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10.3 Resource DiagnosticReport - Content

Orders and Observations Work Group

Maturity Level: 3

Trial Use

Security Category: Patient

Compartments: Device, Encounter, Patient, Practitioner

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.

10.3.4 References to this Resource

• Implements: Event
• Resource References: ChargeItem, Condition, Contract, DeviceRequest, DeviceUsage... Show 14 more, itself, Encounter, FamilyMemberHistory, ImagingStudy, Immunization, MedicationAdministration, MedicationStatement, NutritionIntake, Procedure, RequestOrchestration, ResearchStudy, RiskAssessment, ServiceRequest and SupplyRequest
• Extension References: DiagnosticReport Addendum Of, DiagnosticReport Extends, DiagnosticReport Replaces, DocumentReference Summary Of, Procedure Caused By and Workflow Reason

10.3.5 Resource Content

 

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis

10.3.5.1 Terminology Bindings

Path	ValueSet	Type	Documentation
DiagnosticReport.status	DiagnosticReportStatus	Required	The status of the diagnostic report.
DiagnosticReport.category	DiagnosticServiceSectionCodes (a valid code from diagnosticServiceSectionId )	Example	This value set includes all the codes in HL7 V2 table 0074.
DiagnosticReport.code	LOINCDiagnosticReportCodes (a valid code from LOINC )	Preferred	This value set includes LOINC codes that relate to Diagnostic Observations.
DiagnosticReport.supportingInfo.type	Hl7VSVSObservationType (a valid code from observationType )	Example	Value Set of codes that specify types of observations to enable systems to distinguish between observations sent along with an order, versus observations sent as the result to an order.
DiagnosticReport.conclusionCode	SNOMEDCTClinicalFindings	Example	This value set includes all the "Clinical finding" SNOMED CT codes - concepts where concept is-a 404684003 (Clinical finding (finding)).

10.3.5.2 Constraints

10.3.6 Notes:

10.3.6.1 Identifiers

The identifier datatype has a type element that may be used to distinguish the identifiers assigned by the requester and the performer of the request (known as the 'Placer' and 'Filler' in the HL7 Version 2 Messaging Standard). Use the identifier type code "PLAC" for the Placer Identifier and "FILL" for the Filler identifier as is shown in the example below:

<!-- Placer identifier-->
<identifier>
<type>
<coding>
  <system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
  <code value="PLAC"/>
</coding>
<text value="Placer"/>
</type>
<system value="urn:oid:1.3.4.5.6.7"/>
<value value="2345234234234"/>
</identifier>
<!-- Filler identifier-->
<identifier>
<type>
<coding>
  <system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
  <code value="PLAC"/>
</coding>
<text value="Placer"/>
</type>
<system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
<value value="567890"/>
</identifier>

10.3.6.2 Clinically Relevant Time

If the diagnostic procedure was performed on the patient directly, the effective[x] element is a dateTime, the time it was performed. If specimens were taken, the clinically relevant time of the report can be derived from the specimen collection times, but since detailed specimen information is not always available, and nor is the clinically relevant time always exactly the specimen collection time (e.g. complex timed tests), the reports SHALL always include an effective[x] element. Note that HL7 V2 messages often carry a diagnostically relevant time without carrying any specimen information.

10.3.6.3 Associated Observations

• The DiagnosticReport.code always contains the name of the report itself. The report can also contain a set of Observations in the DiagnosticReport.result element. These Observations can be simple observations (e.g. atomic results) or groups/panels of other observations. The Observation.code indicates the nature of the observation or panel (e.g. individual measure, organism isolate/sensitivity or antibody functional testing). When relevant, the observation can specify a particular specimen from which the result comes.
  • Examples of nesting groups/panels within an observation include reporting a "profile" consisting of several panels as is shown in this example, a group of antibiotic isolate/sensitivities for a bacterial culture, or a set of perinatal measurements on a single fetus.
  • There is rarely a need for more than two levels of nesting in the Observation tree. One known use is for organism sensitivities - an example of a complex Micro Isolate and Sensitivities is provided.

10.3.6.4 Associated Images

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.

10.3.6.5 Diagnostic Report Status

• Applications consuming diagnostic reports must take careful note of updated (revised) reports and ensure that retracted reports are appropriately handled.
• For applications providing diagnostic reports, a report should not be final until all the individual data items reported with it are final or appended.
• If the report has been withdrawn following a previous final release, the DiagnosticReport and associated Observations should be retracted by replacing the status codes with the concept "entered-in-error" and setting the conclusion/comment (if provided) and the text narrative to some text like "This report has been withdrawn" in the appropriate language. A reason for retraction may be provided in the narrative.

10.3.6.6 Report Content

Typically, a report is either: all data, no narrative (e.g. Core lab) or a mix of data with some concluding narrative (e.g. Structured Pathology Report, Bone Density), or all narrative (for example a typical imaging report, histopathology). This resource provides for these 3 different presentations:

• As atomic data items: a hierarchical set of nested references to Observation resources often including pathologist/radiologist interpretation(s), one or more images, and possibly with a conclusion and/or one or more coded diagnoses
• As narrative: an XHTML presentation in the standard resource narrative
• As a "presented form": A rich text representation of the report - typically a PDF

Note that the conclusion and the coded diagnoses are part of the atomic data and SHOULD be duplicated in the narrative and in the presented form if the latter is present. The narrative and the presented form serve the same function: a representation of the report for a human. The presented form is included since diagnostic service reports often contain presentation features that are not easy to reproduce in the HTML narrative. Whether or not the presented form is included, the narrative must be a clinically safe view of the diagnostic report; at a minimum, this could be fulfilled by a note indicating that the narrative is not proper representation of the report, and that the presented form must be used, or a generated view from the atomic data. However, consumers of the report will best be served if the narrative contains clinically relevant data from the form. Commonly, the following patterns are used:

• Simple Laboratory Reports: A single set of atomic observations, and a tabular presentation in narrative. This is typically encountered in high volume areas such as Biochemistry and Hematology
• Histopathology Report: A document report in a presented form and the narrative. Possibly a few key images, and some coded diagnoses for registries. If the service is creating a structured report, some atomic data may be included
• imaging Report: A document report in a presented form and the narrative, with an imaging study reference and possibly some key images. Some imaging reports such as a Bone Density Scan may include some atomic data

Note that the nature of reports from the various disciplines that provide diagnostic reports are changing quickly, as expert systems provide improved narrative reporting in high volume reports, structured reporting brings additional data to areas that have classically been narrative based, and the nature of the imaging and laboratory procedures are merging. Therefore, these patterns described above are only examples of how a diagnostic report can be used.

10.3.6.7 Genomic Reports

Genomic reporting makes heavy use of the DiagnosticReport and Observation resources to capture the genomic data in a highly structured and computable way. An implementation guide describing how to represent genetic results can be found here .

Beyond the structured, computable data available in DiagnosticReport and Observation, metadata about the analysis performed is captured in the GenomicStudy resource. GenomicStudy aims at delineating relevant information of a genomic study. A genomic study 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.

10.3.7 Search Parameters

Search parameters for this resource. See also the full list of search parameters for this resource, and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name	Type	Description	Expression	In Common
based-on	reference	Reference to the service request.	DiagnosticReport.basedOn (CarePlan, MedicationRequest, NutritionOrder, ServiceRequest, ImmunizationRecommendation)
category	token	Which diagnostic discipline/department created the report	DiagnosticReport.category
code	token	The code for the report, as opposed to codes for the atomic results, which are the names on the observation resource referred to from the result	DiagnosticReport.code	22 Resources
conclusion	token	A coded conclusion (interpretation/impression) on the report	DiagnosticReport.conclusionCode
date	date	The clinically relevant time of the report	DiagnosticReport.effective.ofType(dateTime) | DiagnosticReport.effective.ofType(Period)	27 Resources
encounter	reference	The Encounter when the order was made	DiagnosticReport.encounter (Encounter)	29 Resources
identifier	token	An identifier for the report	DiagnosticReport.identifier	65 Resources
issued	date	When the report was issued	DiagnosticReport.issued
media	reference	A reference to the image source.	DiagnosticReport.media.link (DocumentReference)
patient	reference	The subject of the report if a patient	DiagnosticReport.subject.where(resolve() is Patient) (Patient)	66 Resources
performer	reference	Who is responsible for the report	DiagnosticReport.performer (Practitioner, Organization, CareTeam, PractitionerRole)
result	reference	Link to an atomic result (observation resource)	DiagnosticReport.result (Observation)
results-interpreter	reference	Who was the source of the report	DiagnosticReport.resultsInterpreter (Practitioner, Organization, CareTeam, PractitionerRole)
specimen	reference	The specimen details	DiagnosticReport.specimen (Specimen)
status	token	The status of the report	DiagnosticReport.status
study	reference	Studies associated with the diagnostic report	DiagnosticReport.study (GenomicStudy, ImagingStudy)
subject	reference	The subject of the report	DiagnosticReport.subject (Practitioner, Group, Organization, BiologicallyDerivedProduct, Device, Medication, Patient, Substance, Location)