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The Web Enabled Laboratory Information System (LIS) The Future of Your Lab Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI [email protected] J. Mark Tuthill MD Department of Pathology Henry Ford Health System Detroit, MI [email protected] © College of American Pathologists 2004. Materials are used with the permission of the faculty.

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Page 1: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

The Web Enabled Laboratory Information System (LIS)

The Future of Your Lab

Bruce A. Friedman MDDepartment of Pathology

University of Michigan Medical SchoolAnn Arbor, MI

[email protected]

J. Mark Tuthill MDDepartment of PathologyHenry Ford Health System

Detroit, [email protected]

© College of American Pathologists 2004. Materials are used with the permission of the faculty.

Page 2: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Association for Pathology Informatics (API)www.pathologyinformatics.org

…to advance the field of pathology informatics as an academic and a clinical subspecialty of pathology.

Page 3: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

CAPF/API/McKesson Award

Page 4: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Disclosures

Bruce A. Friedman M.D.Pathology Education Consortium (PEC)Consultant in Medical Education Technology (CIMIT)Health Map Laboratories

J. Mark Tuthill, M.D.Trestle Holdings Inc.

Page 5: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Agenda

Total Time 90 Minutes:Introduction and objectives-5 minutesQuestions following each segment during speaker changes-total 10 minutesTopic areas-75 minutes

Page 6: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Agenda

Introduction-TuthillThe classic LIS, the Internet and the Evolution of the Web Enabled Laboratory

TuthillTransforming the Classic LIS to a Web Enabled LIS

FriedmanTechnologic Forces Driving Laboratory Information Systems

TuthillImplications of the Web Enabled Laboratory on the Field/Practice of Pathology

FriedmanSummation-Friedman

Page 7: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

This session will examine the impact of Internet technology on the LIS and clinical laboratory industry.

From the modern stand alone World Wide Web based LIS to Internet enabling your current LIS, this technology will impact your laboratory in a many ways. Internet enabled LIS (laboratory portal) will provide critical support for current lab reporting processes and are nearly required to support point of care testing (POCT), home health, direct access testing, clinical consulting and laboratory outreach programs.

The presenters will discuss this and explain this technology and its impact as well as the resource requirements and first steps to begin developing a program in your institution

Page 8: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Objectives

1. Understand the historical origins of the modern LIS, the impact of Internet technology on LIS and why this is a critical opportunity for laboratory services

2. Define laboratory portal (vs. web site) and the technical and human resources required to implement and maintain one

3. Recognize the relationship of LIS and Internet technology to patient care and business strategies of your organization. e.g. the role of LIS technology in a POCT program

4. Discuss the impact of web enabled LIS on laboratory staff, customers, and patients.

5. Describe the cost, investment return and financial impacts and opportunities of web enabled LIS versus traditional LIS

Page 9: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

The Classic LIS, the Internet and the Evolution of the Web Enabled Laboratory

J. Mark Tuthill, M.D.Department of PathologyHenry Ford Health System

Detroit, MI [email protected]

Page 10: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Laboratory Information System (LIS)

Overview

Page 11: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

The Laboratory Information SystemHistorical Perspective

One of the first hospital information systemsFirst system dedicated to patient care activity

Has evolved from lab application to clinical service tool

Clinicians want the dataComplexity continues to increase

Page 12: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Information Technology in the Diagnostic Laboratory

Lab has long been hostage to need for information management systems

Laboratory Information Systems (LIS) systems are advanced, but often antique“Legacy systems” (corporations) in place

Architectural monumentsbig business: change represents a complex set of problems

Many LIS were MD developed, “cottage applications”

practical not portableNo Standards

Page 13: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

The Laboratory Information SystemComplexities of LIS Data Management

Interfaces-connections to other devicesInternal-instruments, specimen management systems, automation systemsExternal-ADT, Billing, Clinical systems, Reference Laboratory

Multiples disparate discipline are encompassed in Pathology and Laboratory Medicine

Differing Data management needs

E.g. Microbiology versus clinical chemistry versus anatomic pathology

Lots of data, many transactions

Page 14: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

The Laboratory Information SystemEvolution

LIS have grown from single systems with multiple functions to multiple integrated systems with overlapping functions

BB LIS, AP- LIS, Transplant LIS, Tissue LIS, CP LIS Confusion and management complexity increase

Network component for LIS, inherent from the start has grown to an integrated, often un-discussed de facto requirement requirement

TCP/IP Internet communication standard very common networking protocol for LIS

Client server technology becoming ubiquitous versus terminalInternet based systems obvious conclusion of Client Server application model plus TCP/IP networking

Page 15: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Driving Forces for the “New” LIS

Huge volume of data generatedestimates from 75-90% of patient data depending on type of hospital

IT in the Medical EnvironmentFree standing legacy systems in place

HIS: hospital information systemsBusiness systemsAdmission, Discharge, Transfer systemsLIS: laboratory information systemsRIS: radiology information systems

Very heterogeneous, complex environment!

Page 16: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Laboratory Information Systems (LIS)

LIS have been Clinical Pathology orientedAP and CP have different needs

however, need for integration is paramountTypically just large database of values, financial information, and demographics (CP orientation)May have no advanced features

Often, no graphingFew clinically relevant applications implemented widely

Designed for paper based reporting, modern integrated approaches only now coming on line

Page 17: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Anatomic Pathology LISPresent

Has often only consisted of word processing documents saved in a files system

poor accessibility of past resultspoorly integrated as overlay into CP systems

No integration of images into systemLittle effort to control specimens or slides, key components of AP laboratory management

Page 18: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

LIS Ideals

Client-serverAdvanced network communicationsTrackingAdvanced business computingInstrument interfacesAdvanced automation support

Page 19: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Fast, reliable, accurateFlexibleSimple to use

simple to searchMinimal setup and support requiredNon-proprietary

uses standard hardware available anywhereAccessible anywhere by anyone, anytime (networked)Controlled access for sensitive information (secure)

LIS Ideals

Page 20: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

LIS Ideals

Clinically relevant applications:clinical pathways

testing algorithmssmart testing

inter-system integration (pharmacy, molecular)result charting (graphing)patient trackingutilization, and outcomes analysis

Page 21: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

LIS Future

Images will be readily be incorporated into reportingCP and AP systems with electronic patient record

integration with other legacy systems such as pharmacy and radiology

The end of paper reporting?These tools must not only work within the LIS but also on the hospital information system (HIS)

Page 22: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

LIS Future Distributed Laboratory Services

Laboratories are no longer stand alone entitiesCentral Laboratories will support multiple hospitals, and need to do so without loss of quality and contactInformation distribution is key to laboratories success and very survival

New paradigm for LISLab PortalHIS Portal (Enterprise Portal)

Page 23: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

The New Hospital Information System (HIS)

Integrated Applicationspathology, radiology, pharmacy, billing, ADT, recordsIntegration of multiple vendors

High speed networkClinical Data Repository (CDR), or warehouse (CDW)Distributed imaging and patient data

multimedia (electronic) medical recordThe architecture

“Monolithic” vs. “patchwork quilt”Enter the Internet: the glue that connects disparate systems

Page 24: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

The Internet

Page 25: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

The Internet: What is it anyway?

An “inter-network” of many networksrunning TCP/IP protocols

Transmission Control Protocol/Internet Protocol

connected through gateways (network routers)sharing a common name and addressing system

Provides unique serviceslike but unlike

post officestelephoneslibraries

Page 26: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Internet Components

Hardware and Software OverviewTCP/IP Network connected to The InternetServers and Server softwarePC and Application software

Web browser: Netscape, Internet ExplorerTelnet: terminal services (LIS uses this!)FTP: file transferE-mail readingUsenet, newsgroups

Many LIS and HIS already use TCP/IP network communication standards, thus are internet capable

Page 27: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

InternetImplications for Medicine

Internet provides the common network interface to multiple data repositories

access to clinical data warehouseBrowser technology can provide a single interface on the computer desktop for data and application access.

$$ financial, training and resource implications $$

Page 28: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Internet provides a secure network interface to all data streams

efficient retrieval of archive informationclinical pathways integrationall databases may be connected and browsed

Allows desk top accessibility to high quality images and multimedia

distance medicine, medical education

InternetImplications for Medicine

Page 29: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Catalyst for integrated electronic medical record (EMR)

Network infrastructure in place for distributed medical computingall patient encounters can become part of the database and thus part of the outcomes analysis at a fraction of the present costHealth information systems can communicate (function) across multiple institutions using TCP/IP

“Lab online”

InternetImplications for Medicine

Page 30: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

InternetImpact on Pathology

Internet technology and methodologies provides tool set for actualizing many of these goals

intranet vs. internet vs. extranetBrowser technology, and client-server computing will be general structure of LNIS and HIS systems of the futureEases integration of back end (legacy) systems from multiple institutions to and from the laboratory

Page 31: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

The Internet

Basic Definitions

Web site vs. Portal

Page 32: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

What is a web site?

World Wide Web site: An organized collection of documents (web pages, static content) Created in hypertext markup language (HTML) and posted on a web server with a defined uniform resource locator (URL=web site address)Indexes and content pages are “hyper linked”allowing the site to be browsedContent can range from marketing information to detailed processes, procedures

Web links can also point to and run applications but…

Page 33: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

What is a portal?

Information Portal or “Enterprise Information Portal” “EIP”Not just a web site, but access to applications

Often access to legacy applications data used across an enterprise“Web site on steroids”

Integrates across various facets of an enterpriseLinks between many organization web’sWeb links on a portal integrate multiple applications to a single port of entry or “Portal”

Custom tailored to a userAmazon.com, eBay

Vertical versus horizontal portals, B2B portals

Page 34: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

What do I mean by a laboratory portal?

Web browser access to laboratory applications and data Secure

Authenticated, HIPAA compliantSystem level authentication based on user groups

IntegratedOverlapping, yet singular and unique points of entry to multiple resources

Personalized

SearchableInternet browser based connectivity

Thin client, thick client

Page 35: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Laboratory Portals

Support regionally networked laboratoriesImage, video conference capableIntegrate multiple hospitalsIntegrate multiple “back end” LIS systemsCommon Interface

browser and internet technologyinterface to back end systems

Common Patient identifiers

Page 36: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

What technology is involved?Website

InfrastructureWeb serverNetwork bandwidth

SoftwareHTML editorServer software

Human resourcesWeb master, minimum to moderate information technology skillsContent providersGraphic artist

Page 37: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

What technology is involved?Portal

InfrastructureMultiple serversIncreased network bandwidth

SoftwareHTML and server softwareProgramming tools for application development

Enterprise applications on lineHuman Resources

Development team: application programmer, web master, content managers, editors, graphic artist3rd party vendors: LIS vendor, portal vendorHospital IT

Page 38: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Key Point

These terms represent a continuum in the evolution of the primordial web site…

What distinguishes a web site from a portal?

Breadth of contentApplication functionalityResources and support requiredFinancial, technical investmentNumber of institutions involved

Page 39: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Startup Costs

Website (pages)Portal (applications)

$10K to $100K$100K to $1M

These costs typically include: hardware, software, licenses, as well as personnel and art work. Not included is institutional overhead, network costs etc.

Recurring cost include salaries, licenses, and upgrades

Page 40: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Develop Intranet/Internet Content for websites

Develop Intranet/Internet ApplicationsIntegrate Intranet/Internet Applications, Content

Portal

Evolution of a Portal

DevelopTeam

DevelopTools

Pilot Applications/Maintain content

Website Portal

Integrated Portal

Maintain Portal

Links to legacy applications

Page 41: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Pathology User

Hfhs.edu

Henryford.com(Internet)

Henry.hfhs(Intranet)

LaboratoryDatabases

SystemDatabases

AP CP Mol Img$$$

Careplus

ADT Rx

Rad

Rul

Internet Resources

Page 42: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Pathology User

Hfhs.edu

Henryford.com(Internet)

Henry.hfhs(Intranet)

LaboratoryDatabases

SystemDatabases

AP CP Mol Img$$$

Careplus

ADT Rx

Rad

Rul

Internet Resources

Page 43: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Pathology Portal

Hfhs.edu

Henryford.com(Internet)

Henry.hfhs(Intranet)

LaboratoryDatabases

SystemDatabases

AP CP Mol Img$$$

Careplus

ADT Rx

Rad

Rul

Internet Resources

Page 44: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Lab Portal

Hfhs.edu

Henryford.com(Internet)

Henry.hfhs(Intranet)

VPN(Extranet)

Metaframe(Extranet)

LaboratoryDatabases

SystemDatabases

AP CP Mol Img$$$

Careplus

ADT Rx

Rad

Rul

Internet Resources

Page 45: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

NetworkHub

HospitalSystems

CP System(Misys)

AP System

(CoPath)

WebServer

ApplicationServer

Multi-Tier Architecture

Pathology Data

Stores

Tier 1-Browser

Tier 2 Tier 3

Tier 4

Operational SystemsProvidersAnd staff

Lab Portal

Page 46: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

ProvidersAnd staff

Clinical LabSystems

AnatomicPathology Systems

ClinicalDatabase

LabPortal Interface

EngineSystem

Hospitals

Hospitals Reference LabPathology

Pathology Databases

Payors

Research &Education

Molecularsystems

Core Lab Systems Hospital Systems Other Systems

Page 47: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Possible Applications

Department directory Ο, �

Division pagesIndividual pages Virtual tour of laboratoryPersonnel directory

Test directory �Interactive testingTest consultant, virtual Pathology case referral and consultations Lab test referral services

On line order entry �On line result reporting �

Tissue sample database �Clinical studies/trials �Imaging applications Ο,�

E MAutopsySurgical pathologyImage databaseTelepathology

Molecular analysis and storage system Ο,�Reference Laboratory interface �

Ο=website �= portal

Page 48: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Possible Applications

Site search ΟScheduling �Publications Ο

NewslettersTest updatesCommuniqués

On line database �interactionManuals Ο

ProceduresResident on call guide

Physician finder �

Financial data �Account statusCustomer profilePrice listsUtilization dataCompliance data

Lab report card ΟSupplies and inventory �Data logs �Result interfaces for POCT �

Ο=website �= portal

Page 49: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Possible Applications

Education content Ο, �

StaffStudentsClinical providers

Program application ΟLinks to other sites ΟCompetency assessment and tracking �

Educational conference schedule ΟDepartment events Ο

Ο=website �= portal

Page 50: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

References

http://www.pathologyinformatics.orghttp://www.portalscommunity.comhttp://www.traffick.comThe Internet and Healthcare, Louis Nicholson ed, 2nd

edition, Health Administration Press, 1999.Information Architecture for the World Wide Web, Louis Rosenfeld and Peter Morville, 1st edition, O’Reilly & Associates, 1998.Where Wizards Stay Up Late: the origins of the Internet, Katie Hafner and Matthew Lyon, Touchstone, 1996.Managing Healthcare Information Systems with Web-Enabled Technologies, Lauren Eder, Idea Group publishing, 2000.

Page 51: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Transforming the Classic LIS to the Web-Enabled

Virtual LIS

Bruce A. Friedman, MDDepartment of Pathology

University of Michigan Medical SchoolAnn Arbor, MI

[email protected]

Page 52: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Outline Transforming the Classic LIS to the Web-Enabled Virtual LIS

Describe the centralized lab model and show how it has been well-served by the classic LIS (C-LIS) but is now out of date

Discuss new decentralized testing venues that will supplant a portion of central hospital-based lab testing

Describe emergence of virtual LIS (V-LIS) as substitute for central LIS (C-LIS); show how V-LIS=C-LIS + SLAMs

Discuss dis-integration of lab databases as hospital testing becomes less important; special challenge of MD office testing

Explain how the e-lab is complimented by the virtual LIS and these two models will define future of lab computing

Page 53: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Describe centralized lab model; show

how it was well served by classic LIS but is now

out of date

Page 54: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Centralized Lab Model Has Dominated Clinical Lab Operations

Centralized lab model has dominated hospital labs in this era of modern medicine; specimens transported to “lab factories”

Lab “factories” with assembly-line processes spawned need for increasingly sophisticated high-throughput analyzers

Wholesale business with large volume of raw data reported to customers (MDs) who then finish (i.e., interpret) the product

Infrastructure (blood drawing centers, large equipped/staffed labs, LISs) is expensive, discouraging new entrants in market

Hospital labs & [later] large reference labs enjoyed relative monopoly sustained by high test volume & low cost-per-test

Page 55: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Classic LIS Has Served Lab Professionals Well for Three Decades

LISs specifically designed to manage information in hospital environment & based on hospital work flows/processes

For past few decades, total IT purchase by hospital lab directors was simple – buy a classic LIS suitable for lab size

Best-of-breed argument held sway: labs need to continue to optimize LIS/instrument functionality to lower cost-per-test

Fortunately, specialized vendors persisted in market and new entrants continued to offer range of new C-LIS products

C-LISs continued to serve labs well until new testing venues evolved (e.g., POCT, MD offices) that didn’t fit biz model well

Page 56: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Reasons for the Weakening of the Centralized Lab Model

Healthcare, in general, becoming less centralized & removed from hospitals to reduce costs & increase patient convenience

Clinicians and nurses demanding faster TAT and greater control over testing process; little concern about cost-per-test

IVD manufacturers marketing POCT devices directly to clinical units; emphasizing benefits for their workflow and efficiency

New POCT data management and communication standards facilitated order & result integration into LIS/CDR databases

Lab trump cards re: size of budget such as lab efficiency, data integration, & quality issues do not resonate with clinicians

Page 57: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Discuss new decentralized testing venues

that will supplant some central hospital lab

testing

Page 58: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Decentralized Venues That Will Comprise Major Components of Lab Testing

All forms of POCT (critical care & bedside) with rapid TAT requirements

Testing in skilled nursing & chronic care facilities as emerging venues for POCT

Home kits & instruments (e.g., glucometers, cholesterol, pregnancy, HIV)

Home-testing associated with chronic and post-operative care (see next slide)

Direct access testing (e.g., web-mediated, paid for by customers out-of-pocket)

Sophisticated genomic testing offered by biotechs/reference labs to retail testing market

Page 59: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Home Health/Home Testing Matures as Logical Extension of IDN Lab Services

Home health, supported by home lab testing, will be next lab frontier; logical extension of POCT as care migrates to home

Cascade effect to reduce healthcare costs; less sick patients migrate from ICU general care units outpatient units home

Home care workers will draw blood from patients and [soon] perform tests in-home using portable analyzers with broad menu

Such instruments will upload data to nurses/MDs for near real-time monitoring and to hospital databases/ PHRs via the web

Aggressive IDNs will pursue home health/lab as logical extension of other health services to shave costs & retain customer loyalty

Page 60: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

New Definition of “Clinical Lab” Prompted by Growth of Decentralized Testing

A “clinical lab” consists of one or more instruments using biologic specimens to create new information characterizing the sample

A glucometer operated by a diabetic patient in his bedroom is a clinical lab; so is the largest reference lab in the country

Irrelevancies under new definition: size of lab, volume of testing, training of the instrument operator, & IT support

Any new information generated on a patient has some intrinsic value so should be captured, stored, integrated in lab database

From IT perspective, the key issue will be how to capture all relevant lab information and not just hospital-generated lab data

Page 61: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Reimbursement Implications Given This New Definition of Clinical Lab

Everyone will rapidly grasp that this broad definition of a clinical lab has broad reimbursement implications

Current reimbursement model pays for direct service to the patient; procedures always reimbursed at higher rate

Definition implies that background lab info. management services (capture, quality, integration) also reimbursable

Payors strive continuously to decrease & limit rather than increase definition of reimbursable services to physicians

Penny-wise, pound-foolish NOT to reimburse data management services because makes all care more efficient

Page 62: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Pathology Informatics & Decentralized Testing: A Congenial Match

Weakening of centralized lab model has served to weaken centralized LIS model which provided an integrated database

Pathology informaticians need to develop a global strategy for presenting coherent& rational view of data downstream

Need shift of raison d’etre of central lab from primarily data creation to data creation + data integration & management

Hopefully, hospital lab will remain as a central hub through which data streams from many sources will converge/integrate

Biggest challenges will be recruiting sufficient talented personnel & making case for reimbursement for data management efforts

Page 63: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Describe emergence of

virtual LIS (V-LIS) as substitute for

central LIS (C-LIS) and SLAMs

Page 64: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

The Virtual LIS (V-LIS) as a Substitute for the Classic LIS (C-LIS)

Classic LIS (C-LIS) will persist despite limitations but some key functionalities will migrate to “supplemental modules”

We call them SLAMs (supplemental lab application modules); key examples are lab portals and “middleware”

Lab portals are web-based systems initially deployed by reference labs to easily provide OE/RR to physician offices

“Middleware” is software running between instruments and C-LISs to add value to test results (e.g., rules, tags)

The C-LIS plus variety of new & emerging SLAMs called the virtual LIS (V-LIS) which is an integrated lab network

Page 65: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Introducing the Lab Portal: TheFirst ASP/Web Success Story

Lab portal software provides connectivity to lab customers, applications such as OE/RR, & information about tests

Utilizes internet to provide office connectivity; application isaccessed using a browser -- thick client (PC) also possible

Strategy driven by need for easy access in MD offices for outreach but equally good solution for hospital-based MDs

Lab portals example of traditional LIS functionality (e.g., OE/RR) moving to web; software can run also remotely as ASP

Software can be obtained from classic LIS vendors as part of their software suite but also from specialized lab portal vendors

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The Special Case of Middleware; Definition, Function, and Integration

Roche has pioneered the concept of Middleware Solutions®; software located between analyzer & LIS

Roche outsourcing software development to Data Innovations; Beckman Coulter uses Orchard’s Aqueduct middleware

Middleware market driven in part by goal of IVDs to add value to their products & compete successfully with competitors

Also driven by need of IVDs to add useful features (e.g., flags and rules) that some older LISs are unable to provide

Challenge from the lab IT perspective how to integrate “middleware” into the overall lab network dominated by C-LIS

Page 67: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Proliferation of SLAMS to Enhance Lab Efficiency & Productivity

Anatomic pathology LISs

Surgical pathology imaging

Autopsy databases & imaging

Servers supporting TLA

Home lab testing (e.g., glucometers)

Middleware developed and marketed by IVDs

Molecular diagnostics/ genomics/proteomics

Lab portals

Outreach laboratory logistics

Point-of-care testing (POCT)

Positive patient identification systems

Outreach logistics systems, including courier support

Quality control across multiple instruments

Direct access testing (DAT)

Page 68: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Discuss dis-integration of lab

databases; special challenge

of physician office testing

Page 69: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Dis-integration of Lab Data Repositories as Testing Migrates to New Venues

Consequences of POCT, home testing, & expanded office testing: hospital-based lab may lose control of lab data & lab franchise

Phenomenon has both quality & political implications because labpower & influence associated with role of lab data stewardship

Logical conclusion is for lab is to embrace testing decentralization when demanded by customers but emphasize data re-integration

Good business strategy because test performance more commoditized; data integration/management value-adding step

Integration of lab data important process for clinicians who desire one-stop data shopping; also platform for lab medicine consulting

Page 70: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Balancing Two Clinical Data Domains: Hospital CDRs and Office PMSs

Hospital labs with outreach programs & lab portals for office-based OE/RR getting requests from MDs for PMS integration

Lab professionals torn between challenges of enhancing and integrating lab data across hospital and MD office PMS/EMRs

PMS vendors often view products as office EMRs which can also accommodate lab, radiology, & retail pharmacy ordering

Hospital-based lab in unique position of being able to span gap and serve patients & MDs in both hospital/office setting

Integrating hospital & office-based lab testing admirable goal for continuity of care & opportunity to capture business

Page 71: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Explain how e-lab is complimented by virtual LIS and how two models will define future of lab computing

Page 72: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Converting the Hospital Laboratory to a Web-based E-Laboratory

Any e-business manages its transactions over internet & capitalizes on traditional IT + vast reach of the internet/web

Key element of an e-business is offering transactions on the web; most dynamic/interactive processes are placed online

As soon as a hospital offers web-based OE/RR (e.g., using a lab portal for outreach), it then qualifies as an e-laboratory

Moving to e-lab improves service, cuts costs, and increases test volume; the web is a lab’s window on the whole world

Lab portal provide web-enabled OE/RR, enabling lab to compete with large reference labs for outreach business

Page 73: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Business Rationale for Pursuing an E-Laboratory Strategy

Goal is to apply the benefits of internet/web to better manage organization's total value-chain with focus on efficient workflow

Web is most efficient, least expensive, and the most ubiquitous means for managing information on a national/global basis

Lab customers want to order tests, review results, store results from multiple geographic locations using multiple PC platforms

Web also offers advantages in terms of business-to-business information exchange such as with vendors and reference labs

Potential breaches in security & confidentiality, even in light of HIPAA, not a valid excuse for avoiding an e-lab strategy

Page 74: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

V-LIS Meets E-lab; How These Two Models Will Define Future of Lab Computing

V-LIS weans hospital lab from a pure centralized model and provides opportunity to selectively add SLAM functionality

Challenge will be integration of C-LIS with the newly purchased SLAMs without expense of customized interfaces

SLAM market will allow new companies to move into lab space and make more competitive than pure C-LIS model

E-lab model moves hospital labs to more competitive service-oriented, & even retail-oriented business model

Prime example has been lab portal products which allowed lab outreach program to compete with large reference labs

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Technology Driving the Next Generation of Laboratory

Information Systems

Page 76: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Technology and Medicine

Medicine has always evolved uses for technology to advantage patient diagnosis and treatment

Sometimes slowlySometime inefficientlySometimes incorrectly

Application and development driven by cultural beliefs and perspectivesIn the current age technology impacts medical practice at an increasing rate

Page 77: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Assumptions About Technology and Technology’s impact on Healthcare

Technology improves the human life experienceTechnology improves the overall quality of healthcareTechnology can decrease the cost of healthcare

Page 78: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Problems with Technology

Technology is expensiveTechnology can outstrip culture, thwarting widespread adoption

Ethical challenges and dilemmasTechnology can readily be misapplied inadvertently or deliberately

Particularly true either in lifecycle

Page 79: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

New Technology Impacting the Laboratory

Point of Care Testing, direct access testingNear patient testing (home health)

MiniaturizationGlucose probes, multichannel analyzers

Continuous data streamMolecular methods, biotech companies

Gene chips“-omics” revolution: genomics, proteomics,

Communications and telemedicineHome health and direct access testing

Medical advances in other subspecialties

Page 80: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Telemedicine

Page 81: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Telemedicine

“Watson come quickly I need you”Since the advent of telephony physicians and patients have applied the technology

Exciting technologyWe can drive golf carts on Mars, we can…

Perform remote surgeryPathologic, radiological diagnosis and review etc

Page 82: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Telemedicine

The practice of healthcare delivery diagnosis, consultation, treatment, transfer of medical data, and education using interactive audio, video or data communication

Page 83: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Telemedicine

Extensive references provided for those who’d like to learn more about the technologyThe technology is here now…for better or worse it’s here and it works!

Many active programsFunctional turn key systems to support everything from wound care to psychiatry

Page 84: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

TelemedicinePositives

Improved access to careImproved quality of careDecreased cost of care

Page 85: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

TelemedicineWhat is it used for?

33% consultation of other physicians30% tele-imaging of patient records/films22% remote clinical diagnostics10% distance education5% support surgical procedures

Page 86: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Telemedicine and Pathology

Providing remote laboratory results is a component of telemedicine

Not just live telepathology session over a microscopic slide

Telepathology will need to be integrated into LIS for documentation and billing purposes

Page 87: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Molecular Diagnostics

&

Molecular Biology

Page 88: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

What is a gene chip?

Technology allows millions of DNA sequences to be put on a 1cm chip

When combined with amplification technology can provide for rapid diagnosis

Entire human genome is available for $500!

Page 89: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Every cell in your body contains a copy of your entire genetic makeup—some 50,000 known genes and gene variants. But to make that information useful to scientists who are trying to identify genetic markers for cancer and develop drugs that target specific genes, a tool was needed to isolate each gene and make it easily identifiable. The new GeneChip from Affymetrixdoes just that. While previous chips each contained a portion of the human genome, the GeneChipis the first to fit the whole thing on one.

Availability: Now, $300 to $500To Learn More:affymetrix.com

HUMAN GENOME ON A CHIPInventor:Affymetrix

Page 90: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Gene discovery(Many, many applications, to be listed)

Disease diagnosis(Many, many applications, to be listed).

Drug discovery: PharmacogenomicsPharmacogenomics is the hybridization of functional genomics and molecular pharmacology. The goal of pharmacogenomics is to find correlations between therapeutic responses to drugs and the genetic profiles of patients.

Toxicological research: ToxicogenomicsToxicogenomics is the hybridization of functional genomics and molecular toxicology. The goal of toxicogenomics is to find correlations between toxic responses to toxicants and changes in the genetic profiles of the objects exposed to such toxicants.

Applications of DNA Microarray Technology

http://www.gene-chips.com/

Page 91: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

There are several steps in the design and implementation of a DNA microarray experiment. Many strategies have been investigated at each of these steps. 1) DNA types; 2) Chip fabrication; 3) Sample preparation; 4) Assay; 5) Readout; and 6) Software (informatics)

1) Probe(cDNA/oligo with known

identity)

2) Chipfabrication

(Putting probes on the chip)

3) Target(fluorecently

labeled sample)

4) Assay 5) Readout 6) Informatics

Smalloligos,cDNAs,chromosome, (whole organism on a chip?)

Photolithography, pipette, drop-touch, piezoelectric (ink-jet), electric, ...

RNA, (mRNA==>)cDNA

Hybridization, long, short, ligase, base addition, electric, MS, electrophoresis,fluocytometry, PCR-DIRECT, TaqMan, ...

Fluorescence,probeless(conductance, MS, electrophoresis), electronic, ...

Robotics control, Image processing, DBMS, WWW, bioinformatics, data mining and visualization

There are so many options and combinations, as can been seen from the number of companies involved in this business. It seems too early to judge who will be the winner(s) in this game. The forecast is further complicated by

recent fights among companies on intellectual property issues.

http://www.gene-chips.com/

Design of a DNA Microarray System

Page 92: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Chip Readout Appearance

Page 93: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Computing Power for Microarray

Significant amount of primary data per chip per experimental set (gigabytes)

Chips no good without computer!How will the LIS manage this data?

Meta data? i.e. an extract versus primary data storage

Where will the raw data live? Meta-data?Vendor?Your institution?Quandary for LIS!

Page 94: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Emergence of biotech companies

Emergence of biotech companies Sophisticated genomic testing, some of which is non-kit-ized; Biotech companies are now offering DAT genomic and proteomic testing on the web; Integrate data from company with primary laboratory using lab portal software to integrate this data with the LIShow will this affect hospital and commercial labs?

Page 95: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Biotechnology

&

Digital Imaging

Page 96: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Automated Cytology

AutoPap The AutoPap(tm)300 Automatic Pap Screener,

developed by NeoPath, Inc., is an image analysis

sytem which aims to identify normal smears so that they do not need to be screened by the laboratory. It examines the slides and classifies each slide as normal or as "requiring human review". The system "integrates proprietary high-speed image processing computers, video imaging technology and sophisticated image interpretation software to capture and analyze thousands of microscopic images from a Pap smear slide." The AutoPap 300 QC System employs image processing and pattern recognition techniques to classify objects based on their size, shape, optical density, texture and other features. The system is fully automatic and does not require review of digitized images by cytotechnologists prior to manual microscopic human rescreening. The AutoPap 300 QC was approved by the FDA in September of 1995 as a rescreeningdevice. In 1996, Neopath sought FDA approval of a new intended use for the AutoPap System as a primary screener of Pap smear slides. Neopath's goal is for their system to be used as a screening device, replacing the cytopathologist.

Page 97: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Whole Slide Scanning

Interscope Technologies Inc.Xcellerator™ Specifications:

http://www.interscopetech.comSpecification InterScope Xcellerator™

Slide Capture Time(including compression):• Focus• Pre-Process• Capture• View

An average slide (2cm2 tissue) will be scannedin about 4-1/2 Minutes (273 seconds)• 85 seconds• 35 seconds• 153 seconds• Immediately

Trestle Holding Corp http://www.trestlecorp.comAperio Technologies: http://www.aperio.com/Bachus Laboratories Inc. http://www.bacuslabs.com

Page 98: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Implantable Analyzers

Implantable analyzers will create a continuous data stream versus the single point analysis laboratories are familiar with now

Page 99: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool
Page 100: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool
Page 101: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

The Grid

&

Computing Appliances

Page 102: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Enter the Grid

When the network is as fast as the computer's internal links, the machine disintegrates across the net into a set of special purpose appliances.-- Gilder Technology Report, June 2000.

400 million PC’s as powerful as 1990’s super computer

Page 103: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Enter the Grid

first explored in the 1995 I-WAY experiment, in which high-speed networks were used to connect, for a short time, high-end resources at 17 sites across North AmericaUS NSF’s National Technology Grid and NASA’s Information Power Grid are both creating Grid infrastructures to serve university and NASA researchers, respectively

Page 104: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Figure 1: Performance of the Entropia network established for the Great Internet Mersenne Prime Search, which today operates at 1.3 teraflop/s. Over 120,000 PCs are networked to the project worldwide, of which around 30,000 operate at any one time.The discovery of a two million-digit prime in 1999 was reported in a major mathematics journal, and also earned a $50,000 prize for the lucky owner of the PC that uncovered it.

Page 105: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

DefinitionsTeraflop

A teraflop is a measure of a computer's speed and can be expressed as:

A trillion floating point operations per second 10 to the 12th power floating-point operations per second

PetaflopA petaflop is a measure of a computer's processing speed and can be expressed as:

A thousand trillion floating point operations per second 10 to the 15th power FLOPS

Page 106: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Application of Grid Computing

Real-time nuclear magnetic resonance imaging during surgeryComputer-based drug designAstrophysical simulationModeling of environmental pollutionStudy of long-term climate changes

I expect that it will become commonplace for small and large communities of scientists to create "Science Grids“

CA BIG: Cancer Bio Informatics Grid

Page 107: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

What is a computer?

Computers are increasingly heterogeneous devices that serve multiple functions in almost any environment

Personal digital assistant (PDA)

PalmWearable computersEquipment to effect penetration

Page 108: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool
Page 109: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool
Page 110: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool
Page 111: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool
Page 112: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Computing that Grows with YouMA V brings the power and functionality of a state-of-the-art desktop computer from the back of the classroom to the student's backpack, by putting the tools they need within reach. XyberKids provides instant access to computing. The package includes a backpack, powerful speakers and the MA V with an all-light readable flat panel display. Various software programs allow the MA V to be customized for students' specific needs, allowing the product to grow with the students as they learn.

Wearable Computer

Page 113: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

What's a Wearable?To date, personal computers have not lived up to their name. Most machines sit on the desk and interact with their owners for only a small fraction of the day. Smaller and faster notebook computers have made mobility less of an issue, but the same staid user paradigm persists. Wearable computing hopes to shatter this myth of how a computer should be used. A person's computer should be worn, much as eyeglasses or clothing are worn, and interact with the user based on the context of the situation. With heads-up displays, unobtrusive input devices, personal wireless local area networks, and a host of other context sensing and communication tools, the wearable computer can act as an intelligent assistant, whether it be through a Remembrance Agent, augmented reality, or intellectual collectives.

MIThril, the next generation research platform for context aware wearable computing. http://www.media.mit.edu/wearables/mithril/

Page 114: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Handheld computers•Commercial site with good links–www.pdastreet.com–http://www.handheldmed.com/software.php•MD with decent Palm links and general information:–www.jimthompson.net/handhelds/Wearable computershttp://www.xybernaut.comTelemedicineTelemedicine site http://www.wmed.com/telemed.html

Telemedicine website http://www.atmeda.org/

Telemedicine and the Law http://www.netreach.net/~wmanning/telmedar.htm

Office for advancement of telehealth http://telehealth.hrsa.govTelemedicine Systems http://www.mindspring.com/~jln-md/telemedicine.htmTelemedicine and the Law, SHARON R. KLEIN AND WILLIAM L. MANNINGOriginally Reprinted from HEALTHCARE INFORMATION MANAGEMENT: The Journal of the Healthcare Information and Management Systems Society, Summer 1995, here, with updates.

-California Business and Professional Code/2290.5,-Telemedicine, Deering’s Codes Annotated, San Francisco,CA Lexis Publishing Co., 1999-BIOPHOTONICS INTERNATIONAL. December 2003,MARCH 2004-Healthcare Informatics November 2003, 20(11)

References

Page 115: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

ReferencesGene chips-Laboratory Medicine, March, 1999 30(3): 180-188http://www.cbsnews.com/stories/2003/10/03/tech/main576405.shtml-Time Gene Chip link http://www.time.com/time/2003/inventions/invchip.html-Affymetrix Website http://www.affymetrix.com/index.affxPap Smear-Tripath Imaging http://www.tripathimaging.com/aboutus.htmInternet and Portals•http://www.pathologyinformatics.org•http://www.portalscommunity.com•http://www.traffick.com•The Internet and Healthcare, Louis Nicholson ed, 2nd edition, Health Administration Press, 1999.•Information Architecture for the World Wide Web, Louis Rosenfeld and Peter Morville, 1st edition, O’Reilly & Associates, 1998.•Where Wizards Stay Up Late: the origins of the Internet, Katie Hafner and Matthew Lyon, Touchstone, 1996.•Managing Healthcare Information Systems with Web-Enabled Technologies, Lauren Eder, Idea Group publishing, 2000.Grid Computing:http://www.nature.com/nature/webmatters/grid/grid.html

http://www.grid.org/projects/cancer/

http://www.cnn.com/2001/TECH/industry/11/29/grid.cancer.research.idg

Page 116: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Implications of the Web-Enabled Lab for the Practice of Pathology

Bruce A. Friedman, M.D.Department of Pathology

University of Michigan Medical SchoolAnn Arbor, MI

[email protected]

Page 117: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

OutlineImplications of the Web-Enabled Lab for the Practice of Pathology

Show how the web enhances the service mission of the lab and changes relationship of the lab with its customers

Describe the various types of informatics tools that will support the pathologist’s reaching for the “sweet spot”

Discuss some of the new lab products spawned by the web and enabled by the evolution of the e-laboratory

Describe how the virtual LIS will manage molecular diagnostics and other complex sets of lab testing results

Demonstrate how IT standards in the lab and healthcare are critical for the future success of pathology informatics

Page 118: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Show how the web enhances service mission

of lab & changes relationship of

lab to its customers

Page 119: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Challenges to Clinicians in New Healthcare & Lab Environment

Seeing more patients per hour without allowing quality to suffer while maintaining respect & confidence of patients

Laboring under increasing regulatory & payor documentation burden which distracts them from time spent with patients

Malpractice & insurance crisis, driving MD increasingly out of private practice & increasing their estrangement from system

Increasing capital and training costs to enhance the IT capabilities of office practice; clinicians often cyberphobic

Patients surfing the web and increasingly IT savvy; higher expectations about office information-access capabilities

Page 120: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

How Web-Based Services Will Change Lab/Patient Relationship to MD

Lab portal OE/RR will allow office practice to operate more efficiently; avoid patient calls to office staff for result-reporting

Lab portal software as “wraparound” can also provide single on-ramp to hospital-based lab, radiology, & cardiac diagnostic

Integration of OE/RR into office-based physician management systems (PMSs) will promote efficiencies/development of EMR

Decentralization of lab testing (POCT; biotechs offering retail genomic testing) will present new data integration challenges

DAT for consumers/patients will confound their relationship with MDs; patients bring complex results to MDs for interpretation

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The Wired Pathologist: A Vision of Future Role, Capabilities, Mission

We use term “wired pathologist” to represent shift described here for informatics-enabled pathologist in multiplicity of roles

In order to provide “just-in-time” consultations, equipped with headset for digital voice-over-IP (VOIP) conversations

Provides office-based clinician clients with web-access to smart reports using hand-held web-enabled portable devices

Expert in integrating multiple clinical data streams converging in pathology and presented in an understandable format

Expert in datamining large complex clinical/financial databases to answer questions & support strategic initiatives

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Wireless & Web Access to the Lab: New Channels of Communication

As soon as lab OE/RR moves to the web using lab portal software, new communication channels become available

Lab portals provide web-based transactions to office MDs; previously required customized software from reference labs

Many healthcare professionals very mobile; require OE/RR solution that the can access any where and any time

New generation of mobile phones are browser enabled; can access the new high-speed third-generation (3G) network

New mobile phones not only allow MDs to access reports but also permit contact with pathologists for real-time consults

Page 123: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Describe various types of

informatics tools that will support the pathologist’s reaching for the

“sweet spot”

Page 124: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Information Technology & Informatics as Prime Value-Driving Features

Because of lab inspections & quality control, assumption made by customers that most lab testing is roughly equivalent

Assessment of lab services then calibrated by test results TAT, communication, integration, and storage/archival services

Particularly true in service-oriented lab outreach sector where hospital labs must compete with national reference labs

No accident that reference labs pioneered use of lab portal software to push electronic OE/RR into MD private offices

Lab portal software, e-commerce, and direct access testing are also shaping style & substance of early forms of genomic testing

Page 125: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

General Description of Tool Kit Provided by Pathology Informatics

Triaging lab reports to identify most complex cases worthy of lab medicine consultations

Automated rule-based software to screen results

Extend the reach of lab support and consulting into new healthcare delivery venues

More sophisticated POCT and home-based devices

Ideal documentation of gross/micro images; teaching & collaboration tool with clinicians

Image integration into surgical pathology reports

Enable physicians to access lab reports and images using browser software

Wi-Fi enabled Palm devices; smart phones & tablet PCs

Reduced capital costs for IT support; outsources hardware maintenance/security

ASP model for providing LIS and lab portal services

Enhanced capability for lab medicine consulting; easy access to MD office

Web portal software; web-enabled LIS

Application in PathologyName of IT Tool

Page 126: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Describe How These Informatics Tools Will Guide the Pathologist to Sweet Spot

Basic idea is that information technology destroys time and distance; breaks down “glass curtain” between lab/clinicians

IT can provide clinicians the information/consultations in various clinical settings precisely when they need it

Need to move quickly to the “smart report” which is web report with information, images, hot-links to other resources on web

We should view our reports as mini-textbooks about various diseases so valuable that clinicians will file for later reference

Need to create icons on reports such that clinicians can click to get instantaneous access to the pathologist who created them

Page 127: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Defining the “Sweet Spot”; Ideas About How to Navigate to This New Place

The “sweet spot” is the time/place continuum in healthcare delivery when/where the clinician peruses dx/tx options

Critical & prestigious nexus; appropriate goal for pathology should be to increase participation/engagement at sweet spot

No announcement by clinicians when arrive at this juncture but most willing to seek lab consultations if easily/readily available

Because MDs are mobile (e.g., office, hospital, travel) & data sources varied, this availability requirement can be challenging

Good news is that IT annihilates time & distance; feasible for pathologist to be readily available for paid lab consultations

Page 128: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Strengths of Pathology Informatics That Must Be Preserved in Future

Opportunity to develop new consulting relationships with clinicians via real-time web-based communication channels

Existing expertise in information technology and emerging web platforms which will be basis for evolving in-silicomedicine

Control over the laboratory database which will be the repository for new genomic/proteomic test results & images

Control over supply of normal & diseased tissues which will form basis for tissue repositories supporting genomic research

Relationship with pathology-based bench researchers; create translational bridge between basic research and patient care

Page 129: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Discuss new lab products

spawned by web and enabled by development of

the e-lab

Page 130: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Lab Medicine Consulting as New Product Line for Clinical Laboratory

Tradition in clinical pathology [not surgical pathology] of reporting raw data to customers, providing little interpretationfor them

In surgical pathology, like radiology, the reports is the consultation; most consultations on CP side use the “26”modifier

History of automated “lab consults” that report redundant or obvious information to MDs; heavy historical burden to overcome

Value-adding consulting now provides opportunity for additional lab revenue which could be billed under existing CPT codes

Sophisticated lab medicine consulting programs should be initiated now; prepare for complex genomic/proteomic testing

Page 131: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Lab Medicine Consulting: An Integral Component of New Reporting Style

Tradition in clinical pathology is to offer consultative support to clinicians, commonly in person or via the telephoneCPT codes 80500 and 80502 permit reimbursable lab medicine consultations under the following conditions:

Report ordered by the referring physicianReport generated by a pathologistResults prompting the report must be abnormalWritten report must be patient specific and relevant to case

Can create rules that scrutinize lab data as generated and cull out abnormals as candidates for further examination and consultationsKey issues are the review of the lab data integrated with other clinical elements & the provision of meaningful/actionable advice

Page 132: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

What Is Direct Access Testing? What Accounts for Sudden Surge of Interest

DAT enables consumer to order a menu of high-quality lab tests via the web without [obvious] MD intermediary

Although concept not new, web-mediated OE/RR has taken this new this lab product line into homes of all consumers

DAT not a new form of alternate healthcare but rather a new approach to case-finding/wellness-monitoring

DAT only one facet of larger phenomenon of consumer-controlled selection/utilization of healthcare services

Surge of media interest prompted by keen interest on part of readers in new web initiatives and connection to healthcare

Page 133: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Various Rationales for Consumers’ Use of DAT Services

• Alternative medicine enthusiasts; seeking tests not available in traditional channels or more control of processes

• Desire to “game” system; recreational drug user seeking drug screen results prior to interviews

• Consumer places high value on time; sees current test-ordering process as inefficient; desires MD visit with results in-hand

• Desire for privacy and confidentiality of results; may not want family physician to know results (e.g., STDs)

• Worried-well or hypochondriac; physician will not permit sufficient testing to satisfy perceived need for testing

• No physician relationship or insufficient time for physician visit; DAT used as substitute for office visit

Page 134: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Success of Various DAT Programs; Need to Examine Business Models

OSU Medical Center has program in conjunction with Kroger; increases store traffic and showcases OSU logo

Customers selects DAT tests in pharmacy; tests ordered & customer reports to patient service center

Profit margin for DAT testing not the only rationale for the program; program also prompted by competition

Results Direct is DAT program initiated by PAML; regional reference lab spun off from Sacred Heart Health System

Results reported only to DAT customers; health system physicians did not want to be sent results

Results Direct has now spun off new company that will provide turn-key DAT software solutions to hospital lab

Page 135: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Describe how virtual LIS will

manage molecular

diagnostics & other complex

lab testing

Page 136: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Pathology Informatics & Molecular Dx as Major Components of Pathology of Future

How pathologists responded when asked about greatest challenges facing them today: (1) molecular diagnostics & (2) informatics

We define “molecular diagnostics” as encompassing all discoveries of new biology and emerging science (e.g., genomics,proteomics)

We have defined pathology informatics in detail thus far as encompassing data capture, integration, storage, & integration

These two new areas connected in that molecular dx poses challenges about how data of this volume/complexity can be managed

Two disciplines spawning new biz models for labs; Roche & Ameripath1, Lab Corp2 creating “centers of excellence” in new biology

1. http://us.diagnostics.roche.com/press_room/2003/021103.htm2. http://www.labcorp.com/centers_of_excellence/index.html

Page 137: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Genomics and Proteomics Will Spawn New Testing Opportunities & Challenges

Genomic & proteomic testing will overwhelm clinicians with complexity; need IT tools & lab consultation to manage patients

Current LISs cannot acquire & manage deluge of data that will be presented to them from both volume & complexity perspectives

Biotech companies, holding patents to new tests, may not “kit-ize” testing for hospital labs or will license only to selected labs

Consumer sensitivity to genetic testing; may balk at results integration into hospital databases & favor web-based labs

Current testing model may not lend itself to genomics testing; need for recurring alerts/subscription relationship with patients

Page 138: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

The Key to Reporting “New Biology”Test Results: Hot Links to Other

Servers

In same way that smart lab reports will have hot-links to references, “new biology” test results will also be hot-linked

Being transported to another web server solves the formatting, storage, and upgrading challenges for hospital-based LISs/CISs

Because specialized genomic reporting web servers will be layered, will also offer specialize raw data interpretation tools

Personnel supporting these specialized genomic-reporting web servers can update interpretations as the science advances

Unknown at this time how specialized genomics servers will be funded; expensive to offer patient alerts during their lifetime

Page 139: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Demonstrate how IT

standards are critical for future

success of pathology informatics

Page 140: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Future Support for Standards for Data Sharing & Integration

Work product of pathology/labs & radiology is information supplied to clinicians who are responsible for care delivery

It is for for a reason that pathology and radiology are called ancillary services; root word for ancillary is “servant”

Previous care paradigm was to report data/interpretations to clinician(s) with paper record office/hospital documentation

Evolving documentation paradigm is to report electronically in standard format so disparate data can be integrated/retrieved

Influence & “new product lines” for pathology/radiology predicated on added value of integrated longitudinal data

Page 141: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Software Standards as Basis for the Evolution of the Virtual LIS

Have emphasized her notion of the V-LIS as a lab network consisting of the C-LIS plus SLAMs for specialized tasks

Evolution of this integrated network is a tall order given the fact that hospital labs are capital-poor; who pays?

Answer needs to be integrated network based on communication standards and not customized interfaces

Set of web-based standards called Web Services & underpinning e-biz (e.g., SOAP, WSDL) may be answer

Will need vendor or government-endorsed effort to put forward proposal for lab (and healthcare) environment

Page 142: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Take Home Summary Points about E-Lab and the Virtual LIS

Centralized lab model and the classic LIS (C-LIS) which was developed to support this work-flow model becoming obsoleteAs lab testing increasingly decentralized, need more flexible IT support for labs to accommodate to new modes of testingWe advocate notion of the virtual LIS (V-LIS) which is integrated web-based flexible system with specialized SLAMsMarket offerings of SLAMs now proliferating; will increase lab functionality but also increase IT integration challengesConversion to e-lab with ready access to both MD customers and consumers provides new lab product opportunities Path to the V-LIS will be rocky for capital-starved labs; solution will be standards-based approach for C-LIS/SLAM integration

Page 143: Bruce A. Friedman MD · Bruce A. Friedman MD Department of Pathology University of Michigan Medical School Ann Arbor, MI ... Has evolved from lab application to clinical service tool

Thank You!

CAP Copyright Statement:The materials in this presentation are the original works of the speakers, except where noted and referencedQuestions?