321 VI Using Standards

1. 321 VI Using Standards Andrew Casertano VistA Imaging

2. Disclaimer This summarizes work of the Veterans Health Administration, Office of Information (VHA OI). It may amplify elements of private sector activities or products. None of the information is meant to endorse private sector activities, obligate the Federal Government to follow any particular course of action, nor to espouse an official position of the Federal Government, for the present or in the future.

3. What does PACS stand for? • Picture your Assets Completely Spent • Promise Anything to Close Sale • Pain And Constant Suffering • Press Anykey to Crash System • Property the Administrator Can’t Sell • Picture Archiving and Communications System • (all of the above?) Ref: SCAR 2005, Horii

4. HL7 and DICOM • HL7 • Message protocol to update product databases • Standard used by Hospital, Radiology, & Lab Information Systems • DICOM • Used to exchange objects and to integrate with Information Systems • Standard used by acquisition modalities, PACS

5. Typical Standards Overview Training Summary: “DICOM is the standard for medical imaging.” The details:Read these 4,000 pages. Today: Let’s learn about standards differently …

6. Lack of HIT Standards • Inhibits Interoperability • Costs More • Slows Adoption of new technologies • Introduces Medical errors and Patient Risk • Proprietary interfaces mean vendor lock-in and an inflexible environment for any changes • Less effective and efficient

7. Nightmares • Disaster response and recovery • Human and Software Errors leading to patients safety in jeopardy • Improper disclosure of patient health information • Cost Overruns • …

8. HIT Standards • Patient Safety • Interoperability • Rapid Deployment of integrated systems • Reduced cost of integrating devices • Data Recovery • Security/Privacy • Streamlining Patient Care

9. Roles of VistA Imaging Technical Strategy Support/Assistance • Honest Broker/ Facilitator • Develop/Integrate

10. Interoperability –exchange data accurately, securely and consistently between HIT systems HIT systems shall use interoperability standards in contracting Executive Order on Interoperability

11. Clinical Endorsements of Interoperability • The Anesthesia Patient Safety Foundation and The Board of Directors of the American Society of Anesthesiologists endorsed the following statement of support for interoperability:“…that intercommunication and interoperability of electronic medical devices leads to important advances in patient safety and patient care, and that the standards and protocols to allow such seamless intercommunication should be developed fully with these advances in mind.”  • “…interoperability poses safety and medico legal challenges as well.  The development of standards and production should achieve maximum patient safety, efficiency, and outcome benefit.” • Reference: MDPnP Getting Connected for Safety, • http://mdpnp.org/Endorsements_of_Interop.html February 2008:

12. FDA CDRH – oversees the manufacturing performance and safety of devices Class II devices require a ‘510K’ Pre-market Notification The risk analysis Reliance on standards - a declaration of conformity Conformance testing Devices rely on standards

13. HIT systems are unified through a shared VistA EMR All providers have access to complete, up-to-date patient information Patient Centric Database Technology Infrastructure What Interoperability provides Diagnostic Labs Pharmacies Hospitals Patients Radiology Physicians & Staff

14. VistAIntegrated Multimedia EMR

15. The Challenge of Interoperability • Unwillingness of healthcare providers • Psychological and cultural issues • Resistance to change Lack of enterprise vision, Loss of control, Perceived risk • Unwillingness of vendors • Proprietary systems and formats • Loss of competitive advantage • Technical obstacles

16. Imaging Beyond Radiology • The medical enterprise has significant imaging volume beyond radiology • PACS has a proven ROI • Moving the vision of radiology PACS to other clinical departments will: • Improve the effectiveness of your clinical team with a single point of image display • Improve patient care with a more integrated record • Improve the speed of clinical care

17. Evolution of Imaging Single modality applications Radiology-wide applications Interfaced radiology information systems and medical imaging management – RIS/PACS Fully integrated enterprise imaging and workflow solutions

18. Compute intensive reconstruction & analysis Standards-based interoperability Integrated IT architecture Content management & Multi-site image sharing Petabytes of images to be stored and managed for decades Evolution of Medical Imaging Over the next 10 years, storage, computing, and data integration needs willgrow exponentially driven by Medical Imaging.

19. 2008 - 2009 VA/DoD Importer VA/DoD Image Sharing TeleDermatology 2007 TeleReader & IHS Using VI 2006 VistARad Redesign 2005 Remote Image Views 2003 Index Terms 2002 VistA Imaging 3.0 Mandate 2002 Document Scanning 2001 VistA Imaging 2.5 FDA Clearance 1998 Gigabit Ethernet 1998 CPRS GUI 1997 VistA Imaging 2.0 1997 VistARad 1996 VistA Imaging GUI 1995 DICOM Development 1993 1st VistA Imaging PACS Interface 1990 VistA Imaging Operational at Washington DC 1988-90 VistAImagingPrototype for VA 1980’s Personal Computers 1990’s MS Windows – TCP/IP 1980’s Decentralized Hospital Computer Program VistA Imaging Timeline1988 - 2009

20. Where Are We Going? • Respiratory Imaging, Bronchscopy • Gastrointestinal Imaging, Endoscopy • Intra-Operative Imaging, Laproscopy • Orthopedic Imaging, Arthoscopy • Imaging of the eye, Opthalmology • Ear / Nose / Throat, Otolaryngology • Microscope Imaging, Pathology

21. Imaging Enhances an Interdisciplinary Approach • PTSD is strongly associated with mild traumatic brain injury (i.e., concussion), NEJM, January 2008, Vol. 358, No. 5 and The war within : Neurobiological alterations in posttraumatic stress disorder utilized neuroimaging (including PET, MR) accessed May 2008 • Active prevention in diabetic eye disease (visual impairment in diabetics can be prevented with active regular screening) National Library of Medicine www.ncbi.nlm.nih.gov accessed May 2008 • Dental images can detect potentially dangerous calcium deposits in the carotid arteries (associated with strokes and heart attacks) www.sciencedaily.com accessed May 2008

22. More Data Over the Last 3 Years Than Previous 42,000 years Combined 40,000 BCEcave paintings bone tools P e t a b y t e s 3500writing 0 C.E. paper 105 1450printing 1870 electricity, telephone transistor 1947 computing 1950 Late 1960s Internet 1990 The Web 2000 2005 Source: UC Berkeley, School of Information Management and Systems.

23. As of May 2008, 808 million images have been captured, stored and available online using VistA Imaging Software. FY 2004 – 72 million new images. FY 2005 – 104 million new images. FY 2006 – 155 million new images. FY 2007 – 183 million new images. Cumulative Images Captured 2003 – 2008 Over 20K new images captured each hour

24. VistA Saves Money • The cost per patient has remained low and stayed steady for the VA • Compare with Medicare and the medical consumer price index have remained high and are increasing. • GRAPHIC SOURCE: The Washington Post, April 10, 2007

25. The major design feature of what is arguably the world's most advanced transportation system was determined over two thousand years ago by the width of a horse! The Space Shuttle engineers who designed the Solid Rocket Boosters was shipped by train from the factory to the launch site Standards last a long time

26. The US standard railroad width derives via Europe standard This is traced back to original specification of the Imperial Roman war chariot Standards last a long time

27. Technology Lifetime Standards (DICOM, HL7, IHE, SNIA…) 25- 50 years Infrastructure (IP, SAN,…) 10- 20 years Programming Languages (PL/1, Pascal, C, C++, Java, …) 5-10 years Software (data formats, compatibility, …)2-5 years Hardware (Network cards, video cards, processors, …) 1-2 years Shapiro, IBM

28. Volume, Value and Velocity Volume of Data Reference data is growing exponentially and is being stored for long periods of time. Value of Information Image data is actively referenced, and must be stored and protected for life to meet clinical and regulatory requirements. Velocity of Change Address the demands for increased storage and higher performance.

29. Consistent Integration • VistA was awarded with both an Innovations in Government Award and a IHE User Success Story • One interface for over 400 different models of instruments! • Consistency & Interoperability throughout the US

30. Patient Safety: Current Statistics • One in five Americans (22%) report that they or a family member have experienced a medical error of some kind. • Nationally, this translates into an estimated 22.8 million people with at least one family member who experienced a mistake in a doctor's office or hospital. Reference - http://www.patientsafetyfocus.com/ accessed May 2008

31. Deaths and costs continue to rise. In their fifth annual Patient Safety in American Hospitals Study, Health Grades Inc., cites that errors in treatment resulted in 238,337 potentially preventable deaths of Medicare patients in the US, costing $8.8 billion. • HealthGrades Inc. analyzed over 41 million patient records for the study and found that approximately 3 percent of all Medicare patients suffered from some medical error-- which equates to about 1.1 million Patient Safety Incidents (PSIs) from 2004-2006. In the report, Health Grades describes medical errors as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim…[including] problems in practice, products, procedures, and systems." • There were 270,491 actual in hospital deaths that occurred among patients who developed one or more of 16 PSIs and the report states, "Using previous research, we calculated that 238,337 were attributable to patient safety incidents and potentially preventable."

32. “Issues arising from badly designed and poorly integrated HIT systems harm or kill more patients every year than do medications and medical devices yet there is absolutely no control or regulation over them” Quote Reference: Duke University Health System CIO Asif Ahmad Computerworld, April 28, 2008

33. US Population Dose Ref: Dr. S. Balter, Columbia University, Radiation Dose Data Management, February 2008

34. FDA CDRH case study of radiation therapy overexposure resulting in death Contributing factors include lack of clinic verification, no method for entering data into software, interpretation of data by the software Vendors now have proprietary solutions Radiation Overexposure • Reference: FDA Safety Assurance Case Workshop, February 21, 2008

35. Getting Connected for Patient Safety • “Many improvements in patient safety and healthcare efficiency require systems solutions that cannot be implemented due to the lack of interoperability” • Safe device #1 + Safe device #2 = Unsafe system • Reference: FDA Safety Assurance Case Workshop, February 21, 2008

36. Ready for a Disaster?

37. Katrina comes through the window

38. 5.4 M images were recovered after Hurricane Katrina, New Orleans in 2006 13.08 M images were recovered in Tennessee, after a computer room flood in 2008 Data Recovery

39. Gulfport Before and After

40. The Selling of Sensitive Patient Data Reference, The Los Angeles Times, California Board of Health Report, May 13, 2008, accessed online http://www.latimes.com/news/

41. Reference, The Los Angeles Times, California Department of Health Services, May 13, 2008, accessed online http://www.latimes.com/news/

42. Old School Reference: Journal of Digital Imaging, Siegel and Reiner, 2003

43. Law & Order Analogy

44. Why Healthcare IT Standards? • HIT Standards last much longer than hardware and software systems • Standards based solutions provide a higher level of effectiveness and efficiencies • Medical Errors contribute to more than 100K US deaths/yr • Interoperability and proprietary are often mutually exclusive • HIT Standards based solutions provide lower costs, more flexibility and enable better patient care