--- type: "resource-definitions" title: "DiagnosticReport Definitions" resource: "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](/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](/CarePlan), [MedicationRequest](/MedicationRequest), [NutritionOrder](/NutritionOrder), [ServiceRequest](/ServiceRequest)) **Mappings:** workflow=Event.basedOn; v2=ORC? OBR-2/3?; rim=outboundRelationship[typeCode=FLFS].target ## DiagnosticReport.status registered | partial | preliminary | modified | final | amended | corrected | appended | cancelled | entered-in-error | unknown **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](/code) **Binding:** required:[diagnostic-report-status](/valueset-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](/CodeableConcept) **Binding:** example:[diagnostic-service-sections](/valueset-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](/CodeableConcept) **Binding:** preferred:[report-codes](/valueset-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](/Patient), [Group](/Group), [Device](/Device), [Location](/Location), [Organization](/Organization), [Practitioner](/Practitioner), [Medication](/Medication), [Substance](/Substance), [BiologicallyDerivedProduct](/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](/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](/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](/dateTime), [Period](/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](/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](/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](/Practitioner), [PractitionerRole](/PractitionerRole), [Organization](/Organization), [CareTeam](/CareTeam), [HealthcareService](/HealthcareService), [Device](/Device), [Patient](/Patient), [RelatedPerson](/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](/Practitioner), [PractitionerRole](/PractitionerRole), [Organization](/Organization), [CareTeam](/CareTeam), [Patient](/Patient), [RelatedPerson](/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](/Specimen)) **Mappings:** v2=SPM; rim=participation[typeCode=SBJ] ## DiagnosticReport.result Observations **Definition:** [Observations](observation.html) 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](/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](/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](/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](/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](/CodeableConcept) **Binding:** example:[diagnosticreport-relevant-information-types](/valueset-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](/ImagingStudy), [Procedure](/Procedure), [Observation](/Observation), [DiagnosticReport](/DiagnosticReport), [FamilyMemberHistory](/FamilyMemberHistory), [AllergyIntolerance](/AllergyIntolerance), [Condition](/Condition), [DocumentReference](/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](/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](/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](/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](/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](/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](/CodeableReference) **Binding:** example:[clinical-findings](/valueset-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](/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](/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](/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](/List))