At-Home In-Vitro Test Report
1.1.0 - STU 1.1 United States of America flag

This page is part of the At-Home In-Vitro Test Report (v1.1.0: STU 1) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions

Resource Profile: SpecimenAtHomeInVitroTestCovid - Detailed Descriptions

Active as of 2024-08-08

Definitions for the Specimen-at-home-in-vitro-test-covid resource profile.

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

0. Specimen
2. Specimen.type
ShortType of tissue or material. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for the COVID-19 use case.
4. Specimen.type.coding
ShortThe coded specimen type.
Control1..?
Must Supporttrue

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

0. Specimen
Definition

-


A sample to be used for analysis.

ShortSample for analysis
Comments

-

Control0..*
Is Modifierfalse
Must Supportfalse
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. Specimen.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..1
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()))
4. Specimen.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())
6. Specimen.identifier
Definition

Id for specimen.

ShortAt-Home Test Specimen identifier.External Identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. Specimen.identifier.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1
(required to http://hl7.org/fhir/ValueSet/identifier-use|4.0.1)

Identifies the purpose for this identifier, if known .

Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Specimen.status
Definition

The availability of the specimen.

Shortavailable | unavailable | unsatisfactory | entered-in-error
Comments

This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

Control0..1
BindingThe codes SHALL be taken from SpecimenStatushttp://hl7.org/fhir/ValueSet/specimen-status|4.0.1
(required to http://hl7.org/fhir/ValueSet/specimen-status|4.0.1)

Codes providing the status/availability of a specimen.

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()))
12. Specimen.type
Definition

The kind of material that forms the specimen.

ShortType of tissue or material. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for the COVID-19 use case.Kind of material that forms the specimen
Comments

The type can change the way that a specimen is handled and drives what kind of analyses can properly be performed on the specimen. It is frequently used in diagnostic work flow decision making systems.

Control10..1
BindingUnless not suitable, these codes SHALL be taken from For example codes, see Specimen type .http://terminology.hl7.org/ValueSet/v2-0487
(extensible to http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.54)
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Specimen.type.coding
Definition

A reference to a code defined by a terminology system.

ShortThe coded specimen type.Code 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.

Control10..*
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()))
16. Specimen.subject
Definition

Where the specimen came from. This may be from patient(s), from a location (e.g., the source of an environmental sample), or a sampling of a substance or a device.

ShortThe subject is the person who took the at-home test.Where the specimen came from. This may be from patient(s), from a location (e.g., the source of an environmental sample), or a sampling of a substance or a device
Control10..1
TypeReference(US Core Patient Profile, Patient, Group, Device, Substance, Location)
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Must know the subject context.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. Specimen.collection
Definition

Details concerning the specimen collection.

ShortCollection details
Control10..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Specimen.collection.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained 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 can 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 even if unrecognized
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 element that contains them
Summarytrue
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, modifiers
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())
22. Specimen.collection.collected[x]
Definition

Time when specimen was collected from subject - the physiologically relevant time.

ShortAt-Home Test Specimen collected date. V2: SPM-17.1Collection time
Control10..1
TypedateTime, Period
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
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()))

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

0. Specimen
Definition

-

ShortSample for analysis
Comments

-

Control0..*
Is Modifierfalse
Must Supportfalse
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. Specimen.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. Specimen.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
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Specimen.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..1
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()))
8. Specimen.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..1
BindingThe codes SHOULD be taken from CommonLanguages
(preferred to http://hl7.org/fhir/ValueSet/languages)

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()))
10. Specimen.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()))
12. Specimen.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..*
TypeResource
Is Modifierfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
14. Specimen.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())
16. Specimen.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())
18. Specimen.identifier
Definition

Id for specimen.

ShortAt-Home Test Specimen identifier.
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Specimen.identifier.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
22. Specimen.identifier.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 Specimen.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 24. Specimen.identifier.use
    Definition

    The purpose of this identifier.

    Shortusual | official | temp | secondary | old (If known)
    Comments

    Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

    Control0..1
    BindingThe codes SHALL be taken from IdentifierUse
    (required to http://hl7.org/fhir/ValueSet/identifier-use|4.0.1)

    Identifies the purpose for this identifier, if known .

    Typecode
    Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

    Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    26. Specimen.identifier.type
    Definition

    A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

    ShortAt-Home Test Specimen ID assigner ID type. 'ISO' V2: SPM-2.2.4
    Comments

    This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

    Control0..1
    BindingUnless not suitable, these codes SHALL be taken from Identifier Type Codes
    (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

    A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

    TypeCodeableConcept
    Is Modifierfalse
    Summarytrue
    Requirements

    Allows users to make use of identifiers when the identifier system is not known.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    28. Specimen.identifier.system
    Definition

    Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

    ShortAt-Home Specimen ID assigner ID type . See 'Obtaining App Specific Identifiers' (see Guidance->Getting Started for details). If converting FHIR to V2, must be 100 characters or less. V2: SPM-2.2.3
    Comments

    Identifier.system is always case sensitive.

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

    There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

    Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    30. Specimen.identifier.value
    Definition

    The portion of the identifier typically relevant to the user and which is unique within the context of the system.

    ShortAt-Home Test Specimen identifier. {Unique ID assigned to every test by app manufacturer} If converting FHIR to V2, must be 100 characters or less. V2: SPM-2.2.1
    Comments

    If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

    Control0..1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Example<br/><b>General</b>:123456
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    32. Specimen.identifier.period
    Definition

    Time period during which identifier is/was valid for use.

    ShortTime period when id is/was valid for use
    Control0..1
    TypePeriod
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    34. Specimen.identifier.assigner
    Definition

    Organization that issued/manages the identifier.

    ShortOrganization that issued id (may be just text)
    Comments

    The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

    Control0..1
    TypeReference(Organization)
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    36. Specimen.accessionIdentifier
    Definition

    The identifier assigned by the lab when accessioning specimen(s). This is not necessarily the same as the specimen identifier, depending on local lab procedures.

    ShortIdentifier assigned by the lab
    Control0..1
    TypeIdentifier
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    38. Specimen.status
    Definition

    The availability of the specimen.

    Shortavailable | unavailable | unsatisfactory | entered-in-error
    Comments

    This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

    Control0..1
    BindingThe codes SHALL be taken from SpecimenStatus
    (required to http://hl7.org/fhir/ValueSet/specimen-status|4.0.1)

    Codes providing the status/availability of a specimen.

    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()))
    40. Specimen.type
    Definition

    The kind of material that forms the specimen.

    ShortType of tissue or material. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for the COVID-19 use case.
    Comments

    The type can change the way that a specimen is handled and drives what kind of analyses can properly be performed on the specimen. It is frequently used in diagnostic work flow decision making systems.

    Control1..1
    BindingUnless not suitable, these codes SHALL be taken from Specimen type .
    (extensible to http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.54)
    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    42. Specimen.type.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
    44. Specimen.type.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 Specimen.type.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 46. Specimen.type.coding
      Definition

      A reference to a code defined by a terminology system.

      ShortThe coded specimen type.
      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.

      Control1..*
      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()))
      48. Specimen.type.text
      Definition

      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
      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()))
      50. Specimen.subject
      Definition

      Where the specimen came from. This may be from patient(s), from a location (e.g., the source of an environmental sample), or a sampling of a substance or a device.

      ShortThe subject is the person who took the at-home test.
      Control1..1
      TypeReference(US Core Patient Profile)
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Requirements

      Must know the subject context.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      52. Specimen.receivedTime
      Definition

      Time when specimen was received for processing or testing.

      ShortThe time when specimen was received for processing
      Control0..1
      TypedateTime
      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()))
      54. Specimen.parent
      Definition

      Reference to the parent (source) specimen which is used when the specimen was either derived from or a component of another specimen.

      ShortSpecimen from which this specimen originated
      Comments

      The parent specimen could be the source from which the current specimen is derived by some processing step (e.g. an aliquot or isolate or extracted nucleic acids from clinical samples) or one of many specimens that were combined to create a pooled sample.

      Control0..*
      TypeReference(Specimen)
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      56. Specimen.request
      Definition

      Details concerning a service request that required a specimen to be collected.

      ShortWhy the specimen was collected
      Comments

      The request may be explicit or implied such with a ServiceRequest that requires a blood draw.

      Control0..*
      TypeReference(ServiceRequest)
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      58. Specimen.collection
      Definition

      Details concerning the specimen collection.

      ShortCollection details
      Control1..1
      TypeBackboneElement
      Is Modifierfalse
      Must Supporttrue
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      60. Specimen.collection.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
      62. Specimen.collection.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())
      64. Specimen.collection.modifierExtension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained 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 can 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 even if unrecognized
      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 element that contains them
      Summarytrue
      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, modifiers
      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())
      66. Specimen.collection.collector
      Definition

      Person who collected the specimen.

      ShortWho collected the specimen
      Control0..1
      TypeReference(Practitioner, PractitionerRole)
      Is Modifierfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      68. Specimen.collection.collected[x]
      Definition

      Time when specimen was collected from subject - the physiologically relevant time.

      ShortAt-Home Test Specimen collected date. V2: SPM-17.1
      Control1..1
      TypedateTime
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      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()))
      70. Specimen.collection.duration
      Definition

      The span of time over which the collection of a specimen occurred.

      ShortHow long it took to collect specimen
      Control0..1
      TypeDuration
      Is Modifierfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      72. Specimen.collection.quantity
      Definition

      The quantity of specimen collected; for instance the volume of a blood sample, or the physical measurement of an anatomic pathology sample.

      ShortThe quantity of specimen collected
      Control0..1
      TypeQuantity(SimpleQuantity)
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      74. Specimen.collection.method
      Definition

      A coded value specifying the technique that is used to perform the procedure.

      ShortTechnique used to perform collection
      Control0..1
      BindingFor example codes, see FHIRSpecimenCollectionMethod
      (example to http://hl7.org/fhir/ValueSet/specimen-collection-method)

      The technique that is used to perform the procedure.

      TypeCodeableConcept
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      76. Specimen.collection.bodySite
      Definition

      Anatomical location from which the specimen was collected (if subject is a patient). This is the target site. This element is not used for environmental specimens.

      ShortAnatomical collection site
      Comments

      If the use case requires BodySite to be handled as a separate resource instead of an inline coded element (e.g. to identify and track separately) then use the standard extension bodySite.

      Control0..1
      BindingFor example codes, see SNOMEDCTBodyStructures
      (example to http://hl7.org/fhir/ValueSet/body-site)

      Codes describing anatomical locations. May include laterality.

      TypeCodeableConcept
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      78. Specimen.collection.fastingStatus[x]
      Definition

      Abstinence or reduction from some or all food, drink, or both, for a period of time prior to sample collection.

      ShortWhether or how long patient abstained from food and/or drink
      Comments

      Representing fasting status using this element is preferred to representing it with an observation using a 'pre-coordinated code' such as LOINC 2005-7 (Calcium [Moles/​time] in 2 hour Urine --12 hours fasting), or using a component observation such asObservation.component code` = LOINC 49541-6 (Fasting status - Reported).

      Control0..1
      BindingUnless not suitable, these codes SHALL be taken from hl7VS-relevantClincialInformation
      (extensible to http://terminology.hl7.org/ValueSet/v2-0916)

      Codes describing the fasting status of the patient.

      TypeChoice of: CodeableConcept, Duration
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Summarytrue
      Requirements

      Many diagnostic tests require fasting to facilitate accurate interpretation.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      80. Specimen.processing
      Definition

      Details concerning processing and processing steps for the specimen.

      ShortProcessing and processing step details
      Control0..*
      TypeBackboneElement
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      82. Specimen.processing.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
      84. Specimen.processing.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())
      86. Specimen.processing.modifierExtension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained 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 can 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 even if unrecognized
      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 element that contains them
      Summarytrue
      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, modifiers
      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())
      88. Specimen.processing.description
      Definition

      Textual description of procedure.

      ShortTextual description of procedure
      Control0..1
      Typestring
      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()))
      90. Specimen.processing.procedure
      Definition

      A coded value specifying the procedure used to process the specimen.

      ShortIndicates the treatment step applied to the specimen
      Control0..1
      BindingFor example codes, see SpecimenProcessingProcedure
      (example to http://hl7.org/fhir/ValueSet/specimen-processing-procedure)

      Type indicating the technique used to process the specimen.

      TypeCodeableConcept
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      92. Specimen.processing.additive
      Definition

      Material used in the processing step.

      ShortMaterial used in the processing step
      Control0..*
      TypeReference(Substance)
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      94. Specimen.processing.time[x]
      Definition

      A record of the time or period when the specimen processing occurred. For example the time of sample fixation or the period of time the sample was in formalin.

      ShortDate and time of specimen processing
      Control0..1
      TypeChoice of: dateTime, Period
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      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()))
      96. Specimen.container
      Definition

      The container holding the specimen. The recursive nature of containers; i.e. blood in tube in tray in rack is not addressed here.

      ShortDirect container of specimen (tube/slide, etc.)
      Control0..*
      TypeBackboneElement
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      98. Specimen.container.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
      100. Specimen.container.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())
      102. Specimen.container.modifierExtension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained 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 can 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 even if unrecognized
      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 element that contains them
      Summarytrue
      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, modifiers
      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())
      104. Specimen.container.identifier
      Definition

      Id for container. There may be multiple; a manufacturer's bar code, lab assigned identifier, etc. The container ID may differ from the specimen id in some circumstances.

      ShortId for the container
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..*
      TypeIdentifier
      Is Modifierfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      106. Specimen.container.description
      Definition

      Textual description of the container.

      ShortTextual description of the container
      Control0..1
      Typestring
      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()))
      108. Specimen.container.type
      Definition

      The type of container associated with the specimen (e.g. slide, aliquot, etc.).

      ShortKind of container directly associated with specimen
      Control0..1
      BindingFor example codes, see SpecimenContainerType
      (example to http://hl7.org/fhir/ValueSet/specimen-container-type)

      Type of specimen container.

      TypeCodeableConcept
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      110. Specimen.container.capacity
      Definition

      The capacity (volume or other measure) the container may contain.

      ShortContainer volume or size
      Control0..1
      TypeQuantity(SimpleQuantity)
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      112. Specimen.container.specimenQuantity
      Definition

      The quantity of specimen in the container; may be volume, dimensions, or other appropriate measurements, depending on the specimen type.

      ShortQuantity of specimen within container
      Control0..1
      TypeQuantity(SimpleQuantity)
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      114. Specimen.container.additive[x]
      Definition

      Introduced substance to preserve, maintain or enhance the specimen. Examples: Formalin, Citrate, EDTA.

      ShortAdditive associated with container
      Control0..1
      BindingFor example codes, see hl7VS-additivePreservative
      (example to http://terminology.hl7.org/ValueSet/v2-0371)

      Substance added to specimen container.

      TypeChoice of: CodeableConcept, Reference(Substance)
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      116. Specimen.condition
      Definition

      A mode or state of being that describes the nature of the specimen.

      ShortState of the specimen
      Comments

      Specimen condition is an observation made about the specimen. It's a point-in-time assessment. It can be used to assess its quality or appropriateness for a specific test.

      Control0..*
      BindingUnless not suitable, these codes SHALL be taken from hl7VS-specimenCondition
      (extensible to http://terminology.hl7.org/ValueSet/v2-0493)

      Codes describing the state of the specimen.

      TypeCodeableConcept
      Is Modifierfalse
      Summarytrue
      Requirements

      The specimen condition can be used to assess its quality or appropriateness for a specific test.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      118. Specimen.note
      Definition

      To communicate any details or issues about the specimen or during the specimen collection. (for example: broken vial, sent with patient, frozen).

      ShortComments
      Control0..*
      TypeAnnotation
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))