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Orders and Observations Work Group Maturity Level: 1Trial Use Use Context: Any

Definitions for the diagnosticreport-genetics Profile.

DiagnosticReport
Element IdDiagnosticReport
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.

Cardinality0..*
Alternate NamesReport, Test, Result, Results, Labs, Laboratory
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.

Invariants
Inherited by this element
dom-2RuleIf the resource is contained in another resource, it SHALL NOT contain nested Resourcescontained.contained.empty()
dom-3RuleIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resourcecontained.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-4RuleIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdatedcontained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5RuleIf a resource is contained in another resource, it SHALL NOT have a security labelcontained.meta.security.empty()
dom-6GuidelineA resource should have narrative for robust managementtext.div.exists()
This is (only) a best practice guideline because:

When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.

DiagnosticReport.id
Element IdDiagnosticReport.id
Definition

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

Cardinality0..1
Typestring
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.

DiagnosticReport.meta
Element IdDiagnosticReport.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.

Cardinality0..1
TypeMeta
DiagnosticReport.implicitRules
Element IdDiagnosticReport.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.

Cardinality0..1
Typeuri
Is Modifiertrue (Reason: This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation)
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.

DiagnosticReport.language
Element IdDiagnosticReport.language
Definition

The base language in which the resource is written.

Cardinality0..1
Terminology BindingA human language.
The codes SHOULD be taken from Common Languages
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).

DiagnosticReport.text
Element IdDiagnosticReport.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.

Cardinality0..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.

DiagnosticReport.contained
Element IdDiagnosticReport.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.

Cardinality0..*
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.

DiagnosticReport.extension
Element IdDiagnosticReport.extension
Definition

An Extension

Cardinality0..*
TypeExtension
SlicingThis element introduces a set of slices. The slicing rules are:
  • unordered
  • Open
  • discriminators: value:url
DiagnosticReport.extension(AssessedCondition)
Element IdDiagnosticReport.extension:AssessedCondition
Definition

Used to denote condition context for genetic testing, which may influence reported variants and interpretation for large genomic testing panels e.g. lung cancer or familial breast cancer.

Cardinality0..* This element is affected by the following invariants: ele-1
TypeExtension(AssessedCondition)
Invariants
Inherited by this element
ele-1RuleAll FHIR elements must have a @value or childrenhasValue() or (children().count() > id.count())
ext-1RuleMust have either extensions or value[x], not bothextension.exists() != value.exists()
DiagnosticReport.extension(FamilyMemberHistory)
Element IdDiagnosticReport.extension:FamilyMemberHistory
Definition

Significant health events and conditions for a person related to the patient relevant in the context of care for the patient.

Cardinality0..* This element is affected by the following invariants: ele-1
TypeExtension(FamilyMemberHistory)
Invariants
Inherited by this element
ele-1RuleAll FHIR elements must have a @value or childrenhasValue() or (children().count() > id.count())
ext-1RuleMust have either extensions or value[x], not bothextension.exists() != value.exists()
DiagnosticReport.extension(Analysis)
Element IdDiagnosticReport.extension:Analysis
Definition

Knowledge-based comments on the effect of the sequence on patient's condition/medication reaction.

Cardinality0..* This element is affected by the following invariants: ele-1
TypeExtension(Analysis)
Invariants
Inherited by this element
ele-1RuleAll FHIR elements must have a @value or childrenhasValue() or (children().count() > id.count())
ext-1RuleMust have either extensions or value[x], not bothextension.exists() != value.exists()
DiagnosticReport.extension(References)
Element IdDiagnosticReport.extension:References
Definition

Additional bibliographic reference information about genetics, medications, clinical trials, etc. associated with knowledge-based information on genetics/genetic condition.

Cardinality0..* This element is affected by the following invariants: ele-1
TypeExtension(References)
Invariants
Inherited by this element
ele-1RuleAll FHIR elements must have a @value or childrenhasValue() or (children().count() > id.count())
ext-1RuleMust have either extensions or value[x], not bothextension.exists() != value.exists()
DiagnosticReport.modifierExtension
Element IdDiagnosticReport.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).

Cardinality0..*
TypeExtension
Is Modifiertrue (Reason: Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them)
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.

DiagnosticReport.identifier
Element IdDiagnosticReport.identifier
Definition

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

Cardinality0..*
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).

DiagnosticReport.basedOn
Element IdDiagnosticReport.basedOn
Definition

Details concerning a service requested.

Cardinality0..*
TypeReference(CarePlan)
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.

DiagnosticReport.status
Element IdDiagnosticReport.status
Definition

The status of the diagnostic report.

Cardinality1..1
Terminology BindingThe status of the diagnostic report.
The codes SHALL be taken from DiagnosticReportStatus
Typecode
Is Modifiertrue (Reason: This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid)
Requirements

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

DiagnosticReport.category
Element IdDiagnosticReport.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.

Cardinality0..*
Terminology BindingCodes for diagnostic service sections.
For example codes, see Diagnostic Service Section Codes
TypeCodeableConcept
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.

DiagnosticReport.code
Element IdDiagnosticReport.code
Definition

A code or name that describes this diagnostic report.

Cardinality1..1
Terminology BindingCodes that describe Diagnostic Reports.
The codes SHOULD be taken from LOINC Diagnostic Report Codes
TypeCodeableConcept
Alternate NamesType
DiagnosticReport.subject
Element IdDiagnosticReport.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.

Cardinality0..1
TypeReference(Patient)
Requirements

SHALL know the subject context.

Alternate NamesPatient
DiagnosticReport.encounter
Element IdDiagnosticReport.encounter
Definition

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

Cardinality0..1
TypeReference(Encounter)
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).

DiagnosticReport.effective[x]
Element IdDiagnosticReport.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.

Cardinality0..1
TypeChoice of: dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
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.

DiagnosticReport.issued
Element IdDiagnosticReport.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.

Cardinality0..1
Typeinstant
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.

DiagnosticReport.performer
Element IdDiagnosticReport.performer
Definition

The diagnostic service that is responsible for issuing the report.

Cardinality0..*
TypeReference(Practitioner)
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.

DiagnosticReport.resultsInterpreter
Element IdDiagnosticReport.resultsInterpreter
Definition

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

Cardinality0..*
TypeReference(Practitioner)
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.

DiagnosticReport.specimen
Element IdDiagnosticReport.specimen
Definition

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

Cardinality0..*
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.

DiagnosticReport.result
Element IdDiagnosticReport.result
Definition

Observations that are part of this diagnostic report.

Cardinality0..*
TypeReference(Observation)
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.

DiagnosticReport.imagingStudy
Element IdDiagnosticReport.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.

Cardinality0..*
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.

DiagnosticReport.media
Element IdDiagnosticReport.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).

Cardinality0..*
TypeBackboneElement
Requirements

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

Alternate NamesDICOM, Slides, Scans
Invariants
Inherited by this element
ele-1RuleAll FHIR elements must have a @value or childrenhasValue() or (children().count() > id.count())
DiagnosticReport.media.id
Element IdDiagnosticReport.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.

Cardinality0..1
Typestring
DiagnosticReport.media.extension
Element IdDiagnosticReport.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.

Cardinality0..*
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.

DiagnosticReport.media.modifierExtension
Element IdDiagnosticReport.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).

Cardinality0..*
TypeExtension
Is Modifiertrue (Reason: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them)
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.

DiagnosticReport.media.comment
Element IdDiagnosticReport.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.

Cardinality0..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.

DiagnosticReport.media.link
Element IdDiagnosticReport.media.link
Definition

Reference to the image source.

Cardinality1..1
TypeReference(DocumentReference)
DiagnosticReport.conclusion
Element IdDiagnosticReport.conclusion
Definition

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

Cardinality0..1
Typestring
Requirements

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

Alternate NamesReport
DiagnosticReport.conclusionCode
Element IdDiagnosticReport.conclusionCode
Definition

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

Cardinality0..0
Terminology BindingDiagnosis codes provided as adjuncts to the report.
For example codes, see SNOMED CT Clinical Findings
TypeCodeableConcept
DiagnosticReport.presentedForm
Element IdDiagnosticReport.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.

Cardinality0..*
TypeAttachment
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.