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.
10.3.1 Scope and Usage
This resource is an event resource from a FHIR workflow perspective - see Workflow. It is the intent of the Orders and Observation Workgroup to align this resource with the workflow pattern for event resources.
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:
Other diagnostics such as Cardiology, Gastroenterology, etc.
Product quality tests such as pH, Assay, Microbial limits, etc. on product and substance
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.
10.3.2 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.
10.3.3 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.
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 representedForm 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.
A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports + Rule: When a Composition is referenced in `Diagnostic.composition`, all Observation resources referenced in `Composition.entry` must also be referenced in `Diagnostic.entry` or in the references Observations in `Observation.hasMember`
A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports + Rule: When a Composition is referenced in `Diagnostic.composition`, all Observation resources referenced in `Composition.entry` must also be referenced in `Diagnostic.entry` or in the references Observations in `Observation.hasMember`
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.
When a Composition is referenced in `Diagnostic.composition`, all Observation resources referenced in `Composition.entry` must also be referenced in `Diagnostic.entry` or in the references Observations in `Observation.hasMember`
composition.exists() implies (composition.resolve().section.entry.reference.where(resolve() is Observation) in (result.reference|result.reference.resolve().hasMember.reference))
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:
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.
Diagnostics
DiagnosticReport 
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