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# 4.16 Resource DiagnosticReport - Content



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 interpretation, and formatted representation of diagnostic reports.



## 4.16.1 Scope and Usage

A diagnostic report is the set of information that is typically provided by a diagnostic service
when investigations are complete. The information includes a mix of atomic results, text reports, images,
and codes. The mix varies depending on the nature of the diagnostic procedure, and sometimes on the nature
of the outcomes for a particular investigation.

The Diagnostic Report Resource is suitable for the following kinds of Diagnostic Reports:
Laboratory (Clinical Chemistry, Hematology, Microbiology, etc.)
Pathology / Histopathology / related disciplines Imaging Investigations (x-ray, CT, MRI etc.)
* Other diagnostics - Cardiology, Gastroenterology etc.

The Diagnostic Report resource is not intended to support cumulative result presentation (tabular presentation of past and present results in the resource).
The Diagnostic Report resource does not yet provide full support for detailed structured reports of sequencing; this is planned for a future release.



## 4.16.2 Background and Context

The Diagnostic Report resource has the following aspects:

status, issued, identifier, performer, serviceCategory: information about the diagnostic report itself subject, diagnostic[x]: information about the subject of the report
requestDetails.: A set of request information to allow the report to connected to clinical work flows
results: a reference to 0 or more Observation resources which provide a hierarchical tree of groups of results specimen details: the specimens on which the report is based
conclusion, codedDiagnosis: support for structured reporting images, representation: image and media representations of the report and supporting images

### 4.16.2.1 Diagnostic Report Names

The words "‘tests", "‘results’", "observations", "‘panels’" and "‘batteries’" are often used interchangeably when describing
the various parts of a diagnostic report. This leads to much confusion. The naming confusion is
worsened because of the wide variety of forms that the result of a diagnostic investigation can take,
as described above. Languages other than English have their own variations on this theme.

This resource uses one particular set of terms. A practitioner "requests" a set of "tests". The
diagnostic service returns a "report" which may contain a "narrative" - a written summary of the
outcomes, and/or "results" - the individual pieces of atomic data which each are "observations".
The results are assembled in "groups" which are nested structures of Observations that can be used to
represent relationships between the individual data items.

This resource is referenced by [Procedure]

4.16.3

Resource Content






UML Diagram









DiagnosticReport (Resource)A code or name that describes this diagnostic reportname : CodeableConcept 1..1 芦 Codes that describe Diagnostic ReportsDiagnosticReportNames+ 禄The status of the diagnostic report as a whole (this element modifies the meaning of other elements)status : code 1..1 芦 The status of the diagnostic report as a wholeDiagnosticReportStatusThe date and/or time that this version of the report was released from the source diagnostic serviceissued : dateTime 1..1The 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 sourcessubject : Resource(Patient|Group|Device|Location) 1..1The diagnostic service that is responsible for issuing the reportperformer : Resource(Practitioner|Organization) 1..1The local ID assigned to the report by the order filler, usually by the Information System of the diagnostic service provideridentifier : Identifier 0..1Details concerning a test requestedrequestDetail : Resource(DiagnosticOrder) 0..The section of the diagnostic service that performs the examination e.g. biochemistry, hematology, MRIserviceCategory : CodeableConcept 0..1 芦 (Codes for diagnostic service sectionsDiagnosticServiceSection) 禄The time or time-period the observed values are related to. 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 itselfdiagnostic[x] : dateTime|Period 1..1Details about the specimens on which this Disagnostic report is basedspecimen : Resource(Specimen) 0..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")result : Resource(Observation) 0..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 imagesimagingStudy : Resource(ImagingStudy) 0..Concise and clinically contextualized narrative interpretation of the diagnostic reportconclusion : string 0..1Codes for the conclusioncodedDiagnosis : CodeableConcept 0.. 芦 (Diagnoses codes provided as adjuncts to the reportAdjunctDiagnosis) 禄Rich text representation of the entire result as issued by the diagnostic service. Multiple formats are allowed but they SHALL be semantically equivalentpresentedForm : Attachment 0..ImageA 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 featurescomment : string 0..1Reference to the image sourcelink : Resource(Media) 1..1A 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)image0..*




Structure























NameCard.TypeDescription & Constraints
.. DiagnosticReport ResourceA Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
... name 1..1CodeableConceptName/Code for this diagnostic report
DiagnosticReportNames (Incomplete)
... status 1..1coderegistered | partial | final | corrected +
DiagnosticReportStatus (Required)
... issued 1..1dateTimeDate this version was released
... subject 1..1Patient | Group | Device | LocationThe subject of the report, usually, but not always, the patient
... performer 1..1Practitioner | OrganizationResponsible Diagnostic Service
... identifier 0..1IdentifierId for external references to this report
... requestDetail 0..DiagnosticOrderWhat was requested
... serviceCategory 0..1CodeableConceptBiochemistry, Hematology etc.
DiagnosticServiceSection (Example)
... diagnostic[x] Physiologically Relevant time/time-period for report
.... diagnosticDateTime1..1dateTime
.... diagnosticPeriod1..1Period
... specimen 0..SpecimenSpecimens this report is based on
... result 0..ObservationObservations - simple, or complex nested groups
... imagingStudy 0..ImagingStudyReference to full details of imaging associated with the diagnostic report
... image ElementKey images associated with this report
.... comment 0..1stringComment about the image (e.g. explanation)
.... link 1..1MediaReference to the image source
... conclusion 0..1stringClinical Interpretation of test results
... codedDiagnosis 0..CodeableConceptCodes for the conclusion
AdjunctDiagnosis (Example)
... presentedForm 0..AttachmentEntire Report as issued





XML Template



<DiagnosticReport xmlns="http://hl7.org/fhir"&gt; doco
<!– from Resource: extension, modifierExtension, language, text, and contained –>
<name><!– 1..1 CodeableConcept Name/Code for this diagnostic report –></name>
<status value="[code]"/><!– 1..1 registered | partial | final | corrected + § –>
<issued value="[dateTime]"/><!– 1..1 Date this version was released § –>
<subject><!– 1..1 Resource(Patient|Group|Device|Location)
The subject of the report, usually, but not always, the patient §
–></subject>
<performer><!– 1..1 Resource(Practitioner|Organization) Responsible Diagnostic Service § –></performer>
<identifier><!– 0..1 Identifier Id for external references to this report § –></identifier>
<requestDetail><!– 0..* Resource(DiagnosticOrder) What was requested –></requestDetail>
<serviceCategory><!– 0..1 CodeableConcept Biochemistry, Hematology etc. § –></serviceCategory>
<diagnostic[x]><!– 1..1 dateTime|Period
Physiologically Relevant time/time-period for report §
–></diagnostic[x]>
<specimen><!– 0..* Resource(Specimen) Specimens this report is based on –></specimen>
<result><!– 0..* Resource(Observation) Observations - simple, or complex nested groups –></result>
<imagingStudy><!– 0..* Resource(ImagingStudy)
Reference to full details of imaging associated with the diagnostic report
–></imagingStudy>
<image> <!– 0..* Key images associated with this report § –>
<comment value="[string]"/><!– 0..1 Comment about the image (e.g. explanation) –>
<link><!– 1..1 Resource(Media) Reference to the image source § –></link>
</image>
<conclusion value="[string]"/><!– 0..1 Clinical Interpretation of test results –>
<codedDiagnosis><!– 0..* CodeableConcept Codes for the conclusion –></codedDiagnosis>
<presentedForm><!– 0..* Attachment Entire Report as issued –></presentedForm>
</DiagnosticReport>



Alternate definitions: Schema/Schematron,
Resource Profile (XML, JSON)

4.16.3.1

Terminology Bindings







PathDefinitionTypeReference
DiagnosticReport.name Codes that describe Diagnostic ReportsIncompletehttp://hl7.org/fhir/vs/report-names
DiagnosticReport.status The status of the diagnostic report as a wholeFixedhttp://hl7.org/fhir/diagnostic-report-status
DiagnosticReport.serviceCategory Codes for diagnostic service sectionsExamplehttp://hl7.org/fhir/vs/diagnostic-service-sections
DiagnosticReport.codedDiagnosis Diagnoses codes provided as adjuncts to the reportExamplehttp://hl7.org/fhir/vs/clinical-findings

Examples of nested report groups: the antibodyhepatitis order panel code for a goup of hepatitis antibody related tests, or the organism code for a group of antibiotic isolate/sensitivities, or a set of perinatal measurements on a single fetus.

4.16.4

Notes:

  • If the diagnostic procedure was performed on the patient directly, diagnostic[x] is a dateTime, the time it was performed.If specimens were taken, the diagnostically relevant time can be derived from the specimen collection times, butsince detailed specimen information is not always available, and nor is the diagnostically relevant time always exactly the specimen collection time (e.g. complex timed tests), the
    reports SHALL always include a diagnostic[x] element. Note that v2 messages often carry a diagnostically relevant time without carrying any specimen information.

  • A report always contains the name of the report itself. The report can also contain a set of observations, which can themselves be simple observations (e.g. atomic results) or can themselves be groups/panels of other observations.The Observation.name is a code that 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.

  • There is rarely a need for more than two levels of nesting in the Observation tree. One known use is for organism sensitivities - see this example.

  • Applications consuming diagnostic reports must take careful note of updated 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 amended. If a report is retracted, all the results should be retracted by replacingevery result value with the Concept "withdrawn" in the internal terminology "Special values"(url = "http://hl7.org/fhir/special-values&quot;), and setting the conclusion (if provided) and the text narrative to sometext like "This report has been withdrawn" in the appropriate language. A reason for retraction may be provided in thenarrative.

4.16.4.1 Report Content

This resource provides for 3 different ways of presenting the Diagnostic Report:

  • As atomic data items: a hierarchical set of nested references to Observation resources, 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. Typically this is 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. As a consequence the patterns described above are only examples of how a diagnostic report can be used.

4.16.5 Search Parameters

Search parameters for this resource. The standard parameters also apply. See Searching for more information about searching in REST, messaging, and services.


















NameTypeDescriptionPaths
_idtokenThe logical resource id associated with the resource (must be supported by all servers)
_languagetokenThe stated language of the resource
datedateThe clinically relevant time of the reportDiagnosticReport.diagnostic[x]
diagnosistokenA coded diagnosis on the reportDiagnosticReport.codedDiagnosis
identifiertokenAn identifier for the reportDiagnosticReport.identifier
imagereferenceReference to the image sourceDiagnosticReport.image.link
(Media)
issueddateWhen the report was issuedDiagnosticReport.issued
nametokenThe name of the report (e.g. the code for the report as a whole, as opposed to codes for the atomic results, which are the names on the observation resource referred to from the result)DiagnosticReport.name
performerreferenceWho was the source of the report (organization)DiagnosticReport.performer
(Organization, Practitioner)
requestreferenceWhat was requestedDiagnosticReport.requestDetail
(DiagnosticOrder)
resultreferenceLink to an atomic result (observation resource)DiagnosticReport.result
(Observation)
servicetokenWhich diagnostic discipline/department created the reportDiagnosticReport.serviceCategory
specimenreferenceThe specimen detailsDiagnosticReport.specimen
(Specimen)
statustokenThe status of the reportDiagnosticReport.status
subjectreferenceThe subject of the reportDiagnosticReport.subject
(Device, Location, Patient, Group)

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