1. NAACCR Clinical Data Work Group - Pilot to Transmit the Cancer Abstract Using HL7 Clinical Document Architecture (CDA) 2007 NAACCR Conference Ken Gerlach, Health Scientist, CDC-NPCR June 4, 2007

2. NAACCR Background

3. Number One NAACCR Priority January 2007 – at NAACCR Leadership Retreat ……. January 2007 – at NAACCR Leadership Retreat ……. Achieve syntactic and semantic interoperability of cancer registration standards with national standards by 2010 or at the earliest possible time Achieve syntactic and semantic interoperability of cancer registration standards with national standards by 2010 or at the earliest possible time Committees/Work Groups restructured Committees/Work Groups restructured Cancer Abstract Transmission WG >> Clinical Data WG Cancer Abstract Transmission WG >> Clinical Data WG

4. Interoperability Ad Hoc Committee Structure – 2007

5. Clinical Data WG Charge  Explore alternate mechanisms or messages to transmit and receive the cancer abstract  Examine not only the steps to transmit and receive data within the cancer registry community,  But also consider transmissions to organizations typically outside that community

6. Context  The current format to transmit the cancer abstract within the cancer registry community - column-delimited (fixed- width), flat-file  Used for over 10 years  Described in NAACCR Standards for Cancer Registries, Volume II, Data Standards and Data Dictionary

8. History  Cancer Abstract Transmission WG (now Clinical Data WG) formed: October 2005  First Meeting: November 2005  Decision to pursue HL7 CDA: May 2006  Pilot Project Strategy: Summer 2006  Team’s HL7 CDA Experts: Summer 2006 Alschuler Associates, LLC (Contract with CDC- NPCR)  Kick Off (Face-to-Face) Meeting: November 2006  Protocol: February – April, 2007

9. HL7 CDA

11. Copyright Alschuler Associates, LLC 2006 11 Health Level Seven (HL7.org) Standards Development Organization Developing standards for interoperability –Patient care –Public health –Clinical trials –Reimbursement HIPAA DSMO 20 years, 2000 members 30+ international affiliates “A model community”: building standards to a single information model

12. Copyright Alschuler Associates, LLC 2006 12 Clinical Document Architecture ANSI/HL7 CDA R1.0-2000 ANSI/HL7 CDA R2.0-2005 Created & maintained by HL7 Structured Documents Technical Committee (SDTC) A specification for document exchange using –XML, –the HL7 Reference Information Model (RIM) –Version 3 methodology –and vocabulary (SNOMED, ICD, local,…) CDA

13. Copyright Alschuler Associates, LLC 2006 13 XML XML is about investing in information –information design should outlive system design –documents outlive the system on which they are created Platform and vendor independent Data in XML persists over time Data in XML can move between applications

14. Copyright Alschuler Associates, LLC 2006 14 Sample CDA

15. HL7 CDA Experts

16. Copyright Alschuler Associates, LLC 2006 16 Alschuler Associates, LLC –Alschuler Associates, LLC projects Military Health System, “Documents, Files, Images” (DFI) project HITSP Standards Harmonization HISPC Security & Confidentiality Center for Disease Control & Prevention (CDC)—Infections disease reporting, cancer abstract transmission American Hospital Association use case development Commercial software developers implementing standards-based solutions –HL7 volunteer participation Co-editors, CDA, CRS, CCD Co-authors, CDA & CRS Quick Start Guides Co-chair HL7 Structured Documents TC Member, HL7 Board of Directors HL7 IHE Liaison past Chair, KEG & XML SIG & HL7 Marketing Committee –XML experience –www.alschulerassociates.comwww.alschulerassociates.com

17. Pilot Project Strategy  Strawman CDA Message  Implementation Guide (IG): Preliminary and Final  Software to translate Column-Delimited Format to CDA and visa versa  Participants – Alpha and Beta IG Conformant Messages  Transmit and Receive Test Messages  Compile Lessons Learned, Advantages, and Disadvantages  Recommendation – Next Steps

18. Methodology  Transmit cancer abstracts using HL7 CDA from a hospital registry to a central registry Dummy Data NAACCR Record Type A (full case abstract), Version 11.1 All Required (R) and Required when available (R*) Data Items Expanded text – in text-based Data Items

19. Participants  California Sender Software: C/NExT Receiver Software: Eureka  Virginia Sender Software: Abstract Plus* Receiver Software: Rocky Mountain Cancer Data System (RMCDS) * Modified - Virginia Commonwealth University Health System

20. Transition: Flat-File to CDA and CDA to Flat-File Scenarios

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25. Implementation Guide (IG)  A guide describes how to code CDA documents Specific encoding  Tool for implementers: senders and receivers  NAACCR HL7 CDA R2 Implementation Guide for Cancer Registry Reporting

26. IG Table of Contents 1.Introduction 1.1.Scope 1.2.How To Read This Document 1.3.Approach 2.Document Element 3.CDA Header Representation 3.1.Realmcode 3.2.Typeid 3.3.Templateid 3.4.Id (Instance Identifier) 3.5.Code 3.6.Effectivetime 3.7.Confidentiality Code 3.8.Setid 3.9.Versionnumber 3.10.Recordtarget And Patientrole 3.11.Author/Legal Authenticator 3.12.Custodian 3.13.Information Recipient 3.14.CDA Header – Mapping Table 4.CDA Body Representation 4.1.Record ID 4.2.Demographic 4.3.Cancer Identification 4.4.Hospital-Specific 4.5.Stage/Prognostic Factors 4.6.Treatment – 1st Course 4.7.Treatment – Subsequent & Other 4.8.Edit Overrides/Conversion History/System Administration 4.9.Follow-up/Recurrence/Death 4.10.Special Use 4.11.Patient-Confidential 4.12.Hospital-Confidential 4.13.Other-Confidential 4.14.Text – Diagnosis 4.15.Text – Treatment 4.16.Text – Miscellaneous 4.17.CDA Body – Mapping Table

27. Sampling of IG Questions  Repeating capability? Co-morbidity/Complication 1 - 8  Dates - Date Data Type  Author  Custodian  How assign each CDA report a unique ID?  “Effective Time”, time record creation available? Use NAACCR Date Case Completed [2090]

28. Vocabulary  Question Codes: LOINC  Answer Codes National Standards SNOMED CT LOINC NCI Thesaurus PHIN VADS NAACCR Codes Use NAACCR Codes Future - map NAACCR codes to other vocabulary

29. Time Line  Strawman - July 2007  Preliminary IG - September 2007  Translation tools - October 2007  Pilot alpha software - December 2007  Pilot alpha deployment - February 2008  Final Implementation Guide - April 2008  Document advantages/disadvantages - May 2008  Protocol and Cost-Benefit Analysis Report to Board - May 2008

30. Conclusions  Current NAACCR Transmission Standards: Work  Need for more powerful transmission tool  Medical Informatics – National emphasis  Transition to HL7 CDA  First Step: A Pilot to Test and Learn  If …. Full Implementations Plans Two Concurrent Transmission Standards  Educate Cancer Registry Community

31. Acknowledgements  Alschuler Associates, LCC  CDC-NPCR  NAACCR Board and Staff  NAACCR Clinical Data (Cancer Abstract Transmission) Work Group

32. WG Members: 2006-2007  Baral, Sanjeev  Campbell, Dave  Derrick, Larry  Fuchslin, Steve  Gerlach, Ken  Gordon, Barry  Havener, Lori  Hill, Ken  Kosary, Carol  Martin, Jim  Bob McLaughlin  Potts, Mary  Reichman, Marsha  Russell, Carol  Schmidt, Beth Anne  Scoppa, Steve  Schneider, Althea  Thames, Sandy  Tsyvine, Roman

33. Thank you  Ken Gerlach  770-488-3008  kgerlach@cdc.gov kgerlach@cdc.gov The findings and conclusions in this presentation are those of the author(s) and do not necessarily represent the views of the Centers for Disease Control and Prevention