Seamless automation: within reach for AP?

Anne Paxton

August 2014—A familiar optical illusion uses a drawing of a vase that makes your eyes play tricks. First you see the vase, then two faces gazing at each other, then again, the vase…two faces…ad infinitum. It’s a concept that comes to mind when thinking about “tracking” in the anatomic pathology laboratory. Does it refer to a physical track—a conveyor belt to automatically transport and sort specimens—or to a system for “tracking”—that is, electronically keeping tabs on specimens?

As the AP laboratory steadily closes the automation gap with the clinical laboratory, it’s not clear whether machine-age automation or digital-age information technology is more important. But AP laboratory directors and others interviewed by CAP TODAY suggest that IT is increasingly an essential part of freeing the AP lab from reliance on manual workflow processes.

Most feel that while AP lab automation is catching up with automation in the clinical lab, serious differences keep full AP automation just out of reach. At Sonora Quest Laboratories, in Phoenix, Ariz., for example, bar coding and electronic tracking by Ventana Roche Diagnostics have been in place in the histology laboratory for a little more than a year and half, says William DeSalvo, BS, HTL(ASCP), system production manager for anatomic pathology. But he still considers the laboratory semiautomated.

Unlike in the clinical lab, where specimens remain in the same tube throughout the preanalytical process, “our specimens get transformed multiple times,” DeSalvo explains. “A specimen arrives in a cup with fixative, is moved, after being grossed, to a processing cassette or cassettes, and is manually loaded into a tissue processor. From there it’s taken to an embedding center and then to the microtome, where the tissue is cut and sections placed on a slide, then stained and coverslipped. So I can’t take a cassette and put it on an instrument at the beginning and have it come out as a slide at the end.”

Sonora Quest, which handles more than 150,000 cases per year, has two workflows to handle specimens. The pathologist or pathology assistant performing the gross dissection decides whether a specimen will undergo rapid or conventional processing. On the laboratory’s Sakura Xpress continuous-load rapid tissue processor, one to 40 cassettes can be added every 20 minutes. Processing takes one or two hours. The conventional batch processors can take up to 200 cassettes at a time but may require four to 12 hours to complete, depending on tissue types.

The system is efficient, but no tracking of specimens takes place on the tissue processors. The laboratory manually transports the samples from the gross dissection bench because Ventana does not have a tracking module for this process,” DeSalvo says.

As a result, it’s difficult to say that when you purchase any existing automation options for histology, it will reduce the number of units working through your lab. “We have some things that release us from manual tasks,” says DeSalvo, who is past president of the National Society for Histotechnology, “but typically there is a large volume of cassettes and slides that must be manually produced and worked through a multi-task system.”

Sonora Quest is a multi-vendor laboratory—it uses special staining instruments from Dako—but DeSalvo does not feel there are a lot of options for middleware that will connect all of the instrumentation. “There are a couple of middleware systems out there now, but they can be costly because you need to purchase a lot of hardware and software to work with them.”

Based on his work as a consultant to labs that are considering automation, DeSalvo believes the trend in histology across the United States, to reduce FTEs, is to replace smaller histology labs with a core histology laboratory in an integrated system. In fact, that is the model his lab has followed for the past decade. “Our majority partner, Banner Health, has acquired additional hospitals, then we bring in that work and/or integrate their small histology lab into our core lab.” Even though the laboratory’s outreach business also continues to grow, this acquisition pattern has kept the outreach/hospital work ratio at 50/50.

In the process, Sonora Quest has gone from 60-plus FTEs several years ago to a much higher volume and a broader test menu with 50-plus FTEs, relying on attrition to reduce staff. “The initial response to automation is that we’ll be paying for it through FTE reduction, which is not always the case. It’s always difficult for the histology world to look at the bigger picture, but there are other soft costs that have to be considered: quality, risk mitigation, overall process improvement. And you cannot always fund these by just bringing in automation and reducing staff.”

More systems are needed to link processing and embedding with robotics, he says. “We should be able to place a cassette on a tissue processor and have it moved to an automated tissue-embedding instrument and come out ready for cutting or microtomy. The Sakura Tissue-Tek AutoTec does help move technologists to other tasks. But the best improvement would be having a way to connect some of the semiautomated instruments. The difficulty is that because of the variation in quality of the specimen tissue, the process requires manual manipulation.”

The other area where DeSalvo would like to see more efficient processing is with a fully automated microtomy instrument. “That would be where I put the paraffin block in, and through manipulation of the software, it cuts that block to produce quality slides in high volume.” One or both of those process improvements should be available in the next five to 10 years, he predicts.

The histotechnology field is increasingly heading toward cancer diagnostics, DeSalvo says. “With the increased need to identify as early as possible any abnormalities, we’re going to see more and more diagnostic-type biopsies and fewer resection-type tissue samples through the lab. And the small diagnostic biopsies are the ones that require the most additional testing, such as special staining, IHC, FISH probes, and next-generation sequencing.”

So he doesn’t foresee a slowdown in histology. “We’re going to be busier with the samples we work with. That’s why we need the newest technology in the semiautomated areas, and we need true automation to allow us to continue expanding our use of technologies in the histology lab to provide pathologists with a full picture of information.”

Digital pathology, too, promises to make the overall AP laboratory process higher quality and more efficient, but it’s going to require a period of adjustment. “It’s another intrusive technology that will require a lot of hands-on work by the trained histotechnologists,” DeSalvo says.

His laboratory is preparing to move to new scanners for breast digital pathology. “Part of our problem is the histology lab is not completely connected. We’ve always been ‘connected’ through our surgical pathology report. But we are now wired and connected digitally, and it’s a big stumbling block for a lot of histology labs to talk about cabling, bandwidth, and servers. Those are absolute necessities for you to work in the digital age.”

When the AP laboratory of David Smith, MD, started looking for a bar-code solution in 2011, it wasn’t planning for more automation than that. But the laboratory soon found itself stepping into a much fuller automation package.

“We were probably on our third-generation automated immunostainer from Ventana Roche, and they had a bar-coding solution called Vantage and offered us a total, or turnkey, software solution. So we added two Symphony automatic H&E stainers first,” says Dr. Smith, president of the pathology group and medical director of the laboratory at Riverside Regional Medical Center, Newport News, Va.

These replaced two “dip-and-dunk” stainers and a coverslipping instrument that histotechnologists had spent an inordinate amount of time adjusting because it left air bubble artifacts under the coverslip. “The Symphony works with a whole different process,” he explains. “The histotechnologist cuts the paraffin block, puts a section in the slide, puts them into a specially designed tray, then pushes one button on the instrument, and on the other end they get a stained, coverslipped slide.”

The laboratory, which was already a customer of Roche and Cerner, then implemented simultaneously the Cerner CoPath Plus advanced bar-coding and tracking solution and Ventana workflow solution. “We decided to purchase both the Vantage and the CoPath tracking solutions because we wanted bidirectionality of the bar-coding solution.”

The laboratory also added a digital pathology solution from Ventana. Verification took several months, but since the system went live about a year and half ago, Dr. Smith says, it has saved the histotechnologists all kinds of time.
“Having a total solution of the software really ties it all together very nicely,” he adds. “Before, if I wanted to add extra IHC stains to the platform, I would order them and my CoPath system orders would print out, but you would have to retype the information in the computer so proper labels would print; then the case could run. Since we implemented the software solution, orders are automatically received into the special staining and don’t have to be retyped. So it has speeded up the process considerably.”

The laboratory, which now handles about 24,000 surgical pathology specimens a year, has seen its AP volume rise 44 percent in the past two years, due to a growing clinical volume and two hospitals having been added to the health system, and it has not had to add staff. “We credit the automation with our significant growth,” Dr. Smith says.

He points to two main advantages of the increased automation, financed through reagent rental with the vendors. “No. 1 is the assurance that the bar-code solution provides positive patient identification throughout each of the steps in the lab and patient ID errors are driven out. Second, it’s significantly increased the productivity of our histotechnologists in the lab.”

The new system has also eliminated duplicative data entry and allowed secretaries, through the tracking solution, to give clinicians requesting a status report accurate information on the spot. As a pathologist, Dr. Smith says, “I can sit at my computer, order my special stains, and have the assurance they are correct. And I can see how many minutes I have left before the stains are complete.”

It’s a replay, in some ways, of the improvements that took place when the system’s clinical laboratory added automation and robotics, he says. “That was quite a few years ago, but at this point we’ve caught up with the clinical lab.”
Next to be added at Riverside are a whole-slide scanner called I-Scan Coreo and image-management software called Virtuoso, both from Ventana. Software integration is the key technological advance that has brought AP automation into its own, Dr. Smith says.

If you are implementing multiple solutions at the same time, he adds, that’s a serious and significant management decision. “It can be a strain on the IT department and your staff. You have to decide how to phase in implementation of the various solutions.”

Dr. Smith’s advice for any AP laboratory considering stepping up its automation: “Going automated is going to require attaining both hardware and software solutions. If you’re going to have multiple vendors or one vendor, think about the end product and have a serious planning session. Will there be an overarching solution? Or will you have to develop homegrown interfaces to tie everything together?”

USC Keck Medical Center, in Los Angeles, uses the Leica Cerebro tracking system for its outreach services. Cerebro tracks and verifies the identity of every specimen at each point of tissue transfer within the lab. “It works fantastically,” says John Vallone, MD, director of informatics and digital pathology. “We use the tracking functionality of Cerebro in conjunction with a cloud-based AP LIS called PathCentral.” The medical center chose Leica because the company agreed to develop a bidirectional interface with the outreach LIS, he says.

At every point from accessioning to archiving, the patient specimen is validated. The system allows for print-on-demand services, so cassettes and slides are specific to the bar-coded parent container and are generated only as needed—that is, when tissue is transferred from container to cassette or at the microtome when tissue is transferred from block to slide.

Dr. Vallone’s laboratory is now planning to track specimens from their points of origin—in endoscopy suites, surgical rooms, and clinics, for example. “We’ve relooked at how pathology functions within the hospital and we’re incorporating processes that used to occur when specimens hit our gross room into the general hospital workflow,” he says. “We don’t want to know the specimen exists when it hits our desk. We want to know it exists when it is removed from the patient.”

By replacing paper requisitions with electronic requisitions, nurses will be able to generate a tissue request like they would any other order, linking the tissue to the patient’s EHR in real time. Written errors will be prevented and specimen standardization supported, Dr. Vallone says, by allowing nurses to choose from  predefined back-end dictionaries to populate specimen name, specimen location, and other fields.

“The new process will improve efficiency by alleviating the need for nursing to notate dates, procedure type, clamp times for breast cases, and formalin times for immunohistochemical processing because that information is populated as the specimen is acquired,” Dr. Vallone says. Accountability for patient information will reside with the person responsible for generating the information. “And its fidelity is enhanced via programming services that can be automated in the EHR and AP LIS,” he adds.

Once the electronic requisition is complete, a bar-coded label that includes patient demographics and specimen information is generated and placed on the container. “Before the specimen reaches pathology, we will know the specimen exists, when it was generated, where it resides, how many specimens are present, and 95 percent of the accessioning process has already been completed,” Dr. Vallone says. When the specimen arrives in the gross room, its bar code will be scanned, which automates the time received and pulls the information from the electronic requisition within the EHR into the AP LIS. A lab technician will verify the information in the AP LIS, and “the accessioning process is reduced from two to three minutes per case to five to 10 seconds.”

The Department of Pathology will know in real time the number of specimens coming from each location. “This makes it possible for us to plan our personnel for increased specimen loads and makes us immediately aware of specimens that haven’t arrived in pathology,” Dr. Vallone says. The process will continue beyond accessioning, “to track all specimen containers to gross benches where cassettes are printed on demand, into and through histology processing, and ultimately to the pathologist to whom cases are assigned.” Once complete, they will be scanned into archives.

Denise Bland-Piontek, CTBS(AATB)HTL(ASCP)QIHC, senior technical director for histopathology in the pathology service at Massachusetts General Hospital, is a believer in health information technology driving automation.

Her pathology service has experienced significant budget savings by insisting on an open bar-code system, instead of being locked into one vendor. Clinical pathology has long had open bar coding, while some AP vendors initially offered only proprietary systems, she says. “That limited some laboratories’ freedom to think about their ability to improve workflow,” she adds, noting that this is not a common pattern now.