MII IG Kerndatensatz-Modul Biobank
2027.0.0-ballot - Germany

This page is part of the MII IG Kerndatensatz-Modul Biobank (v2027.0.0-ballot: 2027 Ballot 1) based on FHIR (HL7® FHIR® Standard) R4. No current official version has been published yet. For a full list of available versions, see the Directory of published versions

Resource Profile: MII PR Biobank Substance Additiv

Official URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-biobank/StructureDefinition/Substance Version: 2027.0.0-ballot
Active as of 2026-09-10 Computable Name: MII_PR_Biobank_Substance_Additiv

Representation of an additive that can be added to a specimen

Content

A Substance resource represents an additive.

Examples

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots, and their representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Substance 0..* Substance A homogeneous material with a definite composition
... id SΣ 0..1 id Logical id of this artifact
... meta SΣ 0..1 Meta Metadata about the resource
.... source SΣ 0..1 uri Identifies where the resource comes from
.... 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
... status ?!Σ 0..1 code active | inactive | entered-in-error
Binding: FHIRSubstanceStatus (required): A code to indicate if the substance is actively used.
... category SΣ 0..* CodeableConcept What class/type of substance this is
Binding: SubstanceCategoryCodes (extensible): Category or classification of substance.
... code SΣ 1..1 CodeableConcept What substance this is
Binding: MII VS Biobank Substance Additive (extensible)
... ingredient SΣ 0..* BackboneElement Composition information about the substance
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... substance[x] Σ 1..1 A component of the substance
Binding: SubstanceCode (example): Substance Ingredient codes.
..... substanceCodeableConcept CodeableConcept
..... substanceReference Reference(Substance)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Substance.status Base required FHIRSubstanceStatus 📍4.0.1 FHIR Std.
Substance.category Base extensible Substance Category Codes 📍4.0.1 FHIR Std.
Substance.code Base extensible MII VS Biobank Substance Additive 📦2027.0.0-ballot This IG
Substance.ingredient.​substance[x] Base example Substance Code 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Substance If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Substance 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 Substance 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 Substance If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Substance 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()

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Substance 0..* Substance A homogeneous material with a definite composition
... id S 0..1 id Logical id of this artifact
... meta S 0..1 Meta Metadata about the resource
.... source S 0..1 uri Identifies where the resource comes from
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... category S 0..* CodeableConcept What class/type of substance this is
... ingredient S 0..* BackboneElement Composition information about the substance

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Substance.code Base extensible MII VS Biobank Substance Additive 📦2027.0.0-ballot This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Substance 0..* Substance A homogeneous material with a definite composition
... id SΣ 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 SΣ 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
... 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 Σ 0..* Identifier Unique identifier
... status ?!Σ 0..1 code active | inactive | entered-in-error
Binding: FHIRSubstanceStatus (required): A code to indicate if the substance is actively used.
... category SΣ 0..* CodeableConcept What class/type of substance this is
Binding: SubstanceCategoryCodes (extensible): Category or classification of substance.
... code SΣ 1..1 CodeableConcept What substance this is
Binding: MII VS Biobank Substance Additive (extensible)
... description Σ 0..1 string Textual description of the substance, comments
... instance Σ 0..* BackboneElement If this describes a specific package/container of the substance
.... 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
.... identifier Σ 0..1 Identifier Identifier of the package/container
.... expiry Σ 0..1 dateTime When no longer valid to use
.... quantity Σ 0..1 SimpleQuantity(4.0.1) Amount of substance in the package
... ingredient SΣ 0..* BackboneElement Composition information about the substance
.... 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
.... quantity Σ 0..1 Ratio Optional amount (concentration)
.... substance[x] Σ 1..1 A component of the substance
Binding: SubstanceCode (example): Substance Ingredient codes.
..... substanceCodeableConcept CodeableConcept
..... substanceReference Reference(Substance)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Substance.meta.security Base extensible SecurityLabels 📍4.0.1 FHIR Std.
Substance.meta.tag Base example Common Tags 📍4.0.1 FHIR Std.
Substance.language Base preferred Common Languages 📍4.0.1 FHIR Std.
Substance.status Base required FHIRSubstanceStatus 📍4.0.1 FHIR Std.
Substance.category Base extensible Substance Category Codes 📍4.0.1 FHIR Std.
Substance.code Base extensible MII VS Biobank Substance Additive 📦2027.0.0-ballot This IG
Substance.ingredient.​substance[x] Base example Substance Code 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Substance If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Substance 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 Substance 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 Substance If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Substance 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()

Summary

Must-Support: 7 elements

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Substance 0..* Substance A homogeneous material with a definite composition
... id SΣ 0..1 id Logical id of this artifact
... meta SΣ 0..1 Meta Metadata about the resource
.... source SΣ 0..1 uri Identifies where the resource comes from
.... 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
... status ?!Σ 0..1 code active | inactive | entered-in-error
Binding: FHIRSubstanceStatus (required): A code to indicate if the substance is actively used.
... category SΣ 0..* CodeableConcept What class/type of substance this is
Binding: SubstanceCategoryCodes (extensible): Category or classification of substance.
... code SΣ 1..1 CodeableConcept What substance this is
Binding: MII VS Biobank Substance Additive (extensible)
... ingredient SΣ 0..* BackboneElement Composition information about the substance
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... substance[x] Σ 1..1 A component of the substance
Binding: SubstanceCode (example): Substance Ingredient codes.
..... substanceCodeableConcept CodeableConcept
..... substanceReference Reference(Substance)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Substance.status Base required FHIRSubstanceStatus 📍4.0.1 FHIR Std.
Substance.category Base extensible Substance Category Codes 📍4.0.1 FHIR Std.
Substance.code Base extensible MII VS Biobank Substance Additive 📦2027.0.0-ballot This IG
Substance.ingredient.​substance[x] Base example Substance Code 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Substance If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Substance 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 Substance 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 Substance If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Substance 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()

Differential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Substance 0..* Substance A homogeneous material with a definite composition
... id S 0..1 id Logical id of this artifact
... meta S 0..1 Meta Metadata about the resource
.... source S 0..1 uri Identifies where the resource comes from
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... category S 0..* CodeableConcept What class/type of substance this is
... ingredient S 0..* BackboneElement Composition information about the substance

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Substance.code Base extensible MII VS Biobank Substance Additive 📦2027.0.0-ballot This IG

Snapshot ViewView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Substance 0..* Substance A homogeneous material with a definite composition
... id SΣ 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 SΣ 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
... 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 Σ 0..* Identifier Unique identifier
... status ?!Σ 0..1 code active | inactive | entered-in-error
Binding: FHIRSubstanceStatus (required): A code to indicate if the substance is actively used.
... category SΣ 0..* CodeableConcept What class/type of substance this is
Binding: SubstanceCategoryCodes (extensible): Category or classification of substance.
... code SΣ 1..1 CodeableConcept What substance this is
Binding: MII VS Biobank Substance Additive (extensible)
... description Σ 0..1 string Textual description of the substance, comments
... instance Σ 0..* BackboneElement If this describes a specific package/container of the substance
.... 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
.... identifier Σ 0..1 Identifier Identifier of the package/container
.... expiry Σ 0..1 dateTime When no longer valid to use
.... quantity Σ 0..1 SimpleQuantity(4.0.1) Amount of substance in the package
... ingredient SΣ 0..* BackboneElement Composition information about the substance
.... 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
.... quantity Σ 0..1 Ratio Optional amount (concentration)
.... substance[x] Σ 1..1 A component of the substance
Binding: SubstanceCode (example): Substance Ingredient codes.
..... substanceCodeableConcept CodeableConcept
..... substanceReference Reference(Substance)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Substance.meta.security Base extensible SecurityLabels 📍4.0.1 FHIR Std.
Substance.meta.tag Base example Common Tags 📍4.0.1 FHIR Std.
Substance.language Base preferred Common Languages 📍4.0.1 FHIR Std.
Substance.status Base required FHIRSubstanceStatus 📍4.0.1 FHIR Std.
Substance.category Base extensible Substance Category Codes 📍4.0.1 FHIR Std.
Substance.code Base extensible MII VS Biobank Substance Additive 📦2027.0.0-ballot This IG
Substance.ingredient.​substance[x] Base example Substance Code 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Substance If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Substance 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 Substance 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 Substance If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Substance 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()

Summary

Must-Support: 7 elements

 

Other representations of profile: CSV, Excel, Schematron