type: resource-definitionsresource: DiagnosticReport

DiagnosticReport Definitions

DiagnosticReport

A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports

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.

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.

Aliases: Report, Test, Result, Results, Labs, Laboratory, Test Report

Cardinality: 0..*

Constraints: dgr-1 | error | When a Composition is referenced in DiagnosticReport.composition, all Observation resources referenced in Composition.entry must also be referenced in DiagnosticReport.result or in the Observation.hasMember references. | composition.exists() implies (composition.resolve().section.entry.reference.all($this.resolve() is Observation implies $this in (%resource.result.reference|%resource.result.reference.resolve().hasMember.reference)))

Mappings: workflow=Event; v2=ORU -> OBR; rim=Observation[classCode=OBS, moodCode=EVN]; w5=clinical.diagnostics

DiagnosticReport.identifier

Business identifier for report

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

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

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.

Aliases: ReportID, Filler ID, Placer ID

Cardinality: 0..*

Type: Identifier

Summary: true

Mappings: workflow=Event.identifier; w5=FiveWs.identifier; v2=OBR-51/ for globally unique filler ID - OBR-3 , For non-globally unique filler-id the flller/placer number must be combined with the universal service Id - OBR-2(if present)+OBR-3+OBR-4; rim=id

DiagnosticReport.basedOn

What was requested

Definition: Details concerning a service requested.

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.

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

Aliases: Request

Cardinality: 0..*

Type: Reference(CarePlan, MedicationRequest, NutritionOrder, ServiceRequest)

Mappings: workflow=Event.basedOn; v2=ORC? OBR-2/3?; rim=outboundRelationship[typeCode=FLFS].target

DiagnosticReport.status

Definition: The status of the diagnostic report.

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

Cardinality: 1..1

Type: code

Binding: required:diagnostic-report-status

Summary: true

Is Modifier: true (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)

Mappings: workflow=Event.status; w5=FiveWs.status; v2=OBR-25 (not 1:1 mapping); rim=statusCode Note: final and amended are distinguished by whether observation is the subject of a ControlAct event of type "revise"

DiagnosticReport.category

Service 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.

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.

Aliases: Department, Sub-department, Service, Discipline

Cardinality: 0..*

Type: CodeableConcept

Binding: example:diagnostic-service-sections

Summary: true

Mappings: w5=FiveWs.class; v2=OBR-24; rim=inboundRelationship[typeCode=COMP].source[classCode=LIST, moodCode=EVN, code < LabService].code; workflow=Event.category

DiagnosticReport.code

Name/Code for this diagnostic report

Definition: A code or name that describes this diagnostic report.

Comments: DiagnosticReport.code is primarily meant to characterize the nature of the entire report, not to summarize the content in detail. In the case where multiple orderables are included in a single report, then the single DiagnosticReport.code would represent the entire 'panel' that the report is covering.

Aliases: Type

Cardinality: 1..1

Type: CodeableConcept

Binding: preferred:report-codes

Summary: true

Mappings: workflow=Event.code; w5=FiveWs.what[x]; v2=OBR-4 (HL7 V2 doesn't provide an easy way to indicate both the ordered test and the performed panel); rim=code

DiagnosticReport.subject

The subject of the report - usually, but not always, the patient

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.

Requirements: SHALL know the subject context.

Aliases: Patient

Cardinality: 0..1

Type: Reference(Patient, Group, Device, Location, Organization, Practitioner, Medication, Substance, BiologicallyDerivedProduct)

Summary: true

Mappings: workflow=Event.subject; w5=FiveWs.subject; v2=PID-3 (no HL7 V2 mapping for Group or Device); rim=participation[typeCode=SBJ]

DiagnosticReport.relatesTo

Related DiagnosticReports

Definition: Other DiagnosticReports that the current DiagnosticReport replaces, amendens, extends, or otherwise relates to.

Cardinality: 0..*

Type: RelatedArtifact

DiagnosticReport.encounter

Encounter associated with the DiagnosticReport

Definition: The encounter (e.g. a patient and healthcare provider interaction) that is associated with the DiagnosticReport.

Comments: This will typically be the encounter, when it exists, during which the data or specimens (e.g. imaging, blood draw, or assessment procedure) that are being reported by the DiagnosticReport were obtained/acquired. When a DiagnosticReport is based on a ServiceRequest (order), the ServiceRequest.encounter referenced in DiagnosticReport.basedOn may be used to associate the two.

Requirements: Links the report to the Encounter context.

Aliases: Context

Cardinality: 0..1

Type: Reference(Encounter)

Summary: true

Mappings: workflow=Event.encounter; w5=FiveWs.context; v2=PV1-19; rim=inboundRelationship[typeCode=COMP].source[classCode=ENC, moodCode=EVN]

DiagnosticReport.effective[x]

Clinically relevant time/time-period for the results that are included in the report

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.

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.

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

Aliases: Observation time, Effective Time, Occurrence

Cardinality: 0..1

Type: dateTime, Period

Summary: true

Mappings: workflow=Event.occurrence[x]; w5=FiveWs.done[x]; v2=OBR-7; rim=effectiveTime

DiagnosticReport.issued

DateTime this version was made

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

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.

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

Aliases: Date published, Date Issued, Date Verified

Cardinality: 0..1

Type: dateTime

Summary: true

Mappings: w5=FiveWs.recorded; v2=OBR-22; rim=participation[typeCode=VRF or AUT].time

DiagnosticReport.procedure

The performed procedure(s) from which the report was produced

Definition: The performed procedure(s) that are reported on in the DiagnosticReport.

Comments: This is a summary of the report, not a list of results.

Cardinality: 0..*

Type: Reference(Procedure)

Summary: true

DiagnosticReport.performer

Responsible Diagnostic Service

Definition: The diagnostic service that is responsible for issuing the report.

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. In the regulated context of diagnostic laboratory work on humans, it is extremely likely that regulation requires a human performer. Point of care testing, veterinary testing, drug screens, and environmental surveillance are common cases where the device is the performer with no additional human interaction or direct oversight.

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.

Aliases: Laboratory, Service, Practitioner, Department, Company, Authorized by, Director

Cardinality: 0..*

Type: Reference(Practitioner, PractitionerRole, Organization, CareTeam, HealthcareService, Device, Patient, RelatedPerson)

Summary: true

Mappings: workflow=Event.performer.actor; w5=FiveWs.actor; v2=PRT-8 (where this PRT-4-Participation = "PO"); rim=.participation[typeCode=PRF]

DiagnosticReport.resultsInterpreter

Who analyzed and reported the conclusions and interpretations

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

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

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.

Aliases: Analyzed by, Reported by

Cardinality: 0..*

Type: Reference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson)

Summary: true

Mappings: workflow=Event.performer.actor; w5=FiveWs.actor; v2=OBR-32, PRT-8 (where this PRT-4-Participation = "PRI"); rim=.participation[typeCode=PRF]

DiagnosticReport.specimen

Specimens this report is based on

Definition: Details about the specimens on which this diagnostic 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.

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

Cardinality: 0..*

Type: Reference(Specimen)

Mappings: v2=SPM; rim=participation[typeCode=SBJ]

DiagnosticReport.result

Observations

Definition: Observations that are part of this diagnostic report.

Comments: Observations can contain observations.

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

Aliases: Data, Atomic Value, Result, Atomic result, Test, Analyte, Battery, Organizer

Conditions: dgr-1

Cardinality: 0..*

Type: Reference(Observation)

Mappings: v2=OBXs; rim=outboundRelationship[typeCode=COMP].target

DiagnosticReport.note

Comments about the diagnostic report

Definition: Comments about the diagnostic report.

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.

Requirements: Need to be able to provide free text additional information.

Cardinality: 0..*

Type: Annotation

Mappings: rim=unknown; workflow=Event.note

DiagnosticReport.study

Reference to full details of an analysis associated with the diagnostic report

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.

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.

Cardinality: 0..*

Type: Reference(ImagingStudy)

DiagnosticReport.supportingInfo

Additional information supporting the diagnostic report

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.

Comments: Supporting information should only be used for resources that are not referenced elsewhere within the same DiagnosticReport, e.g., DiagnosticReport.comparison.

Cardinality: 0..*

Type: BackboneElement

DiagnosticReport.supportingInfo.type

Supporting information role code

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

Cardinality: 1..1

Type: CodeableConcept

Binding: example:diagnosticreport-relevant-information-types

DiagnosticReport.supportingInfo.reference

Supporting information reference

Definition: The reference for the supporting information in the diagnostic report.

Cardinality: 1..1

Type: Reference(ImagingStudy, Procedure, Observation, DiagnosticReport, FamilyMemberHistory, AllergyIntolerance, Condition, DocumentReference)

DiagnosticReport.media

Key images or data associated with this report

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).

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

Aliases: DICOM, Slides, Scans

Cardinality: 0..*

Type: BackboneElement

Summary: true

Mappings: v2=OBX?; rim=outboundRelationship[typeCode=COMP].target

DiagnosticReport.media.comment

Comment about the image or data (e.g. explanation)

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.

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.

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

Cardinality: 0..1

Type: string

Mappings: rim=.inboundRelationship[typeCode=COMP].source[classCode=OBS, moodCode=EVN, code="annotation"].value

DiagnosticReport.media.link

Reference to the image or data source

Definition: Reference to the image or data source.

Cardinality: 1..1

Type: Reference(DocumentReference)

Summary: true

Mappings: rim=.value.reference

DiagnosticReport.composition

Reference to a Composition resource for the DiagnosticReport structure

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

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.

Conditions: dgr-1

Cardinality: 0..1

Type: Reference(Composition)

Mappings: rim=.value.reference

DiagnosticReport.conclusion

Clinical conclusion (interpretation) of test results

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

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

Aliases: Report

Cardinality: 0..1

Type: markdown

Mappings: v2=OBX; rim=inboundRelationship[typeCode="SPRT"].source[classCode=OBS, moodCode=EVN, code=LOINC:48767-8].value (type=ST)

DiagnosticReport.conclusionCode

Codes and/or references for the clinical conclusion of test results

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

Cardinality: 0..*

Type: CodeableReference

Binding: example:clinical-findings

Mappings: v2=OBX; rim=inboundRelationship[typeCode=SPRT].source[classCode=OBS, moodCode=EVN, code=LOINC:54531-9].value (type=CD)

DiagnosticReport.recomendation

Recommendations based on findings and interpretations

Definition: Proposed follow-up actions based on the findings and interpretations of the diagnostic test for which this report is the subject.

Comments: The resources that should be referenced include CarePlan, ServiceRequest, CommunicationRequest, etc. that allow for proposed actions and next steps.

Cardinality: 0..*

Type: CodeableReference

Summary: true

DiagnosticReport.presentedForm

Entire report as issued

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

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

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

Cardinality: 0..*

Type: Attachment

Mappings: v2=OBX; rim=text (type=ED)

DiagnosticReport.communication

Communication initiated during the reporting process

Definition: Communications initiated during the generation of the DiagnosticReport by members of the organization fulfilling that order. e.g. direct communication of time critical results by the radiologist to the referring physician.

Comments: Note: This can document attempted communications as well as completed communications. Communications that follow publication of the report (e.g. between the referring physician and the patient or a subsequent specialist) are not referenced here. DiagnosticReport.recommendation might also contain references to ServiceRequest or CommunicationRequest instances for proposed subsequent communications.

Requirements: Need to record details of such communications for medico-legal purposes, to support review or the improvement of conformance to best practices for patient safety and quality of care.

Cardinality: 0..*

Type: Reference(Communication)

Summary: false

DiagnosticReport.comparison

Prior data and findings for comparison

Definition: Prior data and findings made available for comparison when determining the current interpretation.

Comments: The List.entry.item can be profiled down to indicate a ImagingStudy | DiagnosticReport | Observation.

Cardinality: 0..1

Type: Reference(List)