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type: resourceresource: DiagnosticReport

DiagnosticReport

Introduction

Scope and Usage

Note to Balloters: To ensure this resource is ready for Normative status, we are seeking ballot comment on the substantive content. The key changes made since R5 include:

Addition of the following elements:

  • DiagnosticReport.relatesTo
  • DiagnosticReport.procedure
  • DiagnosticReport.recommendation
  • DiagnosticReport.communication
  • DiagnosticReport.comparison

Changes to the following elements:

  • DiagnosticReport.conclusionCode datatype

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. In FHIR, the report can be conveyed in a variety of ways including a Document, RESTful API, or Messaging framework. Included within each of these, would be the DiagnosticReport resource itself.

The DiagnosticReport resource has information about the diagnostic report itself, and about the subject and, in the case of laboratory tests, the specimen of the report. It can also refer to the request details and atomic observations details or image instances. Report conclusions can be expressed as a simple text blob, structured coded data or as an attached fully formatted report such as a PDF.

The DiagnosticReport resource is suitable for the following kinds of diagnostic reports:

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

Background and Context

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 (traditionally referred to as "panels" or " batteries" by laboratories) that can be used to represent relationships between the individual data items.

Boundaries and Relationships

Note that many diagnostic processes are procedures that generate observations and diagnostic reports. In many cases, such an observation does not require an explicit representation of the procedure used to create the observation, but where there are details of interest about how the diagnostic procedure was performed, the Procedure resource is used to describe the activity.

In contrast to the Observation resource, the DiagnosticReport resource typically includes additional clinical context and some mix of atomic results, images, imaging reports, textual and coded interpretation, and formatted representations. Laboratory reports, pathology reports, and imaging reports should be represented using the DiagnosticReport resource. The Observation resource should be used to record patient-generated information (e.g., self-test results). The Observation resource is referenced by the DiagnosticReport to provide the atomic results for a particular investigation.

If you have a highly structured report, then use DiagnosticReport - it has data and workflow support. Details about the request for a diagnostic investigation are captured in the various "request" resources (e.g., the ServiceRequest) and allow the report to connect to clinical workflows. For more narrative driven reports with less work flow (histology/mortuary, etc.), the Composition resource would be more appropriate.

The performer and resultsInterpreter elements support references to Patient and RelatedPerson to accommodate self-performed and at-home testing scenarios. When the performer or resultsInterpreter references the same Patient as the subject, this indicates that the patient performed the test themselves (e.g., home glucose monitoring, self-administered COVID-19 tests). When these elements reference a RelatedPerson, this indicates that a family member, caregiver, or other related individual performed the test or interpreted the results on behalf of the patient. The performer element indicates who physically performed or was responsible for the diagnostic procedure, while resultsInterpreter indicates who was responsible for the clinical interpretation of the results. Both roles may be filled by the patient or a related person in home-based and self-care scenarios.

Diagnostic studies, such as those involving radiologic images or genomic data, are referenced via the "study" element.

For image studies, the details and actual image instances can be referenced in the DiagnosticReport using the "media" element or through the "study" element to reference ImagingStudy resources which represent the content produced in a DICOM imaging study or set of DICOM Instances for a patient.

When a report includes genomic testing, the complex metadata about the analysis performed can be captured referenced through the "study" element to reference GenomicStudy resources.

As other complex laboratory areas develop resources to capture metadata about different types of studies, this attribute will be extended to reference those.

Image and media representations of the report and supporting images and data are referenced in the "media" element.

A DiagnosticReport has overlapping characteristics with DocumentReference. The DiagnosticReport is appropriate to reflect a set of discrete results (Observations) and associated contextual details for a specific report, and within those results any further structure within the Observation instances, while a DocumentReference typically reflects a non-FHIR object (e.g., an existing C-CDA document, a scan of a drivers license, or narrative note). There is some overlap potential, such as a scan of a CBC report that can either be referenced via a DocumentReference, or included in a DiagnosticReport as a presentedForm together with the structured, discrete data. In some cases, a single in-system entity may be represented as both resources if they provide relevant metadata or workflow-specific attributes. Specific implementation guides would further clarify which approach is more appropriate.

Notes

Notes:

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:

<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>

<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>

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.

Associated Observations

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.

Diagnostic Report Status

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:

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:

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.

DiagnosticReport could also contain Observations for tests that were not performed. See Observation for more details on how one documents that an observation was not performed.

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.

StructureDefinition

Elements (Simplified)

Mappings

Resource Packs

list-DiagnosticReport-packs.xml

<?xml version="1.0" encoding="UTF-8"?>

<List xmlns="http://hl7.org/fhir" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://hl7.org/fhir ../../publish/List.xsd">
  <id value="DiagnosticReport-packs"/>
  <status value="current"/>
  <mode value="working"/>
</List>

Search Parameters

Full Search Parameters

Examples

Full Examples

Mapping Exceptions

diagnosticreport-event-mapping-exceptions.xml

Divergent Elements

Unknown does not represent "other" - one of the defined statuses must apply. Unknown is used when the authoring system is not sure what the current status is.

Unmapped Elements

diagnosticreport-fivews-mapping-exceptions.xml

Unmapped Elements