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Resource Profile: 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.

Usages:

• Derived from this Profile: ISiKLaboruntersuchungCRP, ISiKLaboruntersuchungGFR, ISiKLaboruntersuchungHb, ISiKLaboruntersuchungPCT... Show 5 more, ISiKLaboruntersuchungSerumkreatinin, ISiKLaboruntersuchungSerumnatrium, ISiKLaboruntersuchungTSH, ISiKLaboruntersuchungThrombozyten and ISiKLaboruntersuchungTroponin
• Examples for this Profile: Observation/ExampleISiKLaboruntersuchungMaximal

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
• Must-Support Comments
• Statistics/References
• All

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation	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:$this
coding:All Slices				Content/Rules for all slices
system	SΣ	1..1	uri	System, aus dem der Code für den Laborparameter stammt (z.B. LOINC)
code	SΣ	1..1	code	Code des Laborparameters entsprechend dem verwendeten System
display	SΣ	0..1	string	Anzeige-/Bezeichnungstext für den Laborparameter-Code
coding:loinc	SΣ	1..*	​?pkp-2?	Code defined by a terminology system Binding: Results Laboratory/Pathology Observation - IPS (extensible) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
version		0..1	string	Version of the system - if relevant
userSelected		0..1	boolean	If this coding was chosen directly by the user
system	SΣ	1..1	uri	System, aus dem der Code für den Laborparameter stammt (z.B. LOINC) Fixed Value: http://loinc.org
code	SΣ	1..1	code	Code des Laborparameters entsprechend dem verwendeten System
display	SΣ	0..1	string	Anzeige-/Bezeichnungstext für den Laborparameter-Code
text	SΣ	0..1	string	Plain text representation of the concept
subject	SΣ	1..1	Reference(Patient)	Referenz auf den Patienten
reference	SΣC	0..1	string	Patienten-Link
encounter	SΣ	0..1	Reference(Encounter)	Referenz auf den Abteilungskontakt
reference	SΣC	0..1	string	Literal reference, Relative, internal or absolute URL
Slices for effective[x]	SΣ	1..1		Zeitpunkt der Untersuchung Slice: Unordered, Open by type:$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, Open 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
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
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
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	extensible	Results Laboratory/Pathology Observation - IPS	⏿2.0.0	tx.hl7europe.eu
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.​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 Observation

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation	Measurements and simple assertions Constraints: isik-obs-1, isik-obs-2
id	S	0..1	id	serverseitige, interne ID des Datensatzes
meta
versionId		0..1	id	Eindeutiger Name der serverseitigen Version des Datensatzes
lastUpdated		0..1	instant	Zeitpunkt der letzten Änderung
implicitRules		0..0		Verweis auf die Regeln, nach denen die Ressource erstellt wurde
Slices for identifier	S	0..*	Identifier	Analyse-Befund-Code Slice: Unordered, Open by pattern:$this
identifier:All Slices				Content/Rules for all slices
type	S	1..1	CodeableConcept	Art des Identifiers
coding	S	1..*	Coding	Kodierung des Identifier-Typs
system	S	1..1	uri	Namensraum des Identifiers
value	S	1..1	string	Der eigentliche Identifier-Wert
identifier:analyseBefundCode	S	0..1	Identifier	Business Identifier for observation Required Pattern: At least the following
type		1..1	CodeableConcept	Description of identifier Fixed Value: (Complex)
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
code		1..1	code	Symbol in syntax defined by the system Fixed Value: OBI
status	S	1..1	code	Status der Laboruntersuchung
Slices for category	S	1..*	CodeableConcept	Kategorie der Laboruntersuchung Slice: Unordered, Open by pattern:$this
category:observation-category	S	1..1	CodeableConcept	Festlegung der Kategorie 'laboratory' Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
category:laborbereich		0..1	CodeableConcept	​Fachlicher Laborbereich Binding: https://gematik.de/fhir/isik/ValueSet/ISiKLaborbereichVS (required)
code	S	1..1	CodeableConcept	Gegenstand der Untersuchung (Laborparameter)
Slices for coding	S	1..*	Coding	Kodierung des Laborparameters Slice: Unordered, Open by pattern:$this
coding:All Slices				Content/Rules for all slices
system	S	1..1	uri	System, aus dem der Code für den Laborparameter stammt (z.B. LOINC)
code	S	1..1	code	Code des Laborparameters entsprechend dem verwendeten System
display	S	0..1	string	Anzeige-/Bezeichnungstext für den Laborparameter-Code
coding:loinc	S	1..*	​?pkp-2?	Code defined by a terminology system Binding: Results Laboratory/Pathology Observation - IPS (extensible) Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
text	S	0..1	string	Plain text representation of the concept
subject	S	1..1	Reference(Patient)	Referenz auf den Patienten
reference	S	0..1	string	Patienten-Link
encounter	S	0..1	Reference(Encounter)	Referenz auf den Abteilungskontakt
reference	S	0..1	string	Literal reference, Relative, internal or absolute URL
Slices for effective[x]	S	1..1	dateTime, Period, Timing, instant	Zeitpunkt der Untersuchung Slice: Unordered, Open by type:$this
effective[x]:effectiveDateTime	S	0..1	dateTime	Clinically relevant time/time-period for observation
issued	S	0..1	instant	Zeitpunkt der Verfügbarkeit des Untersuchungsergebnisses
performer	S	1..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Verantwortliche Person oder Organisation für die Untersuchung
Slices for value[x]	S	0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Festgestellter (Mess)Wert für den Laborparameter Slice: Unordered, Open by type:$this
value[x]:valueQuantity	S	0..1	Quantity	Messwert in quantitativer Form
value	S	1..1	decimal	Der numerische Messwert
unit	S	0..1	string	Einheit des Messwertes (z.B. mg/dL)
system	S	1..1	uri	Kodiersystem für die Einheit (UCUM) Required Pattern: http://unitsofmeasure.org
code	S	1..1	code	UCUM-Code der Einheit
value[x]:valueCodeableConcept		0..1	CodeableConcept	Kodierter Ergebniswert Binding: Results Coded Values Laboratory - IPS (preferred)
dataAbsentReason	S	0..1	CodeableConcept	Angabe eines Grundes weshalb kein Ergebniss der Laboruntersuchung vorliegt
interpretation	S	0..*	CodeableConcept	Interpretation oder Bewertung des Messergebnisses (z.B. „hoch“, „niedrig“, „normal“)
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	S	0..1	string	Literal reference, Relative, internal or absolute URL
identifier	S	0..1	Identifier	Logical reference, when literal reference is not known
system	S	1..1	uri	The namespace for the identifier value
value	S	1..1	string	The value that is unique
device	S	0..1	Reference(Device | DeviceMetric)	Verwendetes Gerät oder Instrument zur Durchführung der Untersuchung
referenceRange	S	0..*	BackboneElement	Referenzbereich zur Interpretation des Messergebnisses (z.B. Normalwerte)
low	S	0..1	SimpleQuantity(4.0.1)	Untergrenze des Referenzbereichs
value	S	1..1	decimal	Numerical value (with implicit precision)
unit	S	0..1	string	Unit representation
system	S	1..1	uri	System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code	S	1..1	code	Coded form of the unit
high	S	0..1	SimpleQuantity(4.0.1)	Obergrenze des Referenzbereichs
value	S	1..1	decimal	Numerical value (with implicit precision)
unit	S	0..1	string	Unit representation
system	S	1..1	uri	System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code	S	1..1	code	Coded form of the unit
type	S	0..1	CodeableConcept	Art des Referenzbereichs (z.B. normal, kritisch)
coding	S	0..*	Coding	Code defined by a terminology system
system	S	1..1	uri	Identity of the terminology system
code	S	1..1	code	Symbol in syntax defined by the system
display	S	0..1	string	Representation defined by the system
text	S	0..1	string	Plain text representation of the concept
appliesTo	S	0..*	CodeableConcept	Für wen der Referenzbereich gilt (z.B. Geschlecht, Alter)
coding	S	0..*	Coding	Kodierte Angabe zur Zielgruppe
system	S	1..1	uri	Identity of the terminology system
code	S	1..1	code	Symbol in syntax defined by the system
display	S	0..1	string	Representation defined by the system
text	S	0..1	string	Plain text representation of the concept
age	S	0..1	Range	Altersbereich, für den der Referenzbereich gilt
low	S	0..1	SimpleQuantity(4.0.1)	Low limit
high	S	0..1	SimpleQuantity(4.0.1)	High limit
text	S	0..1	string	Freitextbeschreibung des Referenzbereichs
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Observation.category:laborbereich	Base	required	​ https://gematik.de/fhir/isik/ValueSet/ISiKLaborbereichVS	Not State	Unknown
Observation.code.coding:loinc	Base	extensible	Results Laboratory/Pathology Observation - IPS	⏿2.0.0	tx.hl7europe.eu
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory - IPS	📦1.1.0	International Patient Summary Implementation Guide v1.1
Observation.method	Base	extensible	​ https://gematik.de/fhir/isik/ValueSet/ISiKLaborMethodeVS	Not State	Unknown

Constraints

Id	Grade	Path(s)	Description	Expression
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())

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation	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: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
system	SΣ	1..1	uri	System, aus dem der Code für den Laborparameter stammt (z.B. LOINC)
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
coding:loinc	SΣ	1..*	​?pkp-2?	Code defined by a terminology system Binding: Results Laboratory/Pathology Observation - IPS (extensible) 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, Open 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
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
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
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	extensible	Results Laboratory/Pathology Observation - IPS	⏿2.0.0	tx.hl7europe.eu
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.​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.​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()

Element	Short description	Notes
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.category:observation-category	Festlegung der Kategorie 'laboratory'	Begründung MS: Pflicht-Slice zur Kennzeichnung als Laboruntersuchung.
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.code	Code des Laborparameters entsprechend dem verwendeten System
Observation.code.coding.display	Anzeige-/Bezeichnungstext für den Laborparameter-Code
Observation.code.coding.system	System, aus dem der Code für den Laborparameter stammt (z.B. LOINC)
Observation.code.coding:loinc
Observation.code.text
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.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.effective[x]	Zeitpunkt der Untersuchung	Begründung Must Support: Die EHDS Kombatiblität erfordert die Angabe von effective. Das Element effective[x] ist zentral, um die Beobachtung - insbesondere bei Laborbefunden - zeitlich korrekt einzuordnen.
Observation.effective[x]:effectiveDateTime
Observation.encounter	Referenz auf den Abteilungskontakt	Begründung MS: Dient der Einordnung in den klinischen Verlauf und ermöglicht Kontextinformationen wie Aufnahmediagnose oder behandelnde Abteilung.
Observation.encounter.reference		​Begründung MS: Die Verlinkung auf eine Encounter-Ressource dient der technischen Zuordnung der Dokumentation zu einem Aufenthalt und ermöglicht wichtige API-Funktionen wie verkettete Suche, (Reverse-)Include etc. Im ISik Kontext MUSS die referenzierte Ressource konform zu ISiKKontaktGesundheitseinrichtung sein. Jenseits von ISiK KÖNNEN weitere Instanzen mit anderen Profilen referenziert werden.
Observation.id	serverseitige, interne ID des Datensatzes	bedingtes Pflichtfeld/bedingtes MS: Alle von einem Server bereitgestellten Ressourcen MÜSSEN über eine id verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine idverfügen.
Observation.identifier	Analyse-Befund-Code	Begründung MS: Ein eindeutiger Identifier ermöglicht die zuverlässige Referenzierung und Nachverfolgung von Laboruntersuchungen über verschiedene Systeme hinweg.
Observation.identifier.system	Namensraum des Identifiers
Observation.identifier.type	Art des Identifiers	Begründung MS: Der Identifier-Typ dient zur fachlichen Unterscheidung verschiedener Identifikatoren eines Laborbefunds.
Observation.identifier.type.coding	Kodierung des Identifier-Typs
Observation.identifier.value	Der eigentliche Identifier-Wert
Observation.identifier:analyseBefundCode
Observation.interpretation	Interpretation oder Bewertung des Messergebnisses (z.B. „hoch“, „niedrig“, „normal“)	Begründung MS: Die Angabe einer Interpretation ist für die klinische Einordnung von Messergebnissen essenziell und wird in vielen Anwendungsfällen (z. B. Entscheidungsunterstützung, Anzeige in Primärsystemen) benötigt.
Observation.issued	Zeitpunkt der Verfügbarkeit des Untersuchungsergebnisses	Begründung MS: Relevant zur Nachvollziehbarkeit und Validierung von Befunden, z.B. wann eine Entscheidung darauf basierte.
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.note	Freitextnotiz oder Kommentar zur Beobachtung (z.B. Hinweise des Labors)	Begründung MS: Dient zur Dokumentation abweichender Umstände, Freitextbefundung oder ergänzender Laborkommentare.
Observation.performer	Verantwortliche Person oder Organisation für die Untersuchung	Begründung MS: Die durchführende Person oder Organisation ist für die Validität und Verantwortlichkeit des Befunds maßgeblich. Begründung Kardinalität: Die EHDS Kombatiblität erfordert mindestens einen Performer.
Observation.referenceRange	Referenzbereich zur Interpretation des Messergebnisses (z.B. Normalwerte)	Begründung MS: Referenzbereiche erlauben die sofortige klinische Bewertung eines Wertes
Observation.referenceRange.age	Altersbereich, für den der Referenzbereich gilt
Observation.referenceRange.age.high
Observation.referenceRange.age.low
Observation.referenceRange.appliesTo	Für wen der Referenzbereich gilt (z.B. Geschlecht, Alter)
Observation.referenceRange.appliesTo.coding	Kodierte Angabe zur Zielgruppe
Observation.referenceRange.appliesTo.coding.code
Observation.referenceRange.appliesTo.coding.display
Observation.referenceRange.appliesTo.coding.system
Observation.referenceRange.appliesTo.text
Observation.referenceRange.high	Obergrenze des Referenzbereichs
Observation.referenceRange.high.code
Observation.referenceRange.high.system
Observation.referenceRange.high.unit
Observation.referenceRange.high.value
Observation.referenceRange.low	Untergrenze des Referenzbereichs
Observation.referenceRange.low.code
Observation.referenceRange.low.system
Observation.referenceRange.low.unit
Observation.referenceRange.low.value
Observation.referenceRange.text	Freitextbeschreibung des Referenzbereichs
Observation.referenceRange.type	Art des Referenzbereichs (z.B. normal, kritisch)
Observation.referenceRange.type.coding
Observation.referenceRange.type.coding.code
Observation.referenceRange.type.coding.display
Observation.referenceRange.type.coding.system
Observation.referenceRange.type.text
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.identifier
Observation.specimen.identifier.system
Observation.specimen.identifier.value
Observation.specimen.reference
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.subject	Referenz auf den Patienten	Begründung MS: Die Verknüpfung zur Patientin oder zum Patienten ist zwingend notwendig für jegliche klinische Verwertbarkeit.
Observation.subject.reference	Patienten-Link	​Begründung MS: Die Verlinkung auf eine Patienten-Ressource dient der technischen Zuordnung der Dokumentation zu einem Patienten und ermöglicht wichtige API-Funktionen wie verkettete Suche, (Reverse-)Include etc. Im ISik Kontext MUSS die referenzierte Ressource konform zu ISiKPatient sein. Jenseits von ISiK KÖNNEN weitere Instanzen mit anderen Profilen referenziert werden.
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.code	UCUM-Code der Einheit
Observation.value[x]:valueQuantity.system	Kodiersystem für die Einheit (UCUM)
Observation.value[x]:valueQuantity.unit	Einheit des Messwertes (z.B. mg/dL)
Observation.value[x]:valueQuantity.value	Der numerische Messwert

This structure is derived from Observation

Summary

Mandatory: 9 elements(19 nested mandatory elements)
Must-Support: 68 elements
Prohibited: 1 element

Structures

This structure refers to these other structures:

• Unable to summarise profile https://gematik.de/fhir/isik/StructureDefinition/ISiKLoincCoding (no profile found)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Observation.identifier
• The element 1 is sliced based on the value of Observation.category
• The element 1 is sliced based on the value of Observation.code.coding
• The element 1 is sliced based on the value of Observation.effective[x]
• The element 1 is sliced based on the value of Observation.value[x]

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation	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:$this
coding:All Slices				Content/Rules for all slices
system	SΣ	1..1	uri	System, aus dem der Code für den Laborparameter stammt (z.B. LOINC)
code	SΣ	1..1	code	Code des Laborparameters entsprechend dem verwendeten System
display	SΣ	0..1	string	Anzeige-/Bezeichnungstext für den Laborparameter-Code
coding:loinc	SΣ	1..*	​?pkp-2?	Code defined by a terminology system Binding: Results Laboratory/Pathology Observation - IPS (extensible) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
version		0..1	string	Version of the system - if relevant
userSelected		0..1	boolean	If this coding was chosen directly by the user
system	SΣ	1..1	uri	System, aus dem der Code für den Laborparameter stammt (z.B. LOINC) Fixed Value: http://loinc.org
code	SΣ	1..1	code	Code des Laborparameters entsprechend dem verwendeten System
display	SΣ	0..1	string	Anzeige-/Bezeichnungstext für den Laborparameter-Code
text	SΣ	0..1	string	Plain text representation of the concept
subject	SΣ	1..1	Reference(Patient)	Referenz auf den Patienten
reference	SΣC	0..1	string	Patienten-Link
encounter	SΣ	0..1	Reference(Encounter)	Referenz auf den Abteilungskontakt
reference	SΣC	0..1	string	Literal reference, Relative, internal or absolute URL
Slices for effective[x]	SΣ	1..1		Zeitpunkt der Untersuchung Slice: Unordered, Open by type:$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, Open 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
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
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
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	extensible	Results Laboratory/Pathology Observation - IPS	⏿2.0.0	tx.hl7europe.eu
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.​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 Observation

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation	Measurements and simple assertions Constraints: isik-obs-1, isik-obs-2
id	S	0..1	id	serverseitige, interne ID des Datensatzes
meta
versionId		0..1	id	Eindeutiger Name der serverseitigen Version des Datensatzes
lastUpdated		0..1	instant	Zeitpunkt der letzten Änderung
implicitRules		0..0		Verweis auf die Regeln, nach denen die Ressource erstellt wurde
Slices for identifier	S	0..*	Identifier	Analyse-Befund-Code Slice: Unordered, Open by pattern:$this
identifier:All Slices				Content/Rules for all slices
type	S	1..1	CodeableConcept	Art des Identifiers
coding	S	1..*	Coding	Kodierung des Identifier-Typs
system	S	1..1	uri	Namensraum des Identifiers
value	S	1..1	string	Der eigentliche Identifier-Wert
identifier:analyseBefundCode	S	0..1	Identifier	Business Identifier for observation Required Pattern: At least the following
type		1..1	CodeableConcept	Description of identifier Fixed Value: (Complex)
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
code		1..1	code	Symbol in syntax defined by the system Fixed Value: OBI
status	S	1..1	code	Status der Laboruntersuchung
Slices for category	S	1..*	CodeableConcept	Kategorie der Laboruntersuchung Slice: Unordered, Open by pattern:$this
category:observation-category	S	1..1	CodeableConcept	Festlegung der Kategorie 'laboratory' Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
category:laborbereich		0..1	CodeableConcept	​Fachlicher Laborbereich Binding: https://gematik.de/fhir/isik/ValueSet/ISiKLaborbereichVS (required)
code	S	1..1	CodeableConcept	Gegenstand der Untersuchung (Laborparameter)
Slices for coding	S	1..*	Coding	Kodierung des Laborparameters Slice: Unordered, Open by pattern:$this
coding:All Slices				Content/Rules for all slices
system	S	1..1	uri	System, aus dem der Code für den Laborparameter stammt (z.B. LOINC)
code	S	1..1	code	Code des Laborparameters entsprechend dem verwendeten System
display	S	0..1	string	Anzeige-/Bezeichnungstext für den Laborparameter-Code
coding:loinc	S	1..*	​?pkp-2?	Code defined by a terminology system Binding: Results Laboratory/Pathology Observation - IPS (extensible) Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
text	S	0..1	string	Plain text representation of the concept
subject	S	1..1	Reference(Patient)	Referenz auf den Patienten
reference	S	0..1	string	Patienten-Link
encounter	S	0..1	Reference(Encounter)	Referenz auf den Abteilungskontakt
reference	S	0..1	string	Literal reference, Relative, internal or absolute URL
Slices for effective[x]	S	1..1	dateTime, Period, Timing, instant	Zeitpunkt der Untersuchung Slice: Unordered, Open by type:$this
effective[x]:effectiveDateTime	S	0..1	dateTime	Clinically relevant time/time-period for observation
issued	S	0..1	instant	Zeitpunkt der Verfügbarkeit des Untersuchungsergebnisses
performer	S	1..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Verantwortliche Person oder Organisation für die Untersuchung
Slices for value[x]	S	0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Festgestellter (Mess)Wert für den Laborparameter Slice: Unordered, Open by type:$this
value[x]:valueQuantity	S	0..1	Quantity	Messwert in quantitativer Form
value	S	1..1	decimal	Der numerische Messwert
unit	S	0..1	string	Einheit des Messwertes (z.B. mg/dL)
system	S	1..1	uri	Kodiersystem für die Einheit (UCUM) Required Pattern: http://unitsofmeasure.org
code	S	1..1	code	UCUM-Code der Einheit
value[x]:valueCodeableConcept		0..1	CodeableConcept	Kodierter Ergebniswert Binding: Results Coded Values Laboratory - IPS (preferred)
dataAbsentReason	S	0..1	CodeableConcept	Angabe eines Grundes weshalb kein Ergebniss der Laboruntersuchung vorliegt
interpretation	S	0..*	CodeableConcept	Interpretation oder Bewertung des Messergebnisses (z.B. „hoch“, „niedrig“, „normal“)
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	S	0..1	string	Literal reference, Relative, internal or absolute URL
identifier	S	0..1	Identifier	Logical reference, when literal reference is not known
system	S	1..1	uri	The namespace for the identifier value
value	S	1..1	string	The value that is unique
device	S	0..1	Reference(Device | DeviceMetric)	Verwendetes Gerät oder Instrument zur Durchführung der Untersuchung
referenceRange	S	0..*	BackboneElement	Referenzbereich zur Interpretation des Messergebnisses (z.B. Normalwerte)
low	S	0..1	SimpleQuantity(4.0.1)	Untergrenze des Referenzbereichs
value	S	1..1	decimal	Numerical value (with implicit precision)
unit	S	0..1	string	Unit representation
system	S	1..1	uri	System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code	S	1..1	code	Coded form of the unit
high	S	0..1	SimpleQuantity(4.0.1)	Obergrenze des Referenzbereichs
value	S	1..1	decimal	Numerical value (with implicit precision)
unit	S	0..1	string	Unit representation
system	S	1..1	uri	System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code	S	1..1	code	Coded form of the unit
type	S	0..1	CodeableConcept	Art des Referenzbereichs (z.B. normal, kritisch)
coding	S	0..*	Coding	Code defined by a terminology system
system	S	1..1	uri	Identity of the terminology system
code	S	1..1	code	Symbol in syntax defined by the system
display	S	0..1	string	Representation defined by the system
text	S	0..1	string	Plain text representation of the concept
appliesTo	S	0..*	CodeableConcept	Für wen der Referenzbereich gilt (z.B. Geschlecht, Alter)
coding	S	0..*	Coding	Kodierte Angabe zur Zielgruppe
system	S	1..1	uri	Identity of the terminology system
code	S	1..1	code	Symbol in syntax defined by the system
display	S	0..1	string	Representation defined by the system
text	S	0..1	string	Plain text representation of the concept
age	S	0..1	Range	Altersbereich, für den der Referenzbereich gilt
low	S	0..1	SimpleQuantity(4.0.1)	Low limit
high	S	0..1	SimpleQuantity(4.0.1)	High limit
text	S	0..1	string	Freitextbeschreibung des Referenzbereichs
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Observation.category:laborbereich	Base	required	​ https://gematik.de/fhir/isik/ValueSet/ISiKLaborbereichVS	Not State	Unknown
Observation.code.coding:loinc	Base	extensible	Results Laboratory/Pathology Observation - IPS	⏿2.0.0	tx.hl7europe.eu
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory - IPS	📦1.1.0	International Patient Summary Implementation Guide v1.1
Observation.method	Base	extensible	​ https://gematik.de/fhir/isik/ValueSet/ISiKLaborMethodeVS	Not State	Unknown

Constraints

Id	Grade	Path(s)	Description	Expression
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())

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation	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: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
system	SΣ	1..1	uri	System, aus dem der Code für den Laborparameter stammt (z.B. LOINC)
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
coding:loinc	SΣ	1..*	​?pkp-2?	Code defined by a terminology system Binding: Results Laboratory/Pathology Observation - IPS (extensible) 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, Open 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
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
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
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	extensible	Results Laboratory/Pathology Observation - IPS	⏿2.0.0	tx.hl7europe.eu
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.​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.​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 Observation

Summary

Mandatory: 9 elements(19 nested mandatory elements)
Must-Support: 68 elements
Prohibited: 1 element

Structures

This structure refers to these other structures:

• Unable to summarise profile https://gematik.de/fhir/isik/StructureDefinition/ISiKLoincCoding (no profile found)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Observation.identifier
• The element 1 is sliced based on the value of Observation.category
• The element 1 is sliced based on the value of Observation.code.coding
• The element 1 is sliced based on the value of Observation.effective[x]
• The element 1 is sliced based on the value of Observation.value[x]