system - if relevant
userSelected		0..1	boolean	If this coding was chosen directly by the user
system	SΣ	1..1	uri	System, aus dem der Code für den Laborparameter stammt (z.B. LOINC) Fixed Value: http://loinc.org
code	SΣ	1..1	code	Code des Laborparameters entsprechend dem verwendeten System
display	SΣ	0..1	string	Anzeige-/Bezeichnungstext für den Laborparameter-Code
text	SΣ	0..1	string	Plain text representation of the concept
subject	SΣ	1..1	Reference(Patient)	Referenz auf den Patienten
reference	SΣC	0..1	string	Patienten-Link
encounter	SΣ	0..1	Reference(Encounter)	Referenz auf den Abteilungskontakt
reference	SΣC	0..1	string	Literal reference, Relative, internal or absolute URL
Slices for effective[x]	SΣ	1..1		Zeitpunkt der Untersuchung Slice: Unordered, Open by type:$this
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
effective[x]:effectiveDateTime	SΣ	0..1	dateTime	Clinically relevant time/time-period for observation
issued	SΣ	0..1	instant	Zeitpunkt der Verfügbarkeit des Untersuchungsergebnisses
performer	SΣ	1..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Verantwortliche Person oder Organisation für die Untersuchung
Slices for value[x]	SΣC	0..1		Festgestellter (Mess)Wert für den Laborparameter Slice: Unordered, Closed by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
value[x]:valueQuantity	SΣC	0..1	Quantity	Messwert in quantitativer Form Binding: ObservationUnitsSerumnatrium (required)
value	SΣ	1..1	decimal	Der numerische Messwert
comparator	?!Σ	0..1	code	< | <= | >= | > - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	0..1	string	Einheit des Messwertes (z.B. mg/dL)
system	SΣC	1..1	uri	Kodiersystem für die Einheit (UCUM) Required Pattern: http://unitsofmeasure.org
code	SΣ	1..1	code	UCUM-Code der Einheit
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConcept	Kodierter Ergebniswert Binding: Results Coded Values Laboratory - IPS (preferred)
dataAbsentReason	SC	0..1	CodeableConcept	Angabe eines Grundes weshalb kein Ergebniss der Laboruntersuchung vorliegt Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation	S	0..*	CodeableConcept	Interpretation oder Bewertung des Messergebnisses (z.B. „hoch“, „niedrig“, „normal“) Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note	S	0..*	Annotation	Freitextnotiz oder Kommentar zur Beobachtung (z.B. Hinweise des Labors)
method	S	0..1	CodeableConcept	​How it was done Binding: https://gematik.de/fhir/isik/ValueSet/ISiKLaborMethodeVS (extensible)
specimen	S	0..1	Reference(Specimen)	Specimen used for this observation
reference	SΣC	0..1	string	Literal reference, Relative, internal or absolute URL
identifier	SΣ	0..1	Identifier	Logical reference, when literal reference is not known
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	SΣ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	The value that is unique Example General: 123456
device	S	0..1	Reference(Device | DeviceMetric)	Verwendetes Gerät oder Instrument zur Durchführung der Untersuchung
referenceRange	SC	0..*	BackboneElement	Referenzbereich zur Interpretation des Messergebnisses (z.B. Normalwerte) Constraints: obs-3
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
low	SC	0..1	SimpleQuantity(4.0.1)	Untergrenze des Referenzbereichs Binding: ObservationUnitsSerumnatrium (required)
value	SΣ	1..1	decimal	Numerical value (with implicit precision)
unit	SΣ	0..1	string	Unit representation
system	SΣC	1..1	uri	System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code	SΣ	1..1	code	Coded form of the unit
high	SC	0..1	SimpleQuantity(4.0.1)	Obergrenze des Referenzbereichs Binding: ObservationUnitsSerumnatrium (required)
value	SΣ	1..1	decimal	Numerical value (with implicit precision)
unit	SΣ	0..1	string	Unit representation
system	SΣC	1..1	uri	System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code	SΣ	1..1	code	Coded form of the unit
type	S	0..1	CodeableConcept	Art des Referenzbereichs (z.B. normal, kritisch) Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
coding	SΣ	0..*	Coding	Code defined by a terminology system
system	SΣ	1..1	uri	Identity of the terminology system
code	SΣ	1..1	code	Symbol in syntax defined by the system
display	SΣ	0..1	string	Representation defined by the system
text	SΣ	0..1	string	Plain text representation of the concept
appliesTo	S	0..*	CodeableConcept	Für wen der Referenzbereich gilt (z.B. Geschlecht, Alter) Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
coding	SΣ	0..*	Coding	Kodierte Angabe zur Zielgruppe
system	SΣ	1..1	uri	Identity of the terminology system
code	SΣ	1..1	code	Symbol in syntax defined by the system
display	SΣ	0..1	string	Representation defined by the system
text	SΣ	0..1	string	Plain text representation of the concept
age	S	0..1	Range	Altersbereich, für den der Referenzbereich gilt
low	SΣ	0..1	SimpleQuantity(4.0.1)	Low limit
high	SΣ	0..1	SimpleQuantity(4.0.1)	High limit
text	S	0..1	string	Freitextbeschreibung des Referenzbereichs
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.identifier.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
Observation.identifier.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
Observation.identifier:analyseBefundCode.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
Observation.identifier:analyseBefundCode.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:observation-category	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:laborbereich	Base	required	​ https://gematik.de/fhir/isik/ValueSet/ISiKLaborbereichVS	Not State	Unknown
Observation.code	Base	example	LOINC Codes	📍4.0.1	FHIR Std.
Observation.code.coding:loinc	Base	required	ObservationCodesSerumnatrium	📦6.0.0-rc	This IG
Observation.value[x]:valueQuantity	Base	required	ObservationUnitsSerumnatrium	📦6.0.0-rc	This IG
Observation.value[x]:valueQuantity.​comparator	Base	required	QuantityComparator	📍4.0.1	FHIR Std.
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory - IPS	📦1.1.0	International Patient Summary Implementation Guide v1.1
Observation.dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.
Observation.method	Base	extensible	​ https://gematik.de/fhir/isik/ValueSet/ISiKLaborMethodeVS	Not State	Unknown
Observation.specimen.​identifier.use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
Observation.referenceRange.​low	Base	required	ObservationUnitsSerumnatrium	📦6.0.0-rc	This IG
Observation.referenceRange.​high	Base	required	ObservationUnitsSerumnatrium	📦6.0.0-rc	This IG
Observation.referenceRange.​type	Base	preferred	Observation Reference Range Meaning Codes	📍4.0.1	FHIR Std.
Observation.referenceRange.​appliesTo	Base	example	Observation Reference Range Applies To Codes	📍4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	Observation	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	error	Observation	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	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both	extension.exists() != value.exists()
isik-obs-1	error	Observation	Wenn der Status der Observation nicht "registered" oder "cancelled" ist, muss mindestens eines der folgenden Elemente vorhanden sein: "value", "dataAbsentReason", "hasMember" oder "component".	(status in ('registered' | 'cancelled')) or value.exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists()
isik-obs-2	error	Observation	Wenn die Observation Komponenten enthält und der Status nicht "registered" oder "cancelled" ist, muss in mindestens einer Observation.component entweder "value" oder "dataAbsentReason" vorhanden sein.	component.exists() implies ((status in ('registered' | 'cancelled')) or component.value.exists() or component.dataAbsentReason.exists())
obs-3	error	Observation.referenceRange	Must have at least a low or a high or text	low.exists() or high.exists() or text.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present	dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	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()

This structure is derived from ISiKLaboruntersuchung

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation		0..*	ISiKLaboruntersuchung	Measurements and simple assertions
code
Slices for coding				Content/Rules for all slices
coding:loinc		1..*	​?pkp-2?	Code defined by a terminology system Binding: ObservationCodesSerumnatrium (required)
Slices for value[x]				Content/Rules for all slices
value[x]:valueQuantity		0..1	Quantity	Messwert in quantitativer Form Binding: ObservationUnitsSerumnatrium (required)
referenceRange
low		0..1	SimpleQuantity(4.0.1)	Untergrenze des Referenzbereichs Binding: ObservationUnitsSerumnatrium (required)
high		0..1	SimpleQuantity(4.0.1)	Obergrenze des Referenzbereichs Binding: ObservationUnitsSerumnatrium (required)
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Observation.code.coding:loinc	Base	required	ObservationCodesSerumnatrium	📦6.0.0-rc	This IG
Observation.value[x]:valueQuantity	Base	required	ObservationUnitsSerumnatrium	📦6.0.0-rc	This IG
Observation.referenceRange.​low	Base	required	ObservationUnitsSerumnatrium	📦6.0.0-rc	This IG
Observation.referenceRange.​high	Base	required	ObservationUnitsSerumnatrium	📦6.0.0-rc	This IG

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	ISiKLaboruntersuchung	Measurements and simple assertions Constraints: obs-6, obs-7, isik-obs-1, isik-obs-2
id	SΣ	0..1	id	serverseitige, interne ID des Datensatzes
meta	Σ	0..1	Meta	Metadata about the resource
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
versionId	Σ	0..1	id	Eindeutiger Name der serverseitigen Version des Datensatzes
lastUpdated	Σ	0..1	instant	Zeitpunkt der letzten Änderung
source	Σ	0..1	uri	Identifies where the resource comes from
profile	Σ	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
security	Σ	0..*	Coding	Security Labels applied to this resource Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
tag	Σ	0..*	Coding	Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	SΣ	0..*	Identifier	Analyse-Befund-Code Slice: Unordered, Open by pattern:$this
identifier:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	SΣ	1..1	CodeableConcept	Art des Identifiers Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..*	Coding	Kodierung des Identifier-Typs
text	Σ	0..1	string	Plain text representation of the concept
system	SΣ	1..1	uri	Namensraum des Identifiers Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	Der eigentliche Identifier-Wert Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
identifier:analyseBefundCode	SΣ	0..1	Identifier	Business Identifier for observation Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	SΣ	1..1	CodeableConcept	Art des Identifiers Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..*	Coding	Kodierung des Identifier-Typs Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: OBI
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
system	SΣ	1..1	uri	Namensraum des Identifiers Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	Der eigentliche Identifier-Wert Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
basedOn	Σ	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	Part of referenced event
status	?!SΣ	1..1	code	Status der Laboruntersuchung Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category	S	1..*	CodeableConcept	Kategorie der Laboruntersuchung Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:observation-category	S	1..1	CodeableConcept	Festlegung der Kategorie 'laboratory' Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
category:laborbereich		0..1	CodeableConcept	​Fachlicher Laborbereich Binding: https://gematik.de/fhir/isik/ValueSet/ISiKLaborbereichVS (required)
code	SΣ	1..1	CodeableConcept	Gegenstand der Untersuchung (Laborparameter) Binding: LOINCCodes (example): Codes identifying names of simple observations.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	SΣ	1..*	Coding	Kodierung des Laborparameters Slice: Unordered, Open by pattern:$this
coding:loinc	SΣ	1..*	​?pkp-2?	Code defined by a terminology system Binding: ObservationCodesSerumnatrium (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	SΣ	1..1	uri	System, aus dem der Code für den Laborparameter stammt (z.B. LOINC) Fixed Value: http://loinc.org
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Code des Laborparameters entsprechend dem verwendeten System
display	SΣ	0..1	string	Anzeige-/Bezeichnungstext für den Laborparameter-Code
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	SΣ	0..1	string	Plain text representation of the concept
subject	SΣ	1..1	Reference(Patient)	Referenz auf den Patienten
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	SΣC	0..1	string	Patienten-Link
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
focus	Σ	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record
encounter	SΣ	0..1	Reference(Encounter)	Referenz auf den Abteilungskontakt
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	SΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
Slices for effective[x]	SΣ	1..1		Zeitpunkt der Untersuchung Slice: Unordered, Open by type:$this
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
effective[x]:effectiveDateTime	SΣ	0..1	dateTime	Clinically relevant time/time-period for observation
issued	SΣ	0..1	instant	Zeitpunkt der Verfügbarkeit des Untersuchungsergebnisses
performer	SΣ	1..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Verantwortliche Person oder Organisation für die Untersuchung
Slices for value[x]	SΣC	0..1		Festgestellter (Mess)Wert für den Laborparameter Slice: Unordered, Closed by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
value[x]:valueQuantity	SΣC	0..1	Quantity	Messwert in quantitativer Form Binding: ObservationUnitsSerumnatrium (required)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Der numerische Messwert
comparator	?!Σ	0..1	code	< | <= | >= | > - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	0..1	string	Einheit des Messwertes (z.B. mg/dL)
system	SΣC	1..1	uri	Kodiersystem für die Einheit (UCUM) Required Pattern: http://unitsofmeasure.org
code	SΣ	1..1	code	UCUM-Code der Einheit
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConcept	Kodierter Ergebniswert Binding: Results Coded Values Laboratory - IPS (preferred)
dataAbsentReason	SC	0..1	CodeableConcept	Angabe eines Grundes weshalb kein Ergebniss der Laboruntersuchung vorliegt Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation	S	0..*	CodeableConcept	Interpretation oder Bewertung des Messergebnisses (z.B. „hoch“, „niedrig“, „normal“) Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note	S	0..*	Annotation	Freitextnotiz oder Kommentar zur Beobachtung (z.B. Hinweise des Labors)
bodySite		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method	S	0..1	CodeableConcept	​How it was done Binding: https://gematik.de/fhir/isik/ValueSet/ISiKLaborMethodeVS (extensible)
specimen	S	0..1	Reference(Specimen)	Specimen used for this observation
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	SΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	SΣ	0..1	Identifier	Logical reference, when literal reference is not known
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	SΣ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
display	Σ	0..1	string	Text alternative for the resource
device	S	0..1	Reference(Device | DeviceMetric)	Verwendetes Gerät oder Instrument zur Durchführung der Untersuchung
referenceRange	SC	0..*	BackboneElement	Referenzbereich zur Interpretation des Messergebnisses (z.B. Normalwerte) Constraints: obs-3
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
low	SC	0..1	SimpleQuantity(4.0.1)	Untergrenze des Referenzbereichs Binding: ObservationUnitsSerumnatrium (required)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Numerical value (with implicit precision)
unit	SΣ	0..1	string	Unit representation
system	SΣC	1..1	uri	System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code	SΣ	1..1	code	Coded form of the unit
high	SC	0..1	SimpleQuantity(4.0.1)	Obergrenze des Referenzbereichs Binding: ObservationUnitsSerumnatrium (required)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Numerical value (with implicit precision)
unit	SΣ	0..1	string	Unit representation
system	SΣC	1..1	uri	System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code	SΣ	1..1	code	Coded form of the unit
type	S	0..1	CodeableConcept	Art des Referenzbereichs (z.B. normal, kritisch) Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	0..*	Coding	Code defined by a terminology system
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	SΣ	1..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Symbol in syntax defined by the system
display	SΣ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	SΣ	0..1	string	Plain text representation of the concept
appliesTo	S	0..*	CodeableConcept	Für wen der Referenzbereich gilt (z.B. Geschlecht, Alter) Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	0..*	Coding	Kodierte Angabe zur Zielgruppe
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	SΣ	1..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Symbol in syntax defined by the system
display	SΣ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	SΣ	0..1	string	Plain text representation of the concept
age	S	0..1	Range	Altersbereich, für den der Referenzbereich gilt
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
low	SΣ	0..1	SimpleQuantity(4.0.1)	Low limit
high	SΣ	0..1	SimpleQuantity(4.0.1)	High limit
text	S	0..1	string	Freitextbeschreibung des Referenzbereichs
hasMember	Σ	0..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	Related resource that belongs to the Observation group
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
component	Σ	0..*	BackboneElement	Component results
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x]	Σ	0..1		Actual component result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.meta.security	Base	extensible	SecurityLabels	📍4.0.1	FHIR Std.
Observation.meta.tag	Base	example	Common Tags	📍4.0.1	FHIR Std.
Observation.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
Observation.identifier.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
Observation.identifier.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
Observation.identifier:analyseBefundCode.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
Observation.identifier:analyseBefundCode.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:observation-category	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:laborbereich	Base	required	​ https://gematik.de/fhir/isik/ValueSet/ISiKLaborbereichVS	Not State	Unknown
Observation.code	Base	example	LOINC Codes	📍4.0.1	FHIR Std.
Observation.code.coding:loinc	Base	required	ObservationCodesSerumnatrium	📦6.0.0-rc	This IG
Observation.subject.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Observation.encounter.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Observation.value[x]:valueQuantity	Base	required	ObservationUnitsSerumnatrium	📦6.0.0-rc	This IG
Observation.value[x]:valueQuantity.​comparator	Base	required	QuantityComparator	📍4.0.1	FHIR Std.
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory - IPS	📦1.1.0	International Patient Summary Implementation Guide v1.1
Observation.dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.
Observation.bodySite	Base	example	SNOMED CT Body Structures	📍4.0.1	FHIR Std.
Observation.method	Base	extensible	​ https://gematik.de/fhir/isik/ValueSet/ISiKLaborMethodeVS	Not State	Unknown
Observation.specimen.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Observation.specimen.​identifier.use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
Observation.specimen.​identifier.type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
Observation.referenceRange.​low	Base	required	ObservationUnitsSerumnatrium	📦6.0.0-rc	This IG
Observation.referenceRange.​high	Base	required	ObservationUnitsSerumnatrium	📦6.0.0-rc	This IG
Observation.referenceRange.​type	Base	preferred	Observation Reference Range Meaning Codes	📍4.0.1	FHIR Std.
Observation.referenceRange.​appliesTo	Base	example	Observation Reference Range Applies To Codes	📍4.0.1	FHIR Std.
Observation.component.​code	Base	example	LOINC Codes	📍4.0.1	FHIR Std.
Observation.component.​dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.component.​interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	Observation	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	error	Observation	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	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both	extension.exists() != value.exists()
isik-obs-1	error	Observation	Wenn der Status der Observation nicht "registered" oder "cancelled" ist, muss mindestens eines der folgenden Elemente vorhanden sein: "value", "dataAbsentReason", "hasMember" oder "component".	(status in ('registered' | 'cancelled')) or value.exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists()
isik-obs-2	error	Observation	Wenn die Observation Komponenten enthält und der Status nicht "registered" oder "cancelled" ist, muss in mindestens einer Observation.component entweder "value" oder "dataAbsentReason" vorhanden sein.	component.exists() implies ((status in ('registered' | 'cancelled')) or component.value.exists() or component.dataAbsentReason.exists())
obs-3	error	Observation.referenceRange	Must have at least a low or a high or text	low.exists() or high.exists() or text.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present	dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	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()

This structure is derived from ISiKLaboruntersuchung

Summary

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	ISiKLaboruntersuchung	Measurements and simple assertions Constraints: obs-6, obs-7, isik-obs-1, isik-obs-2
id	SΣ	0..1	id	serverseitige, interne ID des Datensatzes
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	SΣ	0..*	Identifier	Analyse-Befund-Code Slice: Unordered, Open by pattern:$this
identifier:All Slices				Content/Rules for all slices
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	SΣ	1..1	CodeableConcept	Art des Identifiers Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
coding	SΣ	1..*	Coding	Kodierung des Identifier-Typs
system	SΣ	1..1	uri	Namensraum des Identifiers Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	Der eigentliche Identifier-Wert Example General: 123456
identifier:analyseBefundCode	SΣ	0..1	Identifier	Business Identifier for observation Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
period		0..1	Period	Time period when id is/was valid for use
assigner		0..1	Reference(Organization)	Organization that issued id (may be just text)
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	SΣ	1..1	CodeableConcept	Art des Identifiers Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
text		0..1	string	Plain text representation of the concept
coding	SΣ	1..*	Coding	Kodierung des Identifier-Typs Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: OBI
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
system	SΣ	1..1	uri	Namensraum des Identifiers Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	Der eigentliche Identifier-Wert Example General: 123456
status	?!SΣ	1..1	code	Status der Laboruntersuchung Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category	S	1..*	CodeableConcept	Kategorie der Laboruntersuchung Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:observation-category	S	1..1	CodeableConcept	Festlegung der Kategorie 'laboratory' Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
category:laborbereich		0..1	CodeableConcept	​Fachlicher Laborbereich Binding: https://gematik.de/fhir/isik/ValueSet/ISiKLaborbereichVS (required)
code	SΣ	1..1	CodeableConcept	Gegenstand der Untersuchung (Laborparameter) Binding: LOINCCodes (example): Codes identifying names of simple observations.
Slices for coding	SΣ	1..*	Coding	Kodierung des Laborparameters Slice: Unordered, Open by pattern:$this
coding:loinc	SΣ	1..*	​?pkp-2?	Code defined by a terminology system Binding: ObservationCodesSerumnatrium (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
version		0..1	string	Version of the system - if relevant
userSelected		0..1	boolean	If this coding was chosen directly by the user
system	SΣ	1..1	uri	System, aus dem der Code für den Laborparameter stammt (z.B. LOINC) Fixed Value: http://loinc.org
code	SΣ	1..1	code	Code des Laborparameters entsprechend dem verwendeten System
display	SΣ	0..1	string	Anzeige-/Bezeichnungstext für den Laborparameter-Code
text	SΣ	0..1	string	Plain text representation of the concept
subject	SΣ	1..1	Reference(Patient)	Referenz auf den Patienten
reference	SΣC	0..1	string	Patienten-Link
encounter	SΣ	0..1	Reference(Encounter)	Referenz auf den Abteilungskontakt
reference	SΣC	0..1	string	Literal reference, Relative, internal or absolute URL
Slices for effective[x]	SΣ	1..1		Zeitpunkt der Untersuchung Slice: Unordered, Open by type:$this
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
effective[x]:effectiveDateTime	SΣ	0..1	dateTime	Clinically relevant time/time-period for observation
issued	SΣ	0..1	instant	Zeitpunkt der Verfügbarkeit des Untersuchungsergebnisses
performer	SΣ	1..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Verantwortliche Person oder Organisation für die Untersuchung
Slices for value[x]	SΣC	0..1		Festgestellter (Mess)Wert für den Laborparameter Slice: Unordered, Closed by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
value[x]:valueQuantity	SΣC	0..1	Quantity	Messwert in quantitativer Form Binding: ObservationUnitsSerumnatrium (required)
value	SΣ	1..1	decimal	Der numerische Messwert
comparator	?!Σ	0..1	code	< | <= | >= | > - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	0..1	string	Einheit des Messwertes (z.B. mg/dL)
system	SΣC	1..1	uri	Kodiersystem für die Einheit (UCUM) Required Pattern: http://unitsofmeasure.org
code	SΣ	1..1	code	UCUM-Code der Einheit
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConcept	Kodierter Ergebniswert Binding: Results Coded Values Laboratory - IPS (preferred)
dataAbsentReason	SC	0..1	CodeableConcept	Angabe eines Grundes weshalb kein Ergebniss der Laboruntersuchung vorliegt Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation	S	0..*	CodeableConcept	Interpretation oder Bewertung des Messergebnisses (z.B. „hoch“, „niedrig“, „normal“) Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note	S	0..*	Annotation	Freitextnotiz oder Kommentar zur Beobachtung (z.B. Hinweise des Labors)
method	S	0..1	CodeableConcept	​How it was done Binding: https://gematik.de/fhir/isik/ValueSet/ISiKLaborMethodeVS (extensible)
specimen	S	0..1	Reference(Specimen)	Specimen used for this observation
reference	SΣC	0..1	string	Literal reference, Relative, internal or absolute URL
identifier	SΣ	0..1	Identifier	Logical reference, when literal reference is not known
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	SΣ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	The value that is unique Example General: 123456
device	S	0..1	Reference(Device | DeviceMetric)	Verwendetes Gerät oder Instrument zur Durchführung der Untersuchung
referenceRange	SC	0..*	BackboneElement	Referenzbereich zur Interpretation des Messergebnisses (z.B. Normalwerte) Constraints: obs-3
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
low	SC	0..1	SimpleQuantity(4.0.1)	Untergrenze des Referenzbereichs Binding: ObservationUnitsSerumnatrium (required)
value	SΣ	1..1	decimal	Numerical value (with implicit precision)
unit	SΣ	0..1	string	Unit representation
system	SΣC	1..1	uri	System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code	SΣ	1..1	code	Coded form of the unit
high	SC	0..1	SimpleQuantity(4.0.1)	Obergrenze des Referenzbereichs Binding: ObservationUnitsSerumnatrium (required)
value	SΣ	1..1	decimal	Numerical value (with implicit precision)
unit	SΣ	0..1	string	Unit representation
system	SΣC	1..1	uri	System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code	SΣ	1..1	code	Coded form of the unit
type	S	0..1	CodeableConcept	Art des Referenzbereichs (z.B. normal, kritisch) Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
coding	SΣ	0..*	Coding	Code defined by a terminology system
system	SΣ	1..1	uri	Identity of the terminology system
code	SΣ	1..1	code	Symbol in syntax defined by the system
display	SΣ	0..1	string	Representation defined by the system
text	SΣ	0..1	string	Plain text representation of the concept
appliesTo	S	0..*	CodeableConcept	Für wen der Referenzbereich gilt (z.B. Geschlecht, Alter) Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
coding	SΣ	0..*	Coding	Kodierte Angabe zur Zielgruppe
system	SΣ	1..1	uri	Identity of the terminology system
code	SΣ	1..1	code	Symbol in syntax defined by the system
display	SΣ	0..1	string	Representation defined by the system
text	SΣ	0..1	string	Plain text representation of the concept
age	S	0..1	Range	Altersbereich, für den der Referenzbereich gilt
low	SΣ	0..1	SimpleQuantity(4.0.1)	Low limit
high	SΣ	0..1	SimpleQuantity(4.0.1)	High limit
text	S	0..1	string	Freitextbeschreibung des Referenzbereichs
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.identifier.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
Observation.identifier.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
Observation.identifier:analyseBefundCode.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
Observation.identifier:analyseBefundCode.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:observation-category	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:laborbereich	Base	required	​ https://gematik.de/fhir/isik/ValueSet/ISiKLaborbereichVS	Not State	Unknown
Observation.code	Base	example	LOINC Codes	📍4.0.1	FHIR Std.
Observation.code.coding:loinc	Base	required	ObservationCodesSerumnatrium	📦6.0.0-rc	This IG
Observation.value[x]:valueQuantity	Base	required	ObservationUnitsSerumnatrium	📦6.0.0-rc	This IG
Observation.value[x]:valueQuantity.​comparator	Base	required	QuantityComparator	📍4.0.1	FHIR Std.
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory - IPS	📦1.1.0	International Patient Summary Implementation Guide v1.1
Observation.dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.
Observation.method	Base	extensible	​ https://gematik.de/fhir/isik/ValueSet/ISiKLaborMethodeVS	Not State	Unknown
Observation.specimen.​identifier.use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
Observation.referenceRange.​low	Base	required	ObservationUnitsSerumnatrium	📦6.0.0-rc	This IG
Observation.referenceRange.​high	Base	required	ObservationUnitsSerumnatrium	📦6.0.0-rc	This IG
Observation.referenceRange.​type	Base	preferred	Observation Reference Range Meaning Codes	📍4.0.1	FHIR Std.
Observation.referenceRange.​appliesTo	Base	example	Observation Reference Range Applies To Codes	📍4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	Observation	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	error	Observation	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	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both	extension.exists() != value.exists()
isik-obs-1	error	Observation	Wenn der Status der Observation nicht "registered" oder "cancelled" ist, muss mindestens eines der folgenden Elemente vorhanden sein: "value", "dataAbsentReason", "hasMember" oder "component".	(status in ('registered' | 'cancelled')) or value.exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists()
isik-obs-2	error	Observation	Wenn die Observation Komponenten enthält und der Status nicht "registered" oder "cancelled" ist, muss in mindestens einer Observation.component entweder "value" oder "dataAbsentReason" vorhanden sein.	component.exists() implies ((status in ('registered' | 'cancelled')) or component.value.exists() or component.dataAbsentReason.exists())
obs-3	error	Observation.referenceRange	Must have at least a low or a high or text	low.exists() or high.exists() or text.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present	dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	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()

Differential View

This structure is derived from ISiKLaboruntersuchung

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation		0..*	ISiKLaboruntersuchung	Measurements and simple assertions
code
Slices for coding				Content/Rules for all slices
coding:loinc		1..*	​?pkp-2?	Code defined by a terminology system Binding: ObservationCodesSerumnatrium (required)
Slices for value[x]				Content/Rules for all slices
value[x]:valueQuantity		0..1	Quantity	Messwert in quantitativer Form Binding: ObservationUnitsSerumnatrium (required)
referenceRange
low		0..1	SimpleQuantity(4.0.1)	Untergrenze des Referenzbereichs Binding: ObservationUnitsSerumnatrium (required)
high		0..1	SimpleQuantity(4.0.1)	Obergrenze des Referenzbereichs Binding: ObservationUnitsSerumnatrium (required)
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Observation.code.coding:loinc	Base	required	ObservationCodesSerumnatrium	📦6.0.0-rc	This IG
Observation.value[x]:valueQuantity	Base	required	ObservationUnitsSerumnatrium	📦6.0.0-rc	This IG
Observation.referenceRange.​low	Base	required	ObservationUnitsSerumnatrium	📦6.0.0-rc	This IG
Observation.referenceRange.​high	Base	required	ObservationUnitsSerumnatrium	📦6.0.0-rc	This IG

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	ISiKLaboruntersuchung	Measurements and simple assertions Constraints: obs-6, obs-7, isik-obs-1, isik-obs-2
id	SΣ	0..1	id	serverseitige, interne ID des Datensatzes
meta	Σ	0..1	Meta	Metadata about the resource
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
versionId	Σ	0..1	id	Eindeutiger Name der serverseitigen Version des Datensatzes
lastUpdated	Σ	0..1	instant	Zeitpunkt der letzten Änderung
source	Σ	0..1	uri	Identifies where the resource comes from
profile	Σ	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
security	Σ	0..*	Coding	Security Labels applied to this resource Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
tag	Σ	0..*	Coding	Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	SΣ	0..*	Identifier	Analyse-Befund-Code Slice: Unordered, Open by pattern:$this
identifier:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	SΣ	1..1	CodeableConcept	Art des Identifiers Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..*	Coding	Kodierung des Identifier-Typs
text	Σ	0..1	string	Plain text representation of the concept
system	SΣ	1..1	uri	Namensraum des Identifiers Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	Der eigentliche Identifier-Wert Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
identifier:analyseBefundCode	SΣ	0..1	Identifier	Business Identifier for observation Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	SΣ	1..1	CodeableConcept	Art des Identifiers Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..*	Coding	Kodierung des Identifier-Typs Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: OBI
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
system	SΣ	1..1	uri	Namensraum des Identifiers Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	Der eigentliche Identifier-Wert Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
basedOn	Σ	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	Part of referenced event
status	?!SΣ	1..1	code	Status der Laboruntersuchung Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category	S	1..*	CodeableConcept	Kategorie der Laboruntersuchung Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:observation-category	S	1..1	CodeableConcept	Festlegung der Kategorie 'laboratory' Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
category:laborbereich		0..1	CodeableConcept	​Fachlicher Laborbereich Binding: https://gematik.de/fhir/isik/ValueSet/ISiKLaborbereichVS (required)
code	SΣ	1..1	CodeableConcept	Gegenstand der Untersuchung (Laborparameter) Binding: LOINCCodes (example): Codes identifying names of simple observations.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	SΣ	1..*	Coding	Kodierung des Laborparameters Slice: Unordered, Open by pattern:$this
coding:loinc	SΣ	1..*	​?pkp-2?	Code defined by a terminology system Binding: ObservationCodesSerumnatrium (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	SΣ	1..1	uri	System, aus dem der Code für den Laborparameter stammt (z.B. LOINC) Fixed Value: http://loinc.org
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Code des Laborparameters entsprechend dem verwendeten System
display	SΣ	0..1	string	Anzeige-/Bezeichnungstext für den Laborparameter-Code
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	SΣ	0..1	string	Plain text representation of the concept
subject	SΣ	1..1	Reference(Patient)	Referenz auf den Patienten
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	SΣC	0..1	string	Patienten-Link
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
focus	Σ	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record
encounter	SΣ	0..1	Reference(Encounter)	Referenz auf den Abteilungskontakt
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	SΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
Slices for effective[x]	SΣ	1..1		Zeitpunkt der Untersuchung Slice: Unordered, Open by type:$this
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
effective[x]:effectiveDateTime	SΣ	0..1	dateTime	Clinically relevant time/time-period for observation
issued	SΣ	0..1	instant	Zeitpunkt der Verfügbarkeit des Untersuchungsergebnisses
performer	SΣ	1..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Verantwortliche Person oder Organisation für die Untersuchung
Slices for value[x]	SΣC	0..1		Festgestellter (Mess)Wert für den Laborparameter Slice: Unordered, Closed by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
value[x]:valueQuantity	SΣC	0..1	Quantity	Messwert in quantitativer Form Binding: ObservationUnitsSerumnatrium (required)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Der numerische Messwert
comparator	?!Σ	0..1	code	< | <= | >= | > - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	0..1	string	Einheit des Messwertes (z.B. mg/dL)
system	SΣC	1..1	uri	Kodiersystem für die Einheit (UCUM) Required Pattern: http://unitsofmeasure.org
code	SΣ	1..1	code	UCUM-Code der Einheit
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConcept	Kodierter Ergebniswert Binding: Results Coded Values Laboratory - IPS (preferred)
dataAbsentReason	SC	0..1	CodeableConcept	Angabe eines Grundes weshalb kein Ergebniss der Laboruntersuchung vorliegt Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation	S	0..*	CodeableConcept	Interpretation oder Bewertung des Messergebnisses (z.B. „hoch“, „niedrig“, „normal“) Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note	S	0..*	Annotation	Freitextnotiz oder Kommentar zur Beobachtung (z.B. Hinweise des Labors)
bodySite		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method	S	0..1	CodeableConcept	​How it was done Binding: https://gematik.de/fhir/isik/ValueSet/ISiKLaborMethodeVS (extensible)
specimen	S	0..1	Reference(Specimen)	Specimen used for this observation
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	SΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	SΣ	0..1	Identifier	Logical reference, when literal reference is not known
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	SΣ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
display	Σ	0..1	string	Text alternative for the resource
device	S	0..1	Reference(Device | DeviceMetric)	Verwendetes Gerät oder Instrument zur Durchführung der Untersuchung
referenceRange	SC	0..*	BackboneElement	Referenzbereich zur Interpretation des Messergebnisses (z.B. Normalwerte) Constraints: obs-3
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
low	SC	0..1	SimpleQuantity(4.0.1)	Untergrenze des Referenzbereichs Binding: ObservationUnitsSerumnatrium (required)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Numerical value (with implicit precision)
unit	SΣ	0..1	string	Unit representation
system	SΣC	1..1	uri	System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code	SΣ	1..1	code	Coded form of the unit
high	SC	0..1	SimpleQuantity(4.0.1)	Obergrenze des Referenzbereichs Binding: ObservationUnitsSerumnatrium (required)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	SΣ	1..1	decimal	Numerical value (with implicit precision)
unit	SΣ	0..1	string	Unit representation
system	SΣC	1..1	uri	System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code	SΣ	1..1	code	Coded form of the unit
type	S	0..1	CodeableConcept	Art des Referenzbereichs (z.B. normal, kritisch) Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	0..*	Coding	Code defined by a terminology system
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	SΣ	1..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Symbol in syntax defined by the system
display	SΣ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	SΣ	0..1	string	Plain text representation of the concept
appliesTo	S	0..*	CodeableConcept	Für wen der Referenzbereich gilt (z.B. Geschlecht, Alter) Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	0..*	Coding	Kodierte Angabe zur Zielgruppe
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	SΣ	1..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Symbol in syntax defined by the system
display	SΣ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	SΣ	0..1	string	Plain text representation of the concept
age	S	0..1	Range	Altersbereich, für den der Referenzbereich gilt
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
low	SΣ	0..1	SimpleQuantity(4.0.1)	Low limit
high	SΣ	0..1	SimpleQuantity(4.0.1)	High limit
text	S	0..1	string	Freitextbeschreibung des Referenzbereichs
hasMember	Σ	0..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	Related resource that belongs to the Observation group
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
component	Σ	0..*	BackboneElement	Component results
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x]	Σ	0..1		Actual component result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.meta.security	Base	extensible	SecurityLabels	📍4.0.1	FHIR Std.
Observation.meta.tag	Base	example	Common Tags	📍4.0.1	FHIR Std.
Observation.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
Observation.identifier.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
Observation.identifier.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
Observation.identifier:analyseBefundCode.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
Observation.identifier:analyseBefundCode.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:observation-category	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:laborbereich	Base	required	​ https://gematik.de/fhir/isik/ValueSet/ISiKLaborbereichVS	Not State	Unknown
Observation.code	Base	example	LOINC Codes	📍4.0.1	FHIR Std.
Observation.code.coding:loinc	Base	required	ObservationCodesSerumnatrium	📦6.0.0-rc	This IG
Observation.subject.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Observation.encounter.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Observation.value[x]:valueQuantity	Base	required	ObservationUnitsSerumnatrium	📦6.0.0-rc	This IG
Observation.value[x]:valueQuantity.​comparator	Base	required	QuantityComparator	📍4.0.1	FHIR Std.
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory - IPS	📦1.1.0	International Patient Summary Implementation Guide v1.1
Observation.dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.
Observation.bodySite	Base	example	SNOMED CT Body Structures	📍4.0.1	FHIR Std.
Observation.method	Base	extensible	​ https://gematik.de/fhir/isik/ValueSet/ISiKLaborMethodeVS	Not State	Unknown
Observation.specimen.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Observation.specimen.​identifier.use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
Observation.specimen.​identifier.type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
Observation.referenceRange.​low	Base	required	ObservationUnitsSerumnatrium	📦6.0.0-rc	This IG
Observation.referenceRange.​high	Base	required	ObservationUnitsSerumnatrium	📦6.0.0-rc	This IG
Observation.referenceRange.​type	Base	preferred	Observation Reference Range Meaning Codes	📍4.0.1	FHIR Std.
Observation.referenceRange.​appliesTo	Base	example	Observation Reference Range Applies To Codes	📍4.0.1	FHIR Std.
Observation.component.​code	Base	example	LOINC Codes	📍4.0.1	FHIR Std.
Observation.component.​dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.component.​interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	Observation	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	error	Observation	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	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both	extension.exists() != value.exists()
isik-obs-1	error	Observation	Wenn der Status der Observation nicht "registered" oder "cancelled" ist, muss mindestens eines der folgenden Elemente vorhanden sein: "value", "dataAbsentReason", "hasMember" oder "component".	(status in ('registered' | 'cancelled')) or value.exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists()
isik-obs-2	error	Observation	Wenn die Observation Komponenten enthält und der Status nicht "registered" oder "cancelled" ist, muss in mindestens einer Observation.component entweder "value" oder "dataAbsentReason" vorhanden sein.	component.exists() implies ((status in ('registered' | 'cancelled')) or component.value.exists() or component.dataAbsentReason.exists())
obs-3	error	Observation.referenceRange	Must have at least a low or a high or text	low.exists() or high.exists() or text.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present	dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	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()

This structure is derived from ISiKLaboruntersuchung

Summary