At least one ClinicalDocument/author SHALL be present with a time in accordance with the HL7 CDA R2 standard and further constrained by this specification to require the presence of name, addr and telecom. The author/time element carries the date&time the radiology report was produced. The radiology report can be authored by a software system or by a person or by both.

ClinicalDocument/custodian SHALL be present with an id in accordance with the HL7 CDA R2 standard and further constrained by this specification to require the presence of name, addr and telecom. It represents the organization that is in charge of maintaining the radiology report.

The ClinicalDocument/legalAuthenticator MAY be present. When present, it SHALL be in accordance with the HL7 CDA R2 standard and further constrained by this specification to require the presence of name, addr and telecom. This element carries the person who has legally authenticated the report, and the organization represented by this person. The sub-element time carries the date&time this legal authentication took place. The sub-element signatureCode carries the “signed” (S) status

If this entity happens also to be one of the validators of the radiology results in the report, it SHALL also be documented as a validator.

ClinicalDocument/participant(s) MAY be present. When present, this element SHALL be in accordance with the HL7 CDA R2 standard with a time element and further constrained by this specification to require the presence of name, addr and telecom. In particular, when the ordering provider of the order (or group of orders) fulfilled by this radiology report is present in the CDA, it SHALL be documented as a participant with the attribute typeCode valued “REF” (referrer).

An inFulfillmentOf element represents the Placer Order that is either a group of orders (modeled as PlacerGroup in the Placer Order RMIM of the Orders & Observations domain) or a single order item (modeled as ObservationRequest in the same RMIM). This optionality reflects two major approaches to the grouping of procedures as implemented in the installed base of imaging information systems. These approaches differ in their handling of grouped procedures and how they are mapped to identifiers in the Digital Imaging and Communications in Medicine (DICOM) image and structured reporting data. The example of a CT examination covering chest, abdomen, and pelvis will be used in the discussion below. In the IHE Scheduled Workflow model, the Chest CT, Abdomen CT, and Pelvis CT each represent a Requested Procedure, and all three procedures are grouped under a single Filler Order. The Filler Order number maps directly to the DICOM Accession Number in the DICOM imaging and report data. A widely deployed alternative approach maps the requested procedure identifiers directly to the DICOM Accession Number. The Requested Procedure ID in such implementations may or may not be different from the Accession Number, but is of little identifying importance because there is only one Requested Procedure per Accession Number. There is no identifier that formally connects the requested procedures ordered in this group.

Each serviceEvent indicates an imaging procedure that the provider describes and interprets in the content of the DIR. The main activity being described by this document is the interpretation of the imaging procedure. This is shown by setting the value of the @classCode attribute of the serviceEvent element to ACT, and indicating the duration over which care was provided in the effectiveTime element. Within each documentationOf element, there is one serviceEvent element. This event is the unit imaging procedure corresponding to a billable item. The type of imaging procedure may be further described in the serviceEvent/code element. This guide makes no specific recommendations about the vocabulary to use for describing this event. In IHE Scheduled Workflow environments, one serviceEvent/id element contains the DICOM Study Instance UID from the Modality Worklist, and the second serviceEvent/id element contains the DICOM Requested Procedure ID from the Modality Worklist. These two ids are in a single serviceEvent. The effectiveTime for the serviceEvent covers the duration of the imaging procedure being reported. This event should have one or more performers, which may participate at the same or different periods of time. Service events map to DICOM Requested Procedures. That is, serviceEvent/id is the ID of the Requested Procedure.

A DIR may have three types of parent document: • A superseded version that the present document wholly replaces (typeCode = RPLC). DIRs may go through stages of revision prior to being legally authenticated. Such early stages may be drafts from transcription, those created by residents, or other preliminary versions. Policies not covered by this specification may govern requirements for retention of such earlier versions. Except for forensic purposes, the latest version in a chain of revisions represents the complete and current report. • An original version that the present document appends (typeCode = APND). When a DIR is legally authenticated, it can be amended by a separate addendum document that references the original. • A source document from which the present document is transformed (typeCode = XFRM). A DIR may be created by transformation from a DICOM Structured Report (SR) document or from another DIR. An example of the latter case is the creation of a derived document for inclusion of imaging results in a clinical document.

The id element of the encompassingEncounter represents the identifier for the encounter. When the diagnostic imaging procedure is performed in the context of a hospital stay or an outpatient visit for which there is an Encounter Number, that number should be present as the ID of the encompassingEncounter. The effectiveTime represents the time interval or point in time in which the encounter took place. The encompassing encounter might be that of the hospital or office visit in which the diagnostic imaging procedure was performed. If the effective time is unknown, a nullFlavor attribute can be used.