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 and 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.

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

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.

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

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.

Usually assigned by the Information System of the diagnostic service provider (filler id).

Details concerning a test or procedure service requested.

This allows tracing of authorization for the report and tracking whether proposals/recommendations were acted upon.

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.

The status of the diagnostic report as a whole. report.

Diagnostic services routinely issue provisional/incomplete reports, and sometimes withdraw previously released reports.

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.

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.

A code or name that describes this diagnostic report.

DiagnosticReport.code is primarily meant to characterize the nature of the entire report, not to summarize the content in detail. In the case where multiple orderables are included in a single report, then the single DiagnosticReport.code would represent the entire 'panel' that the report is covering.

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.

SHALL know the subject context.

Other DiagnosticReports that the current DiagnosticReport replaces, amendens, extends, or otherwise relates to.

The healthcare event encounter (e.g. a patient and healthcare provider interaction) which this DiagnosticReport per that is about. associated with the DiagnosticReport.

Links the request report to the Encounter context.

This will typically be the encounter encounter, when it exists, during which the event occurred within, but some events may be initiated prior to data or after the official completion of an encounter specimens (e.g. imaging, blood draw, or episode but still assessment procedure) that are being reported by the DiagnosticReport were obtained/acquired. When a DiagnosticReport is based on a ServiceRequest (order), the ServiceRequest.encounter referenced in DiagnosticReport.basedOn may be tied used to associate the context of the encounter or episode (e.g. pre-admission lab tests). two.

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.

Need to know where in the patient history to file/present this report.

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.

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.

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

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.

Indicates who or what participated The performed procedure(s) that are reported on in producing the report. DiagnosticReport.

This is a summary of the report, not a list of results.

Describes the type of participation (e.g. a The diagnostic service that is responsible party, author, or verifier). for issuing the report.

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.

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. In the regulated context of diagnostic laboratory work on humans, it is extremely likely that regulation requires a human performer. Point of care testing, veterinary testing, drug screens, and environmental surveillance are common cases where the device is the performer with no additional human interaction or direct oversight.

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.

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.

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.

Details about the specimens on which this diagnostic report is based.

Need to be able to report information about the collected specimens on which the report is based.

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.

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").

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.

Observations can contain observations.

Comments about the diagnostic report.

Need to be able to provide free text additional information.

May include general statements about the diagnostic report, or statements about significant, unexpected or unreliable results values contained within the diagnostic report, or information about its source when relevant to its interpretation.

One or more links to full details of any imaging study performed during the diagnostic investigation. An ImagingStudy might comprise a set of radiologic images obtained via a procedure that are analyzed as a group. 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. A GenomicStudy 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.

ImagingStudy For laboratory-type studies like GenomeStudy, type resources will be used for tracking additional metadata and ImageManifest workflow aspects of complex studies. ImagingStudy and the image media element are somewhat overlapping - typically, the list of image references in the image media 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.

This backbone element contains supporting information that was used in the creation of the report not included in the results already included in the report.

Supporting information should only be used for resources that are not referenced elsewhere within the same DiagnosticReport, e.g., DiagnosticReport.comparison.

The code value for the role of the supporting information in the diagnostic report.

The reference for the supporting information in the diagnostic report.

A list of key images or data associated with this report. The images or data are generally created during the diagnostic process, and may be directly of the patient, or of treated specimens (i.e. slides of interest).

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

A comment about the image. image or data. Typically, this is used to provide an explanation for why the image or data is included, or to draw the viewer's attention to important features.

The provider of the report should make a comment about each image or data included in the report.

The comment should be displayed with the image. image or data. It would be common for the report to include additional discussion of the image or data contents or in other sections such as the conclusion.

Reference to the image or data source.

Reference to a Composition resource instance that provides structure for organizing the contents of the DiagnosticReport.

The Composition provides structure to the content of the DiagnosticReport (and only contains contents referenced in the DiagnosticReport) - e.g., to order the sections of an anatomic pathology structured report.

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

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

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

Proposed follow-up actions based on the findings and interpretations of the diagnostic test for which this report is the subject.

The resources that should be referenced include CarePlan, ServiceRequest, CommunicationRequest, etc. that allow for proposed actions and next steps.

Rich text representation of the entire result as issued by the diagnostic service. Multiple formats are allowed but they SHALL be semantically equivalent.

Gives laboratory the ability to provide its own fully formatted report for clinical fidelity.

"application/pdf" "application/pdf" is recommended as the most reliable and interoperable in this context.

Communications initiated during the generation of the DiagnosticReport by members of the organization fulfilling that order. e.g. direct communication of time critical results by the radiologist to the referring physician.

Need to record details of such communications for medico-legal purposes, to support review or the improvement of conformance to best practices for patient safety and quality of care.

Note: This can document attempted communications as well as completed communications. Communications that follow publication of the report (e.g. between the referring physician and the patient or a subsequent specialist) are not referenced here. DiagnosticReport.recommendation might also contain references to ServiceRequest or CommunicationRequest instances for proposed subsequent communications.

Prior data and findings made available for comparison when determining the current interpretation.

The List.entry.item can be profiled down to indicate a ImagingStudy | DiagnosticReport | Observation.