SHALL contain exactly one [1..1] code (). This code SHOULD contain zero or one [0..1] @code), which SHOULD be selected from ValueSet DIRDocumentTypeCode 2.16.840.1.113883.11.20.9.32 DYNAMIC (). Table 1: DIR LOINC Document Type Codes Value Set: DIRDocumentTypeCodes 2.16.840.1.113883.11.20.9.32 DYNAMIC Code System: LOINC 2.16.840.1.113883.6.1 LOINC Code DIR ‘Modality’ Common DIR Display Name Setting ‘System’ Specialty/ Training/ Professional Level ‘Method_Type’ Preferred Code 18748-4 Any Diagnositic Imaging Report Diagnostic Imaging Additional Codes 18747-6 Computed Tomography CT Report CT 18755-9 Magnetic Resonance Imaging MRI Report MRI 18760-9 Ultrasound Ultrasound Report US 18757-5 Nuclear Medicine Nuclear Medicine Report RadNuc 17787-3 Nuclear Medicine Thyroid Scan Report Thyroid RadNuc 18758-3 Positron Emission Tomography PET Scan Report Pet scan 11522-0 Cardiac Ultrasound Echocardiography Report Heart Cardiac echo 18746-8 Colonoscopy Colonoscopy Report Lower GI tract Colonoscopy 18751-8 Endoscopy Endoscopy Report Upper GI tract Endoscopy 11525-3 Ultrasound Obstetrical Ultrasound Report Pelvis+Fetus OB.US 43468-8 X-Ray Radiography Radiography Report XR 49512-7 X-Ray Fluoroscopy Fluoroscopy Report XR.fluor 24606-6 Mammography Screening Report Mammography Screening Report Breast Mam 24605-8 Mammography Diagnostic Report Diagnostic Mammography Report Breast Mam 38269-7 Bone Density Report Bone Density Report Skeletal system XR.DXA
Addendum If the header includes a relatedDocument element with typeCode APND, the component/structuredBody SHALL contain exactly one [1..1] Addendum Section. DIR Clinical Statements A Diagnostic Imaging Report may contain CDA entries in any of its sections that represent, in coded form findings, image references, annotation, and numeric measurements. See PS 3.20 “Transformation of DICOM to and from HL7 Standards” for descriptions of transformations of observations from DICOM Structured Reporting instances. For this document template, Spatial Coordinates region of interest (SCOORD) for linear, area, and volume measurements are not encoded in the CDA document. If it is desired to show images with such graphical annotations, the annotations should be encoded in DICOM Softcopy Presentation State objects that reference the image. Report applications that display referenced images and annotation may retrieve a rendered image using a WADO reference in accordance with PS3.18, including the image and Presentation State, or other DICOM retrieval and rendering methods. This approach avoids the risks of errors in registering a CDA region of interest annotation with DICOM images. Interventional Radiology Report (reserved) Similar to diagnostic; includes consents, sedation, blood loss? Use Procedure Description rather than Current Imaging Procedure Description Anatomic Pathology Report (reserved) Kussaibi, et al. “HL7 CDA Implementation Guide for Structured Anatomic Pathology Reports Methodology and Tools” doi:10.3233/978-1-60750-588-4-289 CLINICAL INFORMATION Clinical information provided by the ordering physician: reason for anatomic pathology procedure, active problems (preoperative and/or postoperative diagnosis, lab data), collection procedure(s) and specimen description(s) for all delivered specimen(s) reported separately. Reason for AP procedure History of present illness Active Problems Specimen clinical information entry Specimen Information Organizer o Collection procedure o Specimen(s) type o Specimen location INTRAOPERATIVE EXAMINATION (conditional) Intraoperative diagnoses +/- images for all delivered specimen( s) reported separately. Intraoperative entry Specimen Information Organizer o Diagnostic observation o Link(s) to images
This informationRecipient, if present, SHALL contain at least one [1..*] name. The intendedRecipient MAY be the health chart of the patient, in which case the receivedOrganization SHALL be the scoping organization of that chart.. This intendedRecipient MAY contain zero or one [0..1] receivedOrganization. This receivedOrganization, if present, SHALL contain exactly one [1..1] name. Figure 30: informationRecipient example <informationRecipient> <intendedRecipient> <informationRecipient> <name> <given>Henry</given> <family>Seven</family> </name> </informationRecipient> <receivedOrganization> <name>Good Health Clinic</name> </receivedOrganization> </intendedRecipient> </informationRecipient> Participant (Referrer) MAY contain zero or one [0..1] participant such that it If participant is present, the assignedEntity/assignedPerson element SHALL be present and SHALL represent the physician requesting the imaging procedure (the referring physician AssociatedEntity that is the target of ClincalDocument/participant@typeCode=REF)..
Figure 32: Authenticator example <authenticator> <time value="20050329224411+0500"/> <signatureCode code="S"/> <assignedEntity> <id extension="KP00017" root="2.16.840.1.113883.19"/> <addr> <streetAddressLine>21 North Ave.</streetAddressLine> <city>Burlington</city> <state>MA</state> <postalCode>02368</postalCode> <country>US</country> </addr> <telecom use="WP" value="tel:(555)555-1003"/> <assignedPerson> <name> <given>Henry</given> <family>Seven</family> </name> </assignedPerson> </assignedEntity> </authenticator> relatedDocument 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. MAY contain zero or one [0..2] relatedDocument such that it When a Diagnostic Imaging Report has been transformed from a DICOM SR document, relatedDocument/@typeCode SHALL be XFRM, and relatedDocument/parentDocument/id SHALL contain the SOP Instance UID of the original DICOM SR document. ().
Release Date (Date of Final Text adoption) Status Draft (will change to Approved on Final Text adoption) Description Clinical details about the case such as presenting signs and symptoms, past clinical history, the overall condition of the patient, etc. Classification CDA Section Level Relationships Context Open/Closed Open Publishing DICOM Part…. Endorsing Authority Revision History (Date of Final Text adoption) Sub-sections Card Data Element or Section Name Template ID and Specification Document Vocabulary Constraint [0..1] [0..1] [0..1] Entries [0..*] [0..*] [0..*] [0..1] Name XPath Card. Verb Data Type Fixed Value Clinical Information section @classCode 1..1 SHALL 2.16.840.1.113883.5.6 (HL7ActClass) = DOCSECT @moodCode 1..1 SHALL 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL SET<II> @root 1..1 SHALL tbd id 1..* SHALL II code 1..1 SHALL CD 55752-0, LOINC, “Clinical Information”
code 1..1 SHALL CD 18834-2, LOINC, “Radiology Comparison study” text text 0..1 SHOULD ED author author 0..1 MAY entry 0..1 MAY Complications Section ID 2.16.840.1.113883.10.20.22.2.37 Name Complications Section Effective Date (Date of Final Text adoption) Version Label Expiration Date None???? Release Date (Date of Final Text adoption) Status Draft (will change to Approved on Final Text adoption) Description The Complications section records problems that occurred during the procedure or other activity. The complications may have been known risks or unanticipated problems. Classification CDA Section Level Relationships Context Open/Closed Open Publishing DICOM Part…. Endorsing Authority Revision History (Date of Final Text adoption) Sub-sections Card Data Element or Section Name Template ID and Specification Document Vocabulary Constraint Entries [0..1] 2.16.840.1.113883.10.20.22.4.4
Expiration Date None???? Release Date (Date of Final Text adoption) Status Draft (will change to Approved on Final Text adoption) Description Records observations related to a fetus confirmed or discovered during an obstetric ultrasound imaging procedure. Classification CDA Section Level Relationships Context Open/Closed Open Publishing DICOM Part…. Endorsing Authority Revision History (Date of Final Text adoption) Participations Card Participation Data Element or Section Name Template ID and Specification Document Vocabulary Constraint [0..1] subject Fetus Subject Context 2.16.840.1.113883.10.20.6.2.3 Sub-sections Card Data Element or Section Name Template ID and Specification Document Vocabulary Constraint [0..*] Entries [0..*] Categorical Observation [0..*] Numeric Observation [0..*] observationMedia (graphical) [0..*] SOP Instance Observation
Name XPath Card. Verb Data Type Fixed Value OB.US Fetus Findings section @classCode 1..1 SHALL 2.16.840.1.113883.5.6 (HL7ActClass) = DOCSECT @moodCode 1..1 SHALL 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL SET<II> @root 1..1 SHALL tbd id 1..* SHALL II code 1..1 SHALL CD 12129-3, LOINC, “Fetal Study observation general US” text text 0..1 SHOULD ED author author 0..1 MAY component 0..* MAY Categorical Observation entry 0..* MAY Numeric Observation entry 0..* MAY (graphical) entry 0..* MAY SOP Instance Observation entry 0..* MAY Findings Section 18782-3 This section SHOULD contain only the direct observations in the report, with topics such as Reason for Study, History, and Impression placed in separate sections. However, in cases where the source of report content provides a single block of text not separated into these sections, that text SHALL be placed in the Findings section. ID 1.3.6.1.4.1.19376.1.4.1.2.11 2.16.840.1.113883.10.20.6.1.2 Name Findings Effective Date (Date of Final Text adoption) Version Label
Findings. Alternatively, findings might be grouped into subsections by anatomy (e.g., a section each for head, neck and chest). The conformance rules apply to entries of the main section and any child subsections. Note 2: Radiation Exposure and Protection Information: A Radiation Exposure and Protection Information Section SHOULD be present if the documented service is CT or X-ray. Name XPath Card. Verb Data Type Fixed Value Findings section @classCode 1..1 SHALL 2.16.840.1.113883.5.6 (HL7ActClass) = DOCSECT @moodCode 1..1 SHALL 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL SET<II> @root 1..1 SHALL tbd id 1..* SHALL II code 1..1 SHALL CD 59776-5, LOINC, “Procedure Findings” text text 0..1 SHOULD ED author author 0..1 MAY component 0..* MAY OB.US Fetus Findings component 0..* MAY component 0..1 SHOULD component 0..1 MAY component 0..1 MAY and component 0..1 MAY Procedure Context entry 1..* MAY Categorical Observation entry 0..* MAY Numeric Observation entry 0..* MAY (graphical) entry 0..* MAY SOP Instance Observation entry 0..* MAY
recommendations for additional imaging tests or other actions, as well as global assessments, such as BI-RADS Categories or the equivalent. Classification CDA Section Level Relationships Context Open/Closed Open Publishing DICOM Part…. Endorsing Authority Revision History (Date of Final Text adoption) Sub-sections Card Data Element or Section Name Template ID and Specification Document Vocabulary Constraint [0..1] Communication of Critical Results [0..1] [0..1] Conclusions [0..1] [0..1] Summary Entries [1..*] Observation "59769-0" LOINC Postprocedure Diagnosis Name XPath Card. Verb Data Type Fixed Value Impressions section @classCode 1..1 SHALL 2.16.840.1.113883.5.6 (HL7ActClass) = DOCSECT @moodCode 1..1 SHALL 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL SET<II> @root 1..1 SHALL tbd id 1..* SHALL II code 1..1 SHALL CD RID13170, RadLex, “Impressions”; 121072, DCM, “Impressions” text text 0..1 SHOULD ED author author 0..1 MAY
Open/Closed Open Publishing DICOM Part…. Endorsing Authority Revision History (Date of Final Text adoption) Sub-sections Card Data Element or Section Name Template ID and Specification Document Vocabulary Constraint Entries [0..*] Name XPath Card. Verb Data Type Fixed Value Procedure Indications section @classCode 1..1 SHALL 2.16.840.1.113883.5.6 (HL7ActClass) = DOCSECT @moodCode 1..1 SHALL 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL SET<II> @root 1..1 SHALL tbd id 1..* SHALL II code 1..1 SHALL CD 59768-2, LOINC, “Procedure Indications” text text 0..1 SHOULD ED author author 0..1 MAY entry 0..1 SHOULD
Table 8: Allergy Observation Constraints Overview Name XPath Card. Verb Data Type Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.7'] @classCode 1..1 SHALL 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL @root 1..1 SHALL id 1..* SHALL II code/@code 1..1 SHALL 2.16.840.1.113883.5.4 (ActCode) = ASSERTION statusCode 1..1 SHALL CS 2.16.840.1.113883.5.14 (ActStatus) = completed adverse Event Date effectiveTime 1..1 SHALL TS or value 1..1 SHALL CD adverse Event Type code 1..1 SHALL (Allergy/Adverse Event Type) originalText 0..1 SHOULD ED reference /@value 0..1 SHOULD product participant 0..1 SHOULD @typeCode 1..1 SHALL 2.16.840.1.113883.5.90 (HL7ParticipationType) = CSM product Detail participant Role 1..1 SHALL @classCode 1..1 SHALL 2.16.840.1.113883.5.110 (RoleClass) = MANU playing Entity 1..1 SHALL @classCode 1..1 SHALL 2.16.840.1.113883.5.41 (EntityClass) = MMAT product Coded code 1..1 SHALL CE product FreeText original Text 0..1 SHOULD ED reference 0..1 SHOULD translation 0..* MAY
Table 32: Problem Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.4'] @classCode 1..1 SHALL @moodCode 1..1 SHALL 2.16.840.1.113883.5.1001 (ActMood) = EVN @negationInd 0..1 MAY id 1..* SHALL II problem Type code 1..1 SHALL CD (Problem Type) problem Name text 0..1 SHOULD ED reference /@value 0..1 SHOULD statusCode 1..1 SHALL CS 2.16.840.1.113883.5.14 (ActStatus) = completed problem Date effectiveTime 0..1 SHOULD TS or problemCode value 1..1 SHALL CD (Problem) @nullFlavor 0..1 MAY ageAtOnset entryRelationship 0..1 MAY @typeCode 1..1 SHALL 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ @inversionInd 1..1 SHALL true problem Status entryRelationship 0..1 MAY @typeCode 1..1 SHALL 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFR entryRelationship 0..1 MAY @typeCode 1..1 SHALL 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFR SHALL contain exactly one [1..1] @classCode. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001). MAY contain zero or one [0..1] @negationInd. negationInd="true" SHALL be used to represent that the problem was not observed. SHALL contain at least one [1..*] id.
Figure 57: Problem status example <observation classCode="OBS" moodCode="EVN"> <!-- Status observation template --> <templateId root="2.16.840.1.113883.10.20.22.4.6"/> <code code="33999-4" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Status"/> <statusCode code="completed"/> <value xsi:type="CD" code="55561003" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="Active"/> </observation> Procedure Activity Act [act: templateId 2.16.840.1.113883.10.20.22.4.12(open)] Table 37: Procedure Activity Act Contexts Used By: Contains Entries: The common notion of "procedure" is broader than that specified by the HL7 Version 3 Reference Information Model (RIM). Therefore procedure templates can be represented with various RIM classes: act (e.g., dressing change), observation (e.g., EEG), procedure (e.g. splenectomy). This clinical statement represents any procedure that cannot be classified as an observation or a procedure according to the HL7 RIM. Examples of these procedures are a dressing change, teaching or feeding a patient or providing comfort measures. Table 38: Procedure Activity Act Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value act[templateId/@root = '2.16.840.1.113883.10.20.22.4.12'] @classCode 1..1 SHALL 2.16.840.1.113883.5.6 (HL7ActClass) = ACT @moodCode 1..1 SHALL (MoodCodeEvnInt) templateId 1..1 SHALL @root 1..1 SHALL procedureId id 1..* SHALL II procedure code 1..1 SHALL CE
Type procedure FreeTextType originalText 0..1 SHOULD ED reference /@value 0..1 SHOULD statusCode 1..1 SHALL CS (ProcedureAct statusCode) procedure DateTime effectiveTime 0..1 SHOULD TS or priorityCode 0..1 MAY CE (ActPriority) performer 0..* SHOULD procedure Performer assignedEntity 1..1 SHALL id 1..* SHALL II addr 1..1 SHALL telecom 1..1 SHALL represented Organization 0..1 SHOULD id 0..* SHOULD II name 0..* MAY PN addr 1..1 SHALL telecom 1..1 SHALL participant 0..* MAY @typeCode 1..1 SHALL 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = LOC entryRelationship 0..* MAY @typeCode 1..1 SHALL 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMP @inversionInd 1..1 SHALL true encounter 1..1 SHALL @classCode 1..1 SHALL 2.16.840.1.113883.5.6 (HL7ActClass) = ENC @moodCode 1..1 SHALL 2.16.840.1.113883.5.1001 (ActMood) = EVN id 1..1 SHALL II
Imaging Procedure Note: derived from Procedure Activity Procedure Table 38: Imaging Procedure Constraints Overview Name XPath Card. Verb Data Type Fixed Value Imaging Procedure @classCode 1..1 SHALL 2.16.840.1.113883.5.6 (HL7ActClass) = PROC @moodCode 1..1 SHALL 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL SET<II> @root 1..1 SHALL Procedure Id id 1..* SHALL II Procedure Type code 1..1 SHALL CD originalText 0..1 SHOULD ED statusCode 1..1 SHALL CS (ProcedureAct statusCode) procedure DateTime effectiveTime 0..1 SHOULD TS or IVL<TS> priority priorityCode 0..1 MAY CE (ActPriority) method methodCode 0..1 MAY SET<CE> 1.2.840.10008.6.1.19 (CID 29 Acquisition Modality) bodySite targetSiteCode 0..* SHOULD (Body Site Value Set) performer 0..* SHOULD assignedEntity 1..1 SHALL procedure performer id id 1..* SHALL II procedure performer addr addr 1..1 SHALL SET<AD> procedure performer telecom telecom 1..1 SHALL playingEntity 1..1 SHALL procedure performer name name 1..1 SHALL PN participant 0..* MAY
unit (UCUM Units of (case sensitive)) Target site 0..1 MAY CD Method 0..1 MAY CD entry Relationship 0..* MAY @typeCode 1..1 SHALL 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SPRT Image 1..1 SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6). SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001). SHALL contain exactly one [1..1] templateId such that it SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.6.2.14". SHALL contain exactly one [1..1] code. SHALL contain exactly one [1..1] value. This value SHALL contain exactly one [1..1] @xsi:type, where the @code="PQ". SHOULD contain zero or one [0..1] effectiveTime. MAY contain zero or more [0..*] entryRelationship such that it SHALL contain exactly one [1..1] @typeCode="SPRT" Has Support (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002). SHALL contain exactly one [1..1] (2.16.840.1.113883.10.20.6.2.8).
This clinical statement represents details of a lab, radiology, or other study performed on a patient. Table 51: Result Observation Constraints Overview Name XPath Card. Verb Data Type CONF# Fixed Value observation[templateId/@root = '2.16.840.1.113883.10.20.22.4.2'] @classCode 1..1 SHALL 2.16.840.1.113883.5.6 (HL7ActClass) = OBS @moodCode 1..1 SHALL 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL @root 1..1 SHALL resultID id 1..* SHALL II resultType code 1..1 SHALL CD text 0..1 SHOULD ED reference /@value 0..1 SHOULD result Status statusCode 1..1 SHALL CS 2.16.840.1.113883.5.14 (ActStatus) = completed resultDate Time effectiveTime 1..1 SHALL TS or resultValue value 1..1 SHALL ANY result interpretation Code 0..* SHOULD CE methodCode 0..1 MAY targetSiteCode 0..1 MAY author 0..1 MAY result Reference Range referenceRange 0..* SHOULD observation Range 1..1 SHALL code 0..0 SHALL NOT SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6). SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001).
Table 66: Sop Instance Observation Constraints Overview Name XPath Card. Verb Data Type Fixed Value Sop Instance observation @classCode 1..1 SHALL 2.16.840.1.113883.5.6 (HL7ActClass) = DGIMG @moodCode 1..1 SHALL 2.16.840.1.113883.5.1001 (ActMood) = EVN templateId 1..1 SHALL SET<II> @root 1..1 SHALL 2.16.840.1.113883.10.20.6.2.8 id 1..* SHALL II code 1..1 SHALL CD text 0..1 SHOULD ED @mediaType 1..1 SHALL application/dicom reference 1..1 SHALL effectiveTime 0..1 SHOULD TS or IVL<TS> @value 1..1 SHALL low 0..0 SHALL NOT TS high 0..0 SHALL NOT TS entryRelationship 0..* MAY @typeCode 1..1 SHALL 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ entryRelationship 0..* MAY @typeCode 1..1 SHALL 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = RSON entryRelationship 0..* MAY @typeCode 1..1 SHALL 2.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMP SHALL contain exactly one [1..1] @classCode="DGIMG" Diagnostic Image (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6). SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001). SHALL contain at least one [1..*] id. The @root contains an OID representing the DICOM SOP Instance UID. SHALL contain exactly one [1..1] code.