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321 VI Using Standards Andrew Casertano VistA Imaging Disclaimer This summarizes work of the Veterans Health Administration, Office of Information (VHA OI). It may amplify elements of private sector activities or products.

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321 vi using standards l.jpg

321 VI Using Standards

Andrew Casertano

VistA Imaging


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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.


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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


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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


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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 …


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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


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Nightmares

  • Disaster response and recovery

  • Human and Software Errors leading to patients safety in jeopardy

  • Improper disclosure of patient health information

  • Cost Overruns


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HIT Standards

  • Patient Safety

  • Interoperability

  • Rapid Deployment of integrated systems

  • Reduced cost of integrating devices

  • Data Recovery

  • Security/Privacy

  • Streamlining Patient Care


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Roles of VistA Imaging

Technical Strategy

Support/Assistance

  • Honest Broker/ Facilitator

  • Develop/Integrate


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Interoperability –exchange data accurately, securely and consistently between HIT systems

HIT systems shall use interoperability standards in contracting

Executive Order on Interoperability


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Clinical Endorsements of Interoperability consistently between HIT systems

  • 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:


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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


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HIT systems are unified through a shared VistA EMR safety of devices

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


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VistA safety of devices Integrated Multimedia EMR


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The Challenge of Interoperability safety of devices

  • 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


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Imaging Beyond Radiology safety of devices

  • 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


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Evolution of Imaging safety of devices

Single modality applications

Radiology-wide applications

Interfaced radiology information systems and medical imaging management – RIS/PACS

Fully integrated enterprise imaging and workflow solutions


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Compute intensive reconstruction & analysis safety of devices

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.


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2008 - 2009 VA/DoD Importer safety of devices

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


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Where Are We Going? safety of devices

  • 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


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Imaging Enhances an Interdisciplinary Approach safety of devices

  • 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


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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.


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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


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VistA Saves Money stored and available online using VistA Imaging Software.

  • 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


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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


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The US standard railroad width derives via Europe standard most advanced transportation system was determined over two thousand years ago by the width of a horse!

This is traced back to original specification of the Imperial Roman war chariot

Standards last a long time


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Technology Lifetime most advanced transportation system was determined over two thousand years ago by the width of a horse!

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


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Volume, Value and Velocity most advanced transportation system was determined over two thousand years ago by the width of a horse!

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.


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Consistent Integration most advanced transportation system was determined over two thousand years ago by the width of a horse!

  • 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


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Patient Safety: Current Statistics most advanced transportation system was determined over two thousand years ago by the width of a horse!

  • 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


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  • Deaths and costs continue to rise. most advanced transportation system was determined over two thousand years ago by the width of a horse! 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."


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“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


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US Population Dose HIT systems

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


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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


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Getting Connected for Patient Safety resulting in death

  • “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


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Ready for a Disaster? resulting in death



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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


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Gulfport Before and After Orleans in 2006


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The Selling of Sensitive Patient Data Orleans in 2006

Reference, The Los Angeles Times, California Board of Health Report,

May 13, 2008, accessed online http://www.latimes.com/news/


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Reference, The Los Angeles Times, California Department of Health Services,

May 13, 2008, accessed online http://www.latimes.com/news/


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Old School Health Services,

Reference: Journal of Digital Imaging, Siegel and Reiner, 2003


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Law & Order Analogy Health Services,


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Why Healthcare IT Standards? Health Services,

  • 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


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