Effective Lab Automation White Paper Comp Pro Med

2017-03-29

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WHITE PAPER

Effective Lab Automation
How modern LIS systems increase
productivity while driving down costs

Effective Lab Automation
How modern LIS systems increase productivity while driving
down costs
Abstract
From staffing issues to increased regulatory oversight to
potential fee cuts, today’s labs are facing a daunting
gauntlet of challenges. A Laboratory Information System
(LIS) is an essential component for effective lab
automation that increases productivity while driving
down costs. This white paper examines what to expect
from a full-featured LIS and how to pick the best one for
your organization.

Challenges for Today’s Labs
Today’s labs are serving a vital function in delivering
improved outcomes for
patients. However, labs are
facing a number of challenges
from staffing to cost increases
to potential fee decreases.
And that’s just for starters. In
order to address these
challenges, small clinics and
large hospitals alike are
turning to lab automation
solutions to drive efficiencies.
Historically, these digital solutions were developed for
specific applications, such as medical billing. Over time
various healthcare systems emerged, including Practice
Management Systems (PMS), Healthcare Informatics
Systems (HIS), Electronic Medical Records (EMR),
Electronic Health Records (EHR), and Laboratory
Information Systems (LIS). Some Information
Technology (IT) vendors bundled all these capabilities
into an all-encompassing solution, but such solutions

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tend to sacrifice in-depth functionality for overall system
requirements.
A best-of-breed LIS can deliver a full set of features at a
lower cost, integrate seamlessly with other healthcare
systems, and be an essential component for increasing
productivity and driving down costs.

What is an LIS?
Clinical laboratories have been able to choose from a
variety of commercial LIS since the 1980s. An LIS is
designed to process, store, and manage patient medical
lab test records. In addition to associating the right test
with the right patient,
cumulative test results can be
examined to investigate
demographic and other statistics
of importance to the medical
community.
Initially, LIS were standalone
solutions that handled basic
medical test data from order
entry to results processing.
Today, LIS can accommodate a variety of medical testing
needs, from inpatient to outpatient, from hematology to
immunology, and now even to molecular genetics. There
are specialized LIS for police crime labs that require strict
Chain of Custody procedures, and there are LIS for
veterinary labs that require species-specific functionality.
The common denominator is the medical test record and
how well the LIS organizes and manages the data.

Effective Lab Automation: How modern LIS systems increase productivity while driving down costs

In a sense, the LIS is a component or module of the larger
EHR solution that contains non-test related patient data,
such as records of hospitalization, visits to healthcare
professionals, patient insurance, etc. As such, how well
the LIS interfaces with the EHR solution is a critical
driver for the overall cost and efficiency of the LIS.

collection and reporting. This all needs to be done in
compliance with state and federal regulations, which
requires flexibility on the part of the LIS since these
regulations often change.

What to Expect from an LIS

LIS selection should be approached using standard
project management methodologies. In addition, because
the final decision crosses departments, the LIS project
team should involve not only the lab but also purchasing

At its core, an LIS is a highly sophisticated relational
database that manages medical lab test records from
requests to results. Because data is captured digitally, the
LIS can reduce the time spent managing test records as
well as reduce transcription errors.
Every LIS will provide a
methodology for lab test
management. This includes a
range of features and functions
that perform patient lab test
ordering and tracking;
interfaces to lab instruments;
interfaces to PMS, HIS, EHR,
EMR and billing systems;
results processing; data
storage; reporting; quality controls; and, statistical
analyses. Within each of those areas, the LIS will have a
range of capabilities designed to streamline the patient
test management process.
However since every lab is unique and has different
workflows and priorities, it’s wise to specify the LIS
attributes most important to yours. Then, when
investigating different LIS solutions, you can ensure that
the LIS meets your specifications, and not get sidetracked
by unnecessary features and functions that add to the
overall cost, but won’t actually help your organization’s
workflows.
In essence, with any LIS the goal is to expedite test record
processes, interface seamlessly with other healthcare
applications and instruments, and automate data
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How to Evaluate Commercial
LIS Offerings

and IT. Purchasing will want the LIS to integrate with the
billing system. IT may have infrastructure requirements
that the LIS must accommodate.
The decision is a team effort.
However the search for an LIS
should start in the lab, since the lab
is the primary LIS user. The
Laboratory Manager will need to
ensure that the LIS not only meets
all the needs of the lab with regard to
managing and reporting test results,
but also confirm that there are userspecific capabilities for physicians and technologists alike
that enable them to perform their LIS-related activities
most efficiently.

User Interface
A simple and elegant user interface is vital to successful
user adoption. The less complicated, the better. Easy to
find, understand, and use functions make access to
patient test data intuitive. For instance, test ordering,
ICD-10 checking, and test result entry and verification
are just a few of the items that should be no more than a
glance and a keystroke away. In fact, the majority of test
activity should be performed and accessible from the
main screen; users should not waste time navigating
through numerous folders and screens to input or retrieve
data.

Effective Lab Automation: How modern LIS systems increase productivity while driving down costs

Functionality & Flexibility
The LIS should offer a full set of functions for
applications that range from pathology to hematology to
toxicology. Determine whether specialized functionality
is included in the LIS or whether there are extra costs for
adding application-specific “modules.” Regardless of how
you will use the LIS, standard functions include userdefinable lists, rules, comments, and result screens;
automated results entry and sample ID number
generation; automated and ad hoc reporting; individual
and batch request and results entry; multiple range
definition based on age, sex, and species; duplicate order
checking; and, easy manual entry for offline results. These
are the minimums; expect to see many more functions in
a robust, full-featured LIS.
You’ll want to ensure that key
industry standards and codes
are supported, including
SNOMED CT, LOINC, HL7,
NDC, and ICD-10. Even if
your initial needs are modest,
don’t ignore the LIS scalability
to accommodate future
growth. Functionality is driven
by system flexibility. For
instance, question how the LIS addresses changes such as
the recently implemented ICD-10 codes. How long did it
take the LIS vendor to integrate the ICD-10 code
changes? Was it well ahead of the deadline? The answer
will provide clues as to how responsive the LIS vendor is
for delivering new functionality.

via a standard HL7 or ASTM interface. Integration also
includes enabling access to the LIS by remote clinics or
other satellite healthcare stations. Thus web-enabled
features for remote access are important in busy,
dispersed medical environments.

Reporting
Reporting is a critical attribute, thus the LIS should
enable an unlimited number of user-definable report
formats. Custom reports should not incur extra costs.
Standard report templates that should be included with
the LIS include patient cumulative summary reports with
graphing; workload reports by category, doctor, and
department; charge code reports with CPT and ICD-10
codes; interim patient reports; laboratory report of
records, patient chartable
reports, and more.

Quality Controls
Quality Control (QC) features
ensure regulatory compliance.
Look for a fully auditable LIS in
which all results are stored, not
just summaries. The ability to
perform Levy-Jennings plots
and charts, cross control level checking, and a range of
reporting from daily to monthly to history to summary
reports by date ranges should all be accommodated by
the LIS. The LIS should comply with CLIA, JCAHO,
HIPAA, HITECH, and state and federal regulations.

Data Storage
Interfacing & Integration
All LIS will enable interfacing with a variety of other
healthcare applications and lab analyzers and
instruments. The challenge of interfacing goes beyond
this basic premise and into the realm of seamless
integration. Virtually any comprehensive LIS should be
easily integrated to any other clinical information system
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How patient data is stored can dramatically impact
system efficiency and responsiveness. Understand the LIS
system configuration. Are multiple redundant databases
supporting the LIS to ensure zero downtime or does the
LIS vendor provide statistics for average system
downtime? Question the LIS data ownership and access
to it. The majority of Software-as-a-Solution (SaaS)

Effective Lab Automation: How modern LIS systems increase productivity while driving down costs

system vendors own all the data, including yours. Ask if
data can be exported to a standard format such as CSV for
use in spreadsheet programs. Many LIS make it very
difficult if not impossible to retrieve and export patient
data, yet this capability is the hallmark of a flexible system.

Statistics & Analytics
Beyond reporting, medical laboratories should have
sophisticated statistical and data mining tools at their
fingertips to perform real-time data analytics on patient
test data. Look for an LIS with population normal range
data mining tools. Examine how the LIS performs
different statistical reports, such as population studies.
The LIS should perform workload accounting
automatically, including the ability to set accounting
weights for customized reporting capabilities.

System
Demonstration
An online demonstration of
the LIS should be done early
in the process to determine
how flexible the system is for
meeting your organization’s
specific requirements and to weed out the systems that
don’t meet those requirements. Ask to see certain
features. Watch how easy it is for the LIS vendor to show
how these features work. Can the system perform specific
tasks on your requirements list? Are regulatory
requirements embedded in the system, such as ICD-10
code screening that automatically confirm accuracy or
flag tests if the code does not match?
How long has the LIS vendor been in business? A
seasoned LIS vendor will have greater knowledge of
industry challenges and deliver the ability to consistently
offer a compliant LIS solution over time. Ask about
customer support. Does the LIS vendor provide direct
live support from system engineers or will you be routed

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through a phone tree? Are remote support capabilities
available via the Internet? How is the LIS vendor
organized; e.g., is it focused on system development or
are there more sales people than system engineers? An
LIS vendor that is weighted toward increasing their
bottom line at the expense of product development is not
focused on customer satisfaction.
There are many criteria to weigh and discuss before
determining the best LIS for your organization. Once you
are close to a final decision, it’s also important to evaluate
the costs associated with the LIS.

Calculating the True Cost of an
LIS
LIS have been proven to increase workflow efficiency and
cut lab costs, however there are a
number of factors besides system
price that affect the overall cost
before a return on investment
(ROI) can be achieved. Bear in
mind that an LIS is not shrinkwrapped off-the-shelf software. It
is custom software designed to
streamline the workflows in your
unique lab set-up.
Before you talk to any LIS vendor, create a Functional
Requirements Specification (FRS). Your FRS should
include equipment, systems and capabilities. Start by
creating a list of all analyzers, reference labs, and any
systems the LIS needs to connect with to determine hard
costs. Determine if you need to replace or add any
equipment when you implement the LIS or if you can use
existing equipment. Include not just computers that will
be used for the LIS, but also printers, bar code printers,
modems, etc. Add these hardware costs to the system
cost. Consider your wants versus your needs carefully.
The accuracy of your list will enable you to accurately
estimate project costs.

Effective Lab Automation: How modern LIS systems increase productivity while driving down costs

The LIS will need to interface with other clinical systems
and equipment. Some LIS include direct bidirectional
interfacing but others require third-party interfaces to
connect to other systems or instruments. What is the cost
of those third-party interfaces? Will the LIS interface to
all the systems it needs to integrate with, including patient
management systems, billing, reference labs, etc.?
Remember that if the LIS uses third-party middleware for
the instrument interfaces, both the LIS and the
middleware need to be updated whenever there is a
change, which complicates any update process and might
incur hidden costs downstream that you need to consider
in your budget.

but 20% will need to be customized to your organization.
Discover whether those functions are user-configurable
or if you will need to pay extra to the LIS vendor to have
those functions implemented. Vendor consulting fees to
create functionality can add up quickly, and affect the
overall cost of the system.
Is the price of the LIS based on the number of users,
concurrent users, or the number of seats (workstations)?
Each scenario will generate a different cost. How much
does it cost if you want to add more users or seats in the
future? If you choose a bare-bones solution, are you also
eliminating required capabilities from your FRS that will
cost extra to add later?

In addition to hardware and interfacing requirements,
examine your workflows and procedures. For instance, do
you schedule all nonemergency tests (such as
thyroid tests) for a specific
day each week and batch all
requests for that day? If so,
can the LIS perform batch
processing, or are you
expected to change your
workflows to accommodate
the LIS infrastructure?
Batch processing is a
standard function, but not all LIS offer it. If you need to
implement a new workflow, this will change your
processes and that often incurs additional labor costs.

How does the LIS vendor handle upgrades to the system;
e.g., are they included in the initial cost of the LIS or will
you need to pay to upgrade and
what is the cost? How often are
upgrades released? For that
matter, how does the LIS vendor
differentiate between updates and
upgrades? Will you be charged for
either while under warranty or a
service agreement? For instance,
the LIS might require software
modifications to comply with
government regulations such as changes to meaningful
use requirements. Does the LIS vendor consider this an
upgrade or an update, and what is the cost to you?

Once your FRS is determined, the various LIS offerings
should be reviewed against those requirements, and a
short list of LIS vendors created. Get specific details from
those LIS vendors on what costs are included and what
costs are extra. For instance, if you need to import
existing patient data into the new LIS, determine what’s
involved with performing this activity and whether it
incurs additional costs. Most LIS roughly follow the 8020 rule: 80% of the functions you need will be standard,

Many LIS vendors promote consulting as an add-on to
the LIS support contract. Even if the functions are userconfigurable, changing a workflow in many of the LIS is
so complicated that users often pay hundreds of dollars in
consulting fees to have the LIS vendor perform the task
after the contract is signed, causing scope creep and
budget overruns. How can you determine if this will be
the case up front? Ask the LIS vendor what their process
is for assisting customers with workflow configurations
and the associated costs. An easy to use LIS is exactly

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Effective Lab Automation: How modern LIS systems increase productivity while driving down costs

that, and the LIS vendor can readily walk you through the
configuration steps as part of the support contract.
Asking tough questions up front helps ensure that you
select an LIS that isn’t subject to scope creep and that you
aren’t surprised with hidden costs downstream.

Summary
Today’s lab environments rely on cutting-edge tools to
supplement previously manual processes associated with
patient lab test management. Full-featured LIS have
become a mission-critical tool in supporting those
activities, particularly in an era of increased regulatory
scrutiny and oversight.
An LIS that is installed and operational in a variety of
clinical settings, has proven flexible enough to
accommodate a variety of functions as well as different
disciplines from hematology to toxicology.
Most LIS realize a rapid ROI if the lab is ordering at least
50-75 tests per day. However, if there have been
transcription errors, lost lab charges, or you plan to grow
lab revenue streams with new service offerings, an LIS can
dramatically improve any lab’s operations.
A full-featured LIS is one tool in the organization’s
arsenal that has proven to increase laboratory and
organizational productivity and profitability.

About Comp Pro Med
Comp Pro Med has been providing clinical laboratory
information solutions since 1983. Our Polytech LIS
allows clinical laboratories to expedite patient record
management processes, interface seamlessly with any
application or instrument, and automate data collection
and reporting - all with zero downtime, and all in
compliance with state and federal regulations.

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