STU 3 Ballot

This page is part of the FHIR Specification (v1.6.0: STU 3 Ballot 4). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3 R2

10.2 Resource DiagnosticReport - Content

Orders and Observations Work GroupMaturity Level: 3Compartments: Device, Encounter, Patient, Practitioner

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 interpretations, and formatted representation of diagnostic reports.

10.2.1 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 lab tests, the specimen of the report. It can also refers 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:

  • Laboratory (Clinical Chemistry, Hematology, Microbiology, etc.)
  • Pathology / Histopathology / related disciplines
  • Imaging Investigations (x-ray, CT, MRI etc.)
  • Other diagnostics - Cardiology, Gastroenterology etc.

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.

10.2.2 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.

10.2.3 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 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 DiagnosticRequest) resource 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.

DSTU Note: The relationship between the two resources is subject to ongoing evaluation during the trial use period.

Feedback is welcome here .

Image and media representations of the report and supporting images are referenced in the DiagnosticReport resource. The details and actual image instances can be referenced directly in Diagnostic report using the "imaging" element or by indirect reference through the ImagingManifest or ImagingStudy resources which represent the content produced in a DICOM imaging study or set of DICOM Instances of a patient.

This resource is referenced by ClinicalImpression, Condition and Procedure

10.2.4 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. DiagnosticReport DomainResourceA Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
... identifier Σ0..*IdentifierId for external references to this report
... status ?!Σ1..1coderegistered | partial | final | corrected | appended | cancelled | entered-in-error
DiagnosticReportStatus (Required)
... category Σ0..1CodeableConceptService category
Diagnostic Service Section Codes (Example)
... code Σ1..1CodeableConceptName/Code for this diagnostic report
LOINC Diagnostic Report Codes (Preferred)
... subject Σ1..1Reference(Patient | Group | Device | Location)The subject of the report, usually, but not always, the patient
... encounter Σ0..1Reference(Encounter)Health care event when test ordered
... effective[x] Σ1..1Clinically Relevant time/time-period for report
.... effectiveDateTimedateTime
.... effectivePeriodPeriod
... issued Σ1..1instantDateTime this version was released
... performer Σ1..*Reference(Practitioner | Organization)Responsible Diagnostic Service
... request 0..*Reference(DiagnosticRequest | ProcedureRequest | ReferralRequest)What was requested
... specimen 0..*Reference(Specimen)Specimens this report is based on
... result 0..*Reference(Observation)Observations - simple, or complex nested groups
... imagingStudy 0..*Reference(ImagingStudy | ImagingManifest)Reference to full details of imaging associated with the diagnostic report
... image Σ0..*BackboneElementKey images associated with this report
.... comment 0..1stringComment about the image (e.g. explanation)
.... link Σ1..1Reference(Media)Reference to the image source
... conclusion 0..1stringClinical Interpretation of test results
... codedDiagnosis 0..*CodeableConceptCodes for the conclusion
SNOMED CT Clinical Findings (Example)
... presentedForm 0..*AttachmentEntire report as issued

doco Documentation for this format

UML Diagram (Legend)

DiagnosticReport (DomainResource)The local ID assigned to the report by the order filler, usually by the Information System of the diagnostic service provideridentifier : Identifier [0..*]The status of the diagnostic report as a whole (this element modifies the meaning of other elements)status : code [1..1] « The status of the diagnostic report as a whole. (Strength=Required)DiagnosticReportStatus! »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 purposescategory : CodeableConcept [0..1] « Codes for diagnostic service sections. (Strength=Example)Diagnostic Service Section ?? »A code or name that describes this diagnostic reportcode : CodeableConcept [1..1] « Codes that describe Diagnostic Reports. (Strength=Preferred)LOINC Diagnostic Report ? »The 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 : Reference [1..1] « Patient|Group|Device|Location »The link to the health care event (encounter) when the order was madeencounter : Reference [0..1] « Encounter »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 itselfeffective[x] : Type [1..1] « dateTime|Period »The date and time that this version of the report was released from the source diagnostic serviceissued : instant [1..1]The diagnostic service that is responsible for issuing the reportperformer : Reference [1..*] « Practitioner|Organization »Details concerning a test or procedure requestedrequest : Reference [0..*] « DiagnosticRequest|ProcedureRequest| ReferralRequest »Details about the specimens on which this diagnostic report is basedspecimen : Reference [0..*] « Specimen »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 : Reference [0..*] « Observation »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 : Reference [0..*] « ImagingStudy|ImagingManifest »Concise and clinically contextualized impression / summary of the diagnostic reportconclusion : string [0..1]Codes for the conclusioncodedDiagnosis : CodeableConcept [0..*] « Diagnoses codes provided as adjuncts to the report. (Strength=Example)SNOMED CT Clinical Findings?? »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..1]Reference to the image sourcelink : Reference [1..1] « Media »A 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)image[0..*]

XML Template

<DiagnosticReport xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Id for external references to this report --></identifier>
 <status value="[code]"/><!-- 1..1 registered | partial | final | corrected | appended | cancelled | entered-in-error -->
 <category><!-- 0..1 CodeableConcept Service category --></category>
 <code><!-- 1..1 CodeableConcept Name/Code for this diagnostic report --></code>
 <subject><!-- 1..1 Reference(Patient|Group|Device|Location) The subject of the report, usually, but not always, the patient --></subject>
 <encounter><!-- 0..1 Reference(Encounter) Health care event when test ordered --></encounter>
 <effective[x]><!-- 1..1 dateTime|Period Clinically Relevant time/time-period for report --></effective[x]>
 <issued value="[instant]"/><!-- 1..1 DateTime this version was released -->
 <performer><!-- 1..* Reference(Practitioner|Organization) Responsible Diagnostic Service --></performer>
 <request><!-- 0..* Reference(DiagnosticRequest|ProcedureRequest|ReferralRequest) What was requested --></request>
 <specimen><!-- 0..* Reference(Specimen) Specimens this report is based on --></specimen>
 <result><!-- 0..* Reference(Observation) Observations - simple, or complex nested groups --></result>
 <imagingStudy><!-- 0..* Reference(ImagingStudy|ImagingManifest) 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 Reference(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>

JSON Template

{doco
  "resourceType" : "DiagnosticReport",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Id for external references to this report
  "status" : "<code>", // R!  registered | partial | final | corrected | appended | cancelled | entered-in-error
  "category" : { CodeableConcept }, // Service category
  "code" : { CodeableConcept }, // R!  Name/Code for this diagnostic report
  "subject" : { Reference(Patient|Group|Device|Location) }, // R!  The subject of the report, usually, but not always, the patient
  "encounter" : { Reference(Encounter) }, // Health care event when test ordered
  // effective[x]: Clinically Relevant time/time-period for report. One of these 2:
  "effectiveDateTime" : "<dateTime>",
  "effectivePeriod" : { Period },
  "issued" : "<instant>", // R!  DateTime this version was released
  "performer" : [{ Reference(Practitioner|Organization) }], // R!  Responsible Diagnostic Service
  "request" : [{ Reference(DiagnosticRequest|ProcedureRequest|ReferralRequest) }], // What was requested
  "specimen" : [{ Reference(Specimen) }], // Specimens this report is based on
  "result" : [{ Reference(Observation) }], // Observations - simple, or complex nested groups
  "imagingStudy" : [{ Reference(ImagingStudy|ImagingManifest) }], // Reference to full details of imaging associated with the diagnostic report
  "image" : [{ // Key images associated with this report
    "comment" : "<string>", // Comment about the image (e.g. explanation)
    "link" : { Reference(Media) } // R!  Reference to the image source
  }],
  "conclusion" : "<string>", // Clinical Interpretation of test results
  "codedDiagnosis" : [{ CodeableConcept }], // Codes for the conclusion
  "presentedForm" : [{ Attachment }] // Entire report as issued
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:DiagnosticReport;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:DiagnosticReport.identifier [ Identifier ], ... ; # 0..* Id for external references to this report
  fhir:DiagnosticReport.status [ code ]; # 1..1 registered | partial | final | corrected | appended | cancelled | entered-in-error
  fhir:DiagnosticReport.category [ CodeableConcept ]; # 0..1 Service category
  fhir:DiagnosticReport.code [ CodeableConcept ]; # 1..1 Name/Code for this diagnostic report
  fhir:DiagnosticReport.subject [ Reference(Patient|Group|Device|Location) ]; # 1..1 The subject of the report, usually, but not always, the patient
  fhir:DiagnosticReport.encounter [ Reference(Encounter) ]; # 0..1 Health care event when test ordered
  # DiagnosticReport.effective[x] : 1..1 Clinically Relevant time/time-period for report. One of these 2
    fhir:DiagnosticReport.effectiveDateTime [ dateTime ]
    fhir:DiagnosticReport.effectivePeriod [ Period ]
  fhir:DiagnosticReport.issued [ instant ]; # 1..1 DateTime this version was released
  fhir:DiagnosticReport.performer [ Reference(Practitioner|Organization) ], ... ; # 1..* Responsible Diagnostic Service
  fhir:DiagnosticReport.request [ Reference(DiagnosticRequest|ProcedureRequest|ReferralRequest) ], ... ; # 0..* What was requested
  fhir:DiagnosticReport.specimen [ Reference(Specimen) ], ... ; # 0..* Specimens this report is based on
  fhir:DiagnosticReport.result [ Reference(Observation) ], ... ; # 0..* Observations - simple, or complex nested groups
  fhir:DiagnosticReport.imagingStudy [ Reference(ImagingStudy|ImagingManifest) ], ... ; # 0..* Reference to full details of imaging associated with the diagnostic report
  fhir:DiagnosticReport.image [ # 0..* Key images associated with this report
    fhir:DiagnosticReport.image.comment [ string ]; # 0..1 Comment about the image (e.g. explanation)
    fhir:DiagnosticReport.image.link [ Reference(Media) ]; # 1..1 Reference to the image source
  ], ...;
  fhir:DiagnosticReport.conclusion [ string ]; # 0..1 Clinical Interpretation of test results
  fhir:DiagnosticReport.codedDiagnosis [ CodeableConcept ], ... ; # 0..* Codes for the conclusion
  fhir:DiagnosticReport.presentedForm [ Attachment ], ... ; # 0..* Entire report as issued
]

Changes since DSTU2

DiagnosticReport
DiagnosticReport.performer Max Cardinality changed from 1 to *
DiagnosticReport.request Remove Reference(DiagnosticOrder), Add Reference(DiagnosticRequest)
DiagnosticReport.imagingStudy Remove Reference(ImagingObjectSelection), Add Reference(ImagingManifest)

See the Full Difference for further information

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. DiagnosticReport DomainResourceA Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
... identifier Σ0..*IdentifierId for external references to this report
... status ?!Σ1..1coderegistered | partial | final | corrected | appended | cancelled | entered-in-error
DiagnosticReportStatus (Required)
... category Σ0..1CodeableConceptService category
Diagnostic Service Section Codes (Example)
... code Σ1..1CodeableConceptName/Code for this diagnostic report
LOINC Diagnostic Report Codes (Preferred)
... subject Σ1..1Reference(Patient | Group | Device | Location)The subject of the report, usually, but not always, the patient
... encounter Σ0..1Reference(Encounter)Health care event when test ordered
... effective[x] Σ1..1Clinically Relevant time/time-period for report
.... effectiveDateTimedateTime
.... effectivePeriodPeriod
... issued Σ1..1instantDateTime this version was released
... performer Σ1..*Reference(Practitioner | Organization)Responsible Diagnostic Service
... request 0..*Reference(DiagnosticRequest | ProcedureRequest | ReferralRequest)What was requested
... specimen 0..*Reference(Specimen)Specimens this report is based on
... result 0..*Reference(Observation)Observations - simple, or complex nested groups
... imagingStudy 0..*Reference(ImagingStudy | ImagingManifest)Reference to full details of imaging associated with the diagnostic report
... image Σ0..*BackboneElementKey images associated with this report
.... comment 0..1stringComment about the image (e.g. explanation)
.... link Σ1..1Reference(Media)Reference to the image source
... conclusion 0..1stringClinical Interpretation of test results
... codedDiagnosis 0..*CodeableConceptCodes for the conclusion
SNOMED CT Clinical Findings (Example)
... presentedForm 0..*AttachmentEntire report as issued

doco Documentation for this format

UML Diagram (Legend)

DiagnosticReport (DomainResource)The local ID assigned to the report by the order filler, usually by the Information System of the diagnostic service provideridentifier : Identifier [0..*]The status of the diagnostic report as a whole (this element modifies the meaning of other elements)status : code [1..1] « The status of the diagnostic report as a whole. (Strength=Required)DiagnosticReportStatus! »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 purposescategory : CodeableConcept [0..1] « Codes for diagnostic service sections. (Strength=Example)Diagnostic Service Section ?? »A code or name that describes this diagnostic reportcode : CodeableConcept [1..1] « Codes that describe Diagnostic Reports. (Strength=Preferred)LOINC Diagnostic Report ? »The 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 : Reference [1..1] « Patient|Group|Device|Location »The link to the health care event (encounter) when the order was madeencounter : Reference [0..1] « Encounter »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 itselfeffective[x] : Type [1..1] « dateTime|Period »The date and time that this version of the report was released from the source diagnostic serviceissued : instant [1..1]The diagnostic service that is responsible for issuing the reportperformer : Reference [1..*] « Practitioner|Organization »Details concerning a test or procedure requestedrequest : Reference [0..*] « DiagnosticRequest|ProcedureRequest| ReferralRequest »Details about the specimens on which this diagnostic report is basedspecimen : Reference [0..*] « Specimen »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 : Reference [0..*] « Observation »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 : Reference [0..*] « ImagingStudy|ImagingManifest »Concise and clinically contextualized impression / summary of the diagnostic reportconclusion : string [0..1]Codes for the conclusioncodedDiagnosis : CodeableConcept [0..*] « Diagnoses codes provided as adjuncts to the report. (Strength=Example)SNOMED CT Clinical Findings?? »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..1]Reference to the image sourcelink : Reference [1..1] « Media »A 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)image[0..*]

XML Template

<DiagnosticReport xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Id for external references to this report --></identifier>
 <status value="[code]"/><!-- 1..1 registered | partial | final | corrected | appended | cancelled | entered-in-error -->
 <category><!-- 0..1 CodeableConcept Service category --></category>
 <code><!-- 1..1 CodeableConcept Name/Code for this diagnostic report --></code>
 <subject><!-- 1..1 Reference(Patient|Group|Device|Location) The subject of the report, usually, but not always, the patient --></subject>
 <encounter><!-- 0..1 Reference(Encounter) Health care event when test ordered --></encounter>
 <effective[x]><!-- 1..1 dateTime|Period Clinically Relevant time/time-period for report --></effective[x]>
 <issued value="[instant]"/><!-- 1..1 DateTime this version was released -->
 <performer><!-- 1..* Reference(Practitioner|Organization) Responsible Diagnostic Service --></performer>
 <request><!-- 0..* Reference(DiagnosticRequest|ProcedureRequest|ReferralRequest) What was requested --></request>
 <specimen><!-- 0..* Reference(Specimen) Specimens this report is based on --></specimen>
 <result><!-- 0..* Reference(Observation) Observations - simple, or complex nested groups --></result>
 <imagingStudy><!-- 0..* Reference(ImagingStudy|ImagingManifest) 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 Reference(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>

JSON Template

{doco
  "resourceType" : "DiagnosticReport",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Id for external references to this report
  "status" : "<code>", // R!  registered | partial | final | corrected | appended | cancelled | entered-in-error
  "category" : { CodeableConcept }, // Service category
  "code" : { CodeableConcept }, // R!  Name/Code for this diagnostic report
  "subject" : { Reference(Patient|Group|Device|Location) }, // R!  The subject of the report, usually, but not always, the patient
  "encounter" : { Reference(Encounter) }, // Health care event when test ordered
  // effective[x]: Clinically Relevant time/time-period for report. One of these 2:
  "effectiveDateTime" : "<dateTime>",
  "effectivePeriod" : { Period },
  "issued" : "<instant>", // R!  DateTime this version was released
  "performer" : [{ Reference(Practitioner|Organization) }], // R!  Responsible Diagnostic Service
  "request" : [{ Reference(DiagnosticRequest|ProcedureRequest|ReferralRequest) }], // What was requested
  "specimen" : [{ Reference(Specimen) }], // Specimens this report is based on
  "result" : [{ Reference(Observation) }], // Observations - simple, or complex nested groups
  "imagingStudy" : [{ Reference(ImagingStudy|ImagingManifest) }], // Reference to full details of imaging associated with the diagnostic report
  "image" : [{ // Key images associated with this report
    "comment" : "<string>", // Comment about the image (e.g. explanation)
    "link" : { Reference(Media) } // R!  Reference to the image source
  }],
  "conclusion" : "<string>", // Clinical Interpretation of test results
  "codedDiagnosis" : [{ CodeableConcept }], // Codes for the conclusion
  "presentedForm" : [{ Attachment }] // Entire report as issued
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:DiagnosticReport;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:DiagnosticReport.identifier [ Identifier ], ... ; # 0..* Id for external references to this report
  fhir:DiagnosticReport.status [ code ]; # 1..1 registered | partial | final | corrected | appended | cancelled | entered-in-error
  fhir:DiagnosticReport.category [ CodeableConcept ]; # 0..1 Service category
  fhir:DiagnosticReport.code [ CodeableConcept ]; # 1..1 Name/Code for this diagnostic report
  fhir:DiagnosticReport.subject [ Reference(Patient|Group|Device|Location) ]; # 1..1 The subject of the report, usually, but not always, the patient
  fhir:DiagnosticReport.encounter [ Reference(Encounter) ]; # 0..1 Health care event when test ordered
  # DiagnosticReport.effective[x] : 1..1 Clinically Relevant time/time-period for report. One of these 2
    fhir:DiagnosticReport.effectiveDateTime [ dateTime ]
    fhir:DiagnosticReport.effectivePeriod [ Period ]
  fhir:DiagnosticReport.issued [ instant ]; # 1..1 DateTime this version was released
  fhir:DiagnosticReport.performer [ Reference(Practitioner|Organization) ], ... ; # 1..* Responsible Diagnostic Service
  fhir:DiagnosticReport.request [ Reference(DiagnosticRequest|ProcedureRequest|ReferralRequest) ], ... ; # 0..* What was requested
  fhir:DiagnosticReport.specimen [ Reference(Specimen) ], ... ; # 0..* Specimens this report is based on
  fhir:DiagnosticReport.result [ Reference(Observation) ], ... ; # 0..* Observations - simple, or complex nested groups
  fhir:DiagnosticReport.imagingStudy [ Reference(ImagingStudy|ImagingManifest) ], ... ; # 0..* Reference to full details of imaging associated with the diagnostic report
  fhir:DiagnosticReport.image [ # 0..* Key images associated with this report
    fhir:DiagnosticReport.image.comment [ string ]; # 0..1 Comment about the image (e.g. explanation)
    fhir:DiagnosticReport.image.link [ Reference(Media) ]; # 1..1 Reference to the image source
  ], ...;
  fhir:DiagnosticReport.conclusion [ string ]; # 0..1 Clinical Interpretation of test results
  fhir:DiagnosticReport.codedDiagnosis [ CodeableConcept ], ... ; # 0..* Codes for the conclusion
  fhir:DiagnosticReport.presentedForm [ Attachment ], ... ; # 0..* Entire report as issued
]

Changes since DSTU2

DiagnosticReport
DiagnosticReport.performer Max Cardinality changed from 1 to *
DiagnosticReport.request Remove Reference(DiagnosticOrder), Add Reference(DiagnosticRequest)
DiagnosticReport.imagingStudy Remove Reference(ImagingObjectSelection), Add Reference(ImagingManifest)

See the Full Difference for further information

 

Alternate definitions: Master Definition (XML, JSON), XML Schema/Schematron (for ) + JSON Schema, ShEx (for Turtle)

10.2.4.1 Terminology Bindings

PathDefinitionTypeReference
DiagnosticReport.status The status of the diagnostic report as a whole.RequiredDiagnosticReportStatus
DiagnosticReport.category Codes for diagnostic service sections.ExampleDiagnostic Service Section Codes
DiagnosticReport.code Codes that describe Diagnostic Reports.PreferredLOINC Diagnostic Report Codes
DiagnosticReport.codedDiagnosis Diagnoses codes provided as adjuncts to the report.ExampleSNOMED CT Clinical Findings

Examples of nested report groups: the antibody hepatitis order panel code for a group 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.

10.2.5 Notes:

10.2.5.1 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 a effective[x] element. Note that HL7 v2 messages often carry a diagnostically relevant time without carrying any specimen information.

10.2.5.2 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.

10.2.5.3 Associated Images

ImagingStudy and ImageObjectStudy and the DiagnosticReport.image element are somewhat overlapping - typically, the list of image references in the image 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.

10.2.5.4 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 amended.
  • 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.

10.2.5.5 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. 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.

10.2.6 Search Parameters

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

NameTypeDescriptionPaths
categorytokenWhich diagnostic discipline/department created the reportDiagnosticReport.category
codetokenThe 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 resultDiagnosticReport.code
datedateThe clinically relevant time of the reportDiagnosticReport.effective[x]
diagnosistokenA coded diagnosis on the reportDiagnosticReport.codedDiagnosis
encounterreferenceThe Encounter when the order was madeDiagnosticReport.encounter
(Encounter)
identifiertokenAn identifier for the reportDiagnosticReport.identifier
imagereferenceA reference to the image source.DiagnosticReport.image.link
(Media)
issueddateWhen the report was issuedDiagnosticReport.issued
patientreferenceThe subject of the report if a patientDiagnosticReport.subject
(Patient)
performerreferenceWho was the source of the report (organization)DiagnosticReport.performer
(Practitioner, Organization)
requestreferenceReference to the test or procedure request.DiagnosticReport.request
(ReferralRequest, ProcedureRequest, DiagnosticRequest)
resultreferenceLink to an atomic result (observation resource)DiagnosticReport.result
(Observation)
specimenreferenceThe specimen detailsDiagnosticReport.specimen
(Specimen)
statustokenThe status of the reportDiagnosticReport.status
subjectreferenceThe subject of the reportDiagnosticReport.subject
(Group, Device, Patient, Location)