DSTU2 QA Preview

This page is part of the FHIR Specification (v1.0.0: DSTU 2 Ballot 3). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

A.??.4 StructureDefinition: USLab-DR - Detailed Descriptions

Definitions for the uslab-dr Profile.

DiagnosticReport(USLab-DR)
Definition

The scope is the sending of lab results from a laboratory to an ambulatory provider.

Control0..*
TypeDiagnosticReport
Alternate NamesReport, Test, Result, Results, Labs, Laboratory, Lab Result, Lab Report
Comments

This is intended to capture a single report, and is not suitable for use in displaying summary information that covers multiple reports. For example, this resource has not been designed for laboratory cumulative reporting formats nor detailed structured reports for sequencing.

DiagnosticReport.id
Definition

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

Control0..1
Typeid
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. Bundles always have an id, though it is usually a generated UUID.

DiagnosticReport.meta
Definition

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

Control0..1
TypeMeta
DiagnosticReport.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.

Control0..1
Typeuri
Is Modifiertrue
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 as much as possible.

DiagnosticReport.language
Definition

The base language in which the resource is written.

Control0..1
BindingA human language
The codes SHALL be taken from http://tools.ietf.org/html/bcp47
Typecode
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).

DiagnosticReport.text
Definition

A human-readable narrative that contains a summary of the resource, and may 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.

Control0..1 This element is affected by the following invariants: dom-1
TypeNarrative
Alternate Namesnarrative, html, xhtml, display
Comments

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative.

DiagnosticReport.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.

Control0..*
TypeResource
Alternate Namesinline resources, anonymous resources, contained 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.

DiagnosticReport.extension
Definition

May be used to represent additional information that is not part of the basic definition of the resource. In order 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
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.

DiagnosticReport.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. Usually modifier elements provide negation or qualification. In order 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.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content
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.

DiagnosticReport.identifier
Definition

The local ID assigned to the report by the order filler, usually by the Information System of the diagnostic service provider.

Control1..*
TypeIdentifier
Must Supporttrue
Requirements

Need to know what identifier to use when making queries about this report from the source laboratory, and for linking to the report outside FHIR context.

Alternate NamesReportID
DiagnosticReport.identifier.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
DiagnosticReport.identifier.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
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.

DiagnosticReport.identifier.use
Definition

The purpose of this identifier.

Control1..1
BindingIdentifies the purpose for this identifier, if known
The codes SHALL be taken from IdentifierUse
Typecode
Is Modifiertrue
Must Supporttrue
Requirements

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

Comments

This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

DiagnosticReport.identifier.type
Definition

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

Control0..1
BindingA coded type for an identifier that can be used to determine which identifier to use for a specific purpose
The codes SHALL be taken from Identifier Type Codes; other codes may be used where these codes are not suitable
TypeCodeableConcept
Requirements

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

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.

DiagnosticReport.identifier.system
Definition

The URI for the laboratory Issuing the report. This establishes the namespace in which set of possible id values is unique.

Control1..1
Typeuri
Must Supporttrue
Requirements

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

Examplehttp://www.acme.com/identifiers/patient or urn:ietf:rfc:3986 if the Identifier.value itself is a full uri
DiagnosticReport.identifier.value
Definition

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

Control1..1
Typestring
Must Supporttrue
Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986.

Example123456
DiagnosticReport.identifier.period
Definition

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

Control0..1
TypePeriod
DiagnosticReport.identifier.assigner
Definition

Organization that issued/manages the identifier.

Control0..1
TypeReference(Organization)
Comments

The reference may be just a text description of the assigner.

DiagnosticReport.status
Definition

The status of the diagnostic report as a whole.

Control1..1
BindingThe status of the diagnostic report as a whole
The codes SHALL be taken from DiagnosticReportStatus
Typecode
Is Modifiertrue
Must Supporttrue
Requirements

Diagnostic services routinely issue provisional/incomplete reports, and sometimes withdraw previously released reports.

Comments

This is labeled as "Is Modifier" because applications need to take appropriate action if a report is withdrawn.

DiagnosticReport.category
Definition

A code that classifies the dlinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.

Control0..1
BindingCodes for diagnostic service sections
For example codes, see Diagnostic Service Section Codes
TypeCodeableConcept
Alternate NamesDepartment, Sub-department, service, discipline
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 DiagnosticReport.code.

DiagnosticReport.code
Definition

The laboratory test, panel or battery that was ordered.

Control1..1
BindingCodes that describe Diagnostic Reports
The codes SHOULD be taken from LOINC Diagnostic Report Codes
TypeCodeableConcept
Must Supporttrue
Comments

UsageNote= The typical patterns for codes are: 1) a LOINC code either as a translation from a "local" code or as a primary code, or 2) a local code only if no suitable LOINC exists, or 3) both the local and the LOINC translation. Systems SHALL be capable of sending the local code if one exists.

DiagnosticReport.code.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
DiagnosticReport.code.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
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.

DiagnosticReport.code.coding(USLabLOINCCoding)
Definition

A reference to a code defined by a terminology system.

Control1..*
BindingLOINC codes
The codes SHALL be taken from US Laboratory Observation Profile Observation Name Codes
TypeCoding
Must Supporttrue
Requirements

Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.

Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the 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 labelled as UserSelected = true.

DiagnosticReport.code.coding.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
DiagnosticReport.code.coding.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
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.

DiagnosticReport.code.coding.system
Definition

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

Control1..1
Typeuri
Must Supporttrue
Requirements

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

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 de-reference to some definition that establish the system clearly and unambiguously.

DiagnosticReport.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.

Control0..1
Typestring
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.

DiagnosticReport.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).

Control1..1
Typecode
Must Supporttrue
Requirements

Need to refer to a particular code in the system.

Comments

Logical Observation Identifiers Names and Codes (LOINC) is a database and universal standard for identifying medical laboratory observations.

DiagnosticReport.code.coding.display
Definition

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

Control0..1
Typestring
Must Supporttrue
Requirements

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

Comments

When using LOINC 'long common name' is preferred although the LOINC 'short name' or the LOINC 'fully-specified name can also be used. ( http://lionc.org.terms-of-use).

DiagnosticReport.code.coding.userSelected
Definition

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

Control0..1
Typeboolean
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.

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.

DiagnosticReport.code.text
Definition

This is the laboratory defined display text for the report if different from the code display text(s).

Control0..1
Typestring
Must Supporttrue
Requirements

Used when the laboratory define how the dsplay text if different from the code display text.

Comments

If this exists, this is the text to be used for display.

DiagnosticReport.subject
Definition

The subject of the report. Usually, but not always, this is a patient. However diagnostic services also perform analyses on specimens collected from a variety of other sources.

Control1..1
TypeChoice of: Reference(US Laboratory Patient Profile), Reference(US Laboratory Patient Profile)
Must Supporttrue
Requirements

SHALL know the subject context.

Alternate NamesPatient
DiagnosticReport.encounter
Definition

The link to the health care event (encounter) when the order was made.

Control0..1
TypeReference(Encounter)
DiagnosticReport.effective[x]
Definition

This is the Specimen Collection Datetime or Period which is the physically relevent dateTime for laboratory tests.

Control1..1
TypeChoice of: dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
Requirements

Need to know where in the patient history to file/present this report.

Alternate NamesObservation time, Effective Time
Comments

If the diagnostic procedure was performed on the patient, this is the time it was performed. If there are specimens, the diagnostically relevant time can be derived from the specimen collection times, but the specimen information is not always available, and the exact relationship between the specimens and the diagnostically relevant time is not always automatic.

DiagnosticReport.issued
Definition

The date and time that this version of the report was released from the source diagnostic service.

Control1..1
Typeinstant
Must Supporttrue
Requirements

Clinicians need to be able to check the date that the report was released.

Alternate NamesDate Created, Date published, Date Issued
Comments

May be different from the update time of the resource itself, because that is the status of the record (potentially a secondary copy), not the actual release time of the report .

DiagnosticReport.performer
Definition

The diagnostic service that is responsible for issuing the report.

Control0..1
TypeReference(US Laboratory Practitioner Profile)
Must Supporttrue
Requirements

Need to know whom to contact if there are queries about the results. Also may need to track the source of reports for secondary data analysis.

Alternate NamesLaboratory, Service, Practitioner, Department, Company
Comments

This is not necessarily the source of the atomic data items - it is the entity that takes responsibility for the clinical report.

DiagnosticReport.request
Definition

Details concerning a test or procedure requested.

Control1..*
TypeReference(US Laboratory Diagnostic Order Profile)
Must Supporttrue
Requirements

Need to be able to track completion of requests based on reports issued and also to report what diagnostic tests were requested (not always the same as what is delivered).

Comments

Note: Usually there is one test request for each result, however in some circumstances multiple test requests may be represented using a single test result resource. Note that there are also cases where one request leads to multiple reports.

DiagnosticReport.specimen
Definition

Details about the specimens on which this diagnostic report is based.

Control0..*
TypeReference(US Laboratory Specimen Profile)
Must Supporttrue
Requirements

Need to be able to report information about the collected specimens on which the report is based.

Comments

If the specimen is sufficiently specified with a code in the Test result name, then this additional data may be redundant. If there are multiple specimens, these may be represented per Observation or group.

DiagnosticReport.result
Definition

Observations that are part of this diagnostic report. Observations can be simple name/value pairs (e.g. "atomic" results), or they can be grouping observations that include references to other members of the group (e.g. "panels").

Control0..*
TypeChoice of: Reference(US Laboratory Observation Profile), Reference(US Laboratory Observation Profile), Reference(US Laboratory Observation Profile), Reference(US Laboratory Observation Profile), Reference(US Laboratory Observation Profile), Reference(US Laboratory Observation Profile)
Must Supporttrue
Requirements

Need to be able to individual results, or report groups of results, where the result grouping is arbitrary, but meaningful. This structure is recursive - observations can contain observations.

Alternate NamesData, Atomic Value, Result, Atomic result, Data, Test, Analyte, Battery, Organiser
DiagnosticReport.imagingStudy
Definition

One or more links to full details of any imaging performed during the diagnostic investigation. Typically, this is imaging performed by DICOM enabled modalities, but this is not required. A fully enabled PACS viewer can use this information to provide views of the source images.

Control0..0
TypeChoice of: Reference(ImagingStudy), Reference(ImagingObjectSelection)
Comments

dImagingStudy and ImageObjectStudy and the image element are somewhat overlapping - typically, the list of image references in the image element will also be found in one of the imaging study resources. However each caters to different types of displays for different types of purposes. Neither, either, or both may be provided.

DiagnosticReport.image
Definition

A list of key images associated with this report. The images are generally created during the diagnostic process, and may be directly of the patient, or of treated specimens (i.e. slides of interest).

Control0..*
TypeBackboneElement
Requirements

Many diagnostic services include images in the report as part of their service.

Alternate NamesDICOM, Slides, Scans
DiagnosticReport.image.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
DiagnosticReport.image.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
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.

DiagnosticReport.image.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 that contains it. Usually modifier elements provide negation or qualification. In order 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.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
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.

DiagnosticReport.image.comment
Definition

A comment about the image. Typically, this is used to provide an explanation for why the image is included, or to draw the viewer's attention to important features.

Control0..1
Typestring
Requirements

The provider of the report should make a comment about each image included in the report.

Comments

The comment should be displayed with the image. It would be common for the report to include additional discussion of the image contents in other sections such as the conclusion.

DiagnosticReport.image.link
Definition

Reference to the image source.

Control1..1
TypeReference(Media)
DiagnosticReport.conclusion
Definition

Concise and clinically contextualized narrative interpretation of the diagnostic report.

Control0..1
Typestring
Must Supporttrue
Requirements

Need to be able to provide a conclusion that is not lost amongst the basic result data.

Alternate NamesReport
Comments

Typically, a report is either [all data, no narrative (e.g. Core lab)] or [a mix of data with some concluding narrative (e.g. Structured Pathology Report, Bone Density)], or [all narrative (e.g. typical imaging report, histopathology)]. In all of these cases, the narrative goes in "text".

DiagnosticReport.codedDiagnosis
Definition

Codes for the conclusion.

Control0..*
BindingSNOMED CT findings codes provided as adjunct diagnosis to the report
The codes SHOULD be taken from SNOMED CT Clinical Findings
TypeCodeableConcept
Must Supporttrue
DiagnosticReport.presentedForm
Definition

Rich text representation of the entire result as issued by the diagnostic service. Multiple formats are allowed but they SHALL be semantically equivalent.

Control0..*
TypeAttachment
Must Supporttrue
Requirements

Gives Laboratory the ability to provide its own fully formatted report for clinical fidelity.

Comments

Application/pdf is recommended as the most reliable and interoperable in this context.