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RSNA 2007 – Course 039 Electronic Reports: HL 7 CDA (Clinical Document Architecture) and RSNA 2007 – Course 039 Electronic Reports: HL 7 CDA (Clinical Document Architecture) and DICOM SR (Structured Reporting) Harry Solomon GE Healthcare DICOM WG 8 Structured Reporting HL 7 Structured Documents TC DICOM WG 20 / HL 7 Imaging Integration SIG IHE Cross-Domain Reporting Task Force 1

Disclosure • Harry Solomon – Employee, GE Healthcare 2 Disclosure • Harry Solomon – Employee, GE Healthcare 2

Acknowledgements • Fred Behlen, co-author of a previous version of this presentation • Fred Acknowledgements • Fred Behlen, co-author of a previous version of this presentation • Fred Behlen, Bob Dolin, Liora Alschuler, Calvin Beebe – cochairs of HL 7 Structured Documents Technical Committee, and authors of presentations on CDA used in this talk • Dave Clunie – former co-chair of DICOM Standards Committee, and author of the definitive book on DICOM Structured Reporting • Kevin O’Donnell – IHE Reporting Task Force 3

Objectives • Understand the key elements for effective radiology reporting, and issues with electronic Objectives • Understand the key elements for effective radiology reporting, and issues with electronic reporting • Understand the HL 7 CDA (Clinical Document Architecture) and its use cases • Understand DICOM SR (Structured Reporting) and its use cases • Understand reporting workflows, the use of DICOM SR and HL 7 CDA in those workflows, and the importance of the IHE (Integrating the Healthcare Enterprise) effort 4

Key Elements of Radiology Reporting 5 Key Elements of Radiology Reporting 5

Paper or Electronic Reports • Accurately convey the findings to the referring physician – Paper or Electronic Reports • Accurately convey the findings to the referring physician – Reflect the competence of the radiologist • Timely communication for patient care • Archived in the patient medical record • Legal record of imaging exam – Radiologist signature • Support ‘secondary’ uses – – Charge capture and billing Teaching and research Clinical data registries, clinical trials Process improvement • Produced making best use of radiologist’s time 6 Typical busy radiologist at Northwestern Memorial Hospital

Benefits and challenges of Electronic Reports (1) • Accuracy + Drive for quality improvement Benefits and challenges of Electronic Reports (1) • Accuracy + Drive for quality improvement with quantitative data, CAD and other measurements + Possible major benefit with attached key images and graphical analysis (picture = 1000 words) – Will systems support graphical reports? • Timely communication + Probable improvement • Archived in the patient medical record – Where is the electronic medical record? (distributed, multiple copies) 7

Benefits and challenges of Electronic Reports (2) • Legal record – What is a Benefits and challenges of Electronic Reports (2) • Legal record – What is a valid electronic signature? – Is an exact visual reproduction required, or only exact semantic content? • Secondary uses + Huge potential improvement, especially with structured and coded data • Use of radiologist’s time – Potential negative impact with transition from traditional dictation workflow – Radiologist pays the cost for improvements downstream 8

This is Process Re-engineering! • Transition to electronic reports is hard – – New This is Process Re-engineering! • Transition to electronic reports is hard – – New systems New architectures New policies and procedures Organizationally disjunct costs/benefits • Minimize the risk and the effort – A standards-based approach – Incremental evolution from current workflow – Leverage the work of IHE (Integrating the Healthcare Enterprise) 9

HL 7 Clinical Document Architecture Overview HL 7 is a Standards Development Organization whose HL 7 Clinical Document Architecture Overview HL 7 is a Standards Development Organization whose domain is clinical and administrative data 10

HL 7 Clinical Document Architecture • The scope of the CDA is the standardization HL 7 Clinical Document Architecture • The scope of the CDA is the standardization of clinical documents for exchange. • A clinical document is a record of observations and other services with the following characteristics: – – – Persistence Stewardship Potential for authentication Wholeness Human readability • A CDA document is a defined and complete information object that can exist outside of a message, and can include text, images, sounds, and other multimedia content. 11

Clinical Document Characteristics • Persistence – Documents exist over time and can be used Clinical Document Characteristics • Persistence – Documents exist over time and can be used in many contexts • Stewardship – Documents must be managed, shared by the steward • Potential for authentication – Intended use as medico-legal documentation • Wholeness – Document includes its relevant context • Human readability – Essential for human authentication 12

CDA Use Cases • • • Diagnostic and therapeutic procedure reports Encounter / discharge CDA Use Cases • • • Diagnostic and therapeutic procedure reports Encounter / discharge summaries Patient history & physical Referrals Claims attachments • Consistent format for all clinical documents 13

Key Aspects of the CDA • CDA documents are encoded in Extensible Markup Language Key Aspects of the CDA • CDA documents are encoded in Extensible Markup Language (XML) • CDA documents derive their meaning from the HL 7 v 3 Reference Information Model (RIM ) and use HL 7 v 3 Data Types • A CDA document consists of a header and a body – Header is consistent across all clinical documents identifies and classifies the document, provides information on patient, provider, encounter, and authentication – Body contains narrative text / multimedia content (level 1), optionally augmented by coded equivalents (levels 2 & 3) 14

CDA Standard • Release 1 (2000) – Standalone standard – Based on early draft CDA Standard • Release 1 (2000) – Standalone standard – Based on early draft v 3 RIM – Level 1 narrative and multimedia • Release 2 (2005) – Incorporated into HL 7 v 3 Standard (Normative Edition) – Level 2 structured narrative and multimedia, plus Level 3 coded statements • Implementation Guides – HL 7 Care Record Summary (CRS) – ASTM/HL 7 Continuity of Care Document (CCD) – IHE Patient Care Coordination Templates 15

CDA Release 2 Information Model Header Participants Start Here Doc ID &Type Body Context CDA Release 2 Information Model Header Participants Start Here Doc ID &Type Body Context Sections/ Headings Clinical Statements/ Coded Entries Extl 16 Refs

CDA Structured Body Arrows are Act Relationships • Has component, Derived from, etc. Entries CDA Structured Body Arrows are Act Relationships • Has component, Derived from, etc. Entries are coded clinical statements • Observation, Procedure, Substance administration, etc. Structured Body Section Text Section Text Entry Coded statement 17

Sample CDA 18 Sample CDA 18

Narrative and Coded Info • CDA structured body requires human-readable “Narrative Block”, all that Narrative and Coded Info • CDA structured body requires human-readable “Narrative Block”, all that is needed to reproduce the legally attested clinical content • CDA allows optional machine-readable coded “Entries”, which drive automated processes • Narrative may be flagged as derived from Entries – Textual rendering of coded entries’ content, and contains no clinical content not derived from the entries • General method for coding clinical statements is a hard, unsolved problem – CDA allows incremental improvement to amount of coded data without breaking the model 19

Narrative and Coded Entry Example 20 Narrative and Coded Entry Example 20

CDA Non-XML Body • Alternative to XML Structured Body • Standard CDA header “wraps” CDA Non-XML Body • Alternative to XML Structured Body • Standard CDA header “wraps” existing document • Any MIME type – Especially PDF (IHE Scanned Document Profile) 21

CDA Implementation Guides • Published by HL 7 – Care Record Summary – encounter CDA Implementation Guides • Published by HL 7 – Care Record Summary – encounter notes, discharge summary – Continuity of Care Document – transfer of care (harmonized with ASTM Continuity of Care Record) • Published by IHE Patient Care Coordination – – – – Emergency Department Referral Pre-procedure History and Physical Scanned Documents Personal Health Record Extract Basic Patient Privacy Consents Antepartum Summary Emergency Department Encounter Summary 22

DICOM Structured Reporting Overview DICOM is a Standards Development Organization whose domain is biomedical DICOM Structured Reporting Overview DICOM is a Standards Development Organization whose domain is biomedical imaging 23

DICOM Structured Reporting • The scope of DICOM SR is the standardization of documents DICOM Structured Reporting • The scope of DICOM SR is the standardization of documents in the imaging environment. • SR documents record observations made for an imaging-based diagnostic or interventional procedure, particularly those that describe or reference images, waveforms, or specific regions of interest. 24

SR Use Cases • • Radiology reports with robust image / ROI references Measurements/analyses SR Use Cases • • Radiology reports with robust image / ROI references Measurements/analyses made on images Computer-aided detection results Notes about images (QC, flag for specific use, quick reads) • Procedure logs for imaging-based therapeutic procedures • Image exchange manifests 25

Use Case Common Features • Structured – Lists and hierarchies • Numeric measurements, coded Use Case Common Features • Structured – Lists and hierarchies • Numeric measurements, coded values – Automatically extractable for database, data mining • Relationships between items – Hierarchical, or arbitrary reference – Power of rich semantic expression • References to images, waveforms, other objects – Collected in DICOM environment • Explicit contextual information – Unambiguous documentation of meaning 26

DICOM SR and the Five Clinical Document Characteristics • The five characteristics: – Persistence: DICOM SR and the Five Clinical Document Characteristics • The five characteristics: – Persistence: SR objects are persistent – Stewardship: SR objects are managed and can identify their steward – Potential for authentication: SR has digital signature capability – Wholeness: SR objects include their relevant context – Human readability: DICOM requires SR objects to be rendered “completely and unambiguously”, but this needs a conformant application • SR emphasizes coded semantic content (especially in relation to images), while CDA emphasizes human readable text through simple XML style sheets 27

Key Aspects of DICOM SR • SR documents are encoded using DICOM standard data Key Aspects of DICOM SR • SR documents are encoded using DICOM standard data elements and leverage DICOM network services (storage, query/retrieve) • SR uses DICOM Patient/Study/Series information model (header), plus hierarchical tree of “Content Items” • Extensive mandatory use of coded content – Allows use of vocabulary/codes from non-DICOM sources • Templates define content constraints for specific types of documents / reports 28

SR Content Item Tree Arrows are parent-child relationships • Contains, Has properties, Inferred from, SR Content Item Tree Arrows are parent-child relationships • Contains, Has properties, Inferred from, etc. Content Items are units of meaning • Text, Numeric, Code, Image, Spatial coordinates, etc. Root Content Item Document Title Content Item Content Item Content Item 29

DICOM SR Example 30 DICOM SR Example 30

DICOM SR Object Classes • Basic Text - Narrative text with image references • DICOM SR Object Classes • Basic Text - Narrative text with image references • Enhanced and Comprehensive - Text, coded content, numeric measurements, spatial and temporal ROI references • CAD - Automated analysis results (mammo, chest, colon) • Key Object Selection (KO) - Flags one or more images – Purpose (for referring physician, for surgery …) and textual note – Used for key image notes and image manifests (in IHE profiles) • Procedure Log - For extended duration procedures (e. g. , cath) • Radiation Dose Report - Projection X-ray; CT 31

DICOM Encapsulated Document • Complementary to DICOM Structured Reporting • Standard DICOM header “wraps” DICOM Encapsulated Document • Complementary to DICOM Structured Reporting • Standard DICOM header “wraps” existing document – Allows use of DICOM infrastructure – object exchange, archive (PACS), query/retrieve • Only specific document types allowed – PDF – CDA 32

PDF (Adobe Portable Document Format) ® • Neither CDA nor SR guarantee exact visual PDF (Adobe Portable Document Format) ® • Neither CDA nor SR guarantee exact visual reproduction of a displayed document, which may be a legal requirement in some locales • PDF allows exact visual reproduction, and display software is readily available • Role for PDF as a presentation-ready equivalent rendering of a coded document • Both CDA and DICOM support wrapping PDF with their standard header, so a presentation-ready PDF can be managed in the same environment with cross-links to the original coded document – Also supports legacy documents scanned into PDF 33

Radiology Reporting Workflows 34 Radiology Reporting Workflows 34

Reporting Starts Before the Radiologist Sees the Study • Reason for exam (from order) Reporting Starts Before the Radiologist Sees the Study • Reason for exam (from order) • Technical aspects of procedure – Protocol – Exam notes from tech • Post-processing results – Measurement and analysis applications (e. g. , vascular, obstetric, cardiac) by tech – Computer Aided Detection results • These need to get to the radiologist and integrated into the report – Produced on modality or imaging workstation 35

Reporting Integration (1) • Review study evidence – Order and relevant clinical information – Reporting Integration (1) • Review study evidence – Order and relevant clinical information – Images and relevant priors – Tech notes and post-processing results • Radiologist interpretation – on imaging workstation – Annotation (virtual grease pencil) – Key image selection – Measurement and analysis applications by radiologist • Radiologist findings reporting – on a different system? – Structured data entry (forms-based) – Dictation + transcription 36 Where’s Waldo going to prepare his report?

Reporting Integration (2) • Report assembly – Findings and selected evidence/interpretation results • Radiologist Reporting Integration (2) • Report assembly – Findings and selected evidence/interpretation results • Radiologist signature – Auditable action, or digital encryption-based • Report communication – To referring physician – To “secondary” users (billing!) • Report archive – And subsequent access 37

The DICOM Solution? • DICOM was supposed to take care of all this, and The DICOM Solution? • DICOM was supposed to take care of all this, and has (almost) all the requisite features and network services • DICOM SR has found vital uses in key subspecialty areas that produce structured data in the examination or postprocessing – Leveraging the DICOM infrastructure is easy and desirable – Results managed with other study evidence • But the end recipients of radiology reports, referring physicians, commonly use systems without DICOM capabilities (imaging or SR) 38

“Evidence” and “Reports” • Evidence Documents – Includes measurements, procedure logs, CAD results, etc. “Evidence” and “Reports” • Evidence Documents – Includes measurements, procedure logs, CAD results, etc. , created in the imaging context, and together with images are interpreted by a radiologist to produce a report – The radiologist may quote or copy parts of Evidence Documents into the report, but doing so is part of the interpretation process at his discretion – Appropriate to be stored in PACS as DICOM SR objects, with same (legal/distribution) status as images • Reports – Become part of the patient’s medical record, with potentially wide distribution – Ideal match to HL 7 CDA, but sometimes SR is appropriate 39

DICOM-HL 7 Synergy (1) • SR and CDA developed simultaneously • DICOM and HL DICOM-HL 7 Synergy (1) • SR and CDA developed simultaneously • DICOM and HL 7 working groups recognized the need to work together • DICOM SR and HL 7 CDA are congruent in key areas – Document persistence – Document identification, versioning and type code – Document’s relation to the patient and to the authoring physicians • SR strength in robust image-related semantic content; CDA strength in human readable narrative report • DICOM WG 10 (Strategic Advisory) suggested composing radiology reports directly in CDA format when appropriate 40

DICOM-HL 7 Synergy (2) • References to CDA documents from within DICOM objects, and DICOM-HL 7 Synergy (2) • References to CDA documents from within DICOM objects, and vice versa • Include CDA documents on DICOM removable disks – As native CDA files, or encapsulated in a DICOM file – Indexed in DICOMDIR for integration with DICOM applications • PDF rendering of SR can be wrapped in a CDA document • Transcoding between SR and CDA feasible for limited subset of reports • CDA Implementation Guide for Diagnostic Reporting in development 41

The Role of IHE • Industry-wide effort to “make it work” • Real world The Role of IHE • Industry-wide effort to “make it work” • Real world use cases drive standards-based approach to integration – Practical evolution from current architectures • Venue for testing implementations and interoperability • Reporting is a high priority task for Radiology Domain • Your participation is welcome! 42

Reporting Profiles • Documented workflow profiles – IHE Evidence Documents Profile – IHE Key Reporting Profiles • Documented workflow profiles – IHE Evidence Documents Profile – IHE Key Image Notes Profile – DICOM Part 17 Dictation-Based Reporting with Image References [Supplement 101] • Ongoing work in IHE Reporting Task Force and Radiology Technical Committee – Revise IHE Simple Image and Numeric Report Profile, consolidate with Post-processing and Reporting Workflow Profiles – Align with Retrieve Information for Display and Cross. Enterprise Document Sharing Profiles 43

Diagnostic reporting Image Viewing Application Reporting Application User control Diagnostic Images Image Sources Viewing Diagnostic reporting Image Viewing Application Reporting Application User control Diagnostic Images Image Sources Viewing settings PACS Archive Diagnostic report Orders, Prior Reports Report Information System 44

Reporting with annotation (use case - desired) Image Viewing Application Reporting Application User control Reporting with annotation (use case - desired) Image Viewing Application Reporting Application User control Diagnostic report Image references & annotation Diagnostic Images Image Sources Viewing settings PACS Archive Orders, Prior Reports Report with image references & annotation Information System 45

Reporting with annotation (what’s available) Image Viewing Application Reporting Application User control Image references Reporting with annotation (what’s available) Image Viewing Application Reporting Application User control Image references & annotation Diagnostic Images Image Sources Viewing settings, image references & annotation PACS Archive Diagnostic report Orders, Prior Reports Report Information System 46

Integrated solution Image Viewing & Reporting Application User control Diagnostic report Image references & Integrated solution Image Viewing & Reporting Application User control Diagnostic report Image references & annotation Orders, Diagnostic images & Prior reports Image Sources Viewing settings, Reports, image references & annotation Integrated PACS & Information System 47

Loosely integrated reporting Image Viewing Application Reporting Application User control Image references & annotation Loosely integrated reporting Image Viewing Application Reporting Application User control Image references & annotation Viewing settings, Diagnostic image references Images & annotation Image references Image PACS & annotation Sources Archive Image retrieval Diagnostic report Orders, Prior Reports Report Information System Report w/ image ref & annot 48

Image Viewing Application Image selection Reporting Application Dictated report Annotation ati ic rif Ve Image Viewing Application Image selection Reporting Application Dictated report Annotation ati ic rif Ve on Transcribed narrative DICOM GSPS object (annotations) DICOM KO object “For Report” Image Archive (DICOM SCP) DICOM Query/Retrieve for all KO objects matching Accession Number Reporting System Validation Functions Reporting Integration Functions DICOM Encapsulated CDA object WADO Server WADO URI references to Images with GSPSs (JPEG rendering) CDA Report 49

Other Use Cases to be Profiled • All the basic elements are standardized and Other Use Cases to be Profiled • All the basic elements are standardized and ready to be fit into integrated reporting workflows – Need consensus approaches to specific use cases (IHE) • Quantitative measurement intensive reporting with DICOM SR inputs – Mammo with CAD input, Obstetric with sonographer measurements, Cardiac with functional assessments – DICOM SR as primary report with PDF wrapped in CDA as distributed version? • Selected key measurements imported into report (loosely coupled architecture) – Similar to Key Image / Annotation workflow – Possible push model of key measurements to RIS? 50

Conclusions • CDA now viewed as a primary format for diagnostic imaging reports – Conclusions • CDA now viewed as a primary format for diagnostic imaging reports – Definition of CDA DI report to be done in 2008 by a balloted HL 7 Implementation Guide – Method is extensible to reports with more structure • DICOM SR will see continued and expanding use for Evidence Documents created in the imaging setting – IHE Evidence Documents Integration Profile • Evolutionary workflows utilizing both standards in coordination are being profiled by IHE – Does not require tight integration of imaging and reporting workstations 51