Harry Solomon GE Healthcare DICOM WG 8 Structured Reporting HL7 Structured Documents TC

1. RSNA 2008 – Course 1029Electronic Reports:HL7 CDA (Clinical Document Architecture)and DICOM SR (Structured Reporting)for Advanced Reporting Harry Solomon GE Healthcare DICOM WG 8 Structured Reporting HL7 Structured Documents TC DICOM WG 20 / HL7 Imaging Integration WG IHE Cross-Domain Reporting Task Force

2. Disclosure • Harry Solomon • Employee, GE Healthcare • Instructor, Medical Informatics, Northwestern University

3. Acknowledgements • Fred Behlen, co-author of a previous version of this presentation • Fred Behlen, Bob Dolin, Liora Alschuler, Calvin Beebe – co-chairs of HL7 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

4. Objectives • Understand the key elementsfor effective radiology reporting, and issues with electronic reportingworkflows • Understand the uses of HL7 CDA (Clinical Document Architecture) and DICOM SR (Structured Reporting) for advanced reporting workflows

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6. For our purposes • An electronic report is created using computer based techniques (workflow), includes some amount of structured and coded content, and may include “multi-media” (for radiology, images) • We will look at two technology standards that apply to electronic reporting

7. Key Elements ofRadiology Reporting

8. 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 Typical busy radiologist at Northwestern Memorial Hospital

9. Benefits (+) and challenges (-)of Electronic Reports • 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)

10. Benefits and challenges of Electronic Reports (cont’d) • 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 • More accurate billing (avoid undercoding) • Use of radiologist’s time • Potential negative impact with transition from traditional dictation workflow • Radiologist pays the cost for improvements downstream

11. Planning forelectronic reporting • What are your goals ? • Better capture of sonographer measurements into report • Add key images into reports • Ability to do research / data mining • What kinds of reports do you need? • Text only • Text + image references • Structured text • Structured text + coded content • Multimedia

12. 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)

13. Radiology ReportingWorkflows

14. Reporting Starts Before the Radiologist Sees the Study • Reason for exam (from order), patient history • 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 • Produced on modality, imaging workstation, or CAD server • These need to get to the radiologist and integrated into the report

15. 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? • Dictation + transcription / speech recognition • Structured data entry (forms-based) Where’s Waldo going to prepare his report?

16. 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!, quality improvement) • Report archive • And subsequent access

17. Diagnostic reporting Image Viewing Application Reporting Application Usercontrol Diagnosticreport Orders, Prior Reports Diagnostic Images Viewing settings (ww/wl, rotation/flip) Report ImageSources PACSArchive Information System

18. Reporting with annotation(use case - desired) Image Viewing Application Reporting Application Usercontrol Diagnosticreport Imagereferences& annotation Reportwith imagereferences &annotation Orders, Prior Reports Diagnostic Images Viewingsettings (ww/wl) ImageSources PACSArchive Information System

19. Reporting with annotation(what’s available) Image Viewing Application Reporting Application Usercontrol Diagnosticreport Imagereferences& annotation Orders, Prior Reports Viewing settings,image references& annotation Diagnostic Images Report ImageSources PACSArchive Information System

20. Reporting with measurements Image Viewing Application Reporting Application Usercontrol Diagnosticreport EDD 0921 BPD 5.2 cm Orders, Prior Reports Viewing settings & confirmed measurements Diagnostic images & measurements Report ImageSources PACSArchive MeasurementSources Information System

21. The issues • How do we bridge the gap between the imaging side and the reporting side • Annotations, key images, and measurements • How do we include these enhanced features in reports?

22. HL7 Clinical Document ArchitectureOverview HL7 is a Standards Development Organization whose domain is clinical and administrative data

23. HL7 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.

24. Why do you need to know about CDA? • Executive Order 13,410 and EHR Safe Harbors Provision (Stark Act relaxation): certain healthcare IT systems must comply with federally recognized interoperability specifications • January 2008: HHS Secretary Leavitt recognizes first HITSP* Interoperability Specifications, including several components using CDA • While not (yet) specified for interoperability of radiology reports, HITSP considers CDA as basis for clinical documentation going forward *Healthcare IT Standards Panel of American National Standards Institute (ANSI), taskedby Dept of Health & Human Services to recommend harmonized standards

25. 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

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

27. Key Aspects of the CDA • CDA documents are encoded in Extensible Markup Language (XML) • CDA documents derive their meaning from the HL7 v3 Reference Information Model (RIM ) and use HL7 v3 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)

28. CDA Standard • Release 1 (2000) • Standalone standard, based on early draft v3 RIM • Level 1 narrative and multimedia • Release 2 (2005) • Incorporated into HL7 v3 Standard (Normative Edition) • Level 2 structured narrative and multimedia, plus Level 3 coded statements • Implementation Guides • HL7 Care Record Summary (CRS) • ASTM/HL7 Continuity of Care Document (CCD) • IHE Patient Care Coordination Templates • Common Document Types project (CDA4CDT) • HL7 Diagnostic Imaging Report Implementation Guide New

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

30. 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 Section Text Section Text Section Text Section Text Entry Coded statement Entry Coded statement Entry Coded statement

31. Sample CDA

32. Principle of Human Readability:Narrative and Coded Information • CDA structured body requireshuman-readable “Narrative Block”, all that is needed to reproduce the legally attested clinical content • CDA allows optionalmachine-readable coded “Entries”, which drive automated processes • By starting with a base of text, CDA allows incremental improvement to amount of coded data without breaking the model

33. Narrative and Coded Entry Example

34. CDA Non-XML Body • Alternative to XML Structured Body • Standard CDA header “wraps” existing document • Allows document management with consistent metadata • Body can be any MIME* type • Especially PDF (IHE Scanned Document Profile) *Multi-part Internet Mail Extension

35. CDA Implementation Guides • Published by HL7 • Care Record Summary – encounter notes, discharge summary • Continuity of Care Document – transfer of care (harmonized with ASTM Continuity of Care Record) • Diagnostic Imaging Report – with robust references to DICOM objects • 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

36. Diagnostic Imaging ReportImplementation Guide Header Structured Body Section DICOM Object Catalog Section Reason for Study Section Findings References to DICOM images with optional Presentation State annotations Section Patient History Section Impressions Entries (Annotated) Image References Section Procedure Description Section Recommendations Entries DICOM Study, Series, Image References Section Comparison Study Section Key Images References to DICOM objects in hierarchical context using native DICOM or WADO access

37. DICOM Structured ReportingOverview DICOM is a Standards Development Organization whose domain is biomedical imaging

38. 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.

39. Why do you need to know about DICOM SR? • DICOM SR is used in key subspecialty areas that produce structured data in the course of image acquisition or post-processing, where: • Leveraging the DICOM infrastructure is easy and desirable • Results should be managed with other study evidence • Examples • Sonographer measurements • Computer-aided detection results • QC notes about images • Radiation dose reports • Image exchange manifests

40. 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

41. 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 Content Item Content Item Content Item Content Item Content Item Content Item

42. DICOM SR Example

43. DICOM SR Object Classes • Enhanced and Comprehensive - Text, coded content, numeric measurements, spatial and temporal ROI references • Templates for ultrasound, cardiac imaging • 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

44. HL7 CDA and DICOM SR -Compare and Contrastand Collaborate

45. “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 • Good match to HL7 CDA

46. DICOM-HL7 Synergy (1) • DICOM and HL7 have recognized the need to work together • DICOM SR and HL7 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 • Coded content using external vocabularies • SR strength in robust image-related semantic content; CDA strength in human readable narrative report

47. DICOM-HL7 Synergy (2) • Methods for referencing CDA documents from within DICOM objects, and vice versa • CDA documents can be included on DICOM exchange disks • As native CDA files, or encapsulated in a DICOM file • Indexed in DICOMDIR for integration with DICOM applications • Transcoding from SR to CDA feasible for measurements, image references, observations • DICOM WG10 (Strategic Advisory) suggested composing radiology reports directly in CDA format when appropriate

48. Approaches to integration • Use these standards! Ask for them from your IT providers • Leverage them in new combinations to achieve desired electronic reporting capabilities • Evolve from current workflows – but recognize there may be process re-engineering

49. Image references& annotation Image retrieval Loosely integrated reporting –add key images to reports Image Viewing Application Reporting Application Usercontrol Diagnosticreport Imagereferences& annotation Orders, Prior Reports Viewing settings,image references& annotation Diagnostic Images Report ImageSources PACSArchive Information System Report w/ image ref & annot

50. Imageselection Dictatedreport Annotation Verification Transcribednarrative DICOM GSPS object (annotations) DICOM KO object“For Report” DICOM Query/Retrieve for all KO objects matching Accession Number DICOM Encapsulated CDA object CDAReport WADO URI references toImages with GSPSs (JPEG rendering) Image Viewing Application Reporting Application Reporting SystemValidation Functions Reporting Integration Functions Image Archive WADO Server