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.

This is intended to capture a single 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.

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels. Contained resources may be a resource type defined in the FHIR specification, or an additional resource.

An Extension

Prior imaging studies that were considered relevant to the current study and made available to the imaging clinician at the time of reporting.

The primary study being reported is referenced from the study element.

Coded Conclusions about Conditions and Observations

A .conclusionCode item, being a CodeableReference, may contain an individual code instead of a reference when a code exists that encompasses the conclusion or impression.

An impression drawn from a *-RADS System, such as BI-RADS TOLINK, is encoded as a .conclusionCode item containing the corresponding code. For example, (397143007, SCT, "Mammography assessment (Category 3) - Probably benign finding, short interval follow-up").

Note 1. *-RADS codes correspond to the result of a composite assessment, and the conclusion may represent a point on a diagnostic pathway, which encompasses both a differential diagnosis and protocolized follow-up actions.

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

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.

These communications are limited to those 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. Communications that follow publication of the report (e.g. between the referring physician and the patient or a subsequent specialist) are not referenced here.

May have originally been extracted from the medical record by imaging staff, automated tools, or by the radiologists themselves.

Imaging procedure used to acquire the study.

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Details concerning a service requested.

Note 1. For result resources like DiagnosticReport, .basedOn references the authorizing request being fulfilled; i.e. the order, not the input data. So DiagnosticReport.basedOn references the imaging ServiceRequest, not the ImagingStudy.

Note 2. Report Creators do not create orders. It is expected that an appropriate ServiceRequest resource will exist which may have been created by another system more integrated with order management. The hospital may originate orders as ServiceRequest resources, or may create ServiceRequests based on HL7 v2 ORM or OMG messages. In either case, reporting systems are not the Source of Truth for order management; it would be disruptive for them to directly create/modify order resources.

Note 3. "Group Cases": While one report typically corresponds to one order (ServiceRequest) comprised of one study, some reports do cover multiple orders. A radiologist may satisfy multiple ServiceRequests in a single report. Depending on site preferences related to billing and workflow, systems should be prepared to handle this as a single report basedOn multiple ServiceRequests, or as multiple copies of the same report, each basedOn a different ServiceRequest.

Note 4. If the DiagnosticReport is associated with an Accession Number, this field should include a reference to that value in the form: identifier.value = (Accession Number Value) identifier.type = ACSN. A reference value pointing to a ServiceRequest resource is allowed but is not required.

Note 5. DiagnosticReport.basedOn may be empty in some scenarios, e.g. when emergency imaging is performed and an order has not been backfilled before reporting.

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

The order for the imaging procedure being reported.

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.

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

The status of the diagnostic report.

Values of preliminary and final shall be used when their conventional meaning for imaging reports applies. A value of registered state be used while the report is being composed during the interpretation process. For addenda, a value of amended shall be used. . Note: Other FHIR status values such as modified, corrected, or appended are not profiled here. They may be addressed in a reporting workflow profile.

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

A code for the diagnostic service that performed the imaging study

It is recommended that this code focus on the service/department, since the modality is already reflected in DiagnosticReport.code.

Potential codes may be drawn from DICOM PS3.16 CID 7030 "Institutional Department/Unit/Service" and the HL7 terminology code set referenced in FHIR.

This value may be copied from the ServiceRequest.category that the report is basedOn.

HL7 V2 table 0074

A code or name that describes this diagnostic report.

Imaging report titles are frequently site specific, but commonly communicate the modality, body part, and/or clinical focus of the performed imaging procedure.

Note 1. Since report titles often mirror the name of the ordered imaging procedure, the codes from the RSNA Radlex Playbook provide a useful example codeset. (Search LOINC for \“playbook\”)

LOINC Codes for Diagnostic Reports

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 sources.

Note 1. Report Creators do not create patient resources. It is expected that an appropriate Patient resource will exist, even if only a John Doe, created by another system more integrated with patient management. Imaging systems are not the Source of Truth for patient demographics and management; it would be disruptive for them to directly create/modify patient resources. If a patient reference is a pre-requisite to publish imaging DiagnosticReport resources, the local infrastructure will arrange for appropriate Patient resources for the Report Creator to use.

SHALL know the subject context.

If present, will reflect the encounter of the imaging procedure being reported (which may also be found in DiagnosticReport.procedure.encounter.) To find the encounter during with the order for the imaging procedure was placed, see DiagnosticReport.basedOn[ServiceRequest].encounter.

This will typically be the encounter, when it exists, during which the data or specimens (e.g. imaging, blood draw, or 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 used to associate the two.

Links the request to the Encounter context.

The date and time that this version of the report was made available to providers, typically after the report was reviewed and verified.

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.

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

The procedure(s) that are reported on in the DiagnosticReport.

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

The diagnostic service that is responsible for issuing the report.

The organization (which may be a diagnostic service) responsible for the report is captured here. The specific clinician is captured in resultsInterpreter.

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.

The diagnostic service that is responsible for issuing the report.

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.

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.

The practitioner or organization that is responsible for the report's conclusions and interpretations.

This is imaging clinician(s) the study is reported by.

Additional report authors may also be referenced. PractitionerRole resources may be used to record participants such as residents, collaborating clinicians and the role they played.

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.

Detailed description of the findings on the imaging study. The findings should be described in a clear and concise manner, using standardized anatomic, pathologic, and radiologic terminology whenever possible.

Observations can contain observations.

Need to support individual results, or groups of results, where the result grouping is arbitrary, but meaningful.

Comments about the diagnostic report.

In imaging diagnostic reports, statements about significant, unexpected or unreliable result values appear as needed in the Findings, Conclusions, or Procedure, not in .note. Other imaging usage was not identified.

Need to be able to provide free text additional information.

Study interpreted by the imaging clinician in this report.

The ImagingStudy for the study being read shall be referenced unless no such ImagingStudy resource exists.

Note 1. Report Creators do not typically create ImagingStudy resources. It is expected that an appropriate ImagingStudy resource will exist, created by another system more integrated with image management, such as the PACS, or the VNA, or the EMR in response to messaging from the PACS or VNA. Report Creators are not the Source of Truth for imaging study management. In the absence of an ImagingStudy, the ServiceRequest and Accession Number will serve to provide basic linkages between the images and the report.

Note 2. Studies available for comparison during reporting are tracked in the comparison element, not the study element.

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).

Graphical elements such as charts and icons that appear in the presentedForm of the report may go here if they cannot be included inline in the format used (PDF, etc.).

The interpreted study is referenced from the .study element, not here. Those study images may be accessible as RESTful resources via DICOMweb (which includes parameterized renderings using the /rendered DICOMweb endpoint to adjust windowing and other parameters). Selected parts or points of those images are encoded as ImagingSelection resources. Comparison studies are referenced from the .comparison element.

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

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Reference to the image or data source.

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

Composition may be included to supplement .text and .presentedForm with additional presentations and compositions of the report content to meet the preferences of different readers, tasks, or site guidelines.

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

Note 1. In the presentedForm (PDF, HTML, etc.), section text titled Impression frequently contains not just impressions, but also recommendations, and communications. IDR profiles usage of specific encodings for those in the recommendation and communication elements.

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.

R6 makes .conclusionCode a CodeableReference to allow a Condition (or Observation) to be a coded conclusion.

Since I haven't figured out how to do that in a Profile (it is an expansion, not a constraint on the underlying resource) I have created a sister element .conclusionCodeR so I can continue building sample objects and resolving brittle build issues.

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 equivalent.

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

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

Identifies the type of the data in the attachment and allows a method to be chosen to interpret or render the data. Includes mime type parameters such as charset where appropriate.

BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049)

Processors of the data need to be able to know how to interpret the data.

The number of bytes of data that make up this attachment (before base64 encoding, if that is done).

The number of bytes is redundant if the data is provided as a base64binary, but is useful if the data is provided as a url reference.

Representing the size allows applications to determine whether they should fetch the content automatically in advance, or refuse to fetch it at all.

The calculated hash of the data using SHA-1. Represented using base64.

The hash is calculated on the data prior to base64 encoding, if the data is based64 encoded. The hash is not intended to support digital signatures. Where protection against malicious threats a digital signature should be considered, see Provenance.signature for mechanism to protect a resource with a digital signature.

Included so that applications can verify that the contents of a location have not changed due to technical failures (e.g., storage rot, transport glitch, incorrect version).

Prior imaging studies that were considered relevant to the current study and made available to the imaging clinician at the time of reporting.

The primary study being reported is referenced from the study element.

A .conclusionCode item, being a CodeableReference, may contain an individual code instead of a reference when a code exists that encompasses the conclusion or impression.

An impression drawn from a *-RADS System, such as BI-RADS TOLINK, is encoded as a .conclusionCode item containing the corresponding code. For example, (397143007, SCT, "Mammography assessment (Category 3) - Probably benign finding, short interval follow-up").

Note 1. *-RADS codes correspond to the result of a composite assessment, and the conclusion may represent a point on a diagnostic pathway, which encompasses both a differential diagnosis and protocolized follow-up actions.

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

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.

These communications are limited to those 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. Communications that follow publication of the report (e.g. between the referring physician and the patient or a subsequent specialist) are not referenced here.

May have originally been extracted from the medical record by imaging staff, automated tools, or by the radiologists themselves.

Imaging procedure used to acquire the study.

Note 1. For result resources like DiagnosticReport, .basedOn references the authorizing request being fulfilled; i.e. the order, not the input data. So DiagnosticReport.basedOn references the imaging ServiceRequest, not the ImagingStudy.

Note 2. Report Creators do not create orders. It is expected that an appropriate ServiceRequest resource will exist which may have been created by another system more integrated with order management. The hospital may originate orders as ServiceRequest resources, or may create ServiceRequests based on HL7 v2 ORM or OMG messages. In either case, reporting systems are not the Source of Truth for order management; it would be disruptive for them to directly create/modify order resources.

Note 3. "Group Cases": While one report typically corresponds to one order (ServiceRequest) comprised of one study, some reports do cover multiple orders. A radiologist may satisfy multiple ServiceRequests in a single report. Depending on site preferences related to billing and workflow, systems should be prepared to handle this as a single report basedOn multiple ServiceRequests, or as multiple copies of the same report, each basedOn a different ServiceRequest.

Note 4. If the DiagnosticReport is associated with an Accession Number, this field should include a reference to that value in the form: identifier.value = (Accession Number Value) identifier.type = ACSN. A reference value pointing to a ServiceRequest resource is allowed but is not required.

Note 5. DiagnosticReport.basedOn may be empty in some scenarios, e.g. when emergency imaging is performed and an order has not been backfilled before reporting.

The order for the imaging procedure being reported.

Values of preliminary and final shall be used when their conventional meaning for imaging reports applies. A value of registered state be used while the report is being composed during the interpretation process. For addenda, a value of amended shall be used. . Note: Other FHIR status values such as modified, corrected, or appended are not profiled here. They may be addressed in a reporting workflow profile.

A code for the diagnostic service that performed the imaging study

It is recommended that this code focus on the service/department, since the modality is already reflected in DiagnosticReport.code.

Potential codes may be drawn from DICOM PS3.16 CID 7030 "Institutional Department/Unit/Service" and the HL7 terminology code set referenced in FHIR.

This value may be copied from the ServiceRequest.category that the report is basedOn.

Imaging report titles are frequently site specific, but commonly communicate the modality, body part, and/or clinical focus of the performed imaging procedure.

Note 1. Since report titles often mirror the name of the ordered imaging procedure, the codes from the RSNA Radlex Playbook provide a useful example codeset. (Search LOINC for \“playbook\”)

Note 1. Report Creators do not create patient resources. It is expected that an appropriate Patient resource will exist, even if only a John Doe, created by another system more integrated with patient management. Imaging systems are not the Source of Truth for patient demographics and management; it would be disruptive for them to directly create/modify patient resources. If a patient reference is a pre-requisite to publish imaging DiagnosticReport resources, the local infrastructure will arrange for appropriate Patient resources for the Report Creator to use.

If present, will reflect the encounter of the imaging procedure being reported (which may also be found in DiagnosticReport.procedure.encounter.) To find the encounter during with the order for the imaging procedure was placed, see DiagnosticReport.basedOn[ServiceRequest].encounter.

The organization (which may be a diagnostic service) responsible for the report is captured here. The specific clinician is captured in resultsInterpreter.

This is imaging clinician(s) the study is reported by.

Additional report authors may also be referenced. PractitionerRole resources may be used to record participants such as residents, collaborating clinicians and the role they played.

Detailed description of the findings on the imaging study. The findings should be described in a clear and concise manner, using standardized anatomic, pathologic, and radiologic terminology whenever possible.

In imaging diagnostic reports, statements about significant, unexpected or unreliable result values appear as needed in the Findings, Conclusions, or Procedure, not in .note. Other imaging usage was not identified.

Study interpreted by the imaging clinician in this report.

The ImagingStudy for the study being read shall be referenced unless no such ImagingStudy resource exists.

Note 1. Report Creators do not typically create ImagingStudy resources. It is expected that an appropriate ImagingStudy resource will exist, created by another system more integrated with image management, such as the PACS, or the VNA, or the EMR in response to messaging from the PACS or VNA. Report Creators are not the Source of Truth for imaging study management. In the absence of an ImagingStudy, the ServiceRequest and Accession Number will serve to provide basic linkages between the images and the report.

Note 2. Studies available for comparison during reporting are tracked in the comparison element, not the study element.

Graphical elements such as charts and icons that appear in the presentedForm of the report may go here if they cannot be included inline in the format used (PDF, etc.).

The interpreted study is referenced from the .study element, not here. Those study images may be accessible as RESTful resources via DICOMweb (which includes parameterized renderings using the /rendered DICOMweb endpoint to adjust windowing and other parameters). Selected parts or points of those images are encoded as ImagingSelection resources. Comparison studies are referenced from the .comparison element.

Composition may be included to supplement .text and .presentedForm with additional presentations and compositions of the report content to meet the preferences of different readers, tasks, or site guidelines.

Note 1. In the presentedForm (PDF, HTML, etc.), section text titled Impression frequently contains not just impressions, but also recommendations, and communications. IDR profiles usage of specific encodings for those in the recommendation and communication elements.

R6 makes .conclusionCode a CodeableReference to allow a Condition (or Observation) to be a coded conclusion.

Since I haven't figured out how to do that in a Profile (it is an expansion, not a constraint on the underlying resource) I have created a sister element .conclusionCodeR so I can continue building sample objects and resolving brittle build issues.

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.

This is intended to capture a single 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.

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

The base language in which the resource is written.

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

IETF language tag for a human language

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels. Contained resources may be a resource type defined in the FHIR specification, or an additional resource.

An Extension

Prior imaging studies that were considered relevant to the current study and made available to the imaging clinician at the time of reporting.

The primary study being reported is referenced from the study element.

Coded Conclusions about Conditions and Observations

A .conclusionCode item, being a CodeableReference, may contain an individual code instead of a reference when a code exists that encompasses the conclusion or impression.

An impression drawn from a *-RADS System, such as BI-RADS TOLINK, is encoded as a .conclusionCode item containing the corresponding code. For example, (397143007, SCT, "Mammography assessment (Category 3) - Probably benign finding, short interval follow-up").

Note 1. *-RADS codes correspond to the result of a composite assessment, and the conclusion may represent a point on a diagnostic pathway, which encompasses both a differential diagnosis and protocolized follow-up actions.

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

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.

These communications are limited to those 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. Communications that follow publication of the report (e.g. between the referring physician and the patient or a subsequent specialist) are not referenced here.

May have originally been extracted from the medical record by imaging staff, automated tools, or by the radiologists themselves.

Imaging procedure used to acquire the study.

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

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

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

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.

Details concerning a service requested.

Note 1. For result resources like DiagnosticReport, .basedOn references the authorizing request being fulfilled; i.e. the order, not the input data. So DiagnosticReport.basedOn references the imaging ServiceRequest, not the ImagingStudy.

Note 2. Report Creators do not create orders. It is expected that an appropriate ServiceRequest resource will exist which may have been created by another system more integrated with order management. The hospital may originate orders as ServiceRequest resources, or may create ServiceRequests based on HL7 v2 ORM or OMG messages. In either case, reporting systems are not the Source of Truth for order management; it would be disruptive for them to directly create/modify order resources.

Note 3. "Group Cases": While one report typically corresponds to one order (ServiceRequest) comprised of one study, some reports do cover multiple orders. A radiologist may satisfy multiple ServiceRequests in a single report. Depending on site preferences related to billing and workflow, systems should be prepared to handle this as a single report basedOn multiple ServiceRequests, or as multiple copies of the same report, each basedOn a different ServiceRequest.

Note 4. If the DiagnosticReport is associated with an Accession Number, this field should include a reference to that value in the form: identifier.value = (Accession Number Value) identifier.type = ACSN. A reference value pointing to a ServiceRequest resource is allowed but is not required.

Note 5. DiagnosticReport.basedOn may be empty in some scenarios, e.g. when emergency imaging is performed and an order has not been backfilled before reporting.

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

The order for the imaging procedure being reported.

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.

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

The status of the diagnostic report.

Values of preliminary and final shall be used when their conventional meaning for imaging reports applies. A value of registered state be used while the report is being composed during the interpretation process. For addenda, a value of amended shall be used. . Note: Other FHIR status values such as modified, corrected, or appended are not profiled here. They may be addressed in a reporting workflow profile.

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

A code for the diagnostic service that performed the imaging study

It is recommended that this code focus on the service/department, since the modality is already reflected in DiagnosticReport.code.

Potential codes may be drawn from DICOM PS3.16 CID 7030 "Institutional Department/Unit/Service" and the HL7 terminology code set referenced in FHIR.

This value may be copied from the ServiceRequest.category that the report is basedOn.

HL7 V2 table 0074

A code or name that describes this diagnostic report.

Imaging report titles are frequently site specific, but commonly communicate the modality, body part, and/or clinical focus of the performed imaging procedure.

Note 1. Since report titles often mirror the name of the ordered imaging procedure, the codes from the RSNA Radlex Playbook provide a useful example codeset. (Search LOINC for \“playbook\”)

LOINC Codes for Diagnostic Reports

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 sources.

Note 1. Report Creators do not create patient resources. It is expected that an appropriate Patient resource will exist, even if only a John Doe, created by another system more integrated with patient management. Imaging systems are not the Source of Truth for patient demographics and management; it would be disruptive for them to directly create/modify patient resources. If a patient reference is a pre-requisite to publish imaging DiagnosticReport resources, the local infrastructure will arrange for appropriate Patient resources for the Report Creator to use.

SHALL know the subject context.

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

If present, will reflect the encounter of the imaging procedure being reported (which may also be found in DiagnosticReport.procedure.encounter.) To find the encounter during with the order for the imaging procedure was placed, see DiagnosticReport.basedOn[ServiceRequest].encounter.

This will typically be the encounter, when it exists, during which the data or specimens (e.g. imaging, blood draw, or 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 used to associate the two.

Links the request to the Encounter context.

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.

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.

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

The date and time that this version of the report was made available to providers, typically after the report was reviewed and verified.

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.

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

The procedure(s) that are reported on in the DiagnosticReport.

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

The diagnostic service that is responsible for issuing the report.

The organization (which may be a diagnostic service) responsible for the report is captured here. The specific clinician is captured in resultsInterpreter.

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.

The diagnostic service that is responsible for issuing the report.

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.

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.

The practitioner or organization that is responsible for the report's conclusions and interpretations.

This is imaging clinician(s) the study is reported by.

Additional report authors may also be referenced. PractitionerRole resources may be used to record participants such as residents, collaborating clinicians and the role they played.

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.

Details about the specimens on which this diagnostic 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.

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

Detailed description of the findings on the imaging study. The findings should be described in a clear and concise manner, using standardized anatomic, pathologic, and radiologic terminology whenever possible.

Observations can contain observations.

Need to support individual results, or groups of results, where the result grouping is arbitrary, but meaningful.

Comments about the diagnostic report.

In imaging diagnostic reports, statements about significant, unexpected or unreliable result values appear as needed in the Findings, Conclusions, or Procedure, not in .note. Other imaging usage was not identified.

Need to be able to provide free text additional information.

Study interpreted by the imaging clinician in this report.

The ImagingStudy for the study being read shall be referenced unless no such ImagingStudy resource exists.

Note 1. Report Creators do not typically create ImagingStudy resources. It is expected that an appropriate ImagingStudy resource will exist, created by another system more integrated with image management, such as the PACS, or the VNA, or the EMR in response to messaging from the PACS or VNA. Report Creators are not the Source of Truth for imaging study management. In the absence of an ImagingStudy, the ServiceRequest and Accession Number will serve to provide basic linkages between the images and the report.

Note 2. Studies available for comparison during reporting are tracked in the comparison element, not the study element.

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.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

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

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).

Graphical elements such as charts and icons that appear in the presentedForm of the report may go here if they cannot be included inline in the format used (PDF, etc.).

The interpreted study is referenced from the .study element, not here. Those study images may be accessible as RESTful resources via DICOMweb (which includes parameterized renderings using the /rendered DICOMweb endpoint to adjust windowing and other parameters). Selected parts or points of those images are encoded as ImagingSelection resources. Comparison studies are referenced from the .comparison element.

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

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

A comment about the 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 comment should be displayed with the 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.

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

Reference to the image or data source.

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

Composition may be included to supplement .text and .presentedForm with additional presentations and compositions of the report content to meet the preferences of different readers, tasks, or site guidelines.

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

Note 1. In the presentedForm (PDF, HTML, etc.), section text titled Impression frequently contains not just impressions, but also recommendations, and communications. IDR profiles usage of specific encodings for those in the recommendation and communication elements.

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.

R6 makes .conclusionCode a CodeableReference to allow a Condition (or Observation) to be a coded conclusion.

Since I haven't figured out how to do that in a Profile (it is an expansion, not a constraint on the underlying resource) I have created a sister element .conclusionCodeR so I can continue building sample objects and resolving brittle build issues.

SNOMED CT Clinical Findings

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.

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

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

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Identifies the type of the data in the attachment and allows a method to be chosen to interpret or render the data. Includes mime type parameters such as charset where appropriate.

BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049)

Processors of the data need to be able to know how to interpret the data.

The human language of the content. The value can be any valid value according to BCP 47.

IETF language tag for a human language.

Users need to be able to choose between the languages in a set of attachments.

The actual data of the attachment - a sequence of bytes, base64 encoded.

The base64-encoded data SHALL be expressed in the same character set as the base resource XML or JSON.

The data needs to able to be transmitted inline.

A location where the data can be accessed.

If both data and url are provided, the url SHALL point to the same content as the data contains. Urls may be relative references or may reference transient locations such as a wrapping envelope using cid: though this has ramifications for using signatures. Relative URLs are interpreted relative to the service url, like a resource reference, rather than relative to the resource itself. If a URL is provided, it SHALL resolve to actual data.

The data needs to be transmitted by reference.

The number of bytes of data that make up this attachment (before base64 encoding, if that is done).

The number of bytes is redundant if the data is provided as a base64binary, but is useful if the data is provided as a url reference.

Representing the size allows applications to determine whether they should fetch the content automatically in advance, or refuse to fetch it at all.

The calculated hash of the data using SHA-1. Represented using base64.

The hash is calculated on the data prior to base64 encoding, if the data is based64 encoded. The hash is not intended to support digital signatures. Where protection against malicious threats a digital signature should be considered, see Provenance.signature for mechanism to protect a resource with a digital signature.

Included so that applications can verify that the contents of a location have not changed due to technical failures (e.g., storage rot, transport glitch, incorrect version).

A label or set of text to display in place of the data.

May sometimes be derived from the source filename.

Applications need a label to display to a human user in place of the actual data if the data cannot be rendered or perceived by the viewer.

The date that the attachment was first created.

This is often tracked as an integrity issue for use of the attachment.

Height of the image in pixels (photo/video).

Width of the image in pixels (photo/video).

The number of frames in a photo. This is used with a multi-page fax, or an imaging acquisition context that takes multiple slices in a single image, or an animated gif. If there is more than one frame, this SHALL have a value in order to alert interface software that a multi-frame capable rendering widget is required.

if the number of frames is not supplied, the value may be unknown. Applications should not assume that there is only one frame unless it is explicitly stated.

The duration of the recording in seconds - for audio and video.

The duration might differ from occurrencePeriod if recording was paused.

The number of pages when printed.

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.

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.

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.