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Orders and Observations Work Group Maturity Level : 3   Trial Use Security Category : Patient Compartments : Device , Encounter , Patient , Practitioner

Detailed Descriptions for the elements in the DiagnosticReport resource.

Comments This is labeled as "Is Modifier" because applications need to take appropriate action if a report is withdrawn. Alternate Names Laboratory; Service; Practitioner; Department; Company
DiagnosticReport
Element Id DiagnosticReport
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.

Control Cardinality 1..1 0..*
Type DomainResource
Requirements

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

Alternate Names Report; Test; Result; Results; Labs; Laboratory
Comments

This is intended to capture a single report, 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 Id DiagnosticReport.identifier
Definition

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

Note This is a business identifer, identifier, not a resource identifier (see discussion )
Control 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 test or procedure service requested.

Control Cardinality 0..*
Type Reference ( CarePlan | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ProcedureRequest | ReferralRequest ServiceRequest )
Patterns Reference(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 Names Request
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 as a whole. report.

Control Cardinality 1..1
Terminology Binding DiagnosticReportStatus ( 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.

Control Cardinality 0..1 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.

Control 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 However, diagnostic services also perform analyses on specimens collected from a variety of other sources.

Control Cardinality 0..1
Type Reference ( Patient | Group | Device | Location )
Patterns Reference(Patient,Group,Device,Location): Common patterns = Participant
Requirements

SHALL know the subject context.

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

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

Control Cardinality 0..1
Type Reference ( Encounter | EpisodeOfCare )
Requirements

Links the request to the Encounter context.

Alternate Names Encounter Context
Summary true
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 or episode but still be tied to the context of the encounter or episode (e.g. pre-admission lab 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.

Control Cardinality 0..1
Type dateTime | Period
[x] Note See 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 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 released from made available to providers, typically after the source diagnostic service. report was reviewed and verified.

Control Cardinality 0..1
Type instant
Requirements

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

Alternate Names Date Created; Date published; Date Issued 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

Indicates who or what participated in producing The diagnostic service that is responsible for issuing the report.

Control Cardinality 0..*
Summary Type true Reference ( Practitioner | PractitionerRole | Organization | CareTeam )
Patterns DiagnosticReport.performer.role Reference(Practitioner,PractitionerRole,Organization,CareTeam): Common patterns = Participant
Definition Requirements

Describes Need to know whom to contact if there are queries about the type results. Also may need to track the source of participation (e.g. a responsible party, author, or verifier). reports for secondary data analysis.

Alternate Names Control 0..1 Laboratory; Service; Practitioner; Department; Company; Authorized by; Director
Terminology Binding Summary Procedure Performer Role Codes ( Example ) true
Type CodeableConcept Comments Summary true

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.performer.actor DiagnosticReport.resultsInterpreter
Element Id DiagnosticReport.resultsInterpreter
Definition

The reference to the practitioner or organization involved in producing the report. For example, the diagnostic service that is responsible for issuing the report. report's conclusions and interpretations.

Control Cardinality 1..1 0..*
Type Reference ( Practitioner | PractitionerRole | Organization | CareTeam )
Patterns Reference(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 Names Analyzed by; Reported by
Summary true
Comments

This is Might not necessarily the source of the atomic data items. It is 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.

Control Cardinality 0..*
Type Reference ( 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 Id DiagnosticReport.result
Definition

Observations that are part of this diagnostic report. Observations can be simple name/value pairs (e.g. "atomic" results), or they can be grouping observations that include references to other members of the group (e.g. "panels").

Control Cardinality 0..*
Type Reference ( Observation )
Requirements

Need to support individual results, or report groups of results, where the result grouping is arbitrary, but meaningful. This structure is recursive - observations can contain observations.

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

Observations can contain observations.

DiagnosticReport.imagingStudy
Element Id DiagnosticReport.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.

Control Cardinality 0..*
Type Reference ( ImagingStudy | ImagingManifest )
Comments

ImagingStudy and ImageManifest 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 However, each caters to different types of displays for different types of purposes. Neither, either, or both may be provided.

DiagnosticReport.image DiagnosticReport.media
Element Id DiagnosticReport.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).

Control Cardinality 0..*
Requirements

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

Alternate Names DICOM; Slides; Scans
Summary true
DiagnosticReport.image.comment DiagnosticReport.media.comment
Element Id DiagnosticReport.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.

Control Cardinality 0..1
Type string
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.image.link DiagnosticReport.media.link
Element Id DiagnosticReport.media.link
Definition

Reference to the image source.

Control Cardinality 1..1
Type Reference ( Media )
Summary true
DiagnosticReport.conclusion
Element Id DiagnosticReport.conclusion
Definition

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

Control Cardinality 0..1
Type string
Requirements

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

Alternate Names Report
DiagnosticReport.codedDiagnosis DiagnosticReport.conclusionCode
Element Id DiagnosticReport.conclusionCode
Definition

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

Control Cardinality 0..*
Terminology Binding SNOMED CT Clinical Findings ( Example )
Type CodeableConcept
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.

Control Cardinality 0..*
Type Attachment
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.