Pain, then gain: one laboratory’s automation story
December 2000 Karen Titus
Inside the small lab conference room at the University of Chicago
Hospitals and Health System, all is calm as Ronald W. McLawhon, MD,
PhD, quietly describes the automation setup in his laboratories.
Just outside the door, where lab personnel are busy processing a
portion of the 4,000 patient samples that pass through the laboratories
each day, all is calm as well. Across the hallway, in another section
of the labs-calm. Ditto the atmosphere in the adjacent offices.
Think of it as the calm after the storm. Bedlam reigned here just
a few short years ago, when UCHHS embarked on an ambitious-some
might say "brave"-plan to automate its laboratories, boost its outreach
business, and save a few bucks in the process.
Today, it’s apparent UCHHS laboratories did all that and more.
Much of their success can be credited to the modular automation
system now in place, which handles routine and stat chemistries,
therapeutic drugs, drugs of abuse, and proteins. The modular approach
is often touted as a fitting alternative to total lab automation,
which indeed was the case at UCHHS, notes Dr. McLawhon, director
of Regional Laboratory Services, medical director of Hospitals Laboratories,
and associate professor in the Department of Pathology.
It would be nice, then, to report that automation enjoyed a flawless
debut at UCHHS. Not surprisingly, it didn’t.
As with any major implementation project, the move to modular
was arduous. Smooth sailing is the stuff of storybooks (and sales
pitches); in the laboratory, such an enormous shift quickly becomes
a tale filled with hassles and heartaches, resentment as well as
rejoicing, with a few unexpected twists thrown in for good measure.
In an interview with CAP TODAY, Dr. McLawhon and laboratory manager
Steven Zibrat, MS, MT(ASCP), recalled the circuitous road that led
to lab automation and offered advice to other labs heading in the
same direction.
Like most laboratories, the clinical labs at UCHHS have
been buffeted by the usual machinations of contemporary medicine:
alliances formed and dissolved; takeovers tried and failed, then
tried again; the incursion of managed care; integrated delivery
system face-lifts; and antipodal pleas to make more money with fewer
staff.
In response, the labs looked to their outreach program, UC MedLabs,
as a solution to at least some of these ills. The program had been
in place since 1986, but it had waxed and waned over the years.
In 1995, "We made the decision to rejuvenate UC MedLabs and step
up our outreach efforts," says Dr. McLawhon, which they hoped would
offset the 20 percent drop in inpatient test volume at UC Hospitals
between 1993 and 1995. They also decided to reposition themselves
as the primary lab service provider for the newly formed and rapidly
evolving UCHealth System. "Prior to that, there were a number of
different lab providers for the same physician offices and various
hospitals," Dr. McLawhon says. "We decided we had to go where the
work was going."
By 1997, the Hospitals Laboratories, which served three hospitals
at the campus medical center, and MedLabs were brought under the
same umbrella, organized as Regional Laboratory Services. The entity
provides all diagnostic and pathology services for all UCHHS facilities,
affiliated and nonaffiliated hospitals, and area clinics and physician
practices.
The simultaneous buildup in lab outreach testing and drop in inpatient
volume placed Dr. McLawhon and his colleagues in the middle of an
economic conundrum: how to downsize while building the business.
"That’s when we started thinking about automated solutions," he
recalls. At the same time, the labs began evaluating other changes
they would need to make to attract and accommodate outreach business,
including adding a central customer service center and transforming
the clerical order entry shop into a technical work unit.
UCHHS’ move toward automation appears to have, in retrospect,
a rather lurching quality to it. "We got halfway through a couple
steps and changed directions a couple of times," Dr. McLawhon concedes.
They first looked at total lab automation, then in its early stages
of development. After lab faculty and management staff and hospital
vice presidents made several on-site visits to view different types
of TLA setups, UCHHS began inching toward TLA.
"Certainly we had
a mixed camp," Dr. McLawhon says. "Some of the people thought [TLA]
might be a possibility, and then there were those who said, ’You
don’t need it, it’s going to erode our academic disciplines, you’re
going to be throwing various clinical subspecialties all together
on one line.’
"The concerns were understandable, but they had to be weighed
in the context of economic pressures and the goals of the entire
enterprise-not just those of the labs," he says. "So we had all
those barriers to deal with internally."
Then there were the physical barriers. Though the building that
houses the labs was erected in 1983, it’s surprisingly antediluvian,
an example of what Dr. McLawhon calls "the old school of laboratory
design, with lots and lots of walls and lots and lots of hallways"-including
a couple of prominent firewalls that ran right down the middle of
the labs.
Finances, surprisingly, were the least problematic. The capital
budget committee approved the project, and the dollars were just
waiting to be spent to renovate space to accommodate the newly available
Roche/Hitachi Clinical Laboratory Automation System, or CLAS.
And then the dollars went away. With the CLASfootprint so large
and the required renovations so extensive, UCHHS ran into other
barriers-this time bureaucratic. Because of the lab’s proximity
to patient care areas, UCHHS spent months navigating municipal and
federal codes-some arguably archaic. "We had to wait for building
permits to be issued to move forward. And the budget committee wouldn’t
release the capital dollars to install CLAS until this was resolved,"
Dr. McLawhon explains. Eventually the labs prevailed, but by that
time the capital cycle had passed for another year and the funding
had been allocated elsewhere.
With the dollars gone, "We just decided, OK, we’re not
going to pursue total lab automation at this point. That’s when
we got introduced to modular," Dr. McLawhon says. "We figured it
would take less space, cost less, probably would accomplish a lot
of the same things, and we didn’t have another year to wait. And
if we did want to go to the point of total lab automation, we could
plug the modular system into that," since the modular system they
were considering was slated to be the heart of Roche/ Hitachi’s
second-generation TLA, CLAS-II.
The labs agreed to serve as an evaluation site for the Roche/Hitachi
MODULAR Analytics and Preanalytics system in August 1997, to be
the first to take on the new combined technology in a clinical setting.
Dr. McLawhon and Zibrat knew the peril of so ambitious a project.
"Being at the leading edge means you’ll often find yourself at the
bleeding edge," Dr. McLawhon admits. Installation began the following
summer.
In between, Dr. McLawhon and his colleagues kept busy with a series
of mind-boggling changes in the labs. For starters, three aging analyzers were replaced. "They were getting
a little long in the tooth, and we needed to make an interim switch
before the MODULAR system came online. So we effectively changed instrumentation
twice within the span of a year," Dr. McLawhon says.
"We also did a renovation project to accommodate the integrated Analytics-Preanalytics
line that literally had this place in shambles for the span of nearly
five months," he continues. "And we had to finish it on an accelerated
timetable, because we had CAP and JCAHO doing their inspections
at the same time." Lab personnel found themselves sharing space
with construction crews jackhammering through the floors, knocking
down walls, and creating new doorways. Recalls Zibrat: "You’d come
into work one day and your analyzer would be over here. You’d come
into work the next day and it would be on the other side of the
room. Fortunately, the staff was just phenomenal in dealing with
that," maintaining a 24/7 testing schedule and performing the initial
evaluation on the Analytics portion of the MODULAR system.
The labs also participated in an international multicenter trial
to evaluate the systems. Prior to installing the final clinical
configuration, the labs assessed a prototype as well as an evaluation
unit as Roche and Hitachi modified the system’s hardware and software.
The clinical release units of the system, both the Analytics and
Preanalytics, were brought into the lab in April 1999. The labs
also had to install a new interface to link their customized Sunquest
LIS to the new system and to yet another new element, the Data Innovations
Instrument Manager workstation. This complicated job was made even
more so by Y2K preparations at UCHHS and Sunquest.
Finally, in September 1999 the lab placed MODULAR Analytics into
routine clinical service. And by last December, after completing
the evaluation of the Preanalytics module, the labs went live with
the integrated system.
"And then we crashed and burned," says Dr. McLawhon with a laugh.
"You go through an evaluation, and it’s a very sterile
environment," he explains. "Everything is well defined, and you
don’t challenge it necessarily with real-world specimens." Although
the UCHHS labs ran practicability studies during the evaluation,
using actual specimens and orders, "When you put it into 24/7 production,
with everyone working on it and not just the principal evaluators,
you’re throwing in some monkey wrenches not there before. Things
are bound to fall apart." The problems were "a combination of everything," he says-a new system,
new software, and new working procedures, typical of any major shift
in routine.
Seemingly small matters, such as specimen tube size,
type, and labeling, proved problematic at first. The UCHHS labs
wanted to switch from glass tubes to plastic ones. "We wanted to
prevent possible breakage from glass that could occur inside the
modules," Zibrat explains. "Plus, plastic is uniform, as opposed
to glass, which can vary as much as a quarter of an inch in height,
for example"-no small consideration when a system is automated.
"When the grabber comes down to get the tube, it has the potential
to rip the top of the tube right off if it’s not at the right height,"
Zibrat says. "Or it might not be able to recap the tube properly,
either."
The labs began shifting their outreach clients to plastic tubes
several months before the system went online, but found their in-house
customers to be less accommodating. "There’s always someone in the
hospital’s clinics who still has 15-mL glass tubes squirreled away
from 20 years ago," Dr. McLawhon says.
Problems with labeling also cropped up in the course of daily
routines. "When you’re evaluating the system, you’re very careful
to make sure every label is perfect," says Dr. McLawhon. Such exactness
is needed for an automated system, which cannot read bar-code labels
facing in the wrong direction or that are crinkled or otherwise
improperly placed or damaged. "If you’re not precise in labeling
practices at the bedside, or if you receive specimens with multiple
layers of labels wrapped around them, the tubes will not spin properly
or be scanned by the system, and an alarm will sound."
Which in itself was problematic. While the manual procedures weren’t
seamless, he notes, "At least you have that down. Everyone knows
the process. But when you make the switch to an automated system,
people don’t know what to do at first. If an alarm goes off, everyone
just stands around and stares, and they don’t know what to do or
they’re scared they might do something wrong."
Making the jump to automation is more complicated than simply
changing instrumentation, Dr. McLawhon contends. "I’ve gone through instrument changes, and they can be wrenching,"
he acknowledges. "But this changes your entire process and approach,
your workflow and mindset. And you constantly have to be on top of
things. If something goes wrong in the process, you’ve got to take
the time to figure out what’s going on. And that’s not easy for everyone
to do, especially since it’s a whole new way of solving problems."
Adds Zibrat: "It’s not just like walking up to the system and
saying, ’Well, it’s just a big analyzer.’ You have to hit everything
at the right time, and if somebody misses their cue, everything
gets backed up."
That said, when the system is fully operational, "You really can
push things through in a rapid fashion," Dr. McLawhon says. The
system now processes up to 450 specimens per hour and generates
5,800 test results per hour.
It’s not that Dr. McLawhon and his colleagues didn’t anticipate
problems arising with the shift to automation. "But you don’t get
a true sense of the magnitude of those problems until you start
to work through them," he says.
In particular, Dr. McLawhon says, both UCHHS and the vendors may
have miscalculated on the training aspect.
Key operators at the UCHHS labs were trained on the Analytics
and Preanalytics portions separately, for example, but were not
trained to handle a combined and fully integrated automation workcell.
Likewise, the vendor "had an expert on the Analytics system and
another for Preanalytics, but not someone who could readily bridge
the two," says Dr. McLawhon. Ultimately, he says, the vendors used
the experiences of his lab to revise their approach. "We all learned
from this process." At the same time, other challenges remain. The system’s autoverification
system remains underutilized, Zibrat notes, because the processor
capacity of the aging Sunquest LIS cannot keep pace with the rate
of information transfer from MODULAR. The Sunquest hardware is set
to be replaced soon.
The system’s stat interrupt feature has also
been largely idle. "The technologists like to keep a hands-on approach
and always see the sample. So they don’t use the feature like they
should," he observes. "That’s just one more example of the mindset
that needs to be broken when you move to automation."
"As well as the system works, and as flexible as it is, there
are some real-world problems you encounter when you make the switch,"
adds Dr. McLawhon.
Touring the labs now, it’s hard to imagine any of those
difficulties ever existed. The construction crews and dust have
vanished, no alarms sound, and laboratory personnel tend the sleek
system with quiet efficiency. "We’re not shy about what we throw
at this system," says Dr. McLawhon. The labs perform 2.7 million
billable tests each year, almost 50 percent more than what they
did in 1997. They serve approximately 110 outreach locations, a
category that has also seen dramatic growth in the last two years.
Revenues from off-campus locations increased tenfold from reference
lab outreach activities and laboratory management services contracts.
None of these increases could have been managed without automation,
Zibrat says, given that "We had the constraints of trying to control
costs at the same time, and had to grow the business while keeping
the staff at status quo." Further automation was slated for the
postanalytic end, with the lab planning to add a decapper/sorter/archiver
module, the Roche PSD1 task-targeted automation system. In addition,
two E170 immunoassay modules will be incorporated into the Analytics
system when they’re available in mid to late 2001.
Dr. McLawhon has at least one other goal of his own. As he and
Zibrat ponder future expansion in the labs and the growth of automation,
they eye two solid-looking walls near the system.
"We do have those walls to contend with," Zibrat says.
"At least for now," Dr. McLawhon replies. "My fantasy is still
to bring those walls down."
Karen Titus is CAP TODAY contributing editor and co-managing
editor.
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