9021 – Best of Breed LIS or Single Vendor Integrated Systems – Which is Best for Your Lab?

Dennis Winsten President, Dennis Winsten & Associates, Inc. Hal Weiner President, Weiner Consulting Services, LLC

www.ascp.org/ascp2014

Speaker Disclosure

In the past 12 months, we have not had a significant financial interest or other relationship with the manufacturer(s) of the product(s) or provider(s) of the service(s) that will be discussed in our presentation.

Many CIO’s are requiring labs to install an enterprise-wide system’s laboratory application e.g. Epic’s “Beaker”, as part of a hospital-wide or health system-wide solution. Would your lab be Better Served by a “Best-of-Breed” LIS ……. Or Not? What makes the most sense for your laboratory? How can issue this be addressed?

THE ISSUES

Topics • Background – Why is this an Issue? • Current State of Affairs • C-Suite and CIO rationale and perspectives • Laboratory Management rationale and perspectives • Point and Counter Point to those perspectives • Generic Comparison Beaker vs. Best-of-Breed LIS • Tactics to obtain evidence to rationally support retention

of your B-o-B LIS-or not-and, if so, to further support your case

• Examples of “gap” data tables used as evidence • Do’s and Don’ts • Conclusions

An Evolving Tension:

EMR vs. LIS

The contemporary “best-of-breed” LIS model is being challenged by the reality of fully-integrated primary vendor EMR solutions, which promise to provide functional equivalence of the “best-of-breed” LIS with the added benefits of an Enterprise-Wide System (EWS) offering:

• Simplified enterprise complexity • Simplified deployment logistics • Reduced total cost of ownership • Simplified long-term stewardship of both software, hardware and data • Enhanced patient safety Courtesy: The Pathology World-View as a Cornerstone of the Next-Generation EHR -Implications for Design, Procurement and Management by Ulysses J. Balis, M.D.

THE CHALLENGES OF “BEST OF BREED”

CIO Perspectives ENTERPRISE-WIDE EMPHASIS (EWS)

Fit with other institutional systems Support hospital’s financial and service level initiatives Achieve higher level integration Homogeneous applications Use common standards, e.g. Communications, data exchange, information

nomenclature Seamless data flow between hospital’s administrative, clinical and financial systems

USER CONSIDERATIONS

Focus on needs of physicians/clients Provide ease of access and of use All staff (Users and I.T.) see the same data presentation

UTILIZE LIS THAT “FITS” BEST WITH

EXISTING OR PLANNED: Other information systems Hardware, database, operating systems, SW tools Network protocols

CIO Perspectives INTERFACING

Interfacing is unreliable and costly Each software upgrade could require upgrading interfaces Minimize interfaces

VENDORS

Vendor should validate their system’s actual benefits Best-of-breed” vendor should be accountable and take leadership responsibility

for any problems that may occur in inter-system operations

Lab Management Perspectives FINANCIAL EMPHASIS

Support laboratory’s financial and service level initiatives Outreach laboratory business is a very important revenue generator Maintain and/or grow Outreach revenue Lower cost does not mean higher value

OPERATIONAL CONSIDERATIONS

Focus on needs of physicians/clients Data display should be optimized for caregiver interpretation Provide ease of access and of use for laboratory users Validation of laboratory-specific transactions assure completeness and accuracy Interfacing is proven and interoperability can be supported without need for full

integration Support for advanced automation (pre-analytical, analytical and/or post analytical)

may not be available Maximum computer functionality with integration as a secondary goal. The laboratory space is mature, interface transactions are well-defined and

straightforward

Lab Management Perspectives

INTERFACING VS. INTEGRATION: Integrated, single vendor systems may not be sufficiently adaptable to changing

business conditions Integrated systems don’t necessarily work well in a multi-entity business model. Its

components, e.g. lab, pharmacy, etc. typically cannot be readily modified to adapt to required business or regulatory changes without affecting the entire integrated system

Loosely–coupled systems can be advantageous

VENDORS Vendor will validate their system’s actual benefits Best-of-breed” vendor will be accountable and take leadership responsibility for any

problems that may occur in inter-system operations Will Enterprise LIS vendors validate integrated systems incremental benefits?

Point – Counter Point CIO Best-of-Bre

We get “Beaker’ license for free - included with enterprise- wide Epic system. Much lower cost! Why should our hospital pay so much more?

Not “free”. License is “bundle implementation fee and othe impact of “gaps” on operatio

Enterprise LIS still less expensive than Best-of-Breed LIS! Our budget is very tight. We need to be “Cost Efficient!

We need to be “Cost Effectiv compared to “cost”. Impact o other key indicators, e.g. B-o competitiveness, service leve for the hospital.

Why should I take the risk? The EWS we are getting has been proven in many other hospitals Our B-o-B LIS has successfully to the enterprise system at “ comparable to ours- so little,

I don’t want to deal with too many Databases, Operating Systems, Hardware vendors!

It is possible that our B-o-B LI operating system, Hardware

Want integration and “seamless’ dataflow between administrative, operational , clinical and financial applications. All staff (users and IT) should look at the same data. B-o-B create “silos”.

Proven interfaces support suc presentation “customized” by clearer, easier to interpret da to make clinical decisions. No

Don’t want “finger-pointing” if problems – just one Vendor and number to call.

Clear service-level agreemen initiative and responsibility t any issues that are related to

Can you prove that the EWS LIS jeopardizes laboratory operations, quality, services, etc? What guarantees are there that the B-o-B LIS will deliver on its promised benefits?

“Gap” analysis of the EWS an significant impacts. e.g. outre safety, service levels, staffing Will either vendor provide co independent benefits realizat

TOP-LEVEL GENERIC COMPARISON EWS LIS VS. B-O-B LIS

Integration-Enterprise-Wide LIS Interfacing-”Best-of-Breed” LIS

Strong C- Suite Commitment Strong Laboratory Commitment

No interfaces required between the laboratory module and other modules of the EWS. All modules share a common database

Interface connectivity required to other system modules including EMR, CPOE and clinical and/or financial modules used by the hospital

Some EWS may not support connectivity to HIS, CPOE, EMR other than their own which may impact future hospital consolidations and/or acquisitions as well as limitations on outreach business.

Most B-o-B LIS can be interfaced to other “foreign” HIS, CPOE, EMR if necessary

Some EWS may provide less complex LIS services and a more limited scope of outreach services

Most B-o-B LIS emphasize support for moe complex LIS services, e.g. MDx, cytogenetics, and broader scope outreach services

High level of “true” integration across EWS modules

Offer “proven” interfaces to most EWS systems

Single sign-on and common “look & feel” across EWS modules

Typically, multiple sign-ons and “look & feel” will differ between LIS and other system modules.

Integration-Enterprise-Wide LIS Interfacing-”Best-of-Breed” LIS

Common, composite view of clinical data for caregivers across multiple departments

Caregivers may have to view each departmental data separately

Expert rules can be applied across multiple EWS modules

Expert rules apply only to laboratory data

Changes to any system data, if applicable, are automatically updated for the LIS module

Changes to other system data, if applicable, are sent to the LIS via the interface

Monolithic integrated structure makes replacement of any module more difficult

Multi-entity architecture allows modules to be replaced but requires new interfaces

Data nomenclature is standard Data nomenclature may vary between the LIS and other modules

All required data files exist in a common database used by all EWS modules

Unique data files existin the LIS and must be synchronized with other modules to assure consistency and timeliness

Hospital I.T. expertise required only for a single operating system and database

Hospital I.T. expertise may be required for multiple different operating systems and databases

Probable lower cost if “bundled” EWS package

Possible better ROI if demonstrable benefits for laboratory operations

TOP LEVEL GENERIC COMPARISON OF EWS LIS VS. B-O-B LIS

WHY EPIC “BEAKER” LIS AS A CASE IN POINT? A Topic of EPIC Proportion

• Using Epic “Beaker” LIS as an example because, of late, EPIC has been the “big dog” with many new users. “Beaker” LIS can be part of the EWS.

• Epic is dominating the market for new EMRs, e.g. Stanford, Peacehealth, Duke, Allina, Kaiser, Michigan, Cleveland Clinic and many more.

• Discussion could also apply to other EWS LIS including:

– McKesson – Siemens – Allscripts – Meditech – Cerner

• Laboratories may feel “pressure” from the C-Suite to accept “Beaker” (or another EWS LIS) as a “single-vendor solution.

• “Beaker” LIS is still a “work-in-process” but much progress has been made.

• Not all laboratories will find “Beaker” (or another EWS LIS) suitable for their needs – some may.

“Beaker” LIS

• Epic has been forthright about “Beaker” LIS capabilities.

• Development “roadmap” has been established.

• More existing capabilities than generally perceived.

• Approaching functional equivalency with other more mature LIS.

“Beaker” LIS is Not Free…

COST ELEMENT BEAKER “LIS”

License Fee – GenLab/Micro May be Included/discounted with Enterprise license

License fees – AP, other additional modules Additional Cost

Instrument Interfaces – Data Innovations Additional Cost

Operating System/Database - Caché Additional Cost

Implementations Additional Cost

Hardware Additional Cost

Support Percentage of system cost

…. BUT MAY STILL BE LESS COSTLY THAN A “BEST-OF-BREED” LIS

EPIC “BEAKER” LIS STATUS CHANGES 2009-2013

CORE LAB-HEMATOLOGY-CHEMISTRY- FUNCTIONS/FEATURES

AVAILABILITY STATUS

DEC. 2009

AVAILABILITY

STATUS DEC. 2013

• Interface to 3rd party Hospital EMR's Not Planned Limited • Update automatically reference range of finalized results if correction made to patient age/gender Future TBD Partial 2012 • Multiple delta check range criteria including logarithmic range Future TBD Partial 2012 • Expert rules to prevent or allow add-on tests based on user-defined criteria Future TBD 2014 • Dashboard presentation of key operational parameters in real-time Future TBD 2012 • Inclusion of scatter diagrams in hematology reports Future TBD Partial 2010 • Validity check sample age/quantity before allowing add-on test Future TBD 2014 • Patient Moving Averages and Bull Algorithm Future TBD Future TBD • 2D Barcodes Future TBD 2010 • Patient age recordable as hours Future TBD 2010 • Two different specimen types on the same test Future TBD 2010 • Ability to receive a PDF report over an interface from a reference lab and send to another EMR Future TBD Partial 2012 • Ability to verify and release partial results, e.g. components of profiles or panels Future TBD 2014 • Receipt verify by Packing list Future TBD 2014 • Multiple time zone support, i.e. time /date adjustment for other time zone specimens Future TBD 2012 • Customize lab result report headers based on performing lab (multi facility) Future TBD 2014

EPIC “BEAKER” LIS STATUS CHANGES 2009-2013

MICROBIOLOGY- FUNCTIONS/FEATURES

AVAILABILITY STATUS

DEC. 2009

AVAILABILITY STATUS

DEC. 2013

• Delta check alerts of antibiogram result changes for "drug-bug-bug" combinations Future TBD Partial 2012 • Automatic printing of media labels Future TBD 2012 • Move tasks manually on a worksheet Now-partial Partial 2009 • Summary reports for susceptibility patterns Future TBD 2012 • Use of user-defined keyboards Now-partial 2009 • Delta checking on patient previous results within defined source and time-window Future TBD 2010

ANATOMIC PATHOLOGY FUNCTIONS/FEATURES

AVAILABILITY STATUS

DEC. 2009

AVAILABILITY STATUS

DEC. 2013

• Specimen in-process tracking within lab, e.g. as received at cutting, embedding, staining work stations Future TBD 2012 • Manual case number assignment or override Future TBD 2012 • Word processing—standard tools (Word or vendor-specific) Future TBD 2014 • Images/illustrations integrated in reports Future TBD Partial 2014 • Report format flexibility, rich text results, variable fonts, etc. Future TBD 2014 • Automatic diagnosis coding Future TBD Partial 2012 • RFID specimen tracking for high value/risk specimens Future TBD Future TBD • Cytogenetics – Flow Cytometry application Future TBD Future TBD • Molecular Diagnostics application Future TBD Future TBD

EPIC “BEAKER” LIS STATUS CHANGES 2009-2013

LAB OUTREACH FUNCTIONS/FEATURES

AVAILABILITY STATUS

DEC. 2009

AVAILABILITY STATUS

DEC. 2013

• Client Services Module including supplies Future TBD Partial 2012 • Client-level comments available for client services Future TBD 2010

• Alerts of client-specific instructions to technologist or client services staff Future TBD 2010

• Web based connectivity for laboratory test catalog Future TBD Future TBD • Fully integrated Call Management including results and client follow-up Future TBD Partial 2012

• Client supply inventory usage and replenishment alerts Future TBD Future TBD

• Telephone call monitoring, e.g. multiple issue logging, statistics by purpose, client, duration

Future TBD 2014

• Auto-Fax automatic alert of transmit failure Future TBD 2014

• Auto-Fax automatic log of success/failure Future TBD 2014

• Send-Out reference lab interface include a "received" at performing lab status Future TBD Future TBD

• Send-Out reference lab expected result completion date (TAT expectation) Future TBD 2012

• Accept "foreign" barcodes on labels from interfaced outreach clients-process without relabeling

Future TBD Future TBD

• Send PDF reports to client EMR's Future TBD Future TBD

• Courier mileage reports Future TBD Future TBD

• Courier operations statistics, e.g. specimens collected, missed specimen pickup, Future TBD Future TBD

• Patient Service Center Report/Utilization Reports Future TBD 2012

EPIC “BEAKER” LIS STATUS CHANGES 2009-2013

LAB BILLING/ACCOUNTS RECEIVABLE FUNCTIONS/FEATURES

AVAILABILITY STATUS

DEC. 2009

AVAILABILITY STATUS

DEC. 2013

• Key indicator tracking (online view of site-assigned key indicators) Future TBD 2012 • Charge bundling - automatic unbundling Future TBD 2012 • Management or marketing reports Future TBD Partial 2012 • Utilization reports for managed care Future TBD 2012 • Discount schedule based on test volume ordered Future TBD 2010 • Ability to cancel a charge, but not the test Future TBD 2010 • 3rd party accounts receivable, e.g. insurance company, etc. follow-up work queues Future TBD 2010 • Multiple fee schedules on a client level Future TBD 2010

EPIC “BEAKER” LIS STATUS TODAY

SYSTEM MANAGEMENT FUNCTIONS/FEATURES

AVAILABILITY STATUS

DEC. 2009

AVAILABILITY STATUS

DEC. 2013

• "Wizards" to guide system table builders step-by-step through process with validation of data entries Future TBD 2012 • Automatic system build validation of "rules" improvements-e.g. abnormalities, deltas, calculations Future TBD 2012

BLOOD BANK FUNCTIONS/FEATURES AVAILABILITY STATUS

DEC. 2009

AVAILABILITY STATUS

DEC. 2013

• Blood Bank Transfusion Not Planned Not Planned • Blood Bank Donor Not Planned Not Planned

Generic Comparison- Our View Today Beaker LIS Best-of-

Breed LIS COST < Bundling may lower costs,

economies of scale > Licenses, Implementation

RISK > Multi-Site, Complexity Variations

< Interfacing

INTEGRATION > Yes, except blood bank < No, Interfaces

OUTREACH <= Missing some components >= Typically robust

IMPLEMENTATION <= Good tools, common nomenclature, Future TBD with rapid growth

>= Variable depending on company

FUNCTION <= Available, rapidly maturing >= More Mature, Proven

FEATURE < In Process > More Sophisticated

FIT > Integrated < Variable

FEEL > = Common look and feel <= Different Views

FOLLOW-UP = TBD as base grows > Depending on company

FINANCIAL >= Strong <= Some strong

FUTURE >= EMR +, LIS TBD <= B-o-B LIS companies TBD

How to Decide • Value of Integration for your hospital?

– Clinical data presentation – Clinical data completeness, continuity, consistency and

timeliness – Broader application of “expert” rules

• Overall cost of ownership – short and long term? • Gap analysis-Relative impact and importance of

“gaps” in functionality? • Arrange for onsite demonstrations of “Beaker” (or

other EWS LIS) and B-o-B candidates

How to Decide • Identify “Gaps” in functions and features:

– From demo as noted by lab staff – From CAP Today guides (LIS, AP, etc.)

• Prioritize “Gaps” e.g. critical, high, moderate, low • Quantify impact of “Gaps” on lab and hospital • Are “Gaps” significant enough?

– What is their impact on: • Staff requirements/workload • Productivity • Quality assurance • Outreach (growth, revenue, profitability) • Timeliness-turnaround of results • Service Levels • Patient safety

Hypothetical “Gap” Analysis – Core Lab

CORE LAB – HEMATOLOGY - CHEMISTRY FUNCTIONS/FEATURES DESIRED OR REQUIRED Available? Importance

$$/other Impact

• Ability to update automatically reference range of finalized results if correction made to patient age/gender Now C

• Multiple delta check range criteria including logarithmic range Now L

• Expert rules to prevent or allow add-on tests based on user-defined criteria Now-Partial M

• Dashboard presentation of key operational parameters in real-time (TAT, Pendings, STATs) Now H

• Inclusion of scatter diagrams in hematology reports (more images such as Electrophoresis) 2014 L

• Validity check sample age before allowing add-on test 2014 C

• Patient age recordable as hours Now C

• Two different specimen types on the same test 2014 C

• Ability to receive a PDF report over an interface from a reference lab Now M

• Ability to verify and release partial results, e.g. components of profiles or panels (Prompt to release final results of a panel when the panel contains multiple results)

Now-Partial H

NOTE: Functions/Features, Availability and Importance above are examples only and do not represent the actual capabilities of Beaker LIS or any EWS LIS

Hypothetical “Gap” Analysis – Anatomic Pathology

ANATOMIC PATHOLOGY FUNCTIONS/FEATURES DESIRED OR REQUIRED Available? Importance

$$/Other Impact

• Specimen in-process tracking within lab, e.g. as received at cutting, embedding, staining work stations

Now M

• Manual case number assignment or override Now C

• Slide etcher/labeler device interfaces Now H

• Cassette/Block labeler device interfaces Now H

• Word processing—standard tools (Word or vendor-specific) Now-Partial H

• Images/illustrations/external reports integrated in reports; ability to annotate images

Now-Partial C

• Pathologist co-sign report Now M

• Report format flexibility, rich text results, variable fonts, etc. 2014 H

• Automatic diagnosis coding Now-Partial M

• RFID specimen tracking for high value/risk specimens Future TBD L

NOTE: Functions/Features, Availability and Importance above are examples only and do not represent the actual capabilities of Beaker LIS

Hypothetical “Gap” Analysis – Lab Outreach

LAB OUTREACH FUNCTIONS/FEATURES Available? Importance $$/Other Impact

• Client Services Module Now-Partial C

• Client-level comments available for client services Now-Partial H

• Alerts of client-specific instructions to technologist or client services staff Now-Partial H

• Web based connectivity for laboratory test catalog Now H

• Client supply inventory usage and replenishment alerts Not Planned H

• Telephone call monitoring, e.g. multiple issue logging, statistics by purpose, client, duration 2015 H

• RFID specimen labeling Future TBD L

• Auto-Fax automatic alert of transmit failure Now C

• Auto-Fax automatic log of success/failure Now C

• Send-Out reference lab interface include a "received" at performing lab status Future TBD L

NOTE: Functions/Features, Availability and Importance above are examples only and do not represent the actual capabilities of Beaker LIS or any EWS LIS

Some Do’s and Don’ts DON’T’s DO’s

Evaluate only Best-of-Breed LIS Evaluate Both EWS and Best-of-Breed LIS

Ignore Valid Issues Raised by the C-Suite Prepare Rational Responses to C-Suite Issues

Ignore “Gaps” in B-o-B Only-Note EWS LIS“Gaps” Identify “Gaps” in B-o-B and EWS LIS

Assess Virtually All “Gaps” as “Critical” Assess “Gaps” Realistically, e.g. low, medium, high

Argue Without Backup Data Collect Evidence to Support Your Case

Rely only on Qualitative Factors Present Quantitative Impacts

Try doing this all by yourself Consider having an Independent Consultant help

Other Considerations

• Lab needs to be in charge of: – System deployment – Staffing – Goverance

• Lab needs a seat at the decision table • Lab needs to be part of Epic overall system

build – not just for Beaker*** *** Very important to be actively involved in test order and result view design and not leave it to IT!!

Summary • Although Epic's "Beaker" LIS is presently less mature, it has made

significant progress, is still evolving and developments are proceeding along a specified timeline.

• Depending on the laboratory’s environment and schedule necessary

to achieve its operational, quality, performance and business requirements “Beaker” or another EWS LIS may not (or may) prove to be a suitable choice for an LIS as part of the enterprise solution.

• An evidence-based assessment can be performed to determine the

feasibility or infeasibility of “Beaker” or any enterprise-wide LIS for your laboratory relative to a contemporary best-of-breed LIS.

• Quantify the impact of “gaps” in the EWS LIS compared to best-of-breed LIS to establish the relative benefits to the hospital.

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