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Orders and Observations 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, 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.

Cardinality0..*
TypeDomainResource
Requirements

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

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.

DiagnosticReport.identifier
Element IdDiagnosticReport.identifier
Definition

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

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.

Cardinality0..*
TypeReference(CarePlan | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)
PatternsReference(CarePlan,ImmunizationRecommendation,MedicationRequest,NutritionOrder,ServiceRequest): Common patterns = Request
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
Element IdDiagnosticReport.status
Definition

The status of the diagnostic report.

Cardinality1..1
Terminology BindingDiagnosticReportStatus (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.

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.

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.

Cardinality0..1
TypeReference(Patient | Group | Device | Location)
PatternsReference(Patient,Group,Device,Location): Common patterns = Participant
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.

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.

Cardinality0..1
TypedateTime|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
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.

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.

Cardinality0..*
TypeReference(Practitioner | PractitionerRole | Organization | CareTeam)
PatternsReference(Practitioner,PractitionerRole,Organization,CareTeam): Common patterns = Participant
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.

Cardinality0..*
TypeReference(Practitioner | PractitionerRole | Organization | CareTeam)
PatternsReference(Practitioner,PractitionerRole,Organization,CareTeam): Common patterns = Participant
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.

Cardinality0..*
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
Element IdDiagnosticReport.result
Definition

Observations that are part of this diagnostic report.

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
Comments

Observations can contain observations.

DiagnosticReport.imagingStudy
Element IdDiagnosticReport.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.

Cardinality0..*
TypeReference(ImagingStudy)
Comments

ImagingStudy 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.media
Element IdDiagnosticReport.media
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).

Cardinality0..*
Requirements

Many diagnostic services include images 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. Typically, this is used to provide an explanation for why the image is included, or to draw the viewer's attention to important features.

Cardinality0..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.media.link
Element IdDiagnosticReport.media.link
Definition

Reference to the image source.

Cardinality1..1
TypeReference(Media)
Summarytrue
DiagnosticReport.conclusion
Element IdDiagnosticReport.conclusion
Definition

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

Cardinality0..1
Typestring
Requirements

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

Alternate NamesReport
DiagnosticReport.conclusionCode
Element IdDiagnosticReport.conclusionCode
Definition

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

Cardinality0..*
Terminology BindingSNOMED CT Clinical Findings (Example)
TypeCodeableConcept
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.

Cardinality0..*
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.