321 VI Using Standards

Andrew CasertanoVistA Imaging

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DisclaimerDisclaimer

• 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?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 DICOMHL7 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 OverviewTypical 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 StandardsLack 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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NightmaresNightmares

• 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 StandardsHIT 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 ImagingRoles of VistA Imaging

• Technical Strategy

• Support/Assistance

• Honest Broker/ Facilitator

• Develop/Integrate

1: Pt registration 12: Pt Update

1: Pt registration 12: Pt Update

Pt registration: 1 Pt Update: 12 2: Placer Order Management

3: Filler Order Management

ADT Master Patient Index

4: Procedure Scheduled 12: Patient Update 13: Procedure Update

Image Manager

Image Archive

Order Placer Order Filler

1: Pt registration 12: Pt Update

1: Pt registration 12: Pt Update

Pt registration: 1 Pt Update: 12 2: Placer Order Management

3: Filler Order Management

ADT Master Patient Index

4: Procedure Scheduled 12: Patient Update 13: Procedure Update

Image Manager

Image Archive

Order Placer Order Filler

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Executive Order on Interoperability Executive Order on Interoperability

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

• HIT systems shall use interoperability standards in contracting

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Clinical Endorsements of Interoperability 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:

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Devices rely on standardsDevices rely on standards

• 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

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What Interoperability provides What Interoperability provides

• HIT systems are unified through a shared VistA EMR

• All providers have access to complete, up-to-date patient information

Physicians Physicians

& Staff& Staff

HospitalsHospitals

PharmaciesPharmaciesDiagnostic Diagnostic

LabsLabs

PatientsPatients

RadiologyRadiology

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VistA Integrated Multimedia EMRVistA Integrated Multimedia EMR

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The Challenge of InteroperabilityThe 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

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Imaging Beyond RadiologyImaging 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

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Evolution of ImagingEvolution 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

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Evolution of Medical ImagingEvolution of Medical Imaging

Over the next 10 years, storage, computing, and data integration needs willgrow exponentially driven by Medical Imaging.

Petabytes of images tobe stored and managed for decades

Petabytes of images tobe stored and managed for decades

Content management &Multi-site image sharing Content management &Multi-site image sharing

Compute intensive reconstruction & analysis

Compute intensive reconstruction & analysis

Integrated IT architectureIntegrated IT architecture

Standards-based interoperabilityStandards-based interoperability

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VistA Imaging Timeline1988 - 2009

VistA Imaging Timeline1988 - 2009

2008 - 2009 VA/DoD ImporterVA/DoD Image Sharing

TeleDermatology

1997 VistARad

1995 DICOM Development

1993 1st VistA Imaging PACS Interface1990 VistA Imaging Operational at Washington DC

1980’s Personal Computers 1990’s MS Windows – TCP/IP

2007 TeleReader & IHS Using VI

1998 Gigabit Ethernet

1988-90 VistA Imaging Prototype for VA

1997 VistA Imaging 2.0

2001 VistA Imaging 2.5 FDA Clearance

2002 Document Scanning

2002 VistA Imaging 3.0 Mandate

2003 Index Terms

2005 Remote Image Views

1996 VistA Imaging GUI

2006 VistARad Redesign

1980’s Decentralized Hospital Computer Program

1998 CPRS GUI

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Where Are We Going?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

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Imaging Enhances an Interdisciplinary ApproachImaging 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

22Source: UC Berkeley, School of Information Management and Systems.

0 C.E.

2005

40,000 BCEcave paintings

bone tools 3500writing

paper 1051450

printing1870

electricity, telephone transistor 1947computing 1950

1990The Web

2000

Late 1960sInternet

P e

t a b

y t e s

More Data Over the Last 3 Years Than Previous 42,000 years Combined

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Cumulative Images Captured 2003 – 2008 Cumulative Images Captured 2003 – 2008

Over 20K new images captured each hour

• 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.

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VistA Saves MoneyVistA 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

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Standards last a long timeStandards last a long time• 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

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Standards last a long timeStandards last a long time

• The US standard railroad width derives via Europe standard

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

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Technology Lifetime 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

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Volume, Value and VelocityVolume, Value and Velocity

Volume of DataReference data is growing exponentially and is being stored for long periods of time.

Value of InformationImage data is actively referenced, and must be stored and protected for life to meet clinical and regulatory requirements.

Velocity of ChangeAddress the demands for increased storage and higher performance.

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Consistent Integration 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

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Patient Safety: Current Statistics 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

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• 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."

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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 US Population Dose

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

Radon Medical Internal Cosmic Terrestrial Other

Source

mS

v / y

ear

1987 - 3.62003 - 6.3

CT 1.45Nuclear 0.70Rad. & Fluoro 0.60 Interventional 0.40Other 0.02

07 NCRP PRELIMINARY

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

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Radiation OverexposureRadiation Overexposure

• 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

•Reference: FDA Safety Assurance Case Workshop, February 21, 2008

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Getting Connected for Patient SafetyGetting 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

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Ready for a Disaster?Ready for a Disaster?

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Katrina comes through the windowKatrina comes through the window

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Data RecoveryData Recovery

• 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

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Gulfport Before and AfterGulfport Before and After

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The Selling of Sensitive Patient DataThe 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/

41Reference, The Los Angeles Times, California Department of Health Services,

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

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Old SchoolOld School

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

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Law & Order AnalogyLaw & Order Analogy

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Why Healthcare IT Standards?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