Breast Imaging Reporting - 2nd STU ballot
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Breast Imaging Reporting - 2nd STU ballot, published by HL7 International - Clinical Interoperability Council. This is not an authorized publication; it is the continuous build for version 0.3.0). This version is based on the current content of https://github.com/HL7/fhir-breast-radiology-ig/ and changes regularly. See the Directory of published versions

Resource Profile: BreastImagingReport - Detailed Descriptions

Draft as of 2019-11-01

Definitions for the BreastImagingReport resource profile.

Guidance on how to interpret the contents of this table can be found here.

1. DiagnosticReport
2. DiagnosticReport.category
SlicingThis element introduces a set of slices on DiagnosticReport.category. The slices are and , and can be differentiated using the following discriminators:
  • @
3. DiagnosticReport.category:categoryImaging
SliceNamecategoryImaging
Control1..1
Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="http://terminology.hl7.org/CodeSystem/observation-category"/>
    <code value="imaging"/>
  </coding>
</valueCodeableConcept>
4. DiagnosticReport.code
BindingThe codes SHALL be taken from Breast Imaging Report Types ValueSetThe codes SHALL be taken from US Core Non Laboratory Codes; other codes may be used where these codes are not suitable
5. DiagnosticReport.specimen
Control0..0*
6. DiagnosticReport.result
Control0..0*
7. DiagnosticReport.conclusionCode
SlicingThis element introduces a set of slices on DiagnosticReport.conclusionCode. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • pattern @ $this
8. DiagnosticReport.conclusionCode:BiRads
SliceNameBiRads
Definition

A required summary conclusion of the breast imaging report. Typically this is the most severe BiRads code found in either of the right or left breast observation sections. In general, it is expected that a BiRads conclusion code will be included, though there are cases where a BiRads conclusion code can not be included.

In these cases the actual non-BiRads code will be found in a separate slice of the FHIR CodeableConcept element that contains this value or alternately (though not preferred) described in the text section of the report.

An example of this being used: A procedure is performed to implant a surgical marker. There is no BiRads code associated with this completion of the procedure, though regulation may require a specific non Birads code to be used to descibe the completion of this procedure.

Control0..1
BindingThe codes SHALL be taken from Breast Assessment Category ValueSet

Guidance on how to interpret the contents of this table can be found here.

1. DiagnosticReport
Definition

-

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.

Control0..*
Alternate NamesReport, Test, Result, Results, Labs, Laboratory, Imaging Report, Radiology Report, Clinical Test Report
Comments

-

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.

InvariantsDefined on this element
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (: contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (: contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (: text.`div`.exists())
us-core-10: effective[x] SHALL be present if the status is 'partial', 'preliminary', 'final', 'amended', 'corrected' or 'appended' (: (status='partial' or status='preliminary' or status='final' or status='amended' or status='corrected' or status='appended' ) implies effective.exists())
2. DiagnosticReport.implicitRules
Definition

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.

Control0..1
Typeuri
Is Modifiertrue
Comments

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 it's narrative along with other profiles, value sets, etc.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
3. DiagnosticReport.modifierExtension
Definition

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 manageable, 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).

Control0..*
TypeExtension
Is Modifiertrue
Requirements

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.

Alternate Namesextensions, user content
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
4. DiagnosticReport.status
Definition

The status of the diagnostic report.

Control1..1 This element is affected by the following invariants: us-core-10
BindingThe codes SHALL be taken from DiagnosticReportStatus
Typecode
Is Modifiertrue
Must Supporttrue
Requirements

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
5. DiagnosticReport.category
Definition

A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.

Control10..*
BindingFor example codes, see DiagnosticServiceSectionCodes

Codes for diagnostic service sections.

TypeCodeableConcept
Must Supporttrue
Alternate NamesDepartment, Sub-department, Service, Discipline
Comments

Multiple categories are allowed using various categorization schemes. The level of granularity is defined by the category concepts in the value set. More fine-grained filtering can be performed using the metadata and/or terminology hierarchy in DiagnosticReport.code.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on DiagnosticReport.category. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • pattern @ $this
6. DiagnosticReport.category:us-core
SliceNameus-core
Definition

A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.

Control0..*
BindingThe codes SHALL be taken from US Core Diagnostic Report Category CodesFor example codes, see DiagnosticServiceSectionCodes
TypeCodeableConcept
Must Supporttrue
Alternate NamesDepartment, Sub-department, Service, Discipline
Comments

Multiple categories are allowed using various categorization schemes. The level of granularity is defined by the category concepts in the value set. More fine-grained filtering can be performed using the metadata and/or terminology hierarchy in DiagnosticReport.code.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
7. DiagnosticReport.category:categoryImaging
SliceNamecategoryImaging
Definition

A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.

Control10..1*
BindingFor example codes, see DiagnosticServiceSectionCodes

Codes for diagnostic service sections.

TypeCodeableConcept
Must Supporttrue
Alternate NamesDepartment, Sub-department, Service, Discipline
Comments

Multiple categories are allowed using various categorization schemes. The level of granularity is defined by the category concepts in the value set. More fine-grained filtering can be performed using the metadata and/or terminology hierarchy in DiagnosticReport.code.

Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="http://terminology.hl7.org/CodeSystem/observation-category"/>
    <code value="imaging"/>
  </coding>
</valueCodeableConcept>
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
8. DiagnosticReport.code
Definition

The test, panel, report, or note that was ordered.

A code or name that describes this diagnostic report.

Control1..1
BindingThe codes SHALL be taken from Breast Imaging Report Types ValueSetThe codes SHOULD be taken from LOINCDiagnosticReportCodes
TypeCodeableConcept
Must Supporttrue
Alternate NamesType
Comments

The typical patterns for codes are: 1) a LOINC code either as a translation from a "local" code or as a primary code, or 2) a local code only if no suitable LOINC exists, or 3) both the local and the LOINC translation. Systems SHALL be capable of sending the local code if one exists.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
9. DiagnosticReport.subject
Definition

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.

Control10..1
TypeReference(USCorePatientProfile|Patient|Group|Device|Location)
Must Supporttrue
Requirements

SHALL know the subject context.

Alternate NamesPatient
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
10. DiagnosticReport.encounter
Definition

The healthcare event (e.g. a patient and healthcare provider interaction) which this DiagnosticReport is about.

Control0..1
TypeReference(USCoreEncounterProfile|Encounter)
Must Supporttrue
Requirements

Links the request to the Encounter context.

Alternate NamesContext
Comments

This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
11. DiagnosticReport.effective[x]
Definition

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.

Control0..1 This element is affected by the following invariants: us-core-10
TypeChoice of: dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
Must Support TypesdateTime
Requirements

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

Alternate NamesObservation time, Effective Time, Occurrence
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
12. DiagnosticReport.issued
Definition

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

Control0..1
Typeinstant
Must Supporttrue
Requirements

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

Alternate NamesDate published, Date Issued, Date Verified
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
13. DiagnosticReport.performer
Definition

The diagnostic service that is responsible for issuing the report.

Control0..*
TypeReference(USCorePractitionerProfile|USCoreOrganizationProfile|USCorePractitionerRoleProfile|USCoreCareTeam|Practitioner|PractitionerRole|Organization|CareTeam)
Must Supporttrue
Must Support TypesReference(USCorePractitionerProfile|USCoreOrganizationProfile)
Requirements

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.

Alternate NamesLaboratory, Service, Practitioner, Department, Company, Authorized by, Director
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
14. DiagnosticReport.specimen
Definition

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

Control0..0*
TypeReference(Specimen)
Requirements

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

Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
15. DiagnosticReport.result
Definition

Observations that are part of this diagnostic report.

Control0..0*
TypeReference(USCoreLaboratoryResultObservationProfile|USCoreObservationClinicalTestResultProfile|USCoreObservationImagingResultProfile|Observation)
Must Supporttrue
Must Support TypesReference(USCoreLaboratoryResultObservationProfile|USCoreObservationClinicalTestResultProfile|USCoreObservationImagingResultProfile)
Requirements

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

Alternate NamesData, Atomic Value, Result, Atomic result, Data, Test, Analyte, Battery, Organizer
Comments

Observations can contain observations.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
16. DiagnosticReport.media
Definition

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).

Control0..*
TypeBackboneElement
Must Supporttrue
Requirements

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

Alternate NamesDICOM, Slides, Scans
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
17. DiagnosticReport.media.modifierExtension
Definition

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 manageable, 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).

Control0..*
TypeExtension
Is Modifiertrue
Requirements

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.

Alternate Namesextensions, user content, modifiers
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
18. DiagnosticReport.media.link
Definition

Reference to the image source.

Control1..1
TypeReference(Media)
Must Supporttrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
19. DiagnosticReport.conclusionCode
Definition

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

Control0..*
BindingFor example codes, see SNOMEDCTClinicalFindings

Diagnosis codes provided as adjuncts to the report.

TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on DiagnosticReport.conclusionCode. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • pattern @ $this
20. DiagnosticReport.conclusionCode:BiRads
SliceNameBiRads
Definition

A required summary conclusion of the breast imaging report. Typically this is the most severe BiRads code found in either of the right or left breast observation sections. In general, it is expected that a BiRads conclusion code will be included, though there are cases where a BiRads conclusion code can not be included.

In these cases the actual non-BiRads code will be found in a separate slice of the FHIR CodeableConcept element that contains this value or alternately (though not preferred) described in the text section of the report.

An example of this being used: A procedure is performed to implant a surgical marker. There is no BiRads code associated with this completion of the procedure, though regulation may require a specific non Birads code to be used to descibe the completion of this procedure.

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

Control0..1*
BindingThe codes SHALL be taken from Breast Assessment Category ValueSetFor example codes, see SNOMEDCTClinicalFindings
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
21. DiagnosticReport.presentedForm
Definition

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

Control0..*
TypeAttachment
Must Supporttrue
Requirements

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

Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be found here.

1. DiagnosticReport
Definition

-

Control0..*
Alternate NamesReport, Test, Result, Results, Labs, Laboratory, Imaging Report, Radiology Report, Clinical Test Report
Comments

-

2. DiagnosticReport.id
Definition

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

Control0..1
Typeid
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

3. DiagnosticReport.meta
Definition

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.

Control0..1
TypeMeta
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
4. DiagnosticReport.implicitRules
Definition

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.

Control0..1
Typeuri
Is Modifiertrue
Comments

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 it's narrative along with other profiles, value sets, etc.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
5. DiagnosticReport.language
Definition

The base language in which the resource is written.

Control0..1
BindingThe codes SHOULD be taken from CommonLanguages A human language
Additional BindingsPurpose
AllLanguagesMax Binding
Typecode
Comments

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).

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
6. DiagnosticReport.text
Definition

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.

Control0..1
TypeNarrative
Alternate Namesnarrative, html, xhtml, display
Comments

Contained resources do not have 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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
7. DiagnosticReport.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

Control0..*
TypeResource
Alternate Namesinline resources, anonymous resources, contained resources
Comments

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.

8. DiagnosticReport.extension
Definition

May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
9. DiagnosticReport.modifierExtension
Definition

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 manageable, 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).

Control0..*
TypeExtension
Is Modifiertrue
Requirements

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.

Alternate Namesextensions, user content
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
10. DiagnosticReport.identifier
Definition

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

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Requirements

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.

Alternate NamesReportID, Filler ID, Placer ID
Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
11. DiagnosticReport.basedOn
Definition

Details concerning a service requested.

Control0..*
TypeReference(CarePlan|ImmunizationRecommendation|MedicationRequest|NutritionOrder|ServiceRequest)
Requirements

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

Alternate NamesRequest
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
12. DiagnosticReport.status
Definition

The status of the diagnostic report.

Control1..1 This element is affected by the following invariants: us-core-10
BindingThe codes SHALL be taken from DiagnosticReportStatus
Typecode
Is Modifiertrue
Must Supporttrue
Requirements

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
13. DiagnosticReport.category
Definition

A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.

Control1..*
BindingFor example codes, see DiagnosticServiceSectionCodes Codes for diagnostic service sections
TypeCodeableConcept
Must Supporttrue
Alternate NamesDepartment, Sub-department, Service, Discipline
Comments

Multiple categories are allowed using various categorization schemes. The level of granularity is defined by the category concepts in the value set. More fine-grained filtering can be performed using the metadata and/or terminology hierarchy in DiagnosticReport.code.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on DiagnosticReport.category. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • pattern @ $this
14. DiagnosticReport.category:us-core
SliceNameus-core
Definition

A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.

Control0..*
BindingThe codes SHALL be taken from US Core Diagnostic Report Category Codes
TypeCodeableConcept
Must Supporttrue
Alternate NamesDepartment, Sub-department, Service, Discipline
Comments

Multiple categories are allowed using various categorization schemes. The level of granularity is defined by the category concepts in the value set. More fine-grained filtering can be performed using the metadata and/or terminology hierarchy in DiagnosticReport.code.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
15. DiagnosticReport.category:categoryImaging
SliceNamecategoryImaging
Definition

A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.

Control1..1
BindingFor example codes, see DiagnosticServiceSectionCodes Codes for diagnostic service sections
TypeCodeableConcept
Must Supporttrue
Alternate NamesDepartment, Sub-department, Service, Discipline
Comments

Multiple categories are allowed using various categorization schemes. The level of granularity is defined by the category concepts in the value set. More fine-grained filtering can be performed using the metadata and/or terminology hierarchy in DiagnosticReport.code.

Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="http://terminology.hl7.org/CodeSystem/observation-category"/>
    <code value="imaging"/>
  </coding>
</valueCodeableConcept>
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
16. DiagnosticReport.code
Definition

The test, panel, report, or note that was ordered.

Control1..1
BindingThe codes SHALL be taken from Breast Imaging Report Types ValueSet
TypeCodeableConcept
Must Supporttrue
Alternate NamesType
Comments

The typical patterns for codes are: 1) a LOINC code either as a translation from a "local" code or as a primary code, or 2) a local code only if no suitable LOINC exists, or 3) both the local and the LOINC translation. Systems SHALL be capable of sending the local code if one exists.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
17. DiagnosticReport.subject
Definition

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.

Control1..1
TypeReference(USCorePatientProfile)
Must Supporttrue
Requirements

SHALL know the subject context.

Alternate NamesPatient
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
18. DiagnosticReport.encounter
Definition

The healthcare event (e.g. a patient and healthcare provider interaction) which this DiagnosticReport is about.

Control0..1
TypeReference(USCoreEncounterProfile)
Must Supporttrue
Requirements

Links the request to the Encounter context.

Alternate NamesContext
Comments

This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
19. DiagnosticReport.effective[x]
Definition

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.

Control0..1 This element is affected by the following invariants: us-core-10
TypeChoice of: dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
Must Support TypesdateTime
Requirements

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

Alternate NamesObservation time, Effective Time, Occurrence
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
20. DiagnosticReport.issued
Definition

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

Control0..1
Typeinstant
Must Supporttrue
Requirements

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

Alternate NamesDate published, Date Issued, Date Verified
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
21. DiagnosticReport.performer
Definition

The diagnostic service that is responsible for issuing the report.

Control0..*
TypeReference(USCorePractitionerProfile|USCoreOrganizationProfile|USCorePractitionerRoleProfile|USCoreCareTeam)
Must Supporttrue
Must Support TypesReference(USCorePractitionerProfile|USCoreOrganizationProfile)
Requirements

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.

Alternate NamesLaboratory, Service, Practitioner, Department, Company, Authorized by, Director
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
22. DiagnosticReport.resultsInterpreter
Definition

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

Control0..*
TypeReference(Practitioner|PractitionerRole|Organization|CareTeam)
Requirements

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.

Alternate NamesAnalyzed by, Reported by
Comments

Might not be the same entity that takes responsibility for the clinical report.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
23. DiagnosticReport.specimen
Definition

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

Control0..0
TypeReference(Specimen)
Requirements

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

Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
24. DiagnosticReport.result
Definition

Observations that are part of this diagnostic report.

Control0..0
TypeReference(USCoreLaboratoryResultObservationProfile|USCoreObservationClinicalTestResultProfile|USCoreObservationImagingResultProfile)
Must Supporttrue
Must Support TypesReference(USCoreLaboratoryResultObservationProfile|USCoreObservationClinicalTestResultProfile|USCoreObservationImagingResultProfile)
Requirements

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

Alternate NamesData, Atomic Value, Result, Atomic result, Data, Test, Analyte, Battery, Organizer
Comments

Observations can contain observations.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
25. DiagnosticReport.imagingStudy
Definition

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 images.

Control0..*
TypeReference(ImagingStudy)
Comments

ImagingStudy and the 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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
26. DiagnosticReport.media
Definition

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).

Control0..*
TypeBackboneElement
Must Supporttrue
Requirements

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

Alternate NamesDICOM, Slides, Scans
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
27. DiagnosticReport.media.id
Definition

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

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
28. DiagnosticReport.media.extension
Definition

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 manageable, 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
29. DiagnosticReport.media.modifierExtension
Definition

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 manageable, 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).

Control0..*
TypeExtension
Is Modifiertrue
Requirements

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.

Alternate Namesextensions, user content, modifiers
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
30. DiagnosticReport.media.comment
Definition

A 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 features.

Control0..1
Typestring
Requirements

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

Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
31. DiagnosticReport.media.link
Definition

Reference to the image source.

Control1..1
TypeReference(Media)
Must Supporttrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
32. DiagnosticReport.conclusion
Definition

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

Control0..1
Typestring
Requirements

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

Alternate NamesReport
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
33. DiagnosticReport.conclusionCode
Definition

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

Control0..*
BindingFor example codes, see SNOMEDCTClinicalFindings Diagnosis codes provided as adjuncts to the report
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on DiagnosticReport.conclusionCode. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • pattern @ $this
34. DiagnosticReport.conclusionCode:BiRads
SliceNameBiRads
Definition

A required summary conclusion of the breast imaging report. Typically this is the most severe BiRads code found in either of the right or left breast observation sections. In general, it is expected that a BiRads conclusion code will be included, though there are cases where a BiRads conclusion code can not be included.

In these cases the actual non-BiRads code will be found in a separate slice of the FHIR CodeableConcept element that contains this value or alternately (though not preferred) described in the text section of the report.

An example of this being used: A procedure is performed to implant a surgical marker. There is no BiRads code associated with this completion of the procedure, though regulation may require a specific non Birads code to be used to descibe the completion of this procedure.

Control0..1
BindingThe codes SHALL be taken from Breast Assessment Category ValueSet
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
35. DiagnosticReport.presentedForm
Definition

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

Control0..*
TypeAttachment
Must Supporttrue
Requirements

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

Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))