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RSNA 2007 – Course 039 Electronic Reports: HL7 CDA (Clinical Document Architecture) and DICOM SR (Structured Reporting) Harry Solomon GE Healthcare DICOM.

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Presentation on theme: "RSNA 2007 – Course 039 Electronic Reports: HL7 CDA (Clinical Document Architecture) and DICOM SR (Structured Reporting) Harry Solomon GE Healthcare DICOM."— Presentation transcript:

1 RSNA 2007 – Course 039 Electronic Reports: HL7 CDA (Clinical Document Architecture) and DICOM SR (Structured Reporting) Harry Solomon GE Healthcare DICOM WG 8 Structured Reporting HL7 Structured Documents TC DICOM WG 20 / HL7 Imaging Integration SIG IHE Cross-Domain Reporting Task Force

2 2 Disclosure Harry Solomon –Employee, GE Healthcare

3 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 ODonnell – IHE Reporting Task Force

4 4 Objectives Understand the key elements for effective radiology reporting, and issues with electronic reporting Understand the HL7 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 HL7 CDA in those workflows, and the importance of the IHE (Integrating the Healthcare Enterprise) effort

5 5 Key Elements of Radiology Reporting

6 6 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 radiologists time Typical busy radiologist at Northwestern Memorial Hospital

7 7 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)

8 8 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 radiologists time –Potential negative impact with transition from traditional dictation workflow –Radiologist pays the cost for improvements downstream

9 9 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)

10 10 HL7 Clinical Document Architecture Overview HL7 is a Standards Development Organization whose domain is clinical and administrative data

11 11 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.

12 12 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

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

14 14 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)

15 15 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

16 16 CDA Release 2 Information Model HeaderBody Participants Sections/ Headings Clinical Statements/ Coded Entries Extl RefsContext Doc ID &Type Start Here

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

18 18 Sample CDA

19 19 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

20 20 Narrative and Coded Entry Example

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

22 22 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) 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

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

24 24 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.

25 25 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

26 26 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

27 27 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

28 28 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

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

30 30 DICOM SR Example

31 31 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

32 32 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

33 33 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

34 34 Radiology Reporting Workflows

35 35 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

36 36 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 Wheres Waldo going to prepare his report?

37 37 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

38 38 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 post-processing –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)

39 39 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 patients medical record, with potentially wide distribution –Ideal match to HL7 CDA, but sometimes SR is appropriate

40 40 DICOM-HL7 Synergy (1) SR and CDA developed simultaneously DICOM and HL7 working groups recognized the need to work together DICOM SR and HL7 CDA are congruent in key areas –Document persistence –Document identification, versioning and type code –Documents 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 WG10 (Strategic Advisory) suggested composing radiology reports directly in CDA format when appropriate

41 41 DICOM-HL7 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

42 42 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!

43 43 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, c onsolidate with Post-processing and Reporting Workflow Profiles –Align with Retrieve Information for Display and Cross- Enterprise Document Sharing Profiles

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

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

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

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

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

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

50 50 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?

51 51 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 HL7 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

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