When you've heard one story about a histology lab's experience with automation, you've heard one story. That's because, of course, each lab has its own goals and chooses its own mix of automated solutions to meet them. But most speak of smoother workflow and shorter turnaround and the always tricky question of cost.
Everything was done manually seven years ago in the
histology lab at the University of Connecticut Health Center, Farmington,
including all of the staining. The laboratory used a 25-year-old tissue
processor for overnight processing. Staff labeled the tissue cassettes
and slides by hand.
Today, automation reigns at the university-hospital-based
lab, which won a state quality improvement award for its automation process
in 2003. Automation has boosted production from 9,023 surgical specimens
in 2000 to about 13,000 this year with no additional staffing, says histology
supervisor Kathy Wiggins, HT (ASCP).
Turnaround times have improved dramatically. "We have
been providing answers the same day as surgery for two years," Wiggins
says. A small biopsy can be reported in four hours. Pre-automation, the
lab reported results for biopsies within 24 hours and within 48 to 72
hours for bigger specimens.
"Everything at the lab is automated with the
exception of embedding and cutting, which are difficult to automate,"
With its three Leica Microsystems ASP 300 S conventional
automated tissue processors, the lab runs a lot of different programs,
including short runs of 1.5 hours for biopsies, rather than include those
in overnight processing.
A Leica ST 5020 Multistainer does the H&E staining.
An attached transfer station moves racks of slides to the Leica CV5030
glass coverslipper that can coverslip a rack of 30 slides in about two
minutes, Wiggins says.
In the past six to nine months, the immunohistochemistry
lab improved turnaround times for its immunostains by bringing on a BondMax
(Leica Microsystems), which requires less technologist time and does the
pretreatment online, Wiggins says.
Melinda Sanders, MD, chair of the pathology department,
finds that if she sees an abnormal case in the morning, she can have a
panel of IHC markers "ready to go before the end of the day so the case
can be complete and signed out." The lab is hoping to use that as a marketing
The move to complete automation represented a makeover
for the lab, allowing it to focus on its specialized muscle, nerve, and
kidney biopsy services that require manual processes that cannot be automated,
Today, labs have the option of using microwave rapid
tissue processors or faster automated conventional processors to improve
their workflows and turnaround times.
To produce more continuous, smaller batches of tissue
cassettes, Nebraska Medical Center is purchasing the Microm STP 420D (Richard
Allen Scientific, now part of Thermo Fisher Scientific), a non-microwave
rapid processor with two retort chambers that can be operated simultaneously
or separately, says David Muirhead, AIMLT, ABMS, MSA, anatomic pathology
manager/assistant professor of pathology and microbiology.
The larger chamber has a patented rotational movement.
Thus, the lab's staff has nicknamed the processor the "washing machine"
because a portal hole makes it possible to view the tissues during processing,
Muirhead says. "It can process up to 4-mm thick tissues in two hours and
Another option for non-microwave rapid tissue processing
is Leica's Peloris. "Labs can use the Peloris for conventional overnight
processing or it can be an integral part of a Lean laboratory workflow
in which smaller, continuous batches are run," says Jim Burris, director
of sales for North America-West, Leica Microsystems, Biosystems Division.
The Peloris lists for about $131,000.
Using the Peloris, Burris says, a laboratory can run
two protocols independently or simultaneously—for example, multiple
small batches, a large and small batch, or two large specimen batches
for a total capacity of 600 cassettes.
In Florida, Palm Beach Pathology bought a Peloris in
the past year, says laboratory manager Judy Collins, CT, HT(ASCP). The
lab has found that it processes biopsies in about an hour, and slightly
larger specimens in two hours with a maximum of six hours for large, fatty
specimens. The tissue goes from there to paraffin.
The Peloris has "evened out" the lab's workflow, Collins
says, so the lab produces a continuous cycle of work instead of everything
in the morning. As a result, it can handle much more volume without hiring
more people. In addition to providing technical and professional pathology
services for 42,000 specimens from physician offices and surgical centers,
the lab has been able to bring in technical work for 25,000 specimens
from hospitals, which it started doing last November, Collins says.
Unlike the Peloris, the Leica ASP 300 S does not allow
a lab to process two simultaneous batches of tissue. Wiggins at the University
of Connecticut had wanted a Peloris when the lab was in the market for
new tissue processors, but the lab's vendor, Leica, didn't own and distribute
the Peloris at the time, she says. To "keep our business," Wiggins adds,
the rep sold the lab two Leica ASP 300 S processors for less than the
price of a Peloris and pointed out that the two Leica ASP 300 S units
"gave us two brains and two bodies" compared with the Peloris' one brain
and two bodies. (The Leica ASP 300 S lists for $43,450, Burris says.)
Each Leica ASP 300 S can process up to 300 cassettes.
Sonora Quest Laboratories/Laboratory Sciences of Arizona
in Tempe, which handles 125,000 specimens a year, is using Sakura Finetek's
rapid microwave tissue processor, the Tissue-Tek Xpress, in its Lean and
Six Sigma laboratory. Turnaround time is down, thanks to work process
changes and the Xpress, from six days to two, and the lab is now aiming
to reduce it further, says William DeSalvo, BS, HTL (ASCP), system production
manager in histology.
The lab had in 2005 "pretty well pushed the envelope"
with conventional processing times when it bought two Xpresses to replace
12 conventional processors (Tissue-Tek VIP 5), DeSalvo says. The conventional
processors had a three-hour to 3.5-hour processing cycle, followed by
a 45-minute cleaning cycle. "So it was four to five hours before we could
reload a processor."
Using the Xpress, the laboratory can load specimens
every 20 minutes, producing a continuous workflow. "You can load 36 specimens
[on the Xpress] using the magazine, which is what we use, or 40 with the
The standard processing time using the Xpress is two
hours, 20 minutes for processing up to 4-mm specimens, he adds. "If you
use the biopsy run, it's one hour and seven minutes, but you must dissect
tissues to 2 mm or less thickness."
Sakura will roll out this month a second generation
of its continuous rapid tissue processors geared toward the smaller-volume
histology lab, says Gilles Lefebvre, vice president of sales, marketing,
and customer relations. "We have perfected the technology where you can
now run larger tissues...," he says. The new equipment will sell for about
$120,000, compared with $200,000 for the Xpress, he says.
For labs interested in automating the embedding step,
Sakura is the only game in town. The company is set to deliver the first
of about 12 of its Tissue-Tek AutoTec machines in the next couple of months,
including some in Europe, Lefebvre says. "The core of the technology"
for the AutoTec is a sectionable cassette made out of a special resin
that Sakura calls Paraform, he says.
Using the Sakura autoembedder, the pathologist or pathologist
assistant doing grossing orients the tissue into the AutoTec Paraform
cassettes. The cassettes then go to the Sakura Xpress for tissue processing.
When the processing is completed, the cassettes go onto the embedding
equipment. The next stop is microtomy. Paraform "has the same cutting
characteristics as paraffin, so the microtome blade is not damaged," Lefebvre
Some labs have expressed concerns that the tissue could
move in the cassette. But Lefebvre says the cassette is designed to immobilize
the tissue between the lid and the bottom without damaging the tissue.
So the only time the tissue could move is if the lab uses a standard cassette
for a small biopsy. If that happened, the technologist could melt the
block to recover the tissue and re-embed it using the correct cassette,
Sakura has introduced a cassette for biopsies that
is compatible with the AutoTec. "The paraffin button size is 13 ¥ 13 mm,
so you can place up to 12 sections on a slide," he says.
Sonora Quest, which is a Sakura demo lab, is passing
on the automatic embedder for now. DeSalvo says that's because about 70
percent or more of the lab's tissues "are small skin shave biopsies and
we are not convinced that Sakura has the right orientation cassettes for
"Once Sakura resolves that issue, we are very
interested [in the AutoTec] because it's the next step in the automation
process," DeSalvo says. It would be able to do the work of three FTEs.
Options for automated H&E staining and coverslipping
abound. Capabilities and costs vary.
Ventana Medical Systems' Symphony, the only discrete
system that integrates staining and coverslipping, is the newest option,
albeit, labs say, an expensive one.
Unlike so-called dip-and-dunk stainers, the H&E stainer
drops fresh reagent on each slide, ensuring each stain is as pristine
as the last. Users have to buy the prepackaged H&E reagent packs from
"The Symphony is designed like the old Xerox
machines where you can make the stain darker or lighter," says Stephen
Hagan, vice president of marketing. "But you don't have to handle reagents
to do that." Of Symphony's higher costs, Hagan says those who believe
they aren't justified haven't "taken into full consideration the inefficiencies
inherent in the dip-and-dunk H&E method and risk management associated
Palm Beach Pathology wanted the Symphony for consistency
in H&E staining, Collins says. "The problem with our H&E stainer is that
you have to pour the solution from jars into the equipment and change
the solution at appropriate intervals. If we get busy and forget to change
it at the right moment, we don't get good results." But the Symphony would
have added more than $200,000 a year in costs, and the lab couldn't afford
it, Collins says.
Robert Babkowski, MD, chief of pathology at Stamford
(Conn.) Hospital, agrees that the costs with Symphony are higher. But
for his lab, the instrument has proved to be an "enormous productivity
improvement tool." And the slides, he says, are "absolutely beautiful."
Using the Symphony has allowed the histotechs to focus
more on producing slides, special stains, IHC, and CISH than on "the mundane
work of H&E staining and coverslipping," Dr. Babkowski says. And that
has increased the lab's revenue, offsetting the costs of the Symphony.
"In our lab, the same three histotechs are able
to do twice the number of immunostains and special stains with much increased
surgical specimen and outreach volume and faster turnaround time," Dr.
Alegent Health in Omaha is going to do a study soon
on how Symphony fits into its Lean process, and to see if the lab can
maintain its current throughput using the instrument, says Janice Mahoney,
HT(ASCP), histology-cytology coordinator. "Given the stellar quality of
the stain," Mahoney suspects "that the instrument may also reduce the
need for second opinions or showing the case around the department."
Alverno Clinical Laboratories, Hammond, Ind., looked
at Symphony but couldn't justify the cost at this time, says Thomas Roberts,
MD, medical director. "Maybe we don't have high-definition eyes," Dr.
Roberts says, but "we could not see a meaningful difference. Others claim
that for certain specimens, particularly prostate biopsies, the high-definition
H&E stain from the Symphony is superior, and I don't doubt that is true
Kaiser Foundation Health Plan Northwest uses the Sakura
Tissue-Tek Prisma for H&E staining, and at CAP TODAY press time had just
completed a cost analysis of the H&E staining, says Robert Milewski, histopathology
technical specialist. The analysis showed the lab is paying "approximately
less than 12 cents a slide if we do it the most efficient way, which is
to completely load three baskets," Milewski says. "We do that about 80
percent of the time." Thus, 80 percent of the slides cost under 12 cents;
the rest are under 20 cents, he says.
For immunohistochemistry staining, the lab at Touro
Infirmary, a community-based hospital in New Orleans, likes the Nemesis
7200 (Biocare Medical).
Jane Goodman, HT (QIHC), Touro's lead histology technologist,
finds the Nemesis software allows for "good record keeping, storing all
of the quality control on the machine. And it allows you to change the
instructions for one run—for example, changing the staining time
for one case." Then it automatically reverts to the routine settings,
acting as a safety feature, she says. The Nemesis is an open system, adds
Goodman, who likes "using lots of products."
The Nemesis, which can also do immunofluorescence applications,
can be programmed for double and triple immunostains. It can stain a maximum
of 72 slides with 84 reagents or 84 slides with 40 reagents, depending
on rack configuration, says Fatima Natar, BS, HT (ASCP), QIHC, senior
technical applications specialist for Biocare Medical. The user can program
up to 50 different steps per slide. With Nemesis the user can generate
a two-dimensional bar-coded slide and reagent labels. The system scans
the slides and ensures that all reagents have been loaded and that sufficient
volumes are present to complete programmed slides. If not, then the system
will not start, Natar says.
The software solutions that accompany automation are
becoming increasingly smart. Nebraska Medical Center recently purchased
the Dako Link solution, a computerized system that can connect all of
a lab's Dako immunostainers and autostainers to function as one, Muirhead
Using the Link system, says Ferran Prat, Dako VP of
sales for North America, "one personal computer can be used to control
up to three instruments and perform laboratory administrative tasks simultaneously,
allowing for a more effective way of managing daily workload." And each
patient specimen is assigned a true positive ID that is maintained throughout
the entire laboratory process. "The system verifies the specimen true
positive ID at every stage, virtually eliminating errors that are associated
with redundant data entry," Prat says.
As Muirhead explains it, the Dako Link system allows
the pathologists at Nebraska Medical Center to place their requests for
immunostains in the Cerner Co-Path pathology information system. The requests
cross to the local area network and populate the worklist in the pending
file in the Dako Link system. The system then prints labels for the slides,
which have the requested antibody written on them, such as a CD4 antibody,
and a bar code that the IHC instrument, Autostainer Link, reads to know
which reagents to put on the slides.
The Link system allows pathologists to use the software
to see where the sections are and the estimated time to completion. The
software can also detect errors, such as a missing or wrong antibody on
the instrument or missing slides, Muirhead explains.
For now, the lab will link only the Dako immunostainers.
But it plans to eventually interface the Dako Artisan, which does special
stains, and the ACIS III image analysis system. Soon, Muirhead says, the
lab hopes to expand the Link system to "add specimen tracking from the
operating room to the pathologist's microscope."
Automated computer solutions in histology are virtually
eliminating patient misidentification errors and specimen mixups.
For example, before the University of Connecticut Health
Center histology laboratory started using the Leica IPC cassette labeler,
it was averaging about three mislabeled blocks a day, which staff caught,
says pathologist assistant Tim Greenwood. The cassette labeler has not
only eliminated the errors but also freed staff from having to stop slide
production in the morning to fix them, he adds.
DermPath Diagnostics/AmeriPath of Pittsburgh has adopted
the Shandon CheckMate system (Thermo Fisher) to prevent patient misidentification
errors. Wayne Holland, HT (ASCP), the histology lab manager there, has
found that such errors tend to occur when specimens "move from one process
to another"—for example, from the specimen container to the cassettes
or from the cassette block to the slide.
Using the CheckMate system, the lab staff matches the
bar-coded specimen container to the 2-D bar code placed on the tissue
cassettes during accessioning. The lab uses a software program to print
the bar-coded labels for the specimen container.
"The slides are bar-coded with corresponding
information that the lab wants to put on them in addition to the patient
name and other unique identifiers, including processing instructions"
and more, Holland says.
When the histologist does microtomy, he or she also
scans the 2-D bar code on the cassette and each pre-bar-coded slide to
ensure a match, he says. "If there is a mismatch, the computer system
produces a warning sound that can be individualized by the user." The
computer screen also has a color-coded system to let the user know if
there's a match or mismatch, Holland says.
Automation has helped histology labs do much more work
with the same number of histotechnologists and lab assistants. Yet in
some labs, the faster pace has shifted a bottleneck downstream to the
pathologist reading slides.
As Sonora Quest's DeSalvo puts it: "We have changed
courier routes, processing, and transcription, but our pathologists still
work traditional hours." And that's led to a "very emotional discussion
at this company" as it seeks to further reduce its turnaround time from
In Alverno's "extremely competitive market" in Indiana,
Dr. Roberts says, "we have practices that have a second shift of pathologists
work from 1 PM to 9 PM to sign out specimens taken in the morning that
same afternoon. These anatomic practices and their labs use same-day turnaround
as a selling point to differentiate themselves from others. It's like
the 15-minute oil change being viewed as a more customer-friendly service
than using the dealer."
But some pathologists, Dr. Roberts among them, question
the goal of ever faster turnaround times in some cases.
"Equating being quick with being good is a seriously
flawed premise in the minds of many pathologists," he says.
Pathologist Dominick DiMaio, MD, of Nebraska Medical
Center, observes that a lot of the demand for faster TAT comes from the
outpatient side even though physicians aren't going to see the patient
after a biopsy for a week. "And to produce a 24-hour turnaround time drives
Dr. DiMaio sees a benefit in an inpatient setting of
providing a cancer diagnosis more quickly because some clinicians want
to begin treating a high-grade lymphoma, for example, in the hospital.
"But for breast and colon carcinomas, as examples, the person can be discharged
and see the oncologist on an outpatient basis in most cases."
Automation that produces continuous flow will expedite
turnaround times when digitizing slides routinely becomes the next step
in automation, in the view of Kenneth Bloom, MD, chief medical officer
and medical director of Clarient Inc., Aliso Viejo, Calif.
"The wave of the future will be imaging pathology
slides so that pathologists can consult with pathologists in other parts
of the world," he says. "For example, large consultative networks may
have U.S.-certified pathologists in London or Australia who can review
slides at 8 AM there when it's evening or nighttime here. A continuous
flow will ensure those cases are reported in a timely fashion."
The times may be changing automationwise in other ways
for histology labs.
Though "histology has always been the orphan department
in the lab," Sakura's Lefebvre says, many are realizing there is profit
in anatomic pathology, especially with the more specialized staining,
such as IHC. So "instead of companies selling $50,000 equipment for histology
labs, we are now reaching the $200,000 level per transaction," he says.
This "wind change in histology," as he puts it, has caught the attention
of companies like Roche Diagnostics, which has a bid to acquire Ventana,
and Danaher, which recently acquired Leica Microsystems and Vision BioSystems.
And as companies "with large-scale automation in clinical
chemistry and hematology enter the market and start introducing equipment,
anatomic pathology labs will find that things change even more rapidly
than they have seen in the past," Lefebvre predicts. "We think what will
happen in automation in histology is similar to what happened in chemistry
and hematology": Labs get the new equipment every three to four years.
If that's the case, some of the best advice for histology
labs navigating the brave new world of automation might include the ageless
After all, says Alverno's Dr. Roberts, no one pays
you extra for having the most big-ticket automation. So "choose wisely,"
he advises, based on validation in your setting that the equipment's greater
productivity or personnel savings justifies the purchase.
Karen Lusky is a writer in Brentwood, Tenn.