FHIR Release 3 (STU)

This page is part of the FHIR Specification (v3.0.2: STU 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 . Page versions: R4B R4 R3

Definitions for the diagnosticreport-genetics Profile.

DiagnosticReport
Definition

The findings and interpretation of diagnostic tests performed on patients, groups of patients, devices, and locations, and/or specimens derived from these. The report includes clinical context such as requesting and provider information, and some mix of atomic results, images, textual and coded interpretations, and formatted representation of diagnostic reports.

Control0..*
Alternate NamesReport, Test, Result, Results, Labs, Laboratory
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.

InvariantsDefined on this element
dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative (xpath: not(parent::f:contained and f:text))
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (xpath: not(parent::f:contained and f:contained))
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource (xpath: not(exists(for $id in f:contained/*/@id return $id[not(ancestor::f:contained/parent::*/descendant::f:reference/@value=concat('#', $id))])))
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (xpath: not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated)))
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.

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.

This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.

DiagnosticReport.language
Definition

The base language in which the resource is written.

Control0..1
Terminology BindingA human language.
The codes SHALL be taken from Common Languages; other codes may be used where these codes are not suitable
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. 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 in formation is added later.

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

An Extension

Control0..*
TypeExtension
SlicingThis element introduces a set of slices. The slicing rules are:
  • unordered
  • Open
  • discriminators: value:url
DiagnosticReport.extension (http://hl7.org/fhir/StructureDefinition/DiagnosticReport-geneticsAssessedCondition)
Definition

Used to denote condition context for genetic testing, which may influence reported variants and interpretation for large genomic testing panels e.g. lung cancer or familial breast cancer.

Control0..* This element is affected by the following invariants: ele-1
Type (Extension Type: Reference(Condition))
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (xpath: @value|f:*|h:div)
ext-1: Must have either extensions or value[x], not both (xpath: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')]))
DiagnosticReport.extension (http://hl7.org/fhir/StructureDefinition/DiagnosticReport-geneticsFamilyMemberHistory)
Definition

Significant health events and conditions for a person related to the patient relevant in the context of care for the patient.

Control0..* This element is affected by the following invariants: ele-1
Type (Extension Type: Reference(FamilyMemberHistory))
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (xpath: @value|f:*|h:div)
ext-1: Must have either extensions or value[x], not both (xpath: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')]))
DiagnosticReport.extension (http://hl7.org/fhir/StructureDefinition/DiagnosticReport-geneticsAnalysis)
Definition

Knowledge-based comments on the effect of the sequence on patient's condition/medication reaction.

Control0..* This element is affected by the following invariants: ele-1
Type (Extension Type: Choice of: base64Binary, boolean, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, Meta)
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (xpath: @value|f:*|h:div)
ext-1: Must have either extensions or value[x], not both (xpath: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')]))
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

Identifiers assigned to this report by the performer or other systems.

Control0..*
TypeIdentifier
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, Filler ID, Placer ID
Comments

Usually assigned by the Information System of the diagnostic service provider (filler id).

DiagnosticReport.basedOn
Definition

Details concerning a test or procedure requested.

Control0..*
TypeChoice of: Reference(CarePlan), Reference(ImmunizationRecommendation), Reference(MedicationRequest), Reference(NutritionOrder), Reference(ProcedureRequest), Reference(ReferralRequest)
Requirements

This allows tracing of authorization for the report and tracking whether proposals/recommendations were acted upon.

Alternate NamesRequest
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.status
Definition

The status of the diagnostic report as a whole.

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

A code or name that describes this diagnostic report.

Control1..1
Terminology BindingCodes that describe Diagnostic Reports.
The codes SHOULD be taken from LOINC Diagnostic Report Codes
TypeCodeableConcept
Alternate NamesType
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.

Control0..1
TypeChoice of: Reference(Patient), Reference(Group), Reference(Device), Reference(Location)
Requirements

SHALL know the subject context.

Alternate NamesPatient
DiagnosticReport.context
Definition

The healthcare event (e.g. a patient and healthcare provider interaction) which this DiagnosticReport per is about.

Control0..1
TypeChoice of: Reference(Encounter), Reference(EpisodeOfCare)
Requirements

Links the request to the Encounter context.

Alternate NamesEncounter
Comments

This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter or episode but still be tied to the context of the encounter or episode (e.g. pre-admission lab tests).

DiagnosticReport.effective[x]
Definition

The time or time-period the observed values are related to. When the subject of the report is a patient, this is usually either the time of the procedure or of specimen collection(s), but very often the source of the date/time is not known, only the date/time itself.

Control0..1
TypeChoice of: dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
Requirements

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

Alternate NamesObservation time, Effective Time, Occurrence
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.

Control0..1
Typeinstant
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

Indicates who or what participated in producing the report.

Control0..*
TypeBackboneElement
Alternate NamesLaboratory, Service, Practitioner, Department, Company
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (xpath: @value|f:*|h:div)
DiagnosticReport.performer.id
Definition

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

Control0..1
Typestring
DiagnosticReport.performer.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.performer.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.performer.role
Definition

Describes the type of participation (e.g. a responsible party, author, or verifier).

Control0..1
Terminology BindingIndicate a role of diagnostic report performer
For example codes, see Procedure Performer Role Codes
TypeCodeableConcept
DiagnosticReport.performer.actor
Definition

The reference to the practitioner or organization involved in producing the report. For example, the diagnostic service that is responsible for issuing the report.

Control1..1
TypeChoice of: Reference(Practitioner), Reference(Organization)
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.

Comments

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

DiagnosticReport.specimen
Definition

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

Control0..*
TypeReference(Specimen)
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..*
TypeReference(Observation)
Requirements

Need to support 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, Organizer
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..*
TypeChoice of: Reference(ImagingStudy), Reference(ImagingManifest)
Comments

ImagingStudy and ImageManifest 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
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (xpath: @value|f:*|h:div)
DiagnosticReport.image.id
Definition

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

Control0..1
Typestring
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 impression / summary of the diagnostic report.

Control0..1
Typestring
Requirements

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

Alternate NamesReport
DiagnosticReport.codedDiagnosis
Definition

Codes for the conclusion.

Control0..0
Terminology BindingDiagnosis codes provided as adjuncts to the report.
For example codes, see SNOMED CT Clinical Findings
TypeCodeableConcept
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
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.