Whether specialists are sending their anatomical pathology (AP) work to large reference labs, keeping it in-house as part of their clinical labs, or retaining the services of specialized pathologists, manufacturers are ready to supply what they need.

Nancy Stoker, system application specialist, Orchard Software, Carmel, Ind, says she has noticed “the trend in large multispecialty group practices in which gastroenterologists, derm pathologists, and even urologists (for prostate biopsies) are wanting to bring the anatomical pathology in-house, as opposed to sending it off for testing purposes. So it seems that clinics are starting to take on more and more of that, and are branching [out] into particular specialties.”

It’s a trend that is likely to continue expanding. Meetings of urology and gastroenterology associations now regularly include sessions on advice for physicians eager to establish their own anatomic pathology labs. According to a Dark Daily special report, “Anatomic pathology services are in the cross-hairs of specialist physicians … During the past 3 years, the pathology profession saw an explosion of interest among these physicians in ways that enable them to capture revenues from the anatomic pathology services provided to their patients.”

Speeding the Process

The goal of any laboratory, regardless of the type of sample they are processing, is to produce the correct answers as efficiently as possible.

Vision Biosystem’s Peloris can handle any workload (large or small) and any workflow (continuous or batch).

“One of the trends we are seeing now is a demand for same-day processing,” says Gary Wiederhold, vice president of Research and Development, Thermo Fisher Scientific Inc, Pittsburgh. “Traditional processing that is usually done overnight in 8 to 12 hours can now be processed, depending on tissue thickness, in as little as one to 1 to 1 1/2 hours. Results have been enhanced, as well, as compared to traditional tissue processing. That’s very exciting, both for the field and because its quicker turnaround time for results translates to less patient anxiety.”

The Fast Flex Tissue Processing System from Thermo Fisher is based on existing technology within a tissue process, with conventional chemistry of the reagent, plus enhancements to speed up the process. The technology is based on existing nonmicrowave technology, so it will fit into any workspace.

“When designing products, our company is looking to either eliminate or integrate steps in the day-to-day process of the technician, because there is a national shortage of technicians out there, the schools are starting to dwindle or evaporate, and there is a lot of on-the-job training,” Wiederhold says. “So, our strategy has been to make their life a little bit easier and allow them to free up time to do a other duties in the laboratory. We are doing that through automation and by eliminating or combining steps in the manual procedures.”

Joining Two Worlds

One of the main reasons AP labs are growing in popularity is found in the value of the information they generate. Making this data available throughout the medical enterprise, in particular with an existing clinical lab, is a critical component of comprehensive medical records.

McKesson’s Horizon Anatomic Pathology Solution is slated for release this summer.

“More than anything it is about the delivery of the real-time information to the pathologist,” says Steve Whitehurst, Lab Solutions vice president and general manager, McKesson Provider Technologies, San Francisco. “As we developed our anatomical pathology products, from a technology standpoint, it was important for us to be able to incorporate the clinical pathology data into the anatomical pathology system.”

McKesson is entering this market with its new Horizon Anatomic Pathology Solution (HAP), slated for release this summer. HAP facilitates tissue and cellular processing, examination, resulting and reporting, and is designed to drive a more efficient workflow, ultimately enabling pathologists to produce concise and clinician-interpretable patient results.

One of the unique features of the solution is a “virtual slide tray,” which features an intuitive, “case-centric” format, displaying not only the standard anatomical pathology information — such as the number of slides in the case, the stains, the gross description — but it also includes clinical pathology results.

“It is basically a digital dashboard for the pathologist to create better efficiencies for their workflow and to provide them with more sources to pull that clinical pathology data through to help them make better informed decisions and better interpretations,” Whitehurst adds.

Because Horizon Anatomic Pathology can connect with any existing information system-—including the picture archiving and communication system, for example, which provides clinical access to medical images—it holds the potential to impact the diagnosis. “This gives the pathologist the ability to rapidly incorporate the clinical data and help them make better interpretations.”

Horizon also includes a user-definable workflow engine. Different from a work list, this functionality was based on a pathology/histology environment and provides all relevant data, including patient history and digital images, on a single screen. It also enables labs to automate the workflow specific to users and their roles.

“It can be dynamically changed, based on what the lab is doing that day; for example, if somebody goes on vacation,” says Stacy Block, senior product marketing manager, Horizon Lab Solutions, McKesson Provider Technologies. “So it allows the pathologist to do the right activity at the right time for the right cost.”

For the initial release, Horizon Anatomic Pathology will be available only as an application integrated with Horizon Lab. Next year, HAP will be used with Horizon Lab or with a laboratory information system from a different manufacturer.

Common Ground

Orchard Software is applying the same philosophy —that pathologists should be able to easily and quickly access patient information—to its Orchard Harvest™ LIS solution.

“In the past, the AP lab was not dependent on the clinical lab, but as we move forward, they are becoming more and more interrelated. Because of automation and the new instrumentation of anatomical pathology, as well as the upcoming molecular pathology, they’re becoming closer connected to the clinical lab,” says Curt Johnson, vice president of sales and marketing, Orchard Software. “And that’s where the advantage of having one consolidated LIS database for separate departments is going to become a huge benefit.”

Orchard’s anatomic pathology module is integrated into The Harvest LIS solution.

Residing on existing hardware systems, the AP module is fully integrated into Harvest LIS and provides direct access to cytology, pathology, and clinical laboratory results, including all historical results.

A single mouse click immediately connects a pathologist with the patient’s entire clinical history. Images can also be tied into the final report. The Harvest LIS AP module’s image management tools permit a user to link gross and/or microscopic images to the case worksheet and patient report, along with any comments associated with the images.

Wading through results and compiling reports are two other functions simplified with the system. The Result Browser allows users to select search criteria related to specific patients, order choices, and tests, and then immediately view results that match those criteria, which can be pulled from a number of different fields. If desired, the criteria can be saved to make future searches easier, or to create reports that run automatically based on the filters put in place.

Because it allows medical professionals to draw information from both databases, it means pathologists are able to deliver more pertinent reports.

“Subsequently, the pathologist is acting not only as the diagnostician for the first path report, but is incorporating clinical results, and they are using all of those results to compile their diagnosis,” Stoker says. “In some cases, especially with molecular, they are even determining risk factors based on both of the clinical pathology results, and the anatomic pathology results and generating a more robust report with an actual predictive value for prognosis and for the disease state itself.”

A good example of such an instance would be a prostate biopsy, where pathologists use recent scores from the surgical pathology, prostate-specific antigen results, and clinical impressions to determine risk.

Working Smarter

With a shrinking pool of qualified technicians, it’s more important than ever that laboratories streamline procedures and apply best practices wherever possible.

To make this happen, many labs are employing Lean management techniques, which are intended to improve the speed at which a business operates, improving quality, and reducing costs.

“There is a lot of discussion about that in the market at the moment, and we’re seeing the industry moving toward all of those concepts very quickly,” says Andrew McLellan, vice president of marketing and business development, Vision BioSystems, Norwell, Mass. “With Lean, the underriding philosophy behind it is reducing your batch sizes so you don’t take a lot of time waiting for samples to build up into a batch before you can process them.”

Products from Vision BioSystems are designed to incorporate these principles. The company’s Bond™ system, which consists of a central host computer and one to five processing modules, allows for continuous flow by dividing its 30-slide capacity split into three independent 10-slide trays. Each tray can start, stop, heat, and dispense separately, which means staining now can be staggered to suit a lab’s workflow, making waiting for a batch before starting processing is a thing of the past.

In addition, the system’s Covertile™ technology means a Covertile sits over each slide throughout the staining process. This creates a staining cavity that eliminates tissue dry-out and allows very small reagent dispense volumes (as little as 100 µL). This system is very gentle on tissue, with a flow-assisted reagent application that ensures even coverage, complete reagent exchange, and no lifted tissue.

Vision BioSystems has also eliminated unnecessary manual processing. “Tissue processing has traditionally been the most time-intensive part of the whole workflow, traditionally taking from 6 to 12 hours. We’ve got tissue processors that actually reduce that time by half, so we’re able to take a huge slice of time out of that whole process,” says McLellan, speaking of Peloris. “There is a wide range of tissue processors on the market, but ours has the unique capacity of reducing the time in half using conventional technologies.”

With dual independent retorts and a 600-cassette capacity, Peloris can handle any workload (large or small) and any workflow (continuous or batch). The Peloris reagent management system is also ideal for laboratories striving for Lean compliance.

The system accurately tracks reagent condition and automatically flags reagent changes, maximizing reagent life while maintaining processing quality. The result is no wasted reagent, no degradation to cutting, staining, or diagnostic clarity, and a reduction in laboratory costs. Peloris also includes a xylene-free option for clean processing and an advanced reagent management system.

Want to read more? Search for “anatomic pathology” in our online archives.

Vision BioSystems also provides training to its customers. “Instead of just supplying instruments, we also provide applications training and after-sales support. We participate in continuing education programs, publish educational newsletters, and have even contributed chapters to histology text books,” says Jan Minshew, marketing manager, Leica Microsystems Inc, Bannockburn, Ill. “We take great pride in our efforts to educate and support the histology community in a variety of ways.” Danaher, Leica Microsystems’ parent company, also owns Vision BioSystems.

Dana Hinesly is a contributing writer to CLP.