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ECHNOLOGY INNOVATIONS AND GROWING DEMAND FOR ACCESS to subspecialist anatomic pathologists are two factors fueling adoption of whole-slide imaging (WSI) and digital pathology (DP). Today, there is consensus that digital pathology is the future of the profession.
Given the growing acceptance and use of WSI and DP, pathology groups across the nation must answer two questions. One: Is this the right time for our practice to implement a full digital pathology system? Two: If the answer is yes, is there a road map or business plan our group can follow to purchase, implement, and operate digital pathology that ensures an acceptable return on investment (ROI)?
The quick answer is yes to both questions. However, success with adoption of WSI and digital pathology systems requires every pathology laboratory to carefully assess its specific needs. That assessment then guides implementation.
“Each pathology laboratory has specific needs that will dictate the size and scope of their digital pathology operation,” said Orly Ardon, PhD, Director of Digital Pathology Operations at Memorial Sloan Kettering Cancer Center in New York City.
Know How to Get There
“Adoption of WSI and digital pathology costs money, but when project leaders commit the plan to writing, it’s not that scary,” stated W. Dean Wallace, MD, Professor of Pathology at Keck School of Medicine at the University of Southern California. “What’s scary is when pathology labs start buying scanners and building a service without knowing where they are going or how to get there.”
Wallace and Ardon spoke during a Dark Daily webinar in May called, “Digital Pathology Implementation Strategies.”
Both Ardon and Wallace agreed that successful digital pathology business plans need to include certain steps, which they described during the webinar. These steps include:
- Clearly state the digital pathology project’s goals.
- Form a project team that reaches beyond the pathology laboratory.
- Outline the lab’s needs and how WSI and DP will contribute to meeting those needs prior to project commencement.
- Consider a full implementation versus phased approach.
- Bring in outside experts in WSI and DP to help determine appropriate return-on-investment metrics applicable to the pathology lab’s specific case mix, subspecialty expertise, and the regional, national, or international areas serviced by the group.
Financial perspectives need to be considered with each of the above steps.
Set Clear Goals for Digital Path
When considering the pros and cons of using whole-slide imaging and a digital pathology system, every pathology laboratory must start the analysis by matching its unique practice composition with the potential advantages that come with use of WSI and DP.
W. Dean Wallace, MD
“Pathology groups won’t know numbers until they conduct their needs assessment,” Wallace said. “Labs must gather their own information and let it inform the equipment needs and overall costs.”
This is the stage where pathologists should identify and gather the metrics that will be used to benchmark the progress of the digital pathology project, as well as its contribution to improved patient care while achieving the desired ROI.
For example, turnaround times for conventional glass slide sign-out, courier costs, and weekend biopsy reads are examples where DP can make positive contributions.
Demonstrate Value of DP
“It is important that the pathology group gather data on its turnaround time up front,” noted Wallace. “This metric will help demonstrate value throughout the staged deployment of WSI and DP.”
He stressed the importance of establishing the goals for implementation. “Is the goal to digitize the entire department or instead do a smaller deployment of some digital pathology services?” he asked.
“Get as specific as possible with the metrics that are gathered, such as the number of slides per day that will be scanned,” Wallace continued. “Information of this type guides development of an effective clinical plan, service plan, and business plan. The goal is a successful transition to digital pathology.”
Ardon next addressed the need to identify external resources, even at this early phase. “Will the pathology lab need external consultants for the digital pathology project, or does it have the internal institutional abilities to get there on its own?” she said.
“Pathology groups don’t have the resources of large academic medical centers,” she continued. “After the pathology practice assesses its in-house expertise, it can tap outside experts in digital pathology who have the needed skills to ensure an effective adoption and use of WSI and DP.”
Form an Effective DP Team
Digital pathology project teams need pathologists and clinical laboratory managers. But other experts are also required for the team to be successful and anticipate all needs.
“Hospital administrators, lab executives in independent organizations, finance personnel, and IT managers are all likely participants,” Wallace advised. “Outside consultants and vendors of equipment and software also are potential choices.”
Having at least one senior executive in the group can help in at least two ways. Wallace noted that, one, it provides motivation for the rest of the team, since senior leadership is engaged. Two, the senior executive is positioned to help non-laboratory stakeholders understand the importance of implementing digital pathology into the clinical workflow.
Involve Leadership in Project
“The DP project will nudge people out of their comfort zones,” Wallace observed. This is why it is really helpful to have leadership helping with implementation instead of standing on the sidelines watching the lab do it.
“When the DP team first meets, don’t assume everyone at the table understands the technology involved in digital pathology and how it can contribute to better patient care,” he explained. “Education is an important initial agenda item. Not everyone on the team will have experience with digital pathology, nor will they understand its capabilities and limitations.”
Wallace next noted that it is essential to forge an effective relationship between the lab and IT managers. “Digital pathology implementation involves installing new technology and the need to integrate it with existing networks, such as a laboratory information system,” he stated. “The IT manager and the lab manager must work together very closely, particularly on a large digital pathology project.
“Another key to success is designating a project manager,” Wallace continued. “Preferably this is someone with experience guiding business rollouts.
“Communication between the lab manager and the project manager is key to a positive project outcome,” he added. “Experience shows that—should the lab manager not provide a sufficient level of oversight—project managers will often create something slightly divergent than what the pathology team intended.
“Communication between the lab manager and the project manager is key to a positive digital pathology project outcome.”
W. Dean Wallace, MD
“Having regular check-ins as the digital pathology project develops is crucial because it can be hard to backtrack if an unintended aspect occurs,” Wallace commented. “It is imperative to keep communication flowing, whether through regular face-to-face team meetings, email-based updates, or other types of check-ins.
“Digital pathology implementation can be disruptive—not just within the laboratory—but also to the whole facility,” he noted. “Clarity in communication prevents disruption in culture. A well-written business plan controls the message while preventing rumors and additional anxiety about costs and staffing roles that could change.”
Outline the Lab’s Needs
Part of a digital pathology business plan is outlining what the laboratory or pathology practice requires from the project.
Orly Ardon, PhD
“This is particularly true when it comes to staffing,” Ardon observed. “Once the digital pathology system goes live, workflows change, along with the need to create whole-slide images from the glass slides.
“Here is where outside experts are useful,” she continued. “Digital pathology vendors or consultants can provide a sense of how many full-time employees a lab will need to operate new equipment—a crucial discussion given the shortage of laboratory personnel across the country.”
Vendors have expertise in this area that labs can draw from. “During development of the implementation plan, labs can ask vendors how many FTEs they recommend for their scanners,” Wallace said. “If this was not addressed up front, it would be a significant expense later on should the lab need to request additional staffing for this function.”
During planning, particular attention needs to be given to how whole-slide imaging and digital pathology change the workflows of the individual pathologists. This is the ideal time to specify the tools that provide pathologists with a supportive working environment and maximize their productivity.
“This is why digital pathology workstation technologies are a key need,” Wallace explained. “In an ideal setup, a pathologist uses two screens and a specialized mouse. In some settings, however, viewing can be performed on a laptop.”
Every DP system requires the infrastructure to manage whole-slide images, making them accessible to pathologists, then archiving them consistent with regulation. “Experience shows us that pathologists may lean into these conversations more than other debates,” he said. “Image management systems are very important to pathologists. That’s because they are daily hands-on users.”
Both Ardon and Wallace agreed pathologists are less engaged in decisions involving scanners. “Commonly, pathologists won’t be aware of scanners or have an opinion about them,” Wallace noted. “Decisions about which scanners to buy are typically left to the lab managers.”
“Additionally, the maintenance cost for scanners should be clearly spelled out during the planning stage,” Ardon recommended. “Maintenance requirements and costs may not always be at the forefront of equipment discussions.
“People don’t think about scanner maintenance as an expense,” he added. “But if a pathology lab’s equipment is down because there is no timely service support, that is a serious issue.”
Identify Space Requirements
To maintain continuous operation of Memorial Sloan Kettering’s whole-slide imaging equipment, Ardon trained on-site staff to handle common technical issues when they were waiting for a vendor maintenance team to arrive.
Equipment space needs should not be overlooked. Don’t tackle this concern after scanners have been purchased, Ardon stressed.
“Memorial Sloan Kettering has limited space,” she observed. “It is crucial to have scanners available right where the glass slides are being produced.”
Wallace recalled a situation where a lab purchased a high-capacity scanner with the intent of supporting frozen services as well as performing general scans.
It turned out, however, that the scanner wasn’t easy to use with frozen sections and was located in a remote location from both the histology lab and the slide archive room.
“Because the lab failed to think through the business plan for this particular instrument, it sat unused and may not have scanned a single frozen section slide,” he noted.
“It’s wise to review equipment choices with vendors before making any final decisions,” he added. “Vendors see the best and worst deployments of their instruments and want their equipment to perform to the lab’s requirements.
“Keep in mind that it’s common for unplanned expenses to surface and that’s okay,” Wallace continued. “Labs will stay on track with a well-developed business plan that is based on a detailed, pre-project needs assessment.”
Full versus Phased Deployment
Some patholology labs—likely in larger hospitals with more resources—go whole hog with plans to launch a full digital pathology implementation, even though it is an involved, laborious process.
“What sort of pathology department do you have? Is it big, complicated, and with a lot of moving parts?” Wallace asked. “For a bigger implementation, the lab needs a bigger project team.”
Some pathology groups opt for a phased implementation by first digitizing certain services, then adding additional services over time. “A phased implementation can be easier. The pathology laboratory may want telepathology to support after-hours frozen section cases,” he said. “That may be an effective way to start.”
Regardless of the size of the rollout, business plans should account for the necessary equipment and software.
“Whether it’s a full department or smaller implementation, labs need a complete solution,” Wallace noted. “This includes a scanner, image management software, and pathologist workstations. If there’s an incomplete implementation, the project team might have to ask for more money.”
Determine ROI Metrics
ROI thresholds will include finances. For example, the federal government is currently conducting a tryout period for new Current Procedural Terminology (CPT) codes for digital pathology services. If enough labs use the new codes, those codes may eventually receive reimbursement from the Medicare program. (See TDR, “New CPT Codes Debut for Digital Pathology Services,” Jan. 23, 2023.)
“Pathology labs can include the new digital pathology CPT codes when calculating their ROI for these projects,” Wallace suggested. “Over the next few years, it is anticipated that the new CPT codes will be reimbursable, which can offset the costs of digitization.”
Involve Leadership in Project
Ardon and Wallace agree that improvements in workflow following implementation of WSI and DP can help pathologists deliver more value.
“Take the example where a pathology lab has a fully-digitized department,” Wallace said. “This makes it quick and easy to pull up cases without the time required to search for the glass slides. In turn, this can shorten conference preparation time from many hours to minutes.”
Wallace also suggested digital pathology labs investigate how specific volumes of images could help certain institutions’ with their research efforts.
“Keck School of Medicine produces a lot of image data, so I can go to my chair and say that—by scanning these slides—the school will have a million digital images a year for research or education,” Wallace said. “That is a very different ROI from a community hospital, so it’s not a one-size-fits-all situation.”
Another relevant ROI metric is how digital pathology might lead to decreased hospital stays for certain patients.
“For example, transplant service patients can be discharged on the same day of their biopsy appointment if digital pathologists can sign off on their case that same day,” Wallace said. “Also, if a lab can show the hospital that the lab can reduce in-patient days by use of digital pathology, leadership will be very happy.”
The Dark Daily webinar, supported by an educational grant from Hamamatsu Photonics, is available free on-demand by going to www.darkdaily.com/webinar.
Contact Dean Wallace, MD, at William.Wallace@med.usc.edu.
Alternatives Exist for Digital Image Storage
STORAGE OF WHOLE-SLIDE IMAGES does not have to be a deterrent to rolling out digital pathology in a laboratory.
That was the message from David McClintock, MD, Chair of the Division of Computational Pathology and Artificial Intelligence at Mayo Clinic and his colleague, Mark Zarella, PhD, Senior Associate Consultant in the same division. The pair guest-authored a blog in March posted by the Digital Pathology Association.
“There is no specific requirement for storing whole-slide images and the prac- tical argument for long-term storing of images may, in fact, be quite niche,” they wrote, noting also that labs may choose to keep only certain images or store all of them for a short-term length of time before deleting the media.
Also, storage strategies should reflect intended use cases outlined in a digital pathology business plan. Options include on-premises storage in servers, cloud- based storage, and archival storage that may not be immediately accessible.
“Storage [of digital images] should not automatically be considered a major burden for digital pathology deployment,” Zarella and McClintock wrote.
Obstacles to Digital Pathology Adoption May Be Generational: Boomer versus Gen X and Y MDs
TODAY, THERE IS CONCENSUS THAT DIGITAL PATHOLOGY IS THE FUTURE OF THE PROFESSION. Yet many pathology groups still wrestle with the economics of “going digital.” Often, it is a generational divide within a private pathology group practice.
On one side are the older partners—most of whom spent the majority of their career working with glass slides and traditional light microscopes.
These older pathologists voice two concerns: First is that the disruption and capital cost of implementing WSI and DP cannot be speedily recouped. Second, they are close to retirement and want to keep the status quo for a few more years (with the added benefit that their partner share of year-end profit distribution will not be reduced by the need to fund the cost of digital pathology).
On the other side are the younger pathologists in the group. They are a growing force in the pathology labs where they serve. For more than a decade, pathology residents and fellows have been trained in academic programs that utilize WSI and DP.
Thus, each year, a new group of young pathologists enters the clinical workplace, fully-trained in the use of whole-slide images and digital pathology systems. They recognize the benefits of digital pathology and would like their daily practice workflow to be digital.
Future advances in whole-slide imaging and digital pathology technologies may reduce the cost of these systems. The tipping point to further adoption of WSI and DP will then come when enough senior pathologists retire and the next generation of pathologists make up the majority of partners in private group practices, giving them more power to invest in digital technologies.