Turning up the volume on lab automation
After a period of slow growth, the lab automation market is
again showing signs of life.
Interest in automation has blossomed, thanks to the chronic shortage
of medical technologists, increasingly attractive returns on investments,
ready availability of proven automation solutions, and evidence
from several installations in large and small labs that automation
can improve not only the bottom line but also quality, patient safety,
Wary of committing to a costly total lab automation overhaul,
many labs are choosing to focus on the front end of the test cycle—sorting,
aliquoting, and centrifuging.
"In our customer base, the bulk of the automation installations
have focused on front-end automation versus total lab automation,"
says Lee Green, CEO of Triple G Corp. "These are very business-oriented
labs, and they have found that, after crunching the numbers, this
is an approach that makes sense."
Early adventures in total lab automation in the mid- and late-1990s
often took excessively long in achieving returns on investments.
Today, labs that are focusing on the front-end process are seeing
"costs and payback times that are coming down into the two-year
range, which is much more acceptable," Green says. ROIs of this
scale make lab automation attractive for not only mid-size labs
but also, as the ROI time frame continues to shrink, for smaller
labs. In some cases, front-end automation is being extended to include
an instrument or two in what might be defined as a modular strategy,
one that allows labs to add automation stations and functions as
budget and other resource constraints permit.
As a result, the market for automation is picking up. Lab automation
pioneer Rodney Markin, MD, PhD, says the company he founded, Lab-InterLink,
will sign 15 contracts this year. "There are probably 50 to 75 automation
sites out there live right now, and depending on the size of the
system, there is a potential total market of perhaps as many as
3,000 clients," says Dr. Markin, professor and vice chairman of
pathology and microbiology and associate dean for clinical affairs
at the University of Nebraska Medical Center, Omaha.
Misys Healthcare Systems (formerly Sunquest Information Systems)
also sees a growing appetite for automation interfaces among its
laboratory information systems clients. From 1996 to 1998, the company
handled one automation interface. In 1999, that number grew to four,
in 2000 to five, and in 2001 it doubled, to 10, reports Elinore
Craig, Misys’ director of laboratory and financials product management.
"We sense that the automation market is on the verge of exploding,"
she says. In her view, the driving forces are largely economic and
pertain to the cost advantages of being able to replace full-time
equivalent employees with robots. "If only because med techs are
in such short supply, labs must find ways to dedicate their skilled
workers to skilled tasks, and if a robot can handle the less-skilled
tasks instead, then they need to look at this opportunity," Craig
Despite the welcome signs of growth, challenges remain. Even when
an automation system is implemented in phased steps over time, the
financial investment is significant. Though installation, training,
and maintenance are not as burdensome as they once were, they still
can be costly and disruptive. Finally, though interfaces between
automation systems and the LIS generally perform well, the software
systems involved can and should operate more harmoniously.
In the last few years, the role of the LIS vis-à-vis the automation
system it interfaces to has been transformed.
"When we first started doing automation interfaces five or six
years ago," says Misys’ Craig, "we thought that perhaps the automation
system would want all its direction and information from the LIS,
that the automation system would just be a dumb robot, basically
a conveyor belt, and that the LIS would have to run that belt."
Many automation systems, however, are so intelligent they need
only minimal information from the LIS and effectively control all
the processes and data once the tube is delivered to the lab. In
short, the automation system, not the LIS, is calling most of the
shots within the test process in an automated lab, including, for
example, managing rules activation, reflex testing, and delta checking.
In many cases, the role of the LIS is simply to uniquely identify
each tube, communicate the test codes associated with that tube,
and acquire and file the results at the end of the process.
As the two systems interact, unless they are carefully coordinated, questions
can arise about which system should handle what chore. And even as these questions
are answered, the two systems can create redundant data requirements, parallel
and even overlapping databases, and inefficiencies that can compromise the performance
of both systems and the laboratory.
Call for an LOS
A few of the more forward-thinking leaders in the lab automation
industry are inherently uneasy about the coexistence of automation
system and LIS. The two should be more tightly integrated, they
say, as has been done in other industries.
"If you look at complicated business systems in manufacturing
as an example, you will see that the manufacturing information systems
include process control along with the information about the product,"
says Dr. Markin. "If you go to GM, for example, and look at how
it manufactures trucks, you will find not only the process information
and all of the history of how a given vehicle was built [residing]
in the system managing that process, but also information about
who it was built for, who owns it, when it was ordered, was it a
special order, a routine order, and so on."
The parallel with the laboratory is self-evident. The potential
problems that can arise in the absence of an integration strategy
are perhaps less obvious.
"The issue is that in the laboratory, we now have two parallel
pathways of information technology that I believe should be fused
into one," says Dr. Markin. On the one hand, the LIS handles orders,
collates and reports results, assists with quality assurance, and
in some areas handles billing. The parallel system—the lab
automation system—represents a "huge overlap" with the LIS
in terms of the elements of its database, but it also contains a
"distinctly different, process-oriented database with information
about the history of the specimen, including its physical location,
historical tracking, its physical state—whole blood, plasma,
frozen, not frozen—and so forth," he adds.
If, says Dr. Markin, you were a process-control expert from GM
and you walked into an automated laboratory and saw these two largely
overlapping systems working in parallel, you would wonder if the
process could be improved. And in Dr. Markin’s view, you would be
"I think that the natural evolution of lab automation is to take
the [laboratory] information system and bolt that together with
the process or the physical automation system," he says. If you
do this, you get what he refers to as a laboratory operating system,
or LOS. Like any other traditional computer operating system, an
LOS would run the hardware and software components of the test process
and provide a platform for more advanced applications and databases.
The barrier to this level of integration of LIS and automation
system, say those closest to both worlds, is not so much technical
as cultural. The level of integration it presupposes would require
greater collaboration between the LIS and in vitro diagnostics industries,
and if history is any measure, that is not likely to happen anytime
"I always thought there was a terrific opportunity for these two
domains to be more integrated than interfaced, but it’s never happened,"
says Bruce Friedman, MD, professor of pathology at the University
of Michigan Medical School, Ann Arbor. Why not? "For one reason,
the IVD industry has traditionally been very large compared to the
LIS industry, which has tended to be a world of smaller shops,"
says Dr. Friedman. "As a result, I think the [IVD manufacturers]
just don’t feel compelled to cooperate closely with the LIS vendors."
There are also, suggests Dr. Friedman, the underlying cultural
differences. "The IVD space is mainly controlled by engineers, who
work under very heavy scrutiny from the FDA," he says, "and who
tend toward a very fastidious engineering mentality that prohibits
bringing products to market until they are fully tested." By contrast,
the LIS world long ago accepted as fact, as have most software developers,
or engineers, that software never goes to market in a fully perfect
form, and that theirs is a world in which products are always evolving
and being revised and upgraded, even while they are being delivered
to and used by customers.
Integration at the level Drs. Markin and Friedman envision raises other questions,
including, for example, that of performance. Says Sue Masarik, laboratory manager
at Chicago’s Northwestern Memorial Hospital, "There’s a lot of overhead to big
integrated, number-intensive systems, and when you hook something that is as
computer-intensive as an LIS can be into it, you very often see performance
hits and slower response speeds, even with the fast computers and networks we
generally have available today."
Beating the ROI game
In the meantime, a laboratory that wants to deploy automation
must make its case on interfaces and projections for returns on
investments. Most laboratory professionals realize that meeting
or beating those estimates can make or break their management and
their future. The good news is that there are a growing number of
clear-cut cases where laboratories have achieved compelling investment
returns in a complex, staged lab automation installation.
Take, for example, the laboratory managed by Leo Serrano for the
West Tennessee Healthcare system. West Tennessee Healthcare, based
in Jackson, Tenn., is an integrated rural organization located midway
between Nashville and Memphis. With a service population of more
than 500,000 and an aggressive outreach program with about 1,000
clients, the lab handles sizable test volumes.
When Serrano arrived in Jackson six-and-a-half years ago, he was
handed the job of doing more with less—specifically, building
an outreach program with FTE constraints. "I was hired with the
understanding that we would expand our outreach and increase our
market share," he says. Serrano, executive director of laboratory
services, realized immediately that the lab, then organized in a
way that was more suitable for the late 1960s, needed a significant
overhaul if it was going to be able to handle such growth.
Relying on his background in management engineering, Serrano conducted
a workflow analysis and came to an initial conclusion that hematology
was one of the major bottlenecks. After reviewing several possible
automation solutions, he invited Sysmex to study the lab and conduct
a workflow analysis. Sysmex’s conclusions closely matched his own,
lending credence to the vendor’s proposal to incorporate the laboratory’s
analyzers into an automation system.
"We took the proposal to the board, promising them that it would
allow us to reallocate three FTEs, which is a very real benefit
in a rural location like ours where it is particularly difficult
to recruit med techs and other lab staff," Serrano says.
The success of the hematology line has far exceeded expectations.
Instead of saving only three FTEs, the lab was able to reallocate
five FTEs and generate a positive ROI in 23 months. The lab also
improved turnaround time for routine testing and absorbed increased
test volumes. "At the time we were doing about 400 CBCs a day,"
recalls Serrano. "Today, we’re doing between 900 and 1,000 a day."
With this initial success under their belt, Serrano and his team
began to consider other areas in the lab where automation might
pay off. "We then took a look at the ’other side of the room,’ as
we call it—chemistry, immunochemistry, and coag," he says.
West Tennessee has one of the premier cardiac programs in the state
so it performs a lot of anticoagulant work—about 500 samples
a day, according to Serrano.
Once again, his group conducted a thorough workflow analysis and
reviewed several vendor offerings. They decided to implement a six-station
system from Lab-InterLink that promised to consolidate much of the
immunochemistry work, which was scattered throughout the laboratory.
The lab knew what it needed in the new automation system. "We
wanted a system that was totally open, that did full front-end processing,
including not only centrifugation but decapping," Serrano says.
"We wanted a system that was smart, that could communicate well
with our LIS, and that was rules-based."
The product had to be able to base rules on the automation system
or the LIS, or both. Lab-InterLink software includes rules, as does
the lab’s Meditech LIS. Before the project began, Serrano wondered
how well the LIS and the automation software would mesh.
"If you’ve had any experience with automation, that’s the big
scare—how the LIS and the process-control system will work
together," he says. In his case, the worry was unjustified. "The
LIS portion of the installation turned out to be the easiest," he
says. "Between Lab-InterLink and Meditech, we were able to create
a combined system that thinks pretty much like a tech."
The system permits autoverification and release of results, knows
where the sample should go after it reads the bar code and queries
the LIS for additional necessary information, knows where the specimen
must be decapped, understands a user-defined centrifugation time,
and much more.
Cost was, of course, a concern, especially since the state of
Tennessee requires a Certificate of Need for projects that exceed
$1 million. To avoid the CON requirement, the lab split the project
into two phases, each costing less than $1 million. Phase one, involving
front-end processes and four stations plus back-end archiving, was
completed in December 2000. Phase two, now underway, will allow
immunochemistry and coagulation specimens to be sampled directly
from the automation track and should be completed by the end of
Serrano and his colleagues again beat their ROI projections. At
the project’s outset, the ROI was estimated at 31 months. "We actually
achieved that sooner than we expected and are now at 27 months,"
Serrano says. "Overall, automation to date has saved us about 11
FTEs, which we have reallocated."
Turnaround times have improved as well. From the time a basic metabolic panel
specimen reaches the lab to when results are available in the emergency room,
for example, is now 19 minutes, and a CBC turnaround time with differential
is 16 minutes, and without differential nine minutes. Serrano makes no secret
of the fact that he is pleased with the results of his automation endeavors,
his internal and external partners, and, most of all, his staff.
The process is the point
Being able to replace costly, imperfect humans with reliable,
accurate, depreciable machines—and in so doing improve patient
care—is, of course, the main appeal of lab automation technology.
And while it’s true that most labs undertake automation projects
primarily to reduce and reallocate FTEs, some argue there are other
benefits that are not as self-evident but are equally, or perhaps
At Northwestern Memorial Hospital, a laboratory team under the
direction of Kenneth Clarke, MHA, MBA, is pursuing a vision of automation
that is more broadly focused than just ROI. "We automated for one
basic reason, one that had a lot of unknown and perhaps unknowable
benefits, and that was to improve our process," says Clarke, who
is administrative director of pathology laboratories.
In Clarke’s view, many of the most powerful benefits of automation
cannot be known in advance. "Any article on automation spells out
the same four or five benefits—FTE efficiency, improved consistency,
better quality, faster turnaround time—and we had all those
things in mind too," he says. "But we think there are a whole set
of things that we can’t know in advance, benefits that will help
us, the hospital, patients, and all the users of the lab, especially
Clarke rejects the strategy of piecemeal, phased, staged, or modular
"We disagree with people who think front-end or modular automation
is the way to go," he says. "We understand the benefit, but we don’t
think you can really improve the process by just dealing with the
parts of it." These strategies still require some sort of manual
intervention or system-to-system handoff, he adds. "We’ve toured
labs that have spent millions on automating some components but
not the $50,000 needed to tie those components together."
Today, one year into its project, the Northwestern Memorial Hospital
laboratory has one Beckman Coulter chemistry line that is up and
running, and a second, two-track system with an operational coagulation
line and a hematology line that is six months away from going live.
So far, one of the unpredictable benefits pertains to the back
end of the process. Refrigeration installed as part of the automation
venture has made it possible to automate the add-on testing that
typically takes place after an initial test series has been ordered—and,
here, the automated process does not need human intervention.
Says Mark Wasielewski, specimen-receiving coordinator: "When we
put an add-on into the system, it automatically goes to the refrigerator,
pulls out the specimen, runs the test, and autoreleases the results.
No one at all needs to know about it, other than the individual
who actually ordered the test."
After Northwestern implements an order-entry system hospital-wide
next year, it will be possible to activate this function remotely,
from the floors or even off-site. The system is already being used
in Northwestern’s emergency department. "As we speak," Clarke says,
"someone in the ED could be ordering a test and the system could
be finding that tube in the refrigerator, pulling it out, sending
it down for testing, running the test, releasing results automatically
back to the system, then sending the sample back to the refrigerator,
all without any of us in the lab even knowing that any of this is
Inspired by the success of this approach, the laboratory has taken
it a step further. It is developing a "draw-and-hold" process for
the emergency department. "As a patient comes in, the emergency
department will draw blood, and we will put that specimen on the
line before any tests are ordered," Clarke says. "Then, when a test
is ordered for that patient, this entirely automated add-on process
will be called up—the system will pull the sample, already
centrifuged, out of the refrigerator and quickly run it, and that
will cut turnaround time significantly." In fact, the laboratory
has already cut its turnaround time to the emergency department
for troponin from 90 minutes to 45. With this draw-and-hold process,
Clarke and his staff foresee being able to cut that time in half.
"This has really eased some of our workload," says laboratory
manager Klaus Nether, "because we don’t see anything in terms of
the add-ons—we just pull our worksheets and the test is already
on it and the specimen is already here."
Along with the unpredictable benefits come more predictable ones,
and Clarke’s team points to two they have already seen. The first
is a reduction in errors.
"People make mistakes," says Wasielewski. "As we move forward
and bring more automation into the hospital, especially with respect
to the labeling that will become available in the order-entry process,
we will see fewer people handling the specimen." Tubes will arrive
in the laboratory already labeled, and staff will simply put them
on the line. By contrast, nurses now fill out a lab requisition
and hand label the tube, a step that can introduce error. Then they
send the specimen to the lab, where a staff person must key in basic
information and relabel the tube with a bar-code label, another
step that can introduce errors. "The fewer people who have to handle
the specimen," Wasielewski says, "the fewer the number of errors
that will occur."
At the same time, being able to enter orders on the floors will
help shift workload out of the lab and into other parts of the hospital—making
it possible for the lab to take on more business. "The automation
line and the instrumentation we have now are capable of processing
a lot more throughput than we’re pumping through it today," Wasielewski
says. "Currently we process about 2,000 tubes a day, but we’re capable
of five times that volume."
Lab manager Nether also names increased throughput as a benefit
of the lab’s automation investments. "We will be able to bring more
testing into the lab," he says. "And even then, I don’t foresee
that we will need to hire another FTE since a lot of the workload
from the front end has been taken care of."
Rough spots remain, however. And some are caused by functions
not yet being available in the LIS, which is scheduled to be upgraded
soon. "We have to validate that every tube that has been ordered
has arrived," says Vida Jesewitz, LIScoordinator. But at the moment,
"certain pieces of information we need to do that—receive
times, collect times, and so on—are not present in the LIS
when the tube arrives. Staff members still have to go into an order-entry/modification
function on our system and manually enter what we have and have
Eric Skjei is a writer in Stinson Beach, Calif.