R6 Ballot (2nd Draft)

Publish-box (todo)

Orders and Observations icon Work GroupMaturity Level: 2 Trial UseSecurity Category: Patient Compartments: Device, Patient, Practitioner

Detailed Descriptions for the elements in the Specimen resource.

Specimen
Element Id Specimen
Definition

A sample to be used for analysis.

Short Display Sample for analysis
Cardinality 0..*
Type DomainResource
Summary false
Invariants
Defined on this element
spm-1Rule Specimen.collection.collector SHALL only be present if Specimen.collection.procedure is not presentcollection.collector.empty() or collection.procedure.empty()
Specimen.identifier
Element Id Specimen.identifier
Definition

Id for specimen.

Short Display External Identifier
Note This is a business identifier, not a resource identifier (see discussion)
Cardinality 0..*
Type Identifier
Summary true
Specimen.accessionIdentifier
Element Id 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.

Short Display Identifier assigned by the lab
Cardinality 0..1
Type Identifier
Summary true
Specimen.status
Element Id Specimen.status
Definition

The availability of the specimen.

Short Display available | unavailable | unsatisfactory | entered-in-error
Cardinality 0..1
Terminology Binding Specimen Status (Required)
Type code
Is Modifier true (Reason: 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)
Summary true
Comments

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

Specimen.type
Element Id Specimen.type
Definition

The kind of material that forms the specimen.

Short Display Kind of material that forms the specimen
Cardinality 0..1
Terminology Binding hl7VS-specimenType icon (Example)
Type CodeableConcept
Summary true
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.

Specimen.subject
Element Id 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, a biologically-derived product, or a device.

Short Display 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, a biologically-derived product, or a device
Cardinality 0..1
Type Reference(Patient | Group | Device | BiologicallyDerivedProduct | Substance | Location)
Requirements

Must know the subject context.

Summary true
Specimen.receivedTime
Element Id Specimen.receivedTime
Definition

Time when specimen is received by the testing laboratory for processing or testing.

Short Display The time when specimen is received by the testing laboratory
Cardinality 0..1
Type dateTime
Summary true
Specimen.parent
Element Id 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.

Short Display Specimen from which this specimen originated
Cardinality 0..*
Type Reference(Specimen)
Hierarchy This reference is part of a strict Hierarchy
Summary false
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.

Specimen.request
Element Id Specimen.request
Definition

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

Short Display Why the specimen was collected
Cardinality 0..*
Type Reference(ServiceRequest)
Summary false
Comments

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

Specimen.combined
Element Id Specimen.combined
Definition

This element signifies if the specimen is part of a group or pooled.

Short Display grouped | pooled
Cardinality 0..1
Terminology Binding Specimen Combined (Required)
Type code
Summary true
Specimen.role
Element Id Specimen.role
Definition

The role or reason for the specimen in the testing workflow.

Short Display The role the specimen serves
Cardinality 0..*
Terminology Binding Specimen Role (Preferred)
Type CodeableConcept
Summary false
Specimen.feature
Element Id Specimen.feature
Definition

A physical feature or landmark on a specimen, highlighted for context by the collector of the specimen (e.g. surgeon), that identifies the type of feature as well as its meaning (e.g. the red ink indicating the resection margin of the right lobe of the excised prostate tissue or wire loop at radiologically suspected tumor location).

Short Display The physical feature of a specimen
Cardinality 0..*
Summary false
Specimen.feature.type
Element Id Specimen.feature.type
Definition

The landmark or feature being highlighted.

Short Display Highlighted feature
Cardinality 1..1
Terminology Binding SNOMED CT Body Structures (Example)
Type CodeableConcept
Summary false
Specimen.feature.description
Element Id Specimen.feature.description
Definition

Description of the feature of the specimen.

Short Display Information about the feature
Cardinality 1..1
Type string
Summary false
Specimen.collection
Element Id Specimen.collection
Definition

Details concerning the specimen collection.

Short Display Collection details
Cardinality 0..1
Summary false
Specimen.collection.collector
Element Id Specimen.collection.collector
Definition

Person who collected the specimen.

Short Display Who collected the specimen
Cardinality 0..1
Type Reference(Organization | Practitioner | PractitionerRole | Patient | RelatedPerson)
Summary true
Invariants
Affect this element
spm-1Rule Specimen.collection.collector SHALL only be present if Specimen.collection.procedure is not presentcollection.collector.empty() or collection.procedure.empty()
Specimen.collection.collected[x]
Element Id Specimen.collection.collected[x]
Definition

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

Short Display Collection time
Cardinality 0..1
Type dateTime|Period
[x] Note See Choice of Datatypes for further information about how to use [x]
Summary true
Specimen.collection.duration
Element Id Specimen.collection.duration
Definition

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

Short Display How long it took to collect specimen
Cardinality 0..1
Type Duration
Summary true
Specimen.collection.quantity
Element Id 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.

Short Display The quantity of specimen collected
Cardinality 0..1
Type SimpleQuantity
Summary false
Specimen.collection.method
Element Id Specimen.collection.method
Definition

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

Short Display Technique used to perform collection
Cardinality 0..1
Terminology Binding FHIR Specimen Collection Method (Example)
Type CodeableConcept
Summary false
Specimen.collection.device
Element Id Specimen.collection.device
Definition

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

Short Display Device used to perform collection
Cardinality 0..1
Terminology Binding SpecimenCollectionDevice:
Type CodeableReference(Device)
Summary false
Specimen.collection.procedure
Element Id Specimen.collection.procedure
Definition

The procedure event during which the specimen was collected (e.g. the surgery leading to the collection of a pathology sample).

Short Display The procedure that collects the specimen
Cardinality 0..1
Type Reference(Procedure)
Summary false
Invariants
Affect this element
spm-1Rule Specimen.collection.collector SHALL only be present if Specimen.collection.procedure is not presentcollection.collector.empty() or collection.procedure.empty()
Specimen.collection.bodySite
Element Id 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.

Short Display Anatomical collection site
Cardinality 0..1
Terminology Binding SNOMED CT Body Structures (Example)
Type CodeableReference(BodyStructure)
Summary false
Comments

Reasons for using BodyStructure reference include: 1.) Need to identify a specific site instance (e.g. a specific mole), 2.) a single pre-coordinated coded concept for the body site does not exist, 3.) a desire to represent bodySite using multiple attributes (e.g. modifiers).

Specimen.collection.fastingStatus[x]
Element Id 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.

Short Display Whether or how long patient abstained from food and/or drink
Cardinality 0..1
Terminology Binding hl7VS-relevantClincialInformation icon (Extensible)
Type CodeableConcept|Duration
[x] Note See Choice of Datatypes for further information about how to use [x]
Requirements

Many diagnostic tests require fasting to facilitate accurate interpretation.

Summary true
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).

Specimen.processing
Element Id Specimen.processing
Definition

Details concerning processing and processing steps for the specimen.

Short Display Processing and processing step details
Cardinality 0..*
Summary false
Specimen.processing.description
Element Id Specimen.processing.description
Definition

Textual description of procedure.

Short Display Textual description of procedure
Cardinality 0..1
Type string
Summary false
Specimen.processing.method
Element Id Specimen.processing.method
Definition

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

Short Display Indicates the treatment step applied to the specimen
Cardinality 0..1
Terminology Binding Specimen Processing Method (Example)
Type CodeableConcept
Summary false
Specimen.processing.performer
Element Id Specimen.processing.performer
Definition

The performer of the processing of the specimen.

Short Display Entity processing specimen
Cardinality 0..1
Type Reference(Practitioner | PractitionerRole | Patient | RelatedPerson)
Summary true
Specimen.processing.device
Element Id Specimen.processing.device
Definition

The device used in the processing of the specimen.

Short Display Device used to process the specimen
Cardinality 0..1
Type Reference(Device)
Summary false
Specimen.processing.additive
Element Id Specimen.processing.additive
Definition

Material used in the processing step.

Short Display Material used in the processing step
Cardinality 0..*
Type Reference(Substance)
Summary false
Specimen.processing.time[x]
Element Id 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.

Short Display Date and time of specimen processing
Cardinality 0..1
Type dateTime|Period|Duration
[x] Note See Choice of Datatypes for further information about how to use [x]
Summary false
Specimen.container
Element Id 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.

Short Display Direct container of specimen (tube/slide, etc.)
Cardinality 0..*
Summary false
Specimen.container.device
Element Id Specimen.container.device
Definition

The device resource for the the container holding the specimen. If the container is in a holder then the referenced device will point to a parent device.

Short Display Device resource for the container
Cardinality 1..1
Type Reference(Device)
Summary false
Specimen.container.specimenQuantity
Element Id Specimen.container.specimenQuantity
Definition

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

Short Display Quantity of specimen within container
Cardinality 0..1
Type SimpleQuantity
Summary false
Specimen.condition
Element Id Specimen.condition
Definition

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

Short Display State of the specimen
Cardinality 0..*
Terminology Binding hl7VS-specimenCondition icon (Extensible)
Type CodeableConcept
Requirements

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

Summary true
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.

Specimen.note
Element Id 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).

Short Display Comments
Cardinality 0..*
Type Annotation
Summary false