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Orders and Observations icon Work GroupMaturity Level: 3 Trial UseSecurity Category: Patient Compartments: Device, Encounter, Patient, Practitioner

Detailed Descriptions for the elements in the DiagnosticReport resource.

DiagnosticReport
Element IdDiagnosticReport
Definition

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

Short DisplayA Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
Cardinality0..*
TypeDomainResource
Requirements

To support reporting for any diagnostic report into a clinical data repository.

Alternate NamesReport; Test; Result; Results; Labs; Laboratory
Summaryfalse
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.

Invariants
Defined on this element
dgr-1Rule When a Composition is referenced in `Diagnostic.composition`, all Observation resources referenced in `Composition.entry` must also be referenced in `Diagnostic.entry` or in the references Observations in `Observation.hasMember`composition.exists() implies (composition.resolve().section.entry.reference.where(resolve() is Observation) in (result.reference|result.reference.resolve().hasMember.reference))
DiagnosticReport.identifier
Element IdDiagnosticReport.identifier
Definition

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

Short DisplayBusiness identifier for report
NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
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
Summarytrue
Comments

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

DiagnosticReport.basedOn
Element IdDiagnosticReport.basedOn
Definition

Details concerning a service requested.

Short DisplayWhat was requested
Cardinality0..*
TypeReference(CarePlan | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)
Requirements

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

Alternate NamesRequest
Summaryfalse
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
Element IdDiagnosticReport.status
Definition

The status of the diagnostic report.

Short Displayregistered | partial | preliminary | modified | final | amended | corrected | appended | cancelled | entered-in-error | unknown
Cardinality1..1
Terminology BindingDiagnostic Report Status (Required)
Typecode
Is Modifiertrue (Reason: This element is labeled 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)
Requirements

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

Summarytrue
DiagnosticReport.category
Element IdDiagnosticReport.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.

Short DisplayService category
Cardinality0..*
Terminology BindingDiagnostic Service Section Codes (Example)
TypeCodeableConcept
Alternate NamesDepartment; Sub-department; Service; Discipline
Summarytrue
Comments

Multiple categories are allowed using various categorization schemes. 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
Element IdDiagnosticReport.code
Definition

A code or name that describes this diagnostic report.

Short DisplayName/Code for this diagnostic report
Cardinality1..1
Terminology BindingLOINC Diagnostic Report Codes (Preferred)
TypeCodeableConcept
Alternate NamesType
Summarytrue
DiagnosticReport.subject
Element IdDiagnosticReport.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.

Short DisplayThe subject of the report - usually, but not always, the patient
Cardinality0..1
TypeReference(Patient | Group | Device | Location | Organization | Practitioner | Medication | Substance | BiologicallyDerivedProduct)
Requirements

SHALL know the subject context.

Alternate NamesPatient
Summarytrue
DiagnosticReport.encounter
Element IdDiagnosticReport.encounter
Definition

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

Short DisplayHealth care event when test ordered
Cardinality0..1
TypeReference(Encounter)
Requirements

Links the request to the Encounter context.

Alternate NamesContext
Summarytrue
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 but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

DiagnosticReport.effective[x]
Element IdDiagnosticReport.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.

Short DisplayClinically relevant time/time-period for report
Cardinality0..1
TypedateTime|Period
[x] NoteSee Choice of Datatypes 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
Summarytrue
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
Element IdDiagnosticReport.issued
Definition

The date and time that this version of the report was made available to providers, typically after the report was reviewed and verified.

Short DisplayDateTime this version was made
Cardinality0..1
Typeinstant
Requirements

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

Alternate NamesDate published; Date Issued; Date Verified
Summarytrue
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
Element IdDiagnosticReport.performer
Definition

The diagnostic service that is responsible for issuing the report.

Short DisplayResponsible Diagnostic Service
Cardinality0..*
TypeReference(Practitioner | PractitionerRole | Organization | CareTeam)
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; Authorized by; Director
Summarytrue
Comments

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

DiagnosticReport.resultsInterpreter
Element IdDiagnosticReport.resultsInterpreter
Definition

The practitioner or organization that is responsible for the report's conclusions and interpretations.

Short DisplayPrimary result interpreter
Cardinality0..*
TypeReference(Practitioner | PractitionerRole | Organization | CareTeam)
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 NamesAnalyzed by; Reported by
Summarytrue
Comments

Might not be the same entity that takes responsibility for the clinical report.

DiagnosticReport.specimen
Element IdDiagnosticReport.specimen
Definition

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

Short DisplaySpecimens this report is based on
Cardinality0..*
TypeReference(Specimen)
Requirements

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

Summaryfalse
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
Element IdDiagnosticReport.result
Definition

Observations that are part of this diagnostic report.

Short DisplayObservations
Cardinality0..*
TypeReference(Observation)
Requirements

Need to support individual results, or groups of results, where the result grouping is arbitrary, but meaningful.

Alternate NamesData; Atomic Value; Result; Atomic result; Data; Test; Analyte; Battery; Organizer
Summaryfalse
Comments

Observations can contain observations.

Invariants
Affect this element
dgr-1Rule When a Composition is referenced in `Diagnostic.composition`, all Observation resources referenced in `Composition.entry` must also be referenced in `Diagnostic.entry` or in the references Observations in `Observation.hasMember`composition.exists() implies (composition.resolve().section.entry.reference.where(resolve() is Observation) in (result.reference|result.reference.resolve().hasMember.reference))
DiagnosticReport.note
Element IdDiagnosticReport.note
Definition

Comments about the diagnostic report.

Short DisplayComments about the diagnostic report
Cardinality0..*
TypeAnnotation
Requirements

Need to be able to provide free text additional information.

Summaryfalse
Comments

May include general statements about the diagnostic report, or statements about significant, unexpected or unreliable results values contained within the diagnostic report, or information about its source when relevant to its interpretation.

DiagnosticReport.study
Element IdDiagnosticReport.study
Definition

One or more links to full details of any study performed during the diagnostic investigation. An ImagingStudy might comprise a set of radiologic images obtained via a procedure that are analyzed as a group. 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. A GenomicStudy might comprise one or more analyses, each serving a specific purpose. These analyses may vary in method (e.g., karyotyping, CNV, or SNV detection), performer, software, devices used, or regions targeted.

Short DisplayReference to full details of an analysis associated with the diagnostic report
Cardinality0..*
TypeReference(GenomicStudy | ImagingStudy)
Summaryfalse
Comments

For laboratory-type studies like GenomeStudy, type resources will be used for tracking additional metadata and workflow aspects of complex studies. ImagingStudy and the media element are somewhat overlapping - typically, the list of image references in the media 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.supportingInfo
Element IdDiagnosticReport.supportingInfo
Definition

This backbone element contains supporting information that was used in the creation of the report not included in the results already included in the report.

Short DisplayAdditional information supporting the diagnostic report
Cardinality0..*
Summaryfalse
DiagnosticReport.supportingInfo.type
Element IdDiagnosticReport.supportingInfo.type
Definition

The code value for the role of the supporting information in the diagnostic report.

Short DisplaySupporting information role code
Cardinality1..1
Terminology Bindinghl7VS-VS-observationType icon (Example)
TypeCodeableConcept
Summaryfalse
DiagnosticReport.supportingInfo.reference
Element IdDiagnosticReport.supportingInfo.reference
Definition

The reference for the supporting information in the diagnostic report.

Short DisplaySupporting information reference
Cardinality1..1
TypeReference(Procedure | Observation | DiagnosticReport | Citation)
Summaryfalse
DiagnosticReport.media
Element IdDiagnosticReport.media
Definition

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

Short DisplayKey images or data associated with this report
Cardinality0..*
Requirements

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

Alternate NamesDICOM; Slides; Scans
Summarytrue
DiagnosticReport.media.comment
Element IdDiagnosticReport.media.comment
Definition

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

Short DisplayComment about the image or data (e.g. explanation)
Cardinality0..1
Typestring
Requirements

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

Summaryfalse
Comments

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

DiagnosticReport.media.link
Element IdDiagnosticReport.media.link
Definition

Reference to the image or data source.

Short DisplayReference to the image or data source
Cardinality1..1
TypeReference(DocumentReference)
Summarytrue
DiagnosticReport.composition
Element IdDiagnosticReport.composition
Definition

Reference to a Composition resource instance that provides structure for organizing the contents of the DiagnosticReport.

Short DisplayReference to a Composition resource for the DiagnosticReport structure
Cardinality0..1
TypeReference(Composition)
Summaryfalse
Comments

The Composition provides structure to the content of the DiagnosticReport (and only contains contents referenced in the DiagnosticReport) - e.g., to order the sections of an anatomic pathology structured report.

Invariants
Affect this element
dgr-1Rule When a Composition is referenced in `Diagnostic.composition`, all Observation resources referenced in `Composition.entry` must also be referenced in `Diagnostic.entry` or in the references Observations in `Observation.hasMember`composition.exists() implies (composition.resolve().section.entry.reference.where(resolve() is Observation) in (result.reference|result.reference.resolve().hasMember.reference))
DiagnosticReport.conclusion
Element IdDiagnosticReport.conclusion
Definition

Concise and clinically contextualized summary conclusion (interpretation/impression) of the diagnostic report.

Short DisplayClinical conclusion (interpretation) of test results
Cardinality0..1
Typemarkdown
Requirements

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

Alternate NamesReport
Summaryfalse
DiagnosticReport.conclusionCode
Element IdDiagnosticReport.conclusionCode
Definition

One or more codes that represent the summary conclusion (interpretation/impression) of the diagnostic report.

Short DisplayCodes for the clinical conclusion of test results
Cardinality0..*
Terminology BindingSNOMED CT Clinical Findings (Example)
TypeCodeableConcept
Summaryfalse
DiagnosticReport.presentedForm
Element IdDiagnosticReport.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.

Short DisplayEntire report as issued
Cardinality0..*
TypeAttachment
Requirements

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

Summaryfalse
Comments

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