US Core Implementation Guide
8.0.0 - STU 8 United States of America flag

US Core Implementation Guide, published by HL7 International / Cross-Group Projects. This guide is not an authorized publication; it is the continuous build for version 8.0.0 built by the FHIR (HL7ยฎ FHIRยฎ Standard) CI Build. This version is based on the current content of https://github.com/HL7/US-Core/ and changes regularly. See the Directory of published versions

Resource Profile: USCoreSpecimenProfile - Detailed Descriptions

Page standards status: Trial-use

Definitions for the us-core-specimen resource profile.

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
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.

ShortSpecimen identifierExternal 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.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
Must Supporttrue
Summarytrue
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.

ShortKind 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.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 patient where the specimen came from.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
Control0..1
TypeReference(US Core Patient Profile, Group, Device, Substance, US Core Location Profile, Patient, Location)
Is Modifierfalse
Must Supporttrue
Must Support TypesReference(US Core Patient Profile)
Summarytrue
Requirements

Must know the subject context.

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

Details concerning the specimen collection.

Short๐—”๐——๐——๐—œ๐—ง๐—œ๐—ข๐—ก๐—”๐—Ÿ ๐—จ๐—ฆ๐—–๐——๐—œ: Collection detailsCollection details
Control0..1
TypeBackboneElement
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. 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())
20. 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.

Short๐—”๐——๐——๐—œ๐—ง๐—œ๐—ข๐—ก๐—”๐—Ÿ ๐—จ๐—ฆ๐—–๐——๐—œ: Specimen Source SiteAnatomical collection site
Comments

Body location from where a specimen was obtained. Examples include but are not limited to right internal jugular, left arm, and right eye.


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
BindingUnless not suitable, these codes SHALL be taken from For example codes, see SNOMEDCTBodyStructureshttp://hl7.org/fhir/ValueSet/body-site
(extensible to http://hl7.org/fhir/ValueSet/body-site)
TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Specimen.condition
Definition

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

Short๐—”๐——๐——๐—œ๐—ง๐—œ๐—ข๐—ก๐—”๐—Ÿ ๐—จ๐—ฆ๐—–๐——๐—œ: Specimen conditionState 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 US Core Specimen Conditionhttp://terminology.hl7.org/ValueSet/v2-0493
(extensible to http://hl7.org/fhir/us/core/ValueSet/us-core-specimen-condition)
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()))