MIO Laborbefund
Version 1.0.0-update - ci-build

Resource Profile: KBV_PR_MIO_LAB_Substance - Detailed Descriptions

Draft as of 2026-06-11

Definitions for the KBV-PR-MIO-LAB-Substance resource profile.

Guidance on how to interpret the contents of this table can be foundhere

0. Substance
Definition

Hier wird eine Substanz abgebildet, die bei der Probenverarbeitung als Zusatz hinzugefügt wird.


A homogeneous material with a definite composition.

ShortA homogeneous material with a definite composition
Control0..*
Is Modifierfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. Substance.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

ShortMetadata about the resource
Control0..1
TypeMeta
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Substance.meta.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..01
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
6. Substance.meta.versionId
Definition

The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

ShortVersion specific identifier
Comments

The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

Control0..1
Typeid
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. Substance.meta.lastUpdated
Definition

When the resource last changed - e.g. when the version changed.

ShortWhen the resource version last changed
Comments

This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

Control0..1
Typeinstant
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Substance.meta.source
Definition

A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.


A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

ShortIdentifies where the resource comes from
Comments

In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used.

This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

Control0..01
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Substance.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Control0..01
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Substance.language
Definition

The base language in which the resource is written.

ShortLanguage of the resource content
Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

Control0..01
BindingThe codes SHOULD be taken from CommonLanguageshttp://hl7.org/fhir/ValueSet/languages|4.0.1
(preferred to http://hl7.org/fhir/ValueSet/languages|4.0.1)

A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. Substance.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

ShortContained, inline Resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

Control0..0*
TypeResource
Is Modifierfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
18. Substance.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
20. Substance.identifier
Definition

Unique identifier for the substance.

ShortUnique identifier
Comments

This identifier is associated with the kind of substance in contrast to the Substance.instance.identifier which is associated with the package/container.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..0*
TypeIdentifier
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Substance.status
Definition

A code to indicate if the substance is actively used.

Shortactive | inactive | entered-in-error
Control0..01
BindingThe codes SHALL be taken from FHIRSubstanceStatushttp://hl7.org/fhir/ValueSet/substance-status|4.0.1
(required to http://hl7.org/fhir/ValueSet/substance-status|4.0.1)

A code to indicate if the substance is actively used.

Typecode
Is Modifiertrue because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. Substance.category
Definition

A code that classifies the general type of substance. This is used for searching, sorting and display purposes.

ShortWhat class/type of substance this is
Comments

The level of granularity is defined by the category concepts in the value set. More fine-grained filtering can be performed using the metadata and/or terminology hierarchy in Substance.code.

Control0..0*
BindingUnless not suitable, these codes SHALL be taken from SubstanceCategoryCodeshttp://hl7.org/fhir/ValueSet/substance-category|4.0.1
(extensible to http://hl7.org/fhir/ValueSet/substance-category|4.0.1)

Category or classification of substance.

TypeCodeableConcept
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. Substance.code
Definition

In diesem Element werden Angaben zu Additiva in Form einer Codierung gemacht. Diese werden als codierte Information und/oder als Freitext angegeben.


A code (or set of codes) that identify this substance.

ShortWhat substance this is
Comments

This could be a reference to an externally defined code. It could also be a locally assigned code (e.g. a formulary), optionally with translations to the standard drug codes.

Control1..1
BindingFor example codes, see SubstanceCodehttp://hl7.org/fhir/ValueSet/substance-code|4.0.1
(example to http://hl7.org/fhir/ValueSet/substance-code|4.0.1)

Substance codes.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. Substance.code.coding
Definition

Angabe der Probenzusätze bei der Probenweiterverarbeitung als codierte Information.


A reference to a code defined by a terminology system.

ShortCode defined by a terminology system
Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Control0..*
BindingThe codes SHOULD be taken from For codes, see Specimen Additive
(preferred to http://hl7.eu/fhir/laboratory/ValueSet/lab-specimenAdditive-eu-lab)
TypeCoding
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. Substance.code.coding.system
Definition

The identification of the code system that defines the meaning of the symbol in the code.

ShortIdentity of the terminology system
Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

Control10..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

Need to be unambiguous about the source of the definition of the symbol.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. Substance.code.coding.version
Definition

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

ShortVersion of the system - if relevant
Comments

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

NoteThis is a business version Id, not a resource version Id (see discussion)
Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. Substance.code.coding.code
Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

ShortSymbol in syntax defined by the system
Control10..1
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

Need to refer to a particular code in the system.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. Substance.code.coding.display
Definition

A representation of the meaning of the code in the system, following the rules of the system.

ShortRepresentation defined by the system
Control10..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. Substance.code.coding.userSelected
Definition

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

ShortIf this coding was chosen directly by the user
Comments

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

Control0..01
Typeboolean
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. Substance.code.text
Definition

Angabe der Probenzusätze bei der Probenweiterverarbeitung als Freitext.


A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

ShortPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. Substance.description
Definition

A description of the substance - its appearance, handling requirements, and other usage notes.

ShortTextual description of the substance, comments
Control0..01
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. Substance.instance
Definition

Substance may be used to describe a kind of substance, or a specific package/container of the substance: an instance.

ShortIf this describes a specific package/container of the substance
Control0..0*
TypeBackboneElement
Is Modifierfalse
Summarytrue
Meaning if MissingIf this element is not present, then the substance resource describes a kind of substance
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
47. Substance.ingredient
Definition

A substance can be composed of other substances.

ShortComposition information about the substance
Control0..0*
TypeBackboneElement
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be foundhere

0. Substance
Definition

Hier wird eine Substanz abgebildet, die bei der Probenverarbeitung als Zusatz hinzugefügt wird.

2. Substance.meta
Must Supporttrue
4. Substance.meta.id
Control0..0
6. Substance.meta.versionId
Must Supporttrue
8. Substance.meta.lastUpdated
Must Supporttrue
10. Substance.meta.source
Control0..0
12. Substance.implicitRules
Control0..0
14. Substance.language
Control0..0
16. Substance.text
18. Substance.text.status
Pattern Valueextensions
20. Substance.contained
Control0..0
22. Substance.identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..0
24. Substance.status
Control0..0
26. Substance.category
Control0..0
28. Substance.code
Definition

In diesem Element werden Angaben zu Additiva in Form einer Codierung gemacht. Diese werden als codierte Information und/oder als Freitext angegeben.

Must Supporttrue
30. Substance.code.coding
Definition

Angabe der Probenzusätze bei der Probenweiterverarbeitung als codierte Information.

BindingThe codes SHOULD be taken from Specimen Additive
(preferred to http://hl7.eu/fhir/laboratory/ValueSet/lab-specimenAdditive-eu-lab)
Must Supporttrue
32. Substance.code.coding.system
Control1..?
Must Supporttrue
34. Substance.code.coding.version
NoteThis is a business version Id, not a resource version Id (see discussion)
Must Supporttrue
36. Substance.code.coding.code
Control1..?
Must Supporttrue
38. Substance.code.coding.display
Control1..?
Must Supporttrue
40. Substance.code.coding.userSelected
Control0..0
42. Substance.code.text
Definition

Angabe der Probenzusätze bei der Probenweiterverarbeitung als Freitext.

Must Supporttrue
44. Substance.description
Control0..0
46. Substance.instance
Control0..0
48. Substance.ingredient
Control0..0

Guidance on how to interpret the contents of this table can be foundhere

0. Substance
Definition

Hier wird eine Substanz abgebildet, die bei der Probenverarbeitung als Zusatz hinzugefügt wird.

ShortA homogeneous material with a definite composition
Control0..*
Is Modifierfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. Substance.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

ShortLogical id of this artifact
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

Control0..1
Typeid
Is Modifierfalse
Summarytrue
4. Substance.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

ShortMetadata about the resource
Control0..1
TypeMeta
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Substance.meta.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..0
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
8. Substance.meta.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Substance.meta.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 10. Substance.meta.versionId
    Definition

    The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

    ShortVersion specific identifier
    Comments

    The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

    Control0..1
    Typeid
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    12. Substance.meta.lastUpdated
    Definition

    When the resource last changed - e.g. when the version changed.

    ShortWhen the resource version last changed
    Comments

    This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

    Control0..1
    Typeinstant
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    14. Substance.meta.source
    Definition

    A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

    ShortIdentifies where the resource comes from
    Comments

    In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used.

    This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

    Control0..0
    Typeuri
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    16. Substance.meta.profile
    Definition

    A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

    ShortProfiles this resource claims to conform to
    Comments

    It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

    Control0..*
    Typecanonical(StructureDefinition)
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    18. Substance.meta.security
    Definition

    Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

    ShortSecurity Labels applied to this resource
    Comments

    The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

    Control0..*
    BindingUnless not suitable, these codes SHALL be taken from All Security Labels
    (extensible to http://hl7.org/fhir/ValueSet/security-labels|4.0.1)

    Security Labels from the Healthcare Privacy and Security Classification System.

    TypeCoding
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    20. Substance.meta.tag
    Definition

    Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

    ShortTags applied to this resource
    Comments

    The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

    Control0..*
    BindingFor example codes, see CommonTags
    (example to http://hl7.org/fhir/ValueSet/common-tags|4.0.1)

    Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

    TypeCoding
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    22. Substance.implicitRules
    Definition

    A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

    ShortA set of rules under which this content was created
    Comments

    Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

    Control0..0
    Typeuri
    Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    24. Substance.language
    Definition

    The base language in which the resource is written.

    ShortLanguage of the resource content
    Comments

    Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

    Control0..0
    BindingThe codes SHOULD be taken from CommonLanguages
    (preferred to http://hl7.org/fhir/ValueSet/languages|4.0.1)

    A human language.

    Additional BindingsPurpose
    AllLanguagesMax Binding
    Typecode
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    26. Substance.text
    Definition

    A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

    ShortText summary of the resource, for human interpretation
    Comments

    Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

    Control0..1
    TypeNarrative
    Is Modifierfalse
    Summaryfalse
    Alternate Namesnarrative, html, xhtml, display
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    28. Substance.text.id
    Definition

    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

    ShortUnique id for inter-element referencing
    Control0..1
    Typestring
    Is Modifierfalse
    XML FormatIn the XML format, this property is represented as an attribute.
    Summaryfalse
    30. Substance.text.extension
    Definition

    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

    ShortAdditional content defined by implementations
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    SlicingThis element introduces a set of slices on Substance.text.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 32. Substance.text.status
      Definition

      The status of the narrative - whether it's entirely generated (from just the defined data or the extensions too), or whether a human authored it and it may contain additional data.

      Shortgenerated | extensions | additional | empty
      Control1..1
      BindingThe codes SHALL be taken from NarrativeStatus
      (required to http://hl7.org/fhir/ValueSet/narrative-status|4.0.1)

      The status of a resource narrative.

      Typecode
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summaryfalse
      Pattern Valueextensions
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      34. Substance.text.div
      Definition

      The actual narrative content, a stripped down version of XHTML.

      ShortLimited xhtml content
      Comments

      The contents of the html element are an XHTML fragment containing only the basic html formatting elements described in chapters 7-11 and 15 of the HTML 4.0 standard, <a> elements (either name or href), images and internally contained stylesheets. The XHTML content SHALL NOT contain a head, a body, external stylesheet references, scripts, forms, base/link/xlink, frames, iframes and objects.

      Control1..1
      Typexhtml
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      txt-1: The narrative SHALL contain only the basic html formatting elements and attributes described in chapters 7-11 (except section 4 of chapter 9) and 15 of the HTML 4.0 standard, <a> elements (either name or href), images and internally contained style attributes (htmlChecks())
      txt-2: The narrative SHALL have some non-whitespace content (htmlChecks())
      36. Substance.contained
      Definition

      These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

      ShortContained, inline Resources
      Comments

      This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

      Control0..0
      TypeResource
      Is Modifierfalse
      Summaryfalse
      Alternate Namesinline resources, anonymous resources, contained resources
      38. Substance.extension
      Definition

      May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

      ShortAdditional content defined by implementations
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      40. Substance.modifierExtension
      Definition

      May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

      ShortExtensions that cannot be ignored
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
      Summaryfalse
      Requirements

      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      42. Substance.identifier
      Definition

      Unique identifier for the substance.

      ShortUnique identifier
      Comments

      This identifier is associated with the kind of substance in contrast to the Substance.instance.identifier which is associated with the package/container.

      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..0
      TypeIdentifier
      Is Modifierfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      44. Substance.status
      Definition

      A code to indicate if the substance is actively used.

      Shortactive | inactive | entered-in-error
      Control0..0
      BindingThe codes SHALL be taken from FHIRSubstanceStatus
      (required to http://hl7.org/fhir/ValueSet/substance-status|4.0.1)

      A code to indicate if the substance is actively used.

      Typecode
      Is Modifiertrue because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      46. Substance.category
      Definition

      A code that classifies the general type of substance. This is used for searching, sorting and display purposes.

      ShortWhat class/type of substance this is
      Comments

      The level of granularity is defined by the category concepts in the value set. More fine-grained filtering can be performed using the metadata and/or terminology hierarchy in Substance.code.

      Control0..0
      BindingUnless not suitable, these codes SHALL be taken from SubstanceCategoryCodes
      (extensible to http://hl7.org/fhir/ValueSet/substance-category|4.0.1)

      Category or classification of substance.

      TypeCodeableConcept
      Is Modifierfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      48. Substance.code
      Definition

      In diesem Element werden Angaben zu Additiva in Form einer Codierung gemacht. Diese werden als codierte Information und/oder als Freitext angegeben.

      ShortWhat substance this is
      Comments

      This could be a reference to an externally defined code. It could also be a locally assigned code (e.g. a formulary), optionally with translations to the standard drug codes.

      Control1..1
      BindingFor example codes, see SubstanceCode
      (example to http://hl7.org/fhir/ValueSet/substance-code|4.0.1)

      Substance codes.

      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      50. Substance.code.id
      Definition

      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

      ShortUnique id for inter-element referencing
      Control0..1
      Typestring
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      52. Substance.code.extension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

      ShortAdditional content defined by implementations
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      SlicingThis element introduces a set of slices on Substance.code.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 54. Substance.code.coding
        Definition

        Angabe der Probenzusätze bei der Probenweiterverarbeitung als codierte Information.

        ShortCode defined by a terminology system
        Comments

        Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

        Control0..*
        BindingThe codes SHOULD be taken from Specimen Additive
        (preferred to http://hl7.eu/fhir/laboratory/ValueSet/lab-specimenAdditive-eu-lab)
        TypeCoding
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Requirements

        Allows for alternative encodings within a code system, and translations to other code systems.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        56. Substance.code.coding.id
        Definition

        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

        ShortUnique id for inter-element referencing
        Control0..1
        Typestring
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        58. Substance.code.coding.extension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

        ShortAdditional content defined by implementations
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        SlicingThis element introduces a set of slices on Substance.code.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 60. Substance.code.coding.system
          Definition

          The identification of the code system that defines the meaning of the symbol in the code.

          ShortIdentity of the terminology system
          Comments

          The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

          Control1..1
          Typeuri
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supporttrue
          Summarytrue
          Requirements

          Need to be unambiguous about the source of the definition of the symbol.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          62. Substance.code.coding.version
          Definition

          The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

          ShortVersion of the system - if relevant
          Comments

          Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

          NoteThis is a business version Id, not a resource version Id (see discussion)
          Control0..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          64. Substance.code.coding.code
          Definition

          A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

          ShortSymbol in syntax defined by the system
          Control1..1
          Typecode
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supporttrue
          Summarytrue
          Requirements

          Need to refer to a particular code in the system.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          66. Substance.code.coding.display
          Definition

          A representation of the meaning of the code in the system, following the rules of the system.

          ShortRepresentation defined by the system
          Control1..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supporttrue
          Summarytrue
          Requirements

          Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          68. Substance.code.coding.userSelected
          Definition

          Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

          ShortIf this coding was chosen directly by the user
          Comments

          Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

          Control0..0
          Typeboolean
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          70. Substance.code.text
          Definition

          Angabe der Probenzusätze bei der Probenweiterverarbeitung als Freitext.

          ShortPlain text representation of the concept
          Comments

          Very often the text is the same as a displayName of one of the codings.

          Control0..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supporttrue
          Summarytrue
          Requirements

          The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          72. Substance.description
          Definition

          A description of the substance - its appearance, handling requirements, and other usage notes.

          ShortTextual description of the substance, comments
          Control0..0
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          74. Substance.instance
          Definition

          Substance may be used to describe a kind of substance, or a specific package/container of the substance: an instance.

          ShortIf this describes a specific package/container of the substance
          Control0..0
          TypeBackboneElement
          Is Modifierfalse
          Summarytrue
          Meaning if MissingIf this element is not present, then the substance resource describes a kind of substance
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          82. Substance.ingredient
          Definition

          A substance can be composed of other substances.

          ShortComposition information about the substance
          Control0..0
          TypeBackboneElement
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))