Description

Immunohistochemistry profile for phosphorylation stains.

Content

This profile describes the IHC finding that detects a protein specifically in its phosphorylated form. There are currently no internationally recognized HL7 specifications for the precise and harmonized representation of post-translational modifications.

This profile is therefore intended to provide a first concept for the generalized representation of post-translational modifications, using phosphorylation as an example. In simplified form, phosphorylated proteins are frequently denoted with the prefix p-, e.g. p-AKT.

This coding may be implicitly understandable in everyday clinical-pathological practice and in standardized diagnostic workflows. However, if the information comes from a pathology system in this form, it is not evident downstream (for DIC staff, researchers, etc.) at which position a phosphorylation is present. Therefore, with the dnpm coding, a precise indication of a phosphorylation site is not possible.

Example: The gene Rb-1 has, with serine, a possible phosphorylation site at position 949 (see the p-RB page on UniProt, under the section PRTM/Processing https://www.uniprot.org/uniprotkb/Q13733/entry). The proteins AKT1, AKT2, and AKT3, on the other hand, have two potential phosphorylation sites that are activated by different enzymes: Thr308 and Ser473, whereby a negative prognosis exists in particular for the detection of the latter mutation.

Several approaches exist for nevertheless distinguishing it from the non-phosphorylated version. For details, refer to the discussion of post-translational modifications on the UniProt page https://www.uniprot.org/help/mod_res:

• Specification of the antibody clone for unambiguous identification of the antibody product used (e.g. via https://www.cellsignal.com/learn-and-support/phosphositeplus-ptm-database or comparable databases)

• Representation of the altered spatial structure of the protein via UniProt
• Reference to a preceding activity

MOD

Content

Mapping of the data set to FHIR

Search parameters

The following search parameters are relevant for the Oncology module, including in combination:

1. The search parameter "_id" MUST be supported:

   Examples:

   GET [base]/Observation?_id=12345

   Usage notes: Further information on searching by "_id" can be found in the FHIR base specification - section "Parameters for all resources".

2. The search parameter "code" MUST be supported:

   Examples:

   GET [base]/Observation?code=http://snomed.info/sct|1234806008

   Usage notes: Further information on searching by "code" can be found in the FHIR base specification - section "token".

3. The search parameter "focus" MUST be supported:

   Examples:

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

   Usage notes: Further information on searching by "focus" can be found in the FHIR base specification - section "reference".

4. The search parameter "interpretation" MUST be supported:

   Examples:

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

   Usage notes: Further information on searching by "interpretation" can be found in the FHIR base specification - section "token".

5. The search parameter "specimen" MUST be supported:

   Examples:

   GET [base]/Observation?specimen=Specimen/1234

   Usage notes: Further information on searching by "specimen" can be found in the FHIR base specification - section "reference".

Examples

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	MII_PR_MTB_Immunohistochemistry	Measurements and simple assertions Constraints: obs-6, obs-7, mii-mtb-ihc-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..*	Identifier	Business Identifier for observation
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 for immunohistochemical examination Binding: MII VS Molekulare Biomarker (extensible)
Slices for coding	SΣ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:$this
coding:generisch	SΣ	1..1	Coding	Generic immunohistochemical examination code Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 1234806008
display		1..1	string	Representation defined by the system Fixed Value: Observation using immunohistochemistry (observable entity)
userSelected		0..1	boolean	If this coding was chosen directly by the user
subject	SΣ	0..1	Reference(Patient | Group)	Patient
focus	SΣ	0..*	Reference(MII PR Onkologie Diagnose Primärtumor | MII PR MTB Diagnose Primärtumor)	What the observation is about, when it is not about the subject of record
encounter	SΣ	0..1	Reference(Encounter)	Kontakt
effective[x]	SΣ	0..1		Zeitpunkt der Beobachtung
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
issued	SΣ	0..1	instant	Freigabedatum
Slices for value[x]	SΣC	0..1		Actual result Slice: Unordered, Open by type:$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]:valueCodeableConcept	SΣC	0..1	CodeableConcept	Result of the immunohistochemical examination
interpretation	S	0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
specimen	S	0..1	Reference(Specimen)	Block / Material ID of the specimen
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..1	BackboneElement	Untersuchtes Gen
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)
component:phosphorylation-localization	SΣ	0..*	BackboneElement	Komponenten
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	SΣ	1..1	CodeableConcept	Phosphorylation localization Binding: LOINCCodes (example): Codes identifying names of simple observations.
Slices for value[x]	Σ	1..1	CodeableConcept	Actual component result Slice: Unordered, Closed by type:$this
Slices for value[x]				Content/Rules for all slices
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Phosphorylation localization
component:protein-isoform	SΣ	0..1	BackboneElement	Komponenten
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.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
Observation.component:phosphorylation-localization.​code	Base	example	LOINC 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-ihc-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 != '1234806008').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()

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation		0..*	MII_PR_MTB_Immunohistochemistry	Measurements and simple assertions
Slices for component				Content/Rules for all slices
component:phosphorylation-localization	S	0..*	BackboneElement	Komponenten
code	S	1..1	CodeableConcept	Phosphorylation localization
Slices for value[x]		1..1	CodeableConcept	Actual component result Slice: Unordered, Open by type:$this
Slices for value[x]				Content/Rules for all slices
value[x]:valueCodeableConcept	S	1..1	CodeableConcept	Phosphorylation localization
component:protein-isoform	S	0..1	BackboneElement	Komponenten
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	MII_PR_MTB_Immunohistochemistry	Measurements and simple assertions Constraints: obs-6, obs-7, mii-mtb-ihc-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..*	Identifier	Business Identifier for observation
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 for immunohistochemical examination 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:$this
coding:generisch	SΣ	1..1	Coding	Generic immunohistochemical examination code Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 1234806008
display		1..1	string	Representation defined by the system Fixed Value: Observation using immunohistochemistry (observable entity)
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
subject	SΣ	0..1	Reference(Patient | Group)	Patient
focus	SΣ	0..*	Reference(MII PR Onkologie Diagnose Primärtumor | MII PR MTB Diagnose Primärtumor)	What the observation is about, when it is not about the subject of record
encounter	SΣ	0..1	Reference(Encounter)	Kontakt
effective[x]	SΣ	0..1		Zeitpunkt der Beobachtung
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
issued	SΣ	0..1	instant	Freigabedatum
performer	Σ	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
Slices for value[x]	SΣC	0..1		Actual result Slice: Unordered, Open by type:$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]:valueCodeableConcept	SΣC	0..1	CodeableConcept	Result of the immunohistochemical examination
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	High, low, normal, etc. 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		0..1	CodeableConcept	How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen	S	0..1	Reference(Specimen)	Block / Material ID of the specimen
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..1	BackboneElement	Untersuchtes Gen
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
component:phosphorylation-localization	SΣ	0..*	BackboneElement	Komponenten
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	SΣ	1..1	CodeableConcept	Phosphorylation localization Binding: LOINCCodes (example): Codes identifying names of simple observations.
Slices for value[x]	Σ	1..1	CodeableConcept	Actual component result Slice: Unordered, Closed by type:$this
Slices for value[x]				Content/Rules for all slices
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Phosphorylation localization
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:protein-isoform	SΣ	0..1	BackboneElement	Komponenten
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	example	Observation Methods	📦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.
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.
Observation.component:phosphorylation-localization.​code	Base	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.component:phosphorylation-localization.​dataAbsentReason	Base	extensible	DataAbsentReason	📦4.0.1	FHIR Std.
Observation.component:phosphorylation-localization.​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-ihc-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 != '1234806008').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()

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	MII_PR_MTB_Immunohistochemistry	Measurements and simple assertions Constraints: obs-6, obs-7, mii-mtb-ihc-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..*	Identifier	Business Identifier for observation
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 for immunohistochemical examination Binding: MII VS Molekulare Biomarker (extensible)
Slices for coding	SΣ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:$this
coding:generisch	SΣ	1..1	Coding	Generic immunohistochemical examination code Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 1234806008
display		1..1	string	Representation defined by the system Fixed Value: Observation using immunohistochemistry (observable entity)
userSelected		0..1	boolean	If this coding was chosen directly by the user
subject	SΣ	0..1	Reference(Patient | Group)	Patient
focus	SΣ	0..*	Reference(MII PR Onkologie Diagnose Primärtumor | MII PR MTB Diagnose Primärtumor)	What the observation is about, when it is not about the subject of record
encounter	SΣ	0..1	Reference(Encounter)	Kontakt
effective[x]	SΣ	0..1		Zeitpunkt der Beobachtung
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
issued	SΣ	0..1	instant	Freigabedatum
Slices for value[x]	SΣC	0..1		Actual result Slice: Unordered, Open by type:$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]:valueCodeableConcept	SΣC	0..1	CodeableConcept	Result of the immunohistochemical examination
interpretation	S	0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
specimen	S	0..1	Reference(Specimen)	Block / Material ID of the specimen
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..1	BackboneElement	Untersuchtes Gen
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)
component:phosphorylation-localization	SΣ	0..*	BackboneElement	Komponenten
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	SΣ	1..1	CodeableConcept	Phosphorylation localization Binding: LOINCCodes (example): Codes identifying names of simple observations.
Slices for value[x]	Σ	1..1	CodeableConcept	Actual component result Slice: Unordered, Closed by type:$this
Slices for value[x]				Content/Rules for all slices
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Phosphorylation localization
component:protein-isoform	SΣ	0..1	BackboneElement	Komponenten
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.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
Observation.component:phosphorylation-localization.​code	Base	example	LOINC 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-ihc-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 != '1234806008').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 View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation		0..*	MII_PR_MTB_Immunohistochemistry	Measurements and simple assertions
Slices for component				Content/Rules for all slices
component:phosphorylation-localization	S	0..*	BackboneElement	Komponenten
code	S	1..1	CodeableConcept	Phosphorylation localization
Slices for value[x]		1..1	CodeableConcept	Actual component result Slice: Unordered, Open by type:$this
Slices for value[x]				Content/Rules for all slices
value[x]:valueCodeableConcept	S	1..1	CodeableConcept	Phosphorylation localization
component:protein-isoform	S	0..1	BackboneElement	Komponenten
Documentation for this format

Snapshot ViewView

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	MII_PR_MTB_Immunohistochemistry	Measurements and simple assertions Constraints: obs-6, obs-7, mii-mtb-ihc-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..*	Identifier	Business Identifier for observation
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 for immunohistochemical examination 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:$this
coding:generisch	SΣ	1..1	Coding	Generic immunohistochemical examination code Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 1234806008
display		1..1	string	Representation defined by the system Fixed Value: Observation using immunohistochemistry (observable entity)
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
subject	SΣ	0..1	Reference(Patient | Group)	Patient
focus	SΣ	0..*	Reference(MII PR Onkologie Diagnose Primärtumor | MII PR MTB Diagnose Primärtumor)	What the observation is about, when it is not about the subject of record
encounter	SΣ	0..1	Reference(Encounter)	Kontakt
effective[x]	SΣ	0..1		Zeitpunkt der Beobachtung
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
issued	SΣ	0..1	instant	Freigabedatum
performer	Σ	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
Slices for value[x]	SΣC	0..1		Actual result Slice: Unordered, Open by type:$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]:valueCodeableConcept	SΣC	0..1	CodeableConcept	Result of the immunohistochemical examination
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	High, low, normal, etc. 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		0..1	CodeableConcept	How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen	S	0..1	Reference(Specimen)	Block / Material ID of the specimen
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..1	BackboneElement	Untersuchtes Gen
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
component:phosphorylation-localization	SΣ	0..*	BackboneElement	Komponenten
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	SΣ	1..1	CodeableConcept	Phosphorylation localization Binding: LOINCCodes (example): Codes identifying names of simple observations.
Slices for value[x]	Σ	1..1	CodeableConcept	Actual component result Slice: Unordered, Closed by type:$this
Slices for value[x]				Content/Rules for all slices
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Phosphorylation localization
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:protein-isoform	SΣ	0..1	BackboneElement	Komponenten
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	example	Observation Methods	📦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.
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.
Observation.component:phosphorylation-localization.​code	Base	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.component:phosphorylation-localization.​dataAbsentReason	Base	extensible	DataAbsentReason	📦4.0.1	FHIR Std.
Observation.component:phosphorylation-localization.​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-ihc-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 != '1234806008').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()

Summary

Mandatory: 0 element(2 nested mandatory elements)
Must-Support: 4 elements

Slices

This structure defines the following Slices:

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