Seamless automation: within reach for AP?

After putting out a request for proposal to vendors of immunohistochemistry automated instruments, MGH chose Leica Biosystems’ BOND-III IHC and in situ hybridization stainers to process the roughly 90,000 specimens it receives per year. “That was a very large RFP,” says Piontek, “and quality was our No. 1 requirement, with turnaround time second, but the LIS interface was third: Do you have a bar code we can interface with?”

This element of workflow was crucial, she says. “We label our slides once with the LIS label, and there’s no double labeling, which can cause major patient ID issues. The order goes right across the interface to the Leica instruments from our LIS without using middleware. The pathologists see every move the lab makes on a case real time in the LIS, including when the slides were put on the stainers.”

As a result of its experience with the BOND-III and Leica’s service, quality, and interface, “we’re actually pushing for other Leica platforms,” Piontek says, though she notes that no company has a big enough portfolio for the range of testing MGH runs, and she expects that multiple vendors will continue to be the norm.

“When I arrived five years ago, we had just entered a 10-year contract with Sunquest CoPath to develop the LIS, including the tracking system, so we’re halfway through that, and it’s been terrific.” MGH will move, over the next 18 months, into the next phase of its Epic EHR system, which will include laboratory testing. The AP laboratory will also expand digital pathology. “We’re in a 10-year agreement with Phillips to design the best digital pathology system available,” Piontek says.

For any AP lab considering automation, cost can be a barrier, she agrees. “It’s quite an undertaking to bring in a new platform, and you need to make sure you are leaning on the vendor as much as possible to do the tasks they are promising for you—the vendor should act like a partner.” MGH works almost completely on a capital purchase basis. “Most hospitals have found that what they’re actually paying in reagent rental agreements is astronomical,” Piontek says, “and they really should have budgeted the expense up front.”

But she promises the current plans won’t be the last word. “We do see automation increasing drastically over the next five years because it’s a patient safety issue. Just what’s been done in the last few years has been amazing. We’re finally starting to catch up to clinical pathology, and my mind almost runs wild with what can be possible 10 years down the road.”

She predicts that for some subspecialties or disease processes, in vivo microscopy and digital gross will significantly change workflow in surgical pathology. “Grossing could occur in completely different ways that may not involve human interaction. Grossing, processing, embedding, and cutting may become a one-step rather than a four-step process through automation. We finally see automated fixation stations and decalcification platforms on the market; you can see the gaps being filled,” says Piontek. “Staining is already mostly automated with attached coverslipping; you can see the line process forming.” She has seen some of the automated microtomes on the market and believes they do a decent job, though they have a ways to go before they can replace histotechnologists.

AP automation at Indiana University Health Pathology Laboratory has also advanced significantly in recent years, as the laboratory has acquired new IHC platforms and pretreatment modules, and especially with the Dako Link software solution and True Positive ID AP tracking system that came online more than three years ago, says Eyas M. Hattab, MD, medical director of the immunohistochemistry laboratory at the Indianapolis facility.

However, AP automation in general is “barely scratching the surface” when compared with the level clinical pathology has achieved, Dr. Hattab says. “Tissue testing presents unique challenges, partly because we need to preserve the architecture of the tissue, in contrast with the testing of fluids and blood products that clinical pathology labs perform. So it’s not really fair to compare the two.”

Dr. Hattab’s laboratory is part of IU Health, a large academic medical center spread across a large geographic area and one that has acquired many partners over the past 10 years. So the IUH Pathology Laboratory has been expanding and increasing its volume. “In the next three months, a couple of our partners will close down their IHC labs for cost-cutting purposes and will be transferring their work to us, both IHC and histology. And we do have the infrastructure set up to handle that.”

As far as automation is concerned, IHC is probably head and shoulders above all other laboratories in AP, he says. Tissue embedding, sectioning, and microtoming are still largely done manually and lag far behind IHC automation. “A few years ago, most special stains were done by hand, but nowadays essentially all our special stains are automated. Our H&Es have been automated for many years.”

The IHC laboratory, which handles about 100,000 specimens per year, has two components, the clinical service and research, and both are equally automated, he says.

In the early 1990s, “we decided that in order for us to stay competitive and provide quality patient service in a timely manner, we needed to automate as many of our procedures as possible. So right now we have a large surgical volume—about 85,000 specimens a year—and there’s absolutely no way we could do this without automation.”

Because the laboratory has been growing, it has added staff over the past five years, Dr. Hattab says. “This may seem counter to the idea of automation, but we’ve become more efficient, our arsenal of IHC tests in the lab and other services we provide have expanded, and our volume has increased by 30 percent.”
Partnering with Dako, an Agilent Technologies company, as a beta testing site for the past several years, his laboratory has been able to experiment with platforms and other AP solutions not available to all. Over the past several weeks the laboratory has been transitioning from the Dako Autostainer Link system to Dako Omnis.

The laboratory opted to switch to Omnis because it offers better quality IHC staining and would provide the laboratory with a better workflow. But the upgrading process can be stressful, Dr. Hattab says. “It’s a labor-intensive installation process that is potentially disruptive to our routine workflow, and that’s inevitable when you are changing the way you’re doing things. Repeat testing, for example, is something that spikes during a new installation process, until our IHC protocols have been optimized to the new standard.”

Switching platforms is also a costly endeavor that often requires large initial capital. “Answering the cost question, ‘How will it impact our bottom line, especially in this new era of lower reimbursement rates?’ is one of the most challenging issues,” Dr. Hattab says. In the past, his institution has worked on a reagent rental basis, but with the Omnis, it has moved to capital purchase because it opted for a different business model. That’s meant increased expenditures.
When should an AP laboratory be considered “automated”? “Would I look at a lab without an integrated workflow solution and tracking system and say this is a state-of-the-art automated lab? No, I would not,” Dr. Hattab says. “I would say an AP lab is automated if it has a fully automated IHC lab, if its special stains are automated, and if it has an integrated workflow solution that enables specimen tracking throughout the AP lab and manages the flow of lab information from one AP instrument to another. I believe this is essential nowadays to any AP lab.”

In his view, moreover, AP labs considering automation can no longer rely on a cost analysis only. “If you are looking for this to be cost-neutral, then you may never move toward automation. But you have to keep in mind the additional benefits that automation provides: better quality control, more reproducible testing environments that don’t vary from one technician to another, fewer chances for error, and, first and foremost, improved patient care.” Nevertheless, buy-in from the institution’s pathologists and technologists is essential. “This is inevit-ably going to be a very laborious and involved process that will test everyone’s patience.”

Dr. Hattab is confident that progress in automation will continue. “Automation in AP has achieved major leaps in the last decade, and I believe we will continue to achieve technological advances that will move us closer to our goal.”

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Anne Paxton is a writer in Seattle. A product guide for anatomic pathology automation will be published in February 2015.