Title: The Virtual LIS VLIS: An Emerging LIS Architecture for the Clinical Laboratories
1The Virtual LIS (V-LIS) An Emerging LIS
Architecture for the Clinical Laboratories
- Bruce A. Friedman, M.D.
- Department of Pathology
- University of Michigan Medical School
- Ann Arbor, MI
- bfriedma_at_umich.edu
2Lecture Outline
- Describe how the centralized lab model supported
by classic LIS but challenged by recent emergence
of decentralized venues - Discuss dis-integration of lab databases as
centralized testing becomes less important
challenge of physician office testing - Describe emergence of virtual LIS (V-LIS) as
substitute for central LIS (C-LIS) show how
(V-LIS)(C-LIS) (SLAMs) - Explain how the e-lab meshes with the virtual LIS
and how these two models will define future of
laboratory computing - New lab product lines stimulated by the
web-based lab computer environment direct access
testing lab consulting - Explain role of pathology informatics in the
rationalization of the emerging complex
lab/healthcare computing environment
3Centralized Lab Model Supported By Classic LIS
Challenged by Multiple Decentralized Lab Venues
4Centralized Lab Model Has Dominated Lab Operations
- Centralized lab model has dominated hospital labs
since the 1950s 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 physician customers who then
interpret the results - Infrastructure (blood drawing centers, analyzers,
LISs) is expensive, discouraging new entrants in
market - Hospital labs reference labs enjoyed relative
monopoly driven by high test volume low
cost-per-test
5Classic LIS Has Served Lab Professionals for
Three Decades
- LISs specifically designed to manage information
in hospitals based on hospital work
flows/processes - For 30years, total IT purchase by hospital lab
directors was simple buy a classic LIS suitable
for lab size - Best-of-breed argument held sway labs optimized
LIS and instrument functionality to lower
cost-per-test - Many LIS vendors persisted in the relatively
small market new entrants developed C-LIS
products - C-LISs served labs well until new testing venues
evolved (e.g., POCT) that didnt fit centralized
lab model well
6Reasons for the Weakening of the Centralized Lab
Model
- Healthcare becoming less centralized removed
from hospitals to reduce costs increase patient
convenience - Clinicians nurses demanding faster TAT
greater control over testing they have little
concern about cost-per-test - IVD manufacturers marketing POCT devices directly
to clinicians emphasizing benefits for their
workflow - New POCT data management and communication
standards facilitated order result integration
into LIS/CDR databases - Key lab drivers (e.g., budget, lab efficiency,
data integration, quality issues) do not
resonate with clinicians
7Decentralized Venues That Will Comprise Major
Components of Lab Testing
- Home-testing associated with chronic and
post-operative care to reduce delivery costs - 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
- All forms of POCT with rapid TAT requirements by
hospitals/clinicians - Testing in skilled nursing chronic care
facilities as emerging venues for lab testing - Home kits instruments (e.g., glucometers,
pregnancy, HIV)
8Home 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 soon draw blood from
patients perform tests in-home with portable
analyzers - 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 services to reduce
costs/retain patients
9New Definition of Clinical Lab Prompted by
Growth of Decentralized Testing
- A clinical lab consists of one instruments
using patient specimens to create new information
about the specimen - 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 about 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 not just
hospital-generated lab data
10Reimbursement 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 usually
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 delivery more
efficient
11Pathology Informatics Decentralized Testing A
Congenial Match
- Weakening of centralized lab model has weakened
classic 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 detre of central lab from
primarily data creation to data creation data
integration management - Hopefully, hospital lab will remain as a central
hub through which multiple data streams will
converge/integrate - Biggest challenges will be recruiting sufficient
talented personnel justifying reimbursement for
data management
12Dis-integration Of Lab Databases Special
Challenge Of Physician Office Testing
13Dis-integration of Lab Data Repositories as
Testing Migrates to New Venues
- Consequences of POCT, home testing, expanded
office testing hospital-based labs may lose
control of lab data - Problem has been exacerbated by the fact that the
EMR is now the prime integrated clinical
database C-LISs feed data to it - Logical conclusion is to embrace decentralization
when demanded by customers but emphasize lab data
re-integration - Good business strategy because test performance
more commoditized data integration as a
value-adding step - Integration of lab data important for clinicians
who desire one-stop data shopping also platform
for lab medicine consulting
14Balancing 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
15Lab Portals Offer Special Challenge to LIS
Separate Database/EMR Integration
- Lab portals unique among SLAMs evolving quickly
as mini-LISs with web-based architecture/cost
advantage - Some lab portals now accessible via the EMR via a
button for lab outreach ordering across entire
health system - Lab portal vendors can be more nimble than LIS
vendors because of more modern architecture/aggres
sive sales - Some hospital lab clients turn to lab portal
vendors for new features when their C-LIS vendor
is unresponsive - If the lab portal has its own unique lab
database, spawns both opportunities and
challenges for hospital lab
16Emergence of the Virtual LIS (V-LIS)(C-LIS)
(SLAMs)
17The 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
constitute the virtual LIS (V-LIS) which is an
integrated lab network
18Examples of SLAMS Used to Enhance Lab Efficiency
Productivity
- Anatomic pathology LISs
- Surgical pathology imaging
- Autopsy databases gross imaging
- Servers supporting TLA (form of middleware)
- Middleware developed and marketed by IVDs
- Home lab testing
- Specialized molecular diagnostics servers
- 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
19Introducing 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 web to provide office connectivity
application is accessed 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 as ASP - Software can be obtained from classic LIS vendors
as part of their software but also from
specialized lab portal vendors
20The Special Case of Middleware Definition,
Function, and Integration
- Roche coined the term of Middleware Solutions
defined as software located between analyzer
LIS - Roche outsourcing software development to Data
Innovations Beckman Coulter uses Orchards
Aqueduct - Middleware market driven in part by goal of IVDs
to add value to their products compete
successfully - Also driven by need of IVDs to add useful
features (e.g., flags rules) that some older
LISs are unable to provide - Challenge from lab perspective is how to
integrate middleware into lab network dominated
by the C-LIS
21Software Standards as Basis for the Evolution of
the Virtual LIS
- Have emphasized the V-LIS as integrated 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
22Virtual LIS Already a Reality for Many Labs Now
Name Available for Architecture
- Complex labs have been supplementing
functionality of their C-LIS for years by
addition of specialized modules - Oldest example of such modules has been the
anatomic pathology LIS (AP-LIS) best-of-breed
now withering - Historically, complex labs have had IT group
sufficiently sophisticated to architect for them
an integrated V-LIS - Lab software market now differs qualitatively
quantitatively due to the proliferation of SLAM
offerings - In addition, smaller labs now also facing more
complex business plan but system integrators
still not available
23E-lab Meshes With Virtual LIS How These Two
Models Will Define Future of Lab Computing
24Converting 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 labs window
on the whole world - Lab portal provide web-enabled OE/RR, enabling
lab to compete with large reference labs for
outreach business
25V-LIS Pus E-lab How Two Models Will Define
Future of Lab Computing
- V-LIS weans hospital lab from a pure C-LIS
provides opportunity to selectively add SLAM
functionality as needed - Challenge will be integration of C-LIS with the
newly purchased SLAMs without expense of
customized interfaces - SLAM market will allow small companies to move
into lab IT space more competitive than pure
C-LIS business 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
26How Web-Based Services Will Change Lab/Patient
Relationship to MD
- Lab portal OE/RR allows MD offices to operate
more efficiently avoid patient calls for
resulting save money - Lab portal software as wraparound can also
provide 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 will complicate their
relationship with MDs patients bring complex
results to MDs for interpretation
27The Wired Pathologist A Vision of Future Role,
Capabilities, Mission
- We use term wired pathologist to represent
shift 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 physicians with web-access
to smart reports using hand-held web-enabled
portable devices - Expert in integrating multiple clinical data
streams converging in pathology and properly
formatted - Expert in developing complex clinical/financial
databases to answer questions support
strategic initiatives
28Challenges to Clinicians in New Healthcare Lab
Environment
- Seeing more patients per hour without allowing
quality to suffer while maintaining respect
confidence of patients - MDs working under increasing regulatory payor
documentation burden distracts them from
patients - Malpractice insurance crisis, driving MD
increasingly out of private practice increasing
their estrangement - 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
29New Lab Product Lines Stimulated by the Web-Based
Lab Computer Environment
30What Is Direct Access Testing? Why 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 this lab product into homes of all
consumers - DAT not a new form of alternate healthcare but
rather a new approach to case-finding/wellness-mo
nitoring - DAT only one facet of larger phenomenon of
consumer-controlled selection/utilization of
healthcare services - Surge of media interest prompted by keen interest
web initiatives, e-business, and connection to
healthcare
31Various Rationales for Consumers Use of DAT
Services
32Success 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 labs
33Pathology Informatics Molecular Dx as Major
Challenges Facing Pathologists
- Pathologists define greatest challenges facing
them today (1) molecular diagnostics (2)
informatics - Molecular diagnostics encompasses all
discoveries of new biology and emerging science
(e.g., genomics, proteomics) - Pathology informatics encompasses capture,
integration, storage, integration of all data
generated in CP and AP - These two new areas linked in that molecular dx
poses challenges about how data of this
complexity can be managed - Two disciplines spawning new biz models Roche
Ameripath1, Lab Corp2 creating centers of
excellence in new biology
1. http//us.diagnostics.roche.com/press_room/200
3/021103.htm 2. http//www.labcorp.com/centers_of
_excellence/index.html
34Genomics and Proteomics Will Spawn New Testing
Opportunities Challenges
- Genomic proteomic testing will overwhelm
clinicians they will need IT tools lab
consultation to manage patients - Current LISs cannot acquire manage deluge of
data that will be presented to 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
35The 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 - Inconspicuous linking to another web server may
solve formatting, storage, upgrading challenges
for hospital LISs - Because genomic reporting web servers will be
layered, will also offer specialized raw data
interpretation tools - Personnel supporting 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 lifetime
36Lab Medicine Consulting as New Product Line for
Clinical Laboratory
- Tradition in clinical pathology not surgical
pathology of reporting raw data, providing
little interpretation for them - In surgical pathology, like radiology, the report
is the consultation CP reimbursed consultations
use 26 modifiers - History of useless automated lab consults that
report redundant or obvious information to MDs - Value-adding consulting provides opportunity for
additional lab revenue that can be billed under
existing CPT codes - Sophisticated lab medicine consulting should be
initiated now prepare for complex molecular dx
testing
37Lab Medicine Consulting An Integral Component of
New Reporting Style
- Tradition in clinical pathology is to offer
consultative support to clinicians, in person or
via the telephone - CPT codes 80500 and 80502 permit reimbursable lab
medicine consultations under the following
conditions - Requirements not onerous to bill under these
codes but this opportunity has not been seized in
the past - Can create rules that scrutinize lab data as
generated cull out abnormals as candidates for
further consultations - Key issues are the review of the lab data
integrated with other clinical elements the
provision of actionable advice
38Role of Pathology Informatics in Rationalization
of Complex Lab/Healthcare Computing Environment
39Information 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, DAT are also
shaping style substance of early forms of
genomic testing
40General Description of Tool Kit Provided by
Pathology Informatics
41Defining 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
at the sweet spot - No announcement by clinicians when arrive at this
juncture but most willing to seek lab
consultations if readily available - Because MDs are mobile (e.g., office, hospital,
travel) data sources varied, this requirement
can be challenging - Good news is that IT annihilates time distance
feasible for pathologist to be readily available
for paid lab consultations
42Describe 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/consulta
tions in various clinical settings precisely when
they need it - Need to move 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 so that
clinicians can click to get rapid access to the
pathologist who created them
43Strengths 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 IT and emerging web
platforms which will be basis for evolving
in-silico medicine - Control over the laboratory database which will
be the repository for new genomic/proteomic test
results images - Control over supply of normal diseased tissues,
forming basis for tissue repositories supporting
genomic research - Relationship with pathology-based bench
researchers create translational bridge between
researchers and care
44Pathology Informatics, Molecular Dx, Oncology
as Basis for Pathology of Future
- When pathologists asked about greatest challenges
in field, they often refer to molecular dx,
oncology, pathology informatics - Molecular dx serves as bridge to incorporate
discoveries of new biology (e.g.,
genomics/proteomics) to healthcare delivery
system - This new discipline will lead to most new lab
testing informatics, in turn, will support the
management of all this new information - The two also connected in that molecular dx poses
challenges about how data of this
volume/complexity can be managed - Molecular dx is the conduit for new biology to
patient, oncology is clinical focus,
informatics provides means to manage new data
45Big Three Clinical Informatics Disciplines with
Staying Power
- Three emerging informatics disciplines with
staying power, funding, opportunity to
create/manage large clinical databases - Oncology informatics, theranostics/internal
medicine, and cardiovascular informatics - Common features among them are also strong links
to the drug development pipeline, research funds,
public health reporting - Plentiful resources available for integration of
clinical data with research data for grant
support and to respond to IRB demands - The associated specialties are favored by
hospital administrators because of number of
admissions lucrative reimbursement - CP and AP data are also critical to the
infostructure of all three of these
disciplines specialties cant operate without
lab data
46Theranostics Driving Toward a New Blend of
Diagnostics Therapeutics
- Normal clinical lab testing used to diagnose or
monitor a disease state but usually provide
little advice/insight to rx - Theranostics describes an approach to healthcare
delivery that merges dx with application
development of rx - Purpose of theranostics is to provide objective
tests based on molecular/biological rationale to
guide drug therapy - A theranostic test provides information on
appropriateness/ efficacy of drug for particular
disease particular patient - Should not be confused with drug assays that
simply monitor the therapeutic level of a drug
in a patient to guide dosages
47Reinventing Pathology Informatics Piggybacking
on Informatics Big Three
- Clinical pathology informatics is in a rut need
to reinvent discipline and serve as a platform
for reenergizing lab medicine - Major problem is that discipline has become too
focused on installing and maintaining LISs
little opportunity for creativity - Pathology informaticians are stewards of critical
lab databases but this resource used generally
only to retrieve patient results - Research pathology informatics is thriving with
great intellectual vigor and ever increasing
funding, particularly in oncology - Migration of major applications like OE/RR to EMR
may be blessing in disguise force informaticians
to return to roots
48Cardiovascular Informatics Has Not Been Invented
Yet Only a Matter of Time
- Logical that oncology informatics evolved first
rapid emergence of tumor tissue banks huge
volume of cancer genomic data - Multiple cardiovascular centers being built,
certainty that clinical, lab, physiological,
imaging data for pts. will be integrated - Clinical pathology data will be of great
importance to this field but, unlike oncology,
few important surgical pathology specimens - Algorithms for wellness testing monitoring will
be critical for these patients also important
links to home health care testing - Hope that this reference to CV informatics will
act as a stimulus for someone in the audience to
act as a catalyst for change
49Why Pathology/Radiology Informatics Are Not
Included among Big Three Disciplines
- Ancillary services not sufficiently clinical and
integrative contribute to, but do not define,
final dx work-ups rx regimens - Constraints on profit margins most lab testing
commoditized because of competition between
hospital and commercial labs - Little direct contact with patients, leading to
diminution of recognition as major contributors
to healthcare delivery - Lab testing can be performed off-site and
therefore outsourceable viewed more like
utility than critical service - Lab has few ties to big business/pharma not
applicable to radiology with GE/Siemens/Phillips
investing in basic research
50Future 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 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 - Influence new product lines for
pathology/radiology predicated on added value of
integrated longitudinal data
51Role of Pathology Informatics as OE/RR Clinical
Databases Migrate to EMR?
- Consider it a given that LIS database will be
transient and integrated into EMR that OE/RR
will also migrate to the EMR - Only reason why LISs have supported
enterprise-wide OE/RR is that the mainframe
computers were not adequate for task - The EMR integrated clinical database will be the
permanent clinical record the virtual LIS will
update it when/if necessary - Also a given that lab managers will be pressed to
justify all capital expenditures for lab software
on basis of business plan - Emphasis of lab IT will shift to enhancing the
value of the lab information product
integrating data from multiple sources
52Take 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 obsolete - As lab testing increasingly decentralized, need
more flexible IT support for labs to accommodate
to new modes of testing - We advocate notion of the virtual LIS (V-LIS)
which is integrated web-based flexible system
with specialized SLAMs - Market offerings of SLAMs now proliferating will
increase lab functionality but also increase IT
integration challenges - Conversion 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
approach for C-LIS/SLAM integration