Breaking bottlenecks at the front end
On the surface, Kaiser Permanente in Berkeley, Calif., would
appear to be a fine candidate for a total laboratory automation
system. Its regional reference laboratory, part of The Permanente
Medical Group Inc., performs 70 percent of the tests ordered on
3 million health plan members in northern California-some 12 million
tests a year. In a 1997 continuous quality improvement project,
the laboratory identified its manual sorting of 12,000 tubes a day
as a problem area that urgently needed a cure.
"There was a bottleneck and the tubes were taking a shift and a
half to get sorted. We were interested in growing the business.
But our turnaround time was getting longer-and you can’t grow when
you’re giving poor service," says Gene F. Pawlick, MD, director
of the laboratory.
Instead of turning to a comprehensive automation system, however,
TPMG chose a modular, task-targeted system from Roche Diagnostics-one
that automated the preanalytical processes of sorting, decapping,
and aliquoting-and a postanalytical archiver. "We considered TLA,"
Dr. Pawlick says. "But we decided not to go in that direction."
Columbia-Presbyterian Medical Center in New York City drew a similar
conclusion following its consolidation three years ago. It chose
last year to install a Labotix system, including an automated centrifuge,
an uncapper, an automated aliquoter, and a specimen sorter.
With more than 2,000 accessions a day, why not a total laboratory
automation, or TLA, system? "We didn’t think it was economically
feasible," says Daniel Fink, MD, director of the core laboratory,
located at New York Presbyterian Hospital, Columbia Presbyterian
Center. When the hospital looked at preanalytical automation only,
"We felt we could get 80 percent of the benefit [of automation]
for 25 percent of the cost," he points out.
Gary V. Catarella, MT(ASCP), MBA, vice president of laboratory
services at Catholic Health System in Buffalo, NY, says even though
the central laboratory there runs 1.4 million of the 2.7 million
laboratory procedures the system bills each year, it did not have
the volume for TLA.
When it started setting up the central laboratory for five hospitals
last November, Catholic Health System installed a Beckman Coulter
front-end system. "We started considering front-end automation when
we were doing a business plan for our centralization and looked
at the volume of specimens we’d be receiving," Catarella says. "We
knew we needed to reduce some steps, standardize our testing, and
streamline our processing, so that is primarily why we were interested."
Move toward modularity. The choices these laboratories made reflect
a broader trend, says Robin A. Felder, PhD, director of the Medical Automation
Research Center and professor of pathology at the University of Virginia, Charlottesville.
It’s a shift from full-scale automation solutions to more contained or modular
approaches. Stand-alone preanalytical devices that may be coupled to TLA systems
but that can also operate independently, he believes, are the next wave in laboratory
automation and will soon be "sold like popcorn." His prediction: "This is where
automation will finally get its foothold and start proliferating."
The pressures to automate are legion. Top-level mandates to reduce
laboratory costs have become routine and continue to prod many hospital
laboratories to explore automation approaches. But the severe shortage
of skilled technologists and technicians is now an equally compelling
factor. A few short years ago a personnel glut led training programs
to shut their doors throughout the country. Thanks to the prolonged
economic boom, however, human resources departments are scrambling
to fill openings in the laboratory.
A recent survey by the Clinical Laboratory Management Association
found that about 24 percent of managerial and technologist positions
are unfilled, and nearly 40 percent of laboratories say there is
an insufficient applicant pool. "Obviously, there’s a huge labor
shortage in the laboratory business. There just aren’t enough people,"
says Ronald Berman, marketing manager for clinical chemistry and
automation at Beckman Coulter.
Coinciding with the shortage is heightened concern about medical
errors and a possible shift in philosophy about how to prevent them.
The Institute of Medicine report, "To Err Is Human," released last
year, unsettled the public with its estimate that 44,000 to 98,000
deaths-at least the equivalent of a packed jumbo jet crashing every
three days-are caused by errors made in the hospital.
The report also shook up the medical establishment with a clear
message and a new mandate: Human error is inevitable; stop looking
for individuals to blame; focus on improving procedures and processes.
"Patient safety," the IOM stressed, "does not reside in a person,
service, or department, but emerges from the interactions of components
of a system."
The White House and Congress have launched initiatives to act on
the IOM’s recommendations. But the report has already infused quality
assurance efforts with a new urgency, at the same time that manufacturers
are making it easier to automate. A growing number of them are "unbundling"
total laboratory automation systems and offering attractively priced
equipment that automates the most labor-intensive functions of the
laboratory-the preanalytical area.
"It’s a very manual area, and there are no economies of scale,"
notes Dr. Fink. Without automation, "if you double the workload
you have to double the people."
Second to the economic advantage, however, is a combination of
quality and safety, says Peter Urwin, former president of Labotix
and now senior vice president and general manager of Lab-InterLink.
"We know of laboratories where people suffered serious injuries
from broken tubes, mistakes were made using the wrong specimens
on tests, tubes have been misplaced. Automation helps reduce that."
At least six companies are marketing or preparing to release products
designed to reduce the hands-on work needed at the front end. Ontario-based
Labotix recently merged with the U.S. firm Lab-InterLink; together
they have some two dozen installations of preanalytical equipment.
Roche Diagnostics and Beckman Coulter have completed beta testing
and have several installed systems, and Olympus, too, offers a preanalytical
product. Abbott/Tecan’s Genesis FE 500 system is in its final clinical
trials, and the company plans a release shortly.
As a result, laboratories that lack the volume to justify total
laboratory automation today are finding it feasible to make the
move gradually-or even planning to automate only functions at the
front end. "It’s obvious that this technology is perfect for small,
medium, and even large labs," Dr. Felder says. "Laboratories with
300 or 500 samples a day can do them pretty readily with human labor.
But preanalytical systems are reasonable for laboratories conducting
tests on 1,000 samples a day, and with more than 1,000 samples,
laboratories will want to consider multiple copies of these processors."
Blurred terminology. Although the term TLA describes a number
of approaches, generally it indicates a comprehensive system that
couples conveyor belts for transporting specimens with discrete
workcells to provide centrifuging, sorting, routing, and actual
placement of the tubes in and out of the analytical systems.
But the distinctions in current use are not clear-cut. Urwin sees
a blurring of the line between partial and total automation. "It’s
definitely true," he says, "there are more people interested in
front-end perspectives, and many people look at that as a way to
enter the market. But as we start discussing it, they invariably
want to put some instruments on line too. Is that front-end automation,
or TLA?" Many of Lab-InterLink’s customers who have not technically
plunged into TLA have nevertheless purchased pre- and postanalytical
Lab-InterLink, he notes, sells a mixture of systems. "We offer
modules to build anything from preanalytical to full-blown automation.
For example, a laboratory in North Hollywood is running in excess
of 1,500 tubes an hour, yet just using front-end automation. That’s
a pretty big lab, and we have others running less than 1,500 tubes
a day that have close to total automation."
Urwin agrees that smaller hospitals are showing more interest in
automating their laboratories. "This business, like all business,
started with the early pioneers. They tended to be the larger labs
that had more money, were quicker to experiment, and found automation
easy to justify. The market now includes a second tier of laboratories
who were waiting to see how the early adopters fared. Now people
are looking at it and saying, ’You mean it’s real? It actually works?’"
"We’re moving into a phase where we’re marketing to more conservative
laboratorians who want a stable, proven product, and don’t want
to take any risks," says Labotix marketing manager David Clarke.
Noting that TLA might have been oversold or too expensive and garnered
a bad name perhaps because of some early installations where TLA
did not go so well, Clarke says that, in its most recent brochure,
Labotix doesn’t refer to TLA at all. "We actually de-emphasized
the terminology. We say we have complete systems, which include
preanalytical, analytical, and postanalytical automation."
A wider market. Laboratories in the United States have never
embraced TLA the way labs in Japan did starting in the 1980s. In
Japan, some 170 automation systems have been installed, while only
about eight percent of North American hospital and commercial laboratories
are even considered suitable for TLA. Among the key obstacles, Dr.
Felder points out, are the extent of consolidation of the laboratory,
its physical layout, the available market for laboratory services,
and the affordability of automation.
There are still hopes that total laboratory automation will become
widely adopted. Lab-InterLink and Labotix Automation have installed
several TLA systems in North America and Europe. The merged company’s
president and chief executive officer, Jack Holthaus, predicts the
TLA market will "grow significantly as hospital management realizes
that automation lets them provide safe, accurate testing while controlling
But, Dr. Felder says, "Given the limited market for TLA, automation
vendors had little choice but to develop modular workstations that
provide the scalability to accommodate the large variety of productivity
"Now labs are deciding they can essentially reduce TLA to its most
valuable elements," he continues. Rather than preparing to pay millions
of dollars for a TLA system, laboratories can gain key advantages
from automation in the $250,000 to $750,000 price range.
"I was interested in something that would allow us to be very flexible
and agile and respond rapidly to any change that might occur either
internally or externally," Dr. Pawlick says. Roche Diagnostics (at
that time Boehringer Mannheim) approached him after hearing TPMG
was experiencing a bottleneck in receiving and suggested that several
laboratories in Germany were solving that problem with preanalytical
So Dr. Pawlick traveled to Germany to see for himself. "I saw probably
six labs with these instruments and it was amazing the throughput
they had. They were light years ahead of what we were doing in the
States at the time. They had huge labs with a lower volume of people.
When I saw them in action I said, ’This is exactly what we are looking
That was how TPMG decided to select the Roche system, becoming
the first installation of Roche’s system in the United States and
its largest installation in the world to date. Dr. Pawlick calls
the task-targeted automation system a smashing success. "We no longer
get 12,000 specimens a day. It’s up to 16,000, basically without
any new FTEs in that area. So we’ve had a 33 percent increase in
work volume without adding any staff and with no compromise in turnaround
time, which is unheard of."
A simple addition at the post-analytical end also made it possible
to reduce staff, he notes. "As we did workflow studies, it became
very apparent that one of the great applications on tap was the
ability to archive specimens after they leave the test area." So
Kaiser’s laboratory bought four instruments dedicated to archiving.
Known as "Archie," the instruments record the row and position
number of the tubes electronically. "So if a cholesterol was done
three days ago, we can find which rack the specimen is in and pull
it out. Ten years ago that was all done manually and it was a real
problem." In this way, automating archiving has also eased the process
of doing add-on tests, Dr. Pawlick says.
Building incrementally. Tom Wilson, director of laboratory
integration marketing for Roche Diagnostics, explains the company’s
approach as a continuum of automation solutions, starting at the
task-targeted level and proceeding to TLA. Modular preanalytics,
launched in 1999, comes in different configurations depending on
the functionality customers require. Two other products, the PSD
I, a primary sorter and archiver, and the VS II, an aliquot system
that can also sort and archive, are now installed in nearly 30 sites.
"The market’s desire for TLA is significantly less than several
years ago. In fact, in terms of requirements, laboratories would
choose task-targeted automation 16 to 1 over TLA," Wilson says.
"But within that set, roughly half of those people would want to
have the ability to build incrementally toward a TLA solution in
the future. What it comes down to is that people have a vision-but
they want to manage risks and budgets and ensure their business
plans are met over a period of time."
Laboratories handling 500 samples or more per day make up Roche’s
major market, he says, but a hospital with 300 samples a day might
be interested if it is on an aggressive outreach campaign. Even
a 200-per-day customer with a high staff turnover at the front end
of the laboratory may be interested. "These are generally less skilled,
lower paid individuals, and if you have difficulty recruiting or
have a high turnover," Roche’s automation solutions can help, he
"We’ve talked to our customers for the last few years, and they
all need to improve productivity, reduce costs, and run more tests,"
says Jeff McHugh, Beckman Coulter’s vice president of diagnostic
commercial operations for the Americas. "The biggest opportunity
to get those kinds of improvements is on the preanalytical side,
Beckman Coulter, which introduced its Power Processor last year
as a stand-alone front-end automation system, shipped about 25 of
them last year and expects to ship another 40 to 50 this year. Although
a few sites have their Power Processor connected to an LX 20 to
automate distribution of the tubes to the analyzers, most of them
employ sneakernet-where a staff person picks up the sorted specimens
and walks them over to the different analyzers. Only about 40 percent
of them are potential candidates for the LX 20, the company estimates.
More than half of the company’s current customers now say they
are interested in some sort of front-end automation, Berman points
out. TLA systems are usually customized but typically would run
close to $3 million, whereas the Power Processor can be acquired
for around $450,000. "Because of the price changes, [the preanalytical
automation] is really getting down to the mid-volume accounts, the
200-bed hospitals," he notes. After two years of sales, Beckman
has found many customers now want to add accessories or options.
"They want to take a very logical, progressive approach," Berman
says. "They really seem to want scalability."
Beckman Coulter has installed at least as many systems in foreign
countries, largely in Europe and the Far East, as in the United
States. "Those customers are very similar," Berman says. "But they’re
not as willing to go to a core lab design to consolidate workstations."
Because there tend to be more turf issues among physicians who control,
say, an immunochemistry department, or immunoassay, these countries
have more of the traditional "silo" type of laboratory. "The core
lab is more of a U.S. concept, but it’s slowly being adapted worldwide,"
One of Beckman Coulter’s first customers to obtain striking results
was St. Mary’s Hospital Center in Montreal, the only CAP-accredited
hospital laboratory in the province of Quebec. In a recent assessment
of front-end automation’s impact on its turnaround time, St. Mary’s
reported that stat chemistry TAT improved by 28 percent, and telephone
calls from unhappy physicians dropped from 28 per day to fewer than
five. Immunoassay TAT improved by 47 percent.
Productivity, or reportable results per staff person, improved
by 17 percent, and even samples not processed on the automated system
improved: routine hematology by 36 percent and stat hematology by
29 percent. Although the TAT for coagulation did not improve significantly,
according to Ralph Dadoun, St. Mary’s vice president for corporate
and support services, the hospital correctly suspected that by automating
two thirds of the volume of blood specimens, it would improve the
entire testing process.
Cautionary voices. That is not to say there is universal
acclamation for front-end automation. When he was associate vice
president and laboratory director at Aultman Hospital in Canton,
Ohio, Scott Whalen, PhD, did research on front-end automation some
four to five years ago and found the options were limited. Aultman
chose to automate its high-volume chemistry, hematology, and immunoassays,
but not the front end. "When we looked at those very early systems,
the cost was quite high, and there were a lot of technical barriers.
There really weren’t any cost-effective solutions," Dr. Whalen says.
"When you look at automation in the area of doing tests, it’s really
a software-driven technology. Transport from one instrument to the
next is important, but more important is how the information is
handled," he explains. Front-end automation really brings in more
of the hardware-and hardware-associated problems along with it.
"For example, if you’re an outreach lab and physicians may use your
lab but for insurance reasons also use others, there may not be
standardization of tubes across all referring physicians."
That was one problem that made the cost of front-end automation
prohibitive, in his view, and he’s not sure how markedly the situation
has changed. At Aultman, "There probably was something that would
have worked, if our goal was a totally automated laboratory, but
the people doing that function were paid less and were extremely
efficient." Despite having 1.5 million accessions per year, "I didn’t
have that many of them even though there was a high volume."
In his current post as chief operating officer of Mt. Carmel West,
part of a three-hospital system in Columbus, Ohio, that has about
the same test volume as Aultman, Dr. Whalen is conducting the same
research. He says it is too early to conclude that front-end automation
is appropriate. Laboratories should evaluate vendors’ claims of
increased efficiency, he advises. In many cases, he believes, since
front-end labor tends to be less expensive, it may be just as efficient
to keep the process operating manually, unless the employment market
is so tight that the laboratory can’t find reliable people to do
On the other hand, he adds, a front-end system would probably reduce
the number of mistakes. "As a general principle, the number of times
you can decrease handling of the tube, you’ll decrease errors,"
he says, pointing to safety features of the newer systems that significantly
reduce human intervention in capping, uncapping, and aliquoting.
Alverno Clinical Laboratories in Hammond, Ind., was not actively
in the market for front-end automation in 1998 because it wanted
to finish consolidating before budgeting the capital expenditure
for automation. But when it had the opportunity to be a beta tester
for Roche Diagnostics’ PSD I, "We actually installed our first piece
of automated equipment almost three full years ahead of the plan,"
says James C. Sparks, PhD, president and CEO of Alverno, a not-for-profit
laboratory formed by the Sisters of St. Francis Health Services
to provide core laboratory services for its hospitals in northwest
Indiana and southern Cook County, Illinois.
After the PSD I and Roche modular analytics system were installed
in 1999, Alverno installed a modular preanalytics system early this
year. "There was a huge bump in our ability to be productive," Dr.
Sparks says. "What we’ve done is essentially tripled our capacity
to handle chemistries, drugs of abuse, therapeutics, and, eventually,
immunochemistry without adding staff."
While the laboratory has not been automated long enough to assess
quality differences, "I can tell you there is a qualitative difference
in the technologists’ ability to get the work done. They’re happier
people, and our processors, rather than being stuck on rote jobs-look,
spin, rack, and send-actually are able to use technology to do those
things, and they’re upbeat too."
The core lab connection. In many, if not most, laboratories
that opt for front-end automation, the process is inseparable from
the creation of a core laboratory. "You have to have a pretty significant
test volume," Dr. Sparks points out, "so core labs are the major
market. We joke that we need to ’feed the monster.’ The expense
isn’t outrageous, but it’s not insignificant, and to get a return
you need lots of volume."
Loyola University Medical Center in Maywood, Ill., decided in the
winter of 1998 that it would work with Beckman Coulter to incorporate
its front-end automation equipment, the ACCELNet system. "To do
that, we needed to create a core lab," says Stephen E. Kahn, PhD,
section chief and director of chemistry, toxicology, and near-patient
testing, and associate professor of pathology and biochemistry at
It took six months of planning to combine the automated areas of
chemistry, hematology, immunoassay, coagulation, and fluid sera
analysis with a specimen receiving-processing area into one large
laboratory section. In late June 1998, the core laboratory operation
went live. It now processes more than 3,000 tests per day.
"Because we were Beckman Coulter chemistry users, and because we
had over the previous years made a number of reductions in staff
positions through attrition and eliminated overtime, we really didn’t
have the fat to trim out of the laboratory to justify a track system,"
Dr. Kahn says. Since Beckman Coulter was interested in conducting
a beta site clinical trial, the timing was right for Loyola to automate
its preanalytical functions, he notes.
The project has been successful, bringing an annual personnel savings
of about $100,000. "We’ve been able to take on an increased workload
with a slight decrease in staff due to some shifting of positions,"
explains Dr. Kahn. "But the incorporation of front-end automation
and creation of the core lab have only succeeded because of the
hard work, professionalism, and commitment of the technical staff,
the core lab manager, and the technical specialists. They’re the
people who have pitched in, suffered through rapid change, worked
overtime, and really taken it upon their shoulders to make the system
In fact, Loyola is unique in having the only core laboratory in
an academic medical center in the Chicago area, as well as the only
robotic workstation in an academic institution, says George Krempel,
Loyola’s administrative director of anatomic and clinical pathology.
He stresses that improvement in turnaround time was a key goal of
the restructuring and automation. "We noticed that 20 percent of
our TAT is associated with the preanalytical phase of testing, and
if we were going to shorten our TAT, we knew the instrument could
only process so much, and the window of opportunity fell in the
preanalytical processing area, which is labor-intensive."
The improvements in service delivery are owed as much to the decision
to develop a core lab, Dr. Kahn believes, as to the incorporation
of front-end automation. "They were both integral, but each had
an independent impact," he points out. "If we had done only one
or the other we wouldn’t be nearly as far along as we are today."
Now Loyola plans to take automation to the next level, by going
to a limited track system capability that will extend all the way
from the front end through the analytical phase to refrigerated
storage, he explains. "We very much have taken a stepwise approach
to incorporating automation."
Moves to automate may be tied in less obvious ways to a health
care system’s decision to set up a core laboratory. Lab-InterLink’s
Urwin points out that when consolidation is in the wind, the laboratory
with the best image is more likely to be a survivor, and automation
has a way of brushing up any department’s image.
Bearing out this phenomenon, Kaiser was surprised by the media
reaction to its installation of preanalytical automation in April
1998. There had been a recent scandal about a technologist in California
who was reusing needles. "So there was a big scare in the news at
the time about transmission of infectious diseases," Dr. Pawlick
"The day we had an open house to go live, we had several TV stations
and newspapers and a formal news conference. But when the press
came in the room and saw the instruments, one of the reporters said,
’Oh, this must reduce the spread of infectious disease,’ because
there’s a big plastic lid that pulls down over the whole operation.
Once the specimens are in there, all this racking and decapping
is actually contained inside a glass casing. So that was the biggest
play on the news that night-not the automation."
Taming adaptation costs. Along with their more modular approach,
most vendors of preanalytical systems are assuring customers they
don’t need to convert their analyzers to achieve compatibility.
Abbott Laboratories, partnered with Tecan, is also preparing to
launch an open automation system that can adapt to any company’s
instruments. The Genesis FE (Front End) Workcell is based on the
concept of configuring preanalytical, analytical, and postanalytical
"islands" in the laboratory.
"When we analyzed the laboratories’ workload, we found the front-end
labor-intensive tasks took up to 65 percent of hands-on time, while
transporting samples from the accessioning area was only two percent,"
says Matthew Noble, Abbott’s integration solutions marketing manager
for the U.S. "Those who didn’t embrace TLA didn’t want to spend
enormous capital and restructure their entire laboratory just to
accommodate a very large automation system. Our mission was to impact
the 65 percent, where there tends to be more potential for errors,
mislabeling, incorrect aliquoting, and lost samples."
Noble believes that the Abbott/Tecan system, which is in place
in two clinical sites, is different because it was intended from
the start to be flexible. In contrast with other manufacturers,
which have track systems that they have modified and scaled down
for North America, Abbott "basically had a clean slate to develop
a system with front-end processes in parallel rather than in a series,
as in the track system," Noble says.
Also taking a workcell approach, the University of Virginia developed
and conducted clinical testing on a versatile device that is being
installed now at Duke University Hospital in Durham, NC. The CoagAutoLink
robotics device, which performs preanalytical processing for coagulation
specimens, is unique, Dr. Felder says, in that it allows specimens
to be delivered in racks of 50 tubes by a medical technologist,
by conveyor belt in TLA, by mobile robot, or by individual tubes
that can be placed stat directly into the instrument.
In time-and-motion studies, the University of Virginia found that
workcell automation completed preanalytical tasks in about 48 minutes
with less variance than humans, who took from 24 to 105 minutes.
However, the robotic workcell was unable to process improperly labeled
specimens or determine if tubes were filled properly. Those features
may be added in the future, Dr. Felder notes.
At Kaiser Permanente in Berkeley, the laboratory saw a significant
reduction in FTEs in the preanalytical area along with a radically
reduced throughput time and improved accuracy, Dr. Pawlick says.
The number of repetitive-motion injuries has also fallen. Because
of the hand and arm motions required, "Occupational injuries in
the laboratory are fairly high for carpal tunnel syndrome," he points
out. "We didn’t seek the system to solve that, but it became very
apparent that it would alleviate the human injury problem."
From the standpoint of mechanics, the system installed by Catholic
Health System in Buffalo has performed as expected, but staff acceptance
is a different matter. "People aren’t sure how it fits yet or how
it will affect them," says Catarella. "I wouldn’t say there’s resistance,
but there is hesitation due to unfamiliarity with such a high level
of sophisticated equipment."
Simplified logistics. Centralized Laboratory Services in
Long Island City, NY, was given a fairly typical charge in 1998.
"Like most laboratories, we were being asked to do more with less,"
says CLS’ technical director, Joseph Stauffer, PhD. With its workload
ranging from 6,000 and 7,000 specimens per day, CLS started looking
for ways to increase its efficiency and productivity through automation.
But the laboratory’s physical layout complicated the automation
"We have a rather old building, which would have required a lot
of reconstruction for any track system," Dr. Stauffer says. "Our
building has a lot of walls and wooden floors, and since most of
the line systems out there are very heavy, they need really level
floors. So we were looking for something that minimized the amount
spent on reconstruction but also had flexibility, since our business
was growing, and we needed to add new pieces on without major expenses."
CLS purchased Roche’s sorters and aliquoters. "From our perspective,
TLA really didn’t fit, because our specimens come in in large batches,"
Dr. Stauffer points out. "Line automation was really conceived for
a continuous flow of specimens. We needed something with a very
high throughput; that’s why we picked individual modules. The stand-alone
sorters are faster than the sorters you see on lines, and the aliquoters
were faster too." Another advantage: The stand-alone units are mobile
and wheeled in rather than fixed to the floor.
"We actually didn’t make any space alterations except electrical
modifications and piping in an air pressure system that’s used by
instruments themselves to manipulate the arms on the sorters and
aliquoters," Dr. Stauffer notes.
At CLS, the staff savings that have been achieved through attrition are significant.
Nontechnical laboratory aides are employed to operate the five pieces of equipment
in accessioning, and Dr. Stauffer expects the accessioning staff ultimately
will be cut by about 50 percent. The machines are "very easy to use, and the
staffing required to run them is very small," he notes.
Unbolting and financing automation. Often, cost is not the
only barrier to TLA, says Clarke, Labotix’s marketing manager. "Sometimes
you don’t have the space for it." At three sites where Labotix has
installed preanalytic automation, the specimens are delivered to
other floors. In one laboratory, the company solved the delivery
problem by building an elevator. In the laboratory at Kaiser Permanente
in Portland, Ore., a rail-based Translogic carrier system was installed,
while at Kaiser in North Hollywood, a robotic cart transfers specimens
from floor to floor.
But one of the key advantages of preanalytical systems is not having
the instruments on line, he emphasizes. "With TLA, if you change
instruments, you have to change the interface between the automation
and the instrument. But preanalytical automation allows the laboratorian
to choose the best of breeds. You can mix and change instruments
on fairly short notice."
That flexibility was one of the features that attracted Kaiser
Permanente in Berkeley to a modular preanalytics system. "The process
of TLA is very confining," Dr. Pawlick maintains. "In my view, once
you bolt a track system to the floor, you suddenly find the driver
of all future lab activity is the bolted-to-the-floor conveyor belt,
and not your agile mind."
Dr. Felder sees financing issues influencing the direction of the
market for preanalytical systems. "It gets a little more complicated
with these systems," he notes. "The manufacturers’ bread and butter
has not been mechanical devices, but reagents. That’s where they
make their money. A preanalytical processor does not have a revenue
stream. It has no reagents, and there are many disposables available
on the open market. So it’s not going to be a real moneymaker when
compared to analyzers. But it will give companies a strategic advantage
they can use as a way of leveraging the sale of additional products."
Catholic Health System in Buffalo does have an arrangement for
its Beckman Coulter product that is similar to a reagent rental.
But most of Beckman Coulter’s customers are leasing the systems.
At some institutions, McHugh points out, there are separate capital
budgets for process improvement within the hospital. "Some of them
have been able to acquire the systems by actually tapping into a
new re-engineering budget."
Financial issues aside, Dr. Felder is optimistic about prospects
for preanalytical automation. "It’s one embodiment of automation
that’s useful to a broad range of people. It doesn’t have to be
reconfigured and tailored to each site." Eventually, he predicts,
a preanalytical processor will become a common device throughout
the laboratory industry. "The automated device will resemble a box
that is rapidly installed by the vendor, training will be provided,
and the device will operate with the ease and reliability of a clinical
analyzer," he says.
Nevertheless, Loyola’s Dr. Kahn cautions, automation has its limits.
"Mislabeled specimens, inappropriately drawn specimens, occasional
specimen clotting if you are dealing with serum-those are preanalytical
errors that are always going to stop you dead in the water, whether
you’re automated or not. There are hardware as well as electronic
components in these systems that can help you identify these kinds
of occurrences and track them down, but you’re not going to make
them go away."
Anne Paxton is a freelance writer in Seattle.