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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 Id DiagnosticReport
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 Display A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
Cardinality 0..*
Type DomainResource
Requirements

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

Alternate Names Report; Test; Result; Results; Labs; Laboratory
Summary false
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 Id DiagnosticReport.identifier
Definition

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

Short Display Business identifier for report
Note This is a business identifier, not a resource identifier (see discussion)
Cardinality 0..*
Type Identifier
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 Names ReportID; Filler ID; Placer ID
Summary true
Comments

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

DiagnosticReport.basedOn
Element Id DiagnosticReport.basedOn
Definition

Details concerning a service requested.

Short Display What was requested
Cardinality 0..*
Type Reference(CarePlan | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)
Requirements

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

Alternate Names Request
Summary false
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 Id DiagnosticReport.status
Definition

The status of the diagnostic report.

Short Display registered | partial | preliminary | modified | final | amended | corrected | appended | cancelled | entered-in-error | unknown
Cardinality 1..1
Terminology Binding Diagnostic Report Status (Required)
Type code
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)
Requirements

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

Summary true
DiagnosticReport.category
Element Id 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.

Short Display Service category
Cardinality 0..*
Terminology Binding Diagnostic Service Section Codes (Example)
Type CodeableConcept
Alternate Names Department; Sub-department; Service; Discipline
Summary true
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 Id DiagnosticReport.code
Definition

A code or name that describes this diagnostic report.

Short Display Name/Code for this diagnostic report
Cardinality 1..1
Terminology Binding LOINC Diagnostic Report Codes (Preferred)
Type CodeableConcept
Alternate Names Type
Summary true
DiagnosticReport.subject
Element Id 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.

Short Display The subject of the report - usually, but not always, the patient
Cardinality 0..1
Type Reference(Patient | Group | Device | Location | Organization | Practitioner | Medication | Substance | BiologicallyDerivedProduct)
Requirements

SHALL know the subject context.

Alternate Names Patient
Summary true
DiagnosticReport.encounter
Element Id DiagnosticReport.encounter
Definition

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

Short Display Encounter associated with the DiagnosticReport
Cardinality 0..1
Type Reference(Encounter)
Requirements

Links the request to the Encounter context.

Alternate Names Context
Summary true
Comments

This will typically be the encounter during which the tests and studies were ordered and/or performed that are being reported by the DiagnosticReport. Some tests or studies 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 Id 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.

Short Display Clinically relevant time/time-period for report
Cardinality 0..1
Type dateTime|Period
[x] Note See 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 Names Observation time; Effective Time; Occurrence
Summary true
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 Id DiagnosticReport.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 Display DateTime this version was made
Cardinality 0..1
Type instant
Requirements

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

Alternate Names Date published; Date Issued; Date Verified
Summary true
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 Id DiagnosticReport.performer
Definition

The diagnostic service that is responsible for issuing the report.

Short Display Responsible Diagnostic Service
Cardinality 0..*
Type Reference(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 Names Laboratory; Service; Practitioner; Department; Company; Authorized by; Director
Summary true
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 Id DiagnosticReport.resultsInterpreter
Definition

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

Short Display Primary result interpreter
Cardinality 0..*
Type Reference(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 Names Analyzed by; Reported by
Summary true
Comments

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

DiagnosticReport.specimen
Element Id DiagnosticReport.specimen
Definition

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

Short Display Specimens this report is based on
Cardinality 0..*
Type Reference(Specimen)
Requirements

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

Summary false
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 Id DiagnosticReport.result
Definition

Observations that are part of this diagnostic report.

Short Display Observations
Cardinality 0..*
Type Reference(Observation)
Requirements

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

Alternate Names Data; Atomic Value; Result; Atomic result; Data; Test; Analyte; Battery; Organizer
Summary false
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 Id DiagnosticReport.note
Definition

Comments about the diagnostic report.

Short Display Comments about the diagnostic report
Cardinality 0..*
Type Annotation
Requirements

Need to be able to provide free text additional information.

Summary false
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 Id DiagnosticReport.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 Display Reference to full details of an analysis associated with the diagnostic report
Cardinality 0..*
Type Reference(GenomicStudy | ImagingStudy)
Summary false
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 Id DiagnosticReport.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 Display Additional information supporting the diagnostic report
Cardinality 0..*
Summary false
DiagnosticReport.supportingInfo.type
Element Id DiagnosticReport.supportingInfo.type
Definition

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

Short Display Supporting information role code
Cardinality 1..1
Terminology Binding hl7VS-VS-observationType icon (Example)
Type CodeableConcept
Summary false
DiagnosticReport.supportingInfo.reference
Element Id DiagnosticReport.supportingInfo.reference
Definition

The reference for the supporting information in the diagnostic report.

Short Display Supporting information reference
Cardinality 1..1
Type Reference(ImagingStudy | Procedure | Observation | DiagnosticReport | Citation | FamilyMemberHistory | AllergyIntolerance | DeviceUsage)
Summary false
DiagnosticReport.media
Element Id DiagnosticReport.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 Display Key images or data associated with this report
Cardinality 0..*
Requirements

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

Alternate Names DICOM; Slides; Scans
Summary true
DiagnosticReport.media.comment
Element Id DiagnosticReport.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 Display Comment about the image or data (e.g. explanation)
Cardinality 0..1
Type string
Requirements

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

Summary false
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 Id DiagnosticReport.media.link
Definition

Reference to the image or data source.

Short Display Reference to the image or data source
Cardinality 1..1
Type Reference(DocumentReference)
Summary true
DiagnosticReport.composition
Element Id DiagnosticReport.composition
Definition

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

Short Display Reference to a Composition resource for the DiagnosticReport structure
Cardinality 0..1
Type Reference(Composition)
Summary false
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 Id DiagnosticReport.conclusion
Definition

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

Short Display Clinical conclusion (interpretation) of test results
Cardinality 0..1
Type markdown
Requirements

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

Alternate Names Report
Summary false
DiagnosticReport.conclusionCode
Element Id DiagnosticReport.conclusionCode
Definition

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

Short Display Codes and/or references for the clinical conclusion of test results
Cardinality 0..*
Terminology Binding SNOMED CT Clinical Findings (Example)
Type CodeableReference(Observation | Condition)
Summary false
DiagnosticReport.recomendation
Element Id DiagnosticReport.recomendation
Definition

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

Short Display Recommendations based on findings and interpretations
Cardinality 0..*
Type CodeableReference(Any)
Summary true
Comments

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

DiagnosticReport.presentedForm
Element Id 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.

Short Display Entire report as issued
Cardinality 0..*
Type Attachment
Requirements

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

Summary false
Comments

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

DiagnosticReport.communication
Element Id DiagnosticReport.communication
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.

Short Display Communication initiated during the reporting process
Cardinality 0..*
Type Reference(Communication)
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.

Summary false
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.