DiagnosticReport

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.

• dgr-1: When a Composition is referenced in `Diagnostic.composition`, all Observation resources referenced in `Composition.entry` must also be referenced in `Diagnostic.entry` or in the references Observations in `Observation.hasMember`
  composition.exists() implies (composition.resolve().section.entry.reference.where(resolve() is Observation) in (result.reference|result.reference.resolve().hasMember.reference))
• 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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()

• rim: Entity, Role, or Act,Observation[classCode=OBS, moodCode=EVN]
• workflow: Event
• w5: clinical.diagnostics
• v2: ORU -> OBR

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.

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

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.

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

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).

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

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.

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

• rim: Act.text?

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.

• rim: N/A

Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as laboratory reports, etc.

• 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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()
• obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
  dataAbsentReason.empty() or value.empty()
• obs-7: If Observation.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value).
  value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
• obs-8: bodyStructure SHALL only be present if Observation.bodySite is not present
  bodySite.exists() implies bodyStructure.empty()

• rim: N/A
• rim: Entity, Role, or Act,Observation[classCode=OBS, moodCode=EVN]
• workflow: Event
• w5: clinical.diagnostics
• sct-concept: < 363787002 |Observable entity|
• v2: OBX

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.

• 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()

• rim: N/A

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.

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.

• 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()

• rim: N/A

Need to know what identifier to use when making queries about this report from the source laboratory, and for linking to the report outside FHIR context.

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

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

• workflow: Event.identifier
• w5: FiveWs.identifier
• v2: OBR-51/ for globally unique filler ID - OBR-3 , For non-globally unique filler-id the flller/placer number must be combined with the universal service Id - OBR-2(if present)+OBR-3+OBR-4
• rim: id

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

Note: Usually there is one test request for each result, however in some circumstances multiple test requests may be represented using a single test result resource. Note that there are also cases where one request leads to multiple reports.

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

• workflow: Event.basedOn
• v2: ORC? OBR-2/3?
• rim: outboundRelationship[typeCode=FLFS].target

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

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

• workflow: Event.status
• w5: FiveWs.status
• v2: OBR-25 (not 1:1 mapping)
• rim: statusCode Note: final and amended are distinguished by whether observation is the subject of a ControlAct event of type "revise"

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.

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

• w5: FiveWs.class
• v2: OBR-24
• rim: inboundRelationship[typeCode=COMP].source[classCode=LIST, moodCode=EVN, code < LabService].code

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

• workflow: Event.code
• w5: FiveWs.what[x]
• v2: OBR-4 (HL7 V2 doesn't provide an easy way to indicate both the ordered test and the performed panel)
• rim: code

SHALL know the subject context.

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

• workflow: Event.subject
• w5: FiveWs.subject[x]
• v2: PID-3 (no HL7 V2 mapping for Group or Device)
• rim: participation[typeCode=SBJ]

Links the request to the Encounter context.

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).

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

• workflow: Event.encounter
• w5: FiveWs.context
• v2: PV1-19
• rim: inboundRelationship[typeCode=COMP].source[classCode=ENC, moodCode=EVN]

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

If the diagnostic procedure was performed on the patient, this is the time it was performed. If there are specimens, the diagnostically relevant time can be derived from the specimen collection times, but the specimen information is not always available, and the exact relationship between the specimens and the diagnostically relevant time is not always automatic.

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

• workflow: Event.occurrence[x]
• w5: FiveWs.done[x]
• v2: OBR-7
• rim: effectiveTime

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

May be different from the update time of the resource itself, because that is the status of the record (potentially a secondary copy), not the actual release time of the report.

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

• w5: FiveWs.recorded
• v2: OBR-22
• rim: participation[typeCode=VRF or AUT].time

Need to know whom to contact if there are queries about the results. Also may need to track the source of reports for secondary data analysis.

This is not necessarily the source of the atomic data items or the entity that interpreted the results. It is the entity that takes responsibility for the clinical report.

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

• workflow: Event.performer.actor
• w5: FiveWs.actor
• v2: PRT-8 (where this PRT-4-Participation = "PO")
• rim: .participation[typeCode=PRF]

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.

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

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

• workflow: Event.performer.actor
• w5: FiveWs.actor
• v2: OBR-32, PRT-8 (where this PRT-4-Participation = "PI")
• rim: .participation[typeCode=PRF]

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

If the specimen is sufficiently specified with a code in the test result name, then this additional data may be redundant. If there are multiple specimens, these may be represented per observation or group.

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

• v2: SPM
• rim: participation[typeCode=SBJ]

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

Observations can contain observations.

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

• v2: OBXs
• rim: outboundRelationship[typeCode=COMP].target

Need to be able to provide free text additional information.

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

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

• rim: unknown

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

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

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

• rim: n/a

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.

• 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()

• rim: n/a

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.

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.

• 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()

• rim: N/A

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

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

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

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

• v2: OBX?
• rim: outboundRelationship[typeCode=COMP].target

• rim: n/a

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.

• 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()

• rim: n/a

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.

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.

• 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()

• rim: N/A

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

The comment should be displayed with the image 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.

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

• rim: .inboundRelationship[typeCode=COMP].source[classCode=OBS, moodCode=EVN, code="annotation"].value

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

• rim: .value.reference

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

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

• rim: .value.reference

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

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

• v2: OBX
• rim: inboundRelationship[typeCode="SPRT"].source[classCode=OBS, moodCode=EVN, code=LOINC:48767-8].value (type=ST)

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

• v2: OBX
• rim: inboundRelationship[typeCode=SPRT].source[classCode=OBS, moodCode=EVN, code=LOINC:54531-9].value (type=CD)

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

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

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

• v2: OBX
• rim: text (type=ED)

• rim: n/a

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.

• 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()

• rim: n/a

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

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

• v2: ED.2+ED.3/RP.2+RP.3. Note conversion may be needed if old style values are being used
• rim: ./mediaType, ./charset

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

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

• rim: ./language

The data needs to able to be transmitted inline.

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

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

• v2: ED.5
• rim: ./data

The data needs to be transmitted by reference.

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.

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

• v2: RP.1+RP.2 - if they refer to a URL (see v2.6)
• rim: ./reference/literal

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

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.

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

• rim: N/A (needs data type R3 proposal)

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).

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.

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

• rim: .integrityCheck[parent::ED/integrityCheckAlgorithm="SHA-1"]

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.

May sometimes be derived from the source filename.

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

• rim: ./title/data

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

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

• rim: N/A (needs data type R3 proposal)

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

• rim: .outboundRelationship[typeCode="COMP].target[classCode="OBS", moodCode="EVN",code="<CODE>"].value

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

• rim: .outboundRelationship[typeCode="COMP].target[classCode="OBS", moodCode="EVN",code="<CODE>"].value

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.

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

• rim: .outboundRelationship[typeCode="COMP].target[classCode="OBS", moodCode="EVN",code="<CODE>"].value

The duration might differ from occurrencePeriod if recording was paused.

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

• rim: .outboundRelationship[typeCode="COMP].target[classCode="OBS", moodCode="EVN",code="<CODE>"].value

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