Inhalt

Dieses Profil beschreibt eine generische Darstellung von Ergebnissen, die aus molekularpathologischen In-Situ-Hybridisierungsuntersuchungen auf Gewebsschnitten basiert.

Das Profil unterstützt verschiedene ISH-Methoden:

• FISH (Fluoreszenz In Situ Hybridization)
• CISH (Chromogenic In Situ Hybridization)
• SISH (Silver In Situ Hybridization)

Profilstruktur

Analog zur IHC-Modellierung wurde folgende Struktur gewählt:

• code: Slicing mit spezifisch und generisch
  • Spezifisch: Konkreter LOINC- oder SNOMED-Code für die Untersuchung (z.B. 49683-6 ERBB2 gene copy number/Chromosome 17 copy number in Tissue by FISH)
  • Generisch: Fallback-Code 51864006 Nucleic acid hybridization, function (observable entity) wenn kein spezifischer Code verfügbar ist
• method (Pflichtfeld): Angabe der ISH-Methode aus dem ValueSet MII_VS_MTB_ISH_Method:
  • 1303773004 - Fluorescence in situ hybridization technique (FISH)
  • 787997001 - Chromogenic in situ hybridization (CISH)
  • 787998006 - Silver in situ hybridization (SISH)
• value[x]: Unterstützt verschiedene Ergebnistypen:
  • valueRatio - für Ratio-Messungen (z.B. HER2/CEP17)
  • valueQuantity - für einzelne Signalzählungen
  • valueCodeableConcept - für kategorische Ergebnisse (positiv/negativ)

Komponenten für Signalzählungen

Für detaillierte FISH-Auswertungen werden folgende Komponenten unterstützt:

Diese Struktur basiert auf dem LOINC Panel für HER2 FISH (74885-5 ERBB2 gene (HER2) duplication associated observations panel - Tissue by FISH).

Verknüpfungen zu anderen Ressourcen

Die In-Situ-Hybridisierung wird wie immunhistochemische Ergebnisse vom Molekular-Pathologie-Report über DiagnosticReport.result verlinkt. Sie kann ihrerseits von diagnostischen oder therapeutischen Implikationen referenziert werden.

Spezialisierte Profile

Für häufige ISH-Untersuchungen existieren spezialisierte Kindprofile:

• MII_PR_MTB_INSITUHYBRIDIZATION_HER2 - HER2/ERBB2 FISH mit Ratio-Berechnung

ValueSet: ISH Methoden

Suchparameter

Folgende Suchparameter sind für das Modul Onkologie relevant, auch in Kombination:

1. Der Suchparameter "_id" MUSS unterstützt werden:

   Beispiele:

   GET [base]/Observation?_id=12345

   Anwendungshinweise: Weitere Informationen zur Suche nach "_id" finden sich in der FHIR-Basisspezifikation - Abschnitt "Parameters for all resources".

2. Der Suchparameter "code" MUSS unterstützt werden:

   Beispiele:

   GET [base]/Observation?code=http://snomed.info/sct|51864006

   Anwendungshinweise: Weitere Informationen zur Suche nach "code" finden sich in der FHIR-Basisspezifikation - Abschnitt "token".

3. Der Suchparameter "method" MUSS unterstützt werden:

   Beispiele:

   GET [base]/Observation?method=http://snomed.info/sct|1303773004

   Anwendungshinweise: Suche nach der verwendeten ISH-Methode (FISH, CISH, SISH).

4. Der Suchparameter "focus" MUSS unterstützt werden:

   Beispiele:

   GET [base]/Observation?focus=Condition/example-mii-mtb-diagnose

   Anwendungshinweise: Weitere Informationen zur Suche nach "focus" finden sich in der FHIR-Basisspezifikation - Abschnitt "reference".

5. Der Suchparameter "interpretation" MUSS unterstützt werden:

   Beispiele:

   GET [base]/Observation?interpretation=http://hl7.org/fhir/uv/genomics-reporting/ValueSet/high-low-codes-vs|high

   Anwendungshinweise: Weitere Informationen zur Suche nach "interpretation" finden sich in der FHIR-Basisspezifikation - Abschnitt "token".

Beispiele

• Schlüsselelemente-Tabelle
• Differential-Tabelle
• Snapshot-Tabelle
• Statistiken/Referenzen
• Alle

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	MII_PR_MTB_Molekularer_Biomarker	Measurements and simple assertions Constraints: obs-6, obs-7, mii-mtb-ish-1
meta	SΣ	0..1	Meta	Metadata about the resource
profile	SΣ	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..1	Identifier	Identifier zur Abgrenzung anderer gleichartiger Untersuchungen
status	?!Σ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category	S	2..*	CodeableConcept	Kategorie Slice: Unordered, Open by value:coding Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:labCategory		1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
coding	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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
category:mbCategory		1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
coding	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: biomarker-category
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
category:geCategory		0..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
coding	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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/v2-0074
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: GE
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
code	SΣ	1..1	CodeableConcept	Code für In Situ Hybridization Untersuchung Binding: MII VS Molekulare Biomarker (extensible)
Slices for coding	SΣ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:$this
coding:generisch	SΣ	1..1	Coding	Generischer ISH Code Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 51864006
display		1..1	string	Representation defined by the system Fixed Value: Nucleic acid hybridization, function (observable entity)
userSelected		0..1	boolean	If this coding was chosen directly by the user
subject	SΣ	0..1	Reference(Patient | Group)	Patient
focus	SΣ	0..*	Reference(MII PR Onkologie Diagnose Primärtumor)	What the observation is about, when it is not about the subject of record
encounter	SΣ	0..1	Reference(Encounter)	Kontakt
effective[x]	SΣ	0..1		Zeitpunkt der Beobachtung
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
issued	SΣ	0..1	instant	Freigabedatum
Slices for value[x]	SΣC	0..1		Actual result Slice: Unordered, Open by type:$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	Quantitatives Ergebnis (z.B. Signalanzahl)
value[x]:valueRatio	SΣC	0..1	Ratio	Ratio-Ergebnis (z.B. HER2/CEP17)
value[x]:valueCodeableConcept	SΣC	0..1	CodeableConcept	Kategorisches Ergebnis (z.B. positiv/negativ)
interpretation	S	0..*	CodeableConcept	Interpretation Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
method	S	1..1	CodeableConcept	FISH | CISH | SISH Binding: MII VS MTB ISH Method (extensible)
Slices for derivedFrom	SΣ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Abgeleitet von Slice: Unordered, Open by profile:resolve()
derivedFrom:variant	Σ	0..*	Reference(MII PR MolGen Variante)	Variant the biomarker is derived from
derivedFrom:genotype	Σ	0..*	Reference(Genotype)	Genotype the biomarker is derived from
derivedFrom:haplotype	Σ	0..*	Reference(Haplotype)	Haplotype the biomarker is derived from
Slices for component	SΣ	0..*	BackboneElement	Komponenten Slice: Unordered, Open by value:code
component:All Slices				Content/Rules for all slices
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.
component:gene-studied	SΣ	0..*	BackboneElement
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	48018-6 Binding: LOINCCodes (example): Codes identifying names of simple observations. 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://loinc.org
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 48018-6
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
value[x]	Σ	1..1	CodeableConcept	The HGNC gene symbol is to be used as display text and the HGNC gene ID used as the code. If no HGNC code issued for this gene yet, NCBI gene IDs SHALL be used. Binding: HUGO Gene Nomenclature Committee Gene Names (HGNC) (extensible)
component:biomarker-category	SΣ	0..*	BackboneElement	Biomarker-Kategorie
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. 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://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: biomarker-category
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
value[x]	Σ	1..1	CodeableConcept	cell receptor | antigen | protein | immune stain Binding: Molecular Biomarker Categories (example)
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.category:labCategory	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.category:mbCategory	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.category:geCategory	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.code	Base	extensible	MII VS Molekulare Biomarker	📦2027.0.0-ballot.1	This IG
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📦4.0.1	FHIR Std.
Observation.method	Base	extensible	MII VS MTB ISH Method	📦2027.0.0-ballot.1	This IG
Observation.component.​code	Base	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.component:gene-studied.​code	Base	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.component:gene-studied.​value[x]	Base	extensible	HUGO Gene Nomenclature Committee Gene Names (HGNC)	📦3.0.0	Genomics Reporting Implementation Guide v3.0
Observation.component:biomarker-category.​code	Base	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.component:biomarker-category.​value[x]	Base	example	Molecular Biomarker Categories	📦3.0.0	Genomics Reporting Implementation Guide v3.0

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()
mii-mtb-ish-1	error	Observation	Entweder muss ein spezifischer Code oder gene-studied angegeben werden (Either a specific code or gene-studied must be provided)	code.coding.where(system != 'http://snomed.info/sct' or code != '51864006').exists() or component.where(code.coding.where(system = 'http://loinc.org' and code = '48018-6').exists()).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()

Diese Struktur ist abgeleitet von MII_PR_MTB_Molekularer_Biomarker

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	MII_PR_MTB_Molekularer_Biomarker	Measurements and simple assertions Constraints: mii-mtb-ish-1
identifier	S	0..1	Identifier	Identifier zur Abgrenzung anderer gleichartiger Untersuchungen
code		1..1	CodeableConcept	Code für In Situ Hybridization Untersuchung
Slices for coding	S	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:$this
coding:generisch	S	1..1	Coding	Generischer ISH Code Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 51864006
display		1..1	string	Representation defined by the system Fixed Value: Nucleic acid hybridization, function (observable entity)
focus		0..*	Reference(MII PR Onkologie Diagnose Primärtumor)	What the observation is about, when it is not about the subject of record
Slices for value[x]	S	0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual result Slice: Unordered, Open by type:$this
value[x]:valueQuantity	S	0..1	Quantity	Quantitatives Ergebnis (z.B. Signalanzahl)
value[x]:valueRatio	S	0..1	Ratio	Ratio-Ergebnis (z.B. HER2/CEP17)
value[x]:valueCodeableConcept	S	0..1	CodeableConcept	Kategorisches Ergebnis (z.B. positiv/negativ)
interpretation	S	0..*	CodeableConcept	Interpretation
method	S	1..1	CodeableConcept	FISH | CISH | SISH Binding: MII VS MTB ISH Method (extensible)
Slices for component				Content/Rules for all slices
component:gene-studied		0..*	BackboneElement
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Observation.method	Base	extensible	MII VS MTB ISH Method	📦2027.0.0-ballot.1	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
mii-mtb-ish-1	error	Observation	Entweder muss ein spezifischer Code oder gene-studied angegeben werden (Either a specific code or gene-studied must be provided)	code.coding.where(system != 'http://snomed.info/sct' or code != '51864006').exists() or component.where(code.coding.where(system = 'http://loinc.org' and code = '48018-6').exists()).exists()

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	MII_PR_MTB_Molekularer_Biomarker	Measurements and simple assertions Constraints: obs-6, obs-7, mii-mtb-ish-1
id	Σ	0..1	id	Logical id of this artifact
meta	SΣ	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	Version specific identifier
lastUpdated	Σ	0..1	instant	When the resource version last changed
source	Σ	0..1	uri	Identifies where the resource comes from
profile	SΣ	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".
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
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
identifier	SΣ	0..1	Identifier	Identifier zur Abgrenzung anderer gleichartiger Untersuchungen
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	?!Σ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category	S	2..*	CodeableConcept	Kategorie Slice: Unordered, Open by value:coding Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:labCategory		1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
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	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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	Σ	0..1	string	Plain text representation of the concept
category:mbCategory		1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
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	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: biomarker-category
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
category:geCategory		0..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
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	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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/v2-0074
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: GE
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
code	SΣ	1..1	CodeableConcept	Code für In Situ Hybridization Untersuchung Binding: MII VS Molekulare Biomarker (extensible)
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	Code defined by a terminology system Slice: Unordered, Open by pattern:$this
coding:generisch	SΣ	1..1	Coding	Generischer ISH Code Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 51864006
display		1..1	string	Representation defined by the system Fixed Value: Nucleic acid hybridization, function (observable entity)
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
subject	SΣ	0..1	Reference(Patient | Group)	Patient
focus	SΣ	0..*	Reference(MII PR Onkologie Diagnose Primärtumor)	What the observation is about, when it is not about the subject of record
encounter	SΣ	0..1	Reference(Encounter)	Kontakt
effective[x]	SΣ	0..1		Zeitpunkt der Beobachtung
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
issued	SΣ	0..1	instant	Freigabedatum
performer	Σ	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
Slices for value[x]	SΣC	0..1		Actual result Slice: Unordered, Open by type:$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	Quantitatives Ergebnis (z.B. Signalanzahl)
value[x]:valueRatio	SΣC	0..1	Ratio	Ratio-Ergebnis (z.B. HER2/CEP17)
value[x]:valueCodeableConcept	SΣC	0..1	CodeableConcept	Kategorisches Ergebnis (z.B. positiv/negativ)
dataAbsentReason	C	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation	S	0..*	CodeableConcept	Interpretation Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note		0..*	Annotation	Comments about the observation
bodySite		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method	S	1..1	CodeableConcept	FISH | CISH | SISH Binding: MII VS MTB ISH Method (extensible)
specimen		0..1	Reference(Specimen)	Specimen used for this observation
device		0..1	Reference(Device | DeviceMetric)	(Measurement) Device
referenceRange	C	0..*	BackboneElement	Provides guide for interpretation 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	C	0..1	SimpleQuantity	Low Range, if relevant
high	C	0..1	SimpleQuantity	High Range, if relevant
type		0..1	CodeableConcept	Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo		0..*	CodeableConcept	Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age		0..1	Range	Applicable age range, if relevant
text		0..1	string	Text based reference range in an observation
hasMember	Σ	0..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	Related resource that belongs to the Observation group
Slices for derivedFrom	SΣ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Abgeleitet von Slice: Unordered, Open by profile:resolve()
derivedFrom:variant	Σ	0..*	Reference(MII PR MolGen Variante)	Variant the biomarker is derived from
derivedFrom:genotype	Σ	0..*	Reference(Genotype)	Genotype the biomarker is derived from
derivedFrom:haplotype	Σ	0..*	Reference(Haplotype)	Haplotype the biomarker is derived from
Slices for component	SΣ	0..*	BackboneElement	Komponenten Slice: Unordered, Open by value:code
component: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
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
component:gene-studied	SΣ	0..*	BackboneElement
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	48018-6 Binding: LOINCCodes (example): Codes identifying names of simple observations. 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://loinc.org
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 48018-6
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
value[x]	Σ	1..1	CodeableConcept	The HGNC gene symbol is to be used as display text and the HGNC gene ID used as the code. If no HGNC code issued for this gene yet, NCBI gene IDs SHALL be used. Binding: HUGO Gene Nomenclature Committee Gene Names (HGNC) (extensible)
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
component:biomarker-category	SΣ	0..*	BackboneElement	Biomarker-Kategorie
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. 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://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: biomarker-category
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
value[x]	Σ	1..1	CodeableConcept	cell receptor | antigen | protein | immune stain Binding: Molecular Biomarker Categories (example)
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.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.category:labCategory	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.category:mbCategory	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.category:geCategory	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.code	Base	extensible	MII VS Molekulare Biomarker	📦2027.0.0-ballot.1	This IG
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	MII VS MTB ISH Method	📦2027.0.0-ballot.1	This IG
Observation.referenceRange.​type	Base	preferred	Observation Reference Range Meaning Codes	📦4.0.1	FHIR Std.
Observation.referenceRange.​appliesTo	Base	example	Observation Reference Range Applies To Codes	📦4.0.1	FHIR Std.
Observation.component.​code	Base	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.component.​dataAbsentReason	Base	extensible	DataAbsentReason	📦4.0.1	FHIR Std.
Observation.component.​interpretation	Base	extensible	Observation Interpretation Codes	📦4.0.1	FHIR Std.
Observation.component:gene-studied.​code	Base	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.component:gene-studied.​value[x]	Base	extensible	HUGO Gene Nomenclature Committee Gene Names (HGNC)	📦3.0.0	Genomics Reporting Implementation Guide v3.0
Observation.component:gene-studied.​dataAbsentReason	Base	extensible	DataAbsentReason	📦4.0.1	FHIR Std.
Observation.component:gene-studied.​interpretation	Base	extensible	Observation Interpretation Codes	📦4.0.1	FHIR Std.
Observation.component:biomarker-category.​code	Base	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.component:biomarker-category.​value[x]	Base	example	Molecular Biomarker Categories	📦3.0.0	Genomics Reporting Implementation Guide v3.0
Observation.component:biomarker-category.​dataAbsentReason	Base	extensible	DataAbsentReason	📦4.0.1	FHIR Std.
Observation.component:biomarker-category.​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()
mii-mtb-ish-1	error	Observation	Entweder muss ein spezifischer Code oder gene-studied angegeben werden (Either a specific code or gene-studied must be provided)	code.coding.where(system != 'http://snomed.info/sct' or code != '51864006').exists() or component.where(code.coding.where(system = 'http://loinc.org' and code = '48018-6').exists()).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()

Schlüsselelemente-Ansicht

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	MII_PR_MTB_Molekularer_Biomarker	Measurements and simple assertions Constraints: obs-6, obs-7, mii-mtb-ish-1
meta	SΣ	0..1	Meta	Metadata about the resource
profile	SΣ	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..1	Identifier	Identifier zur Abgrenzung anderer gleichartiger Untersuchungen
status	?!Σ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category	S	2..*	CodeableConcept	Kategorie Slice: Unordered, Open by value:coding Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:labCategory		1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
coding	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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
category:mbCategory		1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
coding	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: biomarker-category
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
category:geCategory		0..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
coding	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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/v2-0074
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: GE
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
code	SΣ	1..1	CodeableConcept	Code für In Situ Hybridization Untersuchung Binding: MII VS Molekulare Biomarker (extensible)
Slices for coding	SΣ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:$this
coding:generisch	SΣ	1..1	Coding	Generischer ISH Code Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 51864006
display		1..1	string	Representation defined by the system Fixed Value: Nucleic acid hybridization, function (observable entity)
userSelected		0..1	boolean	If this coding was chosen directly by the user
subject	SΣ	0..1	Reference(Patient | Group)	Patient
focus	SΣ	0..*	Reference(MII PR Onkologie Diagnose Primärtumor)	What the observation is about, when it is not about the subject of record
encounter	SΣ	0..1	Reference(Encounter)	Kontakt
effective[x]	SΣ	0..1		Zeitpunkt der Beobachtung
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
issued	SΣ	0..1	instant	Freigabedatum
Slices for value[x]	SΣC	0..1		Actual result Slice: Unordered, Open by type:$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	Quantitatives Ergebnis (z.B. Signalanzahl)
value[x]:valueRatio	SΣC	0..1	Ratio	Ratio-Ergebnis (z.B. HER2/CEP17)
value[x]:valueCodeableConcept	SΣC	0..1	CodeableConcept	Kategorisches Ergebnis (z.B. positiv/negativ)
interpretation	S	0..*	CodeableConcept	Interpretation Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
method	S	1..1	CodeableConcept	FISH | CISH | SISH Binding: MII VS MTB ISH Method (extensible)
Slices for derivedFrom	SΣ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Abgeleitet von Slice: Unordered, Open by profile:resolve()
derivedFrom:variant	Σ	0..*	Reference(MII PR MolGen Variante)	Variant the biomarker is derived from
derivedFrom:genotype	Σ	0..*	Reference(Genotype)	Genotype the biomarker is derived from
derivedFrom:haplotype	Σ	0..*	Reference(Haplotype)	Haplotype the biomarker is derived from
Slices for component	SΣ	0..*	BackboneElement	Komponenten Slice: Unordered, Open by value:code
component:All Slices				Content/Rules for all slices
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.
component:gene-studied	SΣ	0..*	BackboneElement
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	48018-6 Binding: LOINCCodes (example): Codes identifying names of simple observations. 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://loinc.org
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 48018-6
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
value[x]	Σ	1..1	CodeableConcept	The HGNC gene symbol is to be used as display text and the HGNC gene ID used as the code. If no HGNC code issued for this gene yet, NCBI gene IDs SHALL be used. Binding: HUGO Gene Nomenclature Committee Gene Names (HGNC) (extensible)
component:biomarker-category	SΣ	0..*	BackboneElement	Biomarker-Kategorie
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. 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://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: biomarker-category
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
value[x]	Σ	1..1	CodeableConcept	cell receptor | antigen | protein | immune stain Binding: Molecular Biomarker Categories (example)
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.category:labCategory	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.category:mbCategory	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.category:geCategory	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.code	Base	extensible	MII VS Molekulare Biomarker	📦2027.0.0-ballot.1	This IG
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📦4.0.1	FHIR Std.
Observation.method	Base	extensible	MII VS MTB ISH Method	📦2027.0.0-ballot.1	This IG
Observation.component.​code	Base	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.component:gene-studied.​code	Base	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.component:gene-studied.​value[x]	Base	extensible	HUGO Gene Nomenclature Committee Gene Names (HGNC)	📦3.0.0	Genomics Reporting Implementation Guide v3.0
Observation.component:biomarker-category.​code	Base	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.component:biomarker-category.​value[x]	Base	example	Molecular Biomarker Categories	📦3.0.0	Genomics Reporting Implementation Guide v3.0

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()
mii-mtb-ish-1	error	Observation	Entweder muss ein spezifischer Code oder gene-studied angegeben werden (Either a specific code or gene-studied must be provided)	code.coding.where(system != 'http://snomed.info/sct' or code != '51864006').exists() or component.where(code.coding.where(system = 'http://loinc.org' and code = '48018-6').exists()).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-Ansicht

Diese Struktur ist abgeleitet von MII_PR_MTB_Molekularer_Biomarker

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	MII_PR_MTB_Molekularer_Biomarker	Measurements and simple assertions Constraints: mii-mtb-ish-1
identifier	S	0..1	Identifier	Identifier zur Abgrenzung anderer gleichartiger Untersuchungen
code		1..1	CodeableConcept	Code für In Situ Hybridization Untersuchung
Slices for coding	S	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:$this
coding:generisch	S	1..1	Coding	Generischer ISH Code Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 51864006
display		1..1	string	Representation defined by the system Fixed Value: Nucleic acid hybridization, function (observable entity)
focus		0..*	Reference(MII PR Onkologie Diagnose Primärtumor)	What the observation is about, when it is not about the subject of record
Slices for value[x]	S	0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual result Slice: Unordered, Open by type:$this
value[x]:valueQuantity	S	0..1	Quantity	Quantitatives Ergebnis (z.B. Signalanzahl)
value[x]:valueRatio	S	0..1	Ratio	Ratio-Ergebnis (z.B. HER2/CEP17)
value[x]:valueCodeableConcept	S	0..1	CodeableConcept	Kategorisches Ergebnis (z.B. positiv/negativ)
interpretation	S	0..*	CodeableConcept	Interpretation
method	S	1..1	CodeableConcept	FISH | CISH | SISH Binding: MII VS MTB ISH Method (extensible)
Slices for component				Content/Rules for all slices
component:gene-studied		0..*	BackboneElement
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Observation.method	Base	extensible	MII VS MTB ISH Method	📦2027.0.0-ballot.1	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
mii-mtb-ish-1	error	Observation	Entweder muss ein spezifischer Code oder gene-studied angegeben werden (Either a specific code or gene-studied must be provided)	code.coding.where(system != 'http://snomed.info/sct' or code != '51864006').exists() or component.where(code.coding.where(system = 'http://loinc.org' and code = '48018-6').exists()).exists()

Snapshot-AnsichtView

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	MII_PR_MTB_Molekularer_Biomarker	Measurements and simple assertions Constraints: obs-6, obs-7, mii-mtb-ish-1
id	Σ	0..1	id	Logical id of this artifact
meta	SΣ	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	Version specific identifier
lastUpdated	Σ	0..1	instant	When the resource version last changed
source	Σ	0..1	uri	Identifies where the resource comes from
profile	SΣ	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".
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
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
identifier	SΣ	0..1	Identifier	Identifier zur Abgrenzung anderer gleichartiger Untersuchungen
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	?!Σ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category	S	2..*	CodeableConcept	Kategorie Slice: Unordered, Open by value:coding Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:labCategory		1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
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	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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	Σ	0..1	string	Plain text representation of the concept
category:mbCategory		1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
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	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: biomarker-category
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
category:geCategory		0..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
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	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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/v2-0074
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: GE
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
code	SΣ	1..1	CodeableConcept	Code für In Situ Hybridization Untersuchung Binding: MII VS Molekulare Biomarker (extensible)
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	Code defined by a terminology system Slice: Unordered, Open by pattern:$this
coding:generisch	SΣ	1..1	Coding	Generischer ISH Code Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 51864006
display		1..1	string	Representation defined by the system Fixed Value: Nucleic acid hybridization, function (observable entity)
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
subject	SΣ	0..1	Reference(Patient | Group)	Patient
focus	SΣ	0..*	Reference(MII PR Onkologie Diagnose Primärtumor)	What the observation is about, when it is not about the subject of record
encounter	SΣ	0..1	Reference(Encounter)	Kontakt
effective[x]	SΣ	0..1		Zeitpunkt der Beobachtung
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
issued	SΣ	0..1	instant	Freigabedatum
performer	Σ	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
Slices for value[x]	SΣC	0..1		Actual result Slice: Unordered, Open by type:$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	Quantitatives Ergebnis (z.B. Signalanzahl)
value[x]:valueRatio	SΣC	0..1	Ratio	Ratio-Ergebnis (z.B. HER2/CEP17)
value[x]:valueCodeableConcept	SΣC	0..1	CodeableConcept	Kategorisches Ergebnis (z.B. positiv/negativ)
dataAbsentReason	C	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation	S	0..*	CodeableConcept	Interpretation Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note		0..*	Annotation	Comments about the observation
bodySite		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method	S	1..1	CodeableConcept	FISH | CISH | SISH Binding: MII VS MTB ISH Method (extensible)
specimen		0..1	Reference(Specimen)	Specimen used for this observation
device		0..1	Reference(Device | DeviceMetric)	(Measurement) Device
referenceRange	C	0..*	BackboneElement	Provides guide for interpretation 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	C	0..1	SimpleQuantity	Low Range, if relevant
high	C	0..1	SimpleQuantity	High Range, if relevant
type		0..1	CodeableConcept	Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo		0..*	CodeableConcept	Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age		0..1	Range	Applicable age range, if relevant
text		0..1	string	Text based reference range in an observation
hasMember	Σ	0..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	Related resource that belongs to the Observation group
Slices for derivedFrom	SΣ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Abgeleitet von Slice: Unordered, Open by profile:resolve()
derivedFrom:variant	Σ	0..*	Reference(MII PR MolGen Variante)	Variant the biomarker is derived from
derivedFrom:genotype	Σ	0..*	Reference(Genotype)	Genotype the biomarker is derived from
derivedFrom:haplotype	Σ	0..*	Reference(Haplotype)	Haplotype the biomarker is derived from
Slices for component	SΣ	0..*	BackboneElement	Komponenten Slice: Unordered, Open by value:code
component: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
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
component:gene-studied	SΣ	0..*	BackboneElement
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	48018-6 Binding: LOINCCodes (example): Codes identifying names of simple observations. 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://loinc.org
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 48018-6
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
value[x]	Σ	1..1	CodeableConcept	The HGNC gene symbol is to be used as display text and the HGNC gene ID used as the code. If no HGNC code issued for this gene yet, NCBI gene IDs SHALL be used. Binding: HUGO Gene Nomenclature Committee Gene Names (HGNC) (extensible)
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
component:biomarker-category	SΣ	0..*	BackboneElement	Biomarker-Kategorie
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. 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://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: biomarker-category
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
value[x]	Σ	1..1	CodeableConcept	cell receptor | antigen | protein | immune stain Binding: Molecular Biomarker Categories (example)
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.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.category:labCategory	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.category:mbCategory	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.category:geCategory	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.code	Base	extensible	MII VS Molekulare Biomarker	📦2027.0.0-ballot.1	This IG
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	MII VS MTB ISH Method	📦2027.0.0-ballot.1	This IG
Observation.referenceRange.​type	Base	preferred	Observation Reference Range Meaning Codes	📦4.0.1	FHIR Std.
Observation.referenceRange.​appliesTo	Base	example	Observation Reference Range Applies To Codes	📦4.0.1	FHIR Std.
Observation.component.​code	Base	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.component.​dataAbsentReason	Base	extensible	DataAbsentReason	📦4.0.1	FHIR Std.
Observation.component.​interpretation	Base	extensible	Observation Interpretation Codes	📦4.0.1	FHIR Std.
Observation.component:gene-studied.​code	Base	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.component:gene-studied.​value[x]	Base	extensible	HUGO Gene Nomenclature Committee Gene Names (HGNC)	📦3.0.0	Genomics Reporting Implementation Guide v3.0
Observation.component:gene-studied.​dataAbsentReason	Base	extensible	DataAbsentReason	📦4.0.1	FHIR Std.
Observation.component:gene-studied.​interpretation	Base	extensible	Observation Interpretation Codes	📦4.0.1	FHIR Std.
Observation.component:biomarker-category.​code	Base	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.component:biomarker-category.​value[x]	Base	example	Molecular Biomarker Categories	📦3.0.0	Genomics Reporting Implementation Guide v3.0
Observation.component:biomarker-category.​dataAbsentReason	Base	extensible	DataAbsentReason	📦4.0.1	FHIR Std.
Observation.component:biomarker-category.​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()
mii-mtb-ish-1	error	Observation	Entweder muss ein spezifischer Code oder gene-studied angegeben werden (Either a specific code or gene-studied must be provided)	code.coding.where(system != 'http://snomed.info/sct' or code != '51864006').exists() or component.where(code.coding.where(system = 'http://loinc.org' and code = '48018-6').exists()).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()

Diese Struktur ist abgeleitet von MII_PR_MTB_Molekularer_Biomarker

Summary

Mandatory: 3 elements
Must-Support: 9 elements

Structures

This structure refers to these other structures:

• MII PR Onkologie Diagnose Primärtumor (https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-diagnose-primaertumor)

Slices

This structure defines the following Slices:

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