bruce a. friedman md · bruce a. friedman md department of pathology university of michigan medical...
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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
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.
Association for Pathology Informatics (API)www.pathologyinformatics.org
…to advance the field of pathology informatics as an academic and a clinical subspecialty of pathology.
CAPF/API/McKesson Award
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.
Agenda
Total Time 90 Minutes:Introduction and objectives-5 minutesQuestions following each segment during speaker changes-total 10 minutesTopic areas-75 minutes
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
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
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
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]
Laboratory Information System (LIS)
Overview
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
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
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
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
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!
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
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
LIS Ideals
Client-serverAdvanced network communicationsTrackingAdvanced business computingInstrument interfacesAdvanced automation support
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
LIS Ideals
Clinically relevant applications:clinical pathways
testing algorithmssmart testing
inter-system integration (pharmacy, molecular)result charting (graphing)patient trackingutilization, and outcomes analysis
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)
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)
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
The Internet
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
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
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.
$$ financial, training and resource implications $$
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
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
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
The Internet
Basic Definitions
Web site vs. Portal
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…
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
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
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
What technology is involved?Website
InfrastructureWeb serverNetwork bandwidth
SoftwareHTML editorServer software
Human resourcesWeb master, minimum to moderate information technology skillsContent providersGraphic artist
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
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
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
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
Pathology User
Hfhs.edu
Henryford.com(Internet)
Henry.hfhs(Intranet)
LaboratoryDatabases
SystemDatabases
AP CP Mol Img$$$
Careplus
ADT Rx
Rad
Rul
Internet Resources
Pathology User
Hfhs.edu
Henryford.com(Internet)
Henry.hfhs(Intranet)
LaboratoryDatabases
SystemDatabases
AP CP Mol Img$$$
Careplus
ADT Rx
Rad
Rul
Internet Resources
Pathology Portal
Hfhs.edu
Henryford.com(Internet)
Henry.hfhs(Intranet)
LaboratoryDatabases
SystemDatabases
AP CP Mol Img$$$
Careplus
ADT Rx
Rad
Rul
Internet Resources
Lab Portal
Hfhs.edu
Henryford.com(Internet)
Henry.hfhs(Intranet)
VPN(Extranet)
Metaframe(Extranet)
LaboratoryDatabases
SystemDatabases
AP CP Mol Img$$$
Careplus
ADT Rx
Rad
Rul
Internet Resources
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
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
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
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
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
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.
Transforming the Classic LIS to the Web-Enabled
Virtual LIS
Bruce A. Friedman, MDDepartment of Pathology
University of Michigan Medical SchoolAnn Arbor, MI
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
Describe centralized lab model; show
how it was well served by classic LIS but is now
out of date
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
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
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
Discuss new decentralized testing venues
that will supplant some central hospital lab
testing
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
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
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
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
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
Describe emergence of
virtual LIS (V-LIS) as substitute for
central LIS (C-LIS) and SLAMs
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
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
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
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)
Discuss dis-integration of lab
databases; special challenge
of physician office testing
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
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
Explain how e-lab is complimented by virtual LIS and how two models will define future of lab computing
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
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
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
Technology Driving the Next Generation of Laboratory
Information Systems
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
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
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
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
Telemedicine
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
Telemedicine
The practice of healthcare delivery diagnosis, consultation, treatment, transfer of medical data, and education using interactive audio, video or data communication
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
TelemedicinePositives
Improved access to careImproved quality of careDecreased cost of care
TelemedicineWhat is it used for?
33% consultation of other physicians30% tele-imaging of patient records/films22% remote clinical diagnostics10% distance education5% support surgical procedures
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
Molecular Diagnostics
&
Molecular Biology
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!
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
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/
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
Chip Readout Appearance
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!
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?
Biotechnology
&
Digital Imaging
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.
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
Implantable Analyzers
Implantable analyzers will create a continuous data stream versus the single point analysis laboratories are familiar with now
The Grid
&
Computing Appliances
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
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
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.
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
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
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
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
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/
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
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
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
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
Show how the web enhances service mission
of lab & changes relationship of
lab to its customers
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
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
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
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
Describe various types of
informatics tools that will support the pathologist’s reaching for the
“sweet spot”
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
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
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
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
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
Discuss new lab products
spawned by web and enabled by development of
the e-lab
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
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
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
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
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
Describe how virtual LIS will
manage molecular
diagnostics & other complex
lab testing
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
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
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
Demonstrate how IT
standards are critical for future
success of pathology informatics
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
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
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
Thank You!
CAP Copyright Statement:The materials in this presentation are the original works of the speakers, except where noted and referencedQuestions?