Some evolving trends in anatomic pathology (AP) informatics are impacted by developing technologies such as molecular testing and whole slide image systems (WSI). Other informatics trends are directly attributed to the competitive pathology market environment, as a result of vendor acquisitions and competition among healthcare systems or national, regional, local and in-house specialty labs. Others are based on government legislation (“Meaningful Use” and regulations affecting EHRs / EMRs)—or a combination of all of the above. AP Laboratory Information System (LIS) vendors must be cognizant of these trends as they develop software for future use, and, more importantly, should provide flexibility in their software no matter what trend(s) emerge into the mainstream pathology marketplace.
The argument: “Enterprise-Wide Solutions” or “Best of Breed”?
We read much about how large healthcare systems are trying to migrate their IT infrastructure to an enterprise-wide solution in which one vendor offers software solutions at departmental levels, on a single platform, throughout the entire enterprise. In an ideal world, there would be cost-effective, state-of-the-art IT solutions offered by multiple software vendors, providing a selection for the healthcare system's IT staff to evaluate. These “Single Vendor/ Single Platform Enterprise-Wide Solutions” ideally would enable the efficient and 100% accurate acquisition and documentation of patient information obtained from various departments throughout the healthcare enterprise. This would include a wide range of departments such as Radiology, Clinical Medicine, Nuclear Medicine, Dietary, Pharmacy, Billing, Nursing, and the Laboratory. The information then would be transferrable across the healthcare continuum. All of this would be on a single software platform, a shared database, managed by a single vendor and service organization. The available information would be both historical and current and, when appropriate, could be shared confidentially with clinicians, healthcare providers, business operations within the facility, Accountable Care Organizations (ACO), relevant government agencies, and the patient. As long as the Single Vendor/Single Platform Enterprise-Wide Solution meets each of these criteria, and is committed to continued development as healthcare requirements change, nothing else should really matter from the perspective of either IT or the individual departments. The Solution would be expected to reduce the overall cost of healthcare delivery and enable clinicians and patients to collaborate on the best possible patient care in a way that provides for statistical data analysis benefiting us all in many different ways.
There are a limited number of Single Vendor/Single Platform Enterprise-Wide Solution vendors offering a solution that encompasses most departments in the hospital. This may be the best approach if the facility does not have an Anatomic Pathology department or if the AP department is signing out a very small number of routine, in-house cases. The benefits offered to an AP Lab by an enterprise-wide solution become much less attractive as the case volume increases, however, or if the functionality of the AP Lab expands beyond the basics and begins to incorporate more sophisticated technologies.
Some software vendors offer a “Partial Enterprise-Wide Solution.” These vendors generally compete head-to-head with the few Single Vendor/Single Platform Enterprise-Wide Solution vendors. Unlike them, however, some of the “Partial Solution” vendors recognize that they do not have a competitive AP LIS comparable to the “Best-of-Breed” vendors. They know they must partner with a Best-of-Breed AP LIS vendor to provide a robust AP LIS solution for their mutual customer. Unfortunately for the IT department, this partnering approach does force the institution to deal with a second vendor, and perhaps to manage an interface between the two software platforms. Fortunately for the anatomic pathologist and lab manager, this is viewed as a much better approach for the AP Department.
“Enterprise-Wide” augmented with “Best-of-Breed”
In today's environment, seamless interfacing between software systems is no longer a challenge. If a better solution exists, why settle for anything less? An Enterprise-Wide approach, augmented with a Best-of-Breed solution (when appropriate at a departmental level), is often in the best interest of the facility, the department, and, most importantly, the patient.
Six months ago, I received a call from a pathologist telling me that his healthcare system was going to consider upgrading its AP LIS and, if I wanted our Best-of-Breed Anatomic Pathology LIS system to be considered, I should contact its IT department. I did so and was referred to a consultant who was working with the health system. After reaching the consultant, I was told that the health system was only considering a Single Vendor/Single Platform Enterprise-Wide Solution. “Thank you very much. Don't call us, we'll call you.”
Fast forward to last month. A different consultant, working with the same healthcare system, called to let me know that it was going to “open up” its consideration for AP laboratory information systems to Best-of-Breed vendors. The system realized that the Enterprise-Wide approach, while suitable for most functional areas within the hospital, was not the best approach for its Anatomic Pathology Department. In this case, IT ultimately recognized the need for a more robust AP solution, and abandoned its search for a suitable Single Vendor/Single Platform Enterprise-Wide Solution.
The Best-of-Breed vs. Enterprise-Wide Solution for anatomic pathology will be debated until there truly is one Single Vendor/Single Platform Enterprise-Wide Solution with a fully robust AP system. If your facility is in search of an Enterprise Wide Solution that includes a robust AP LIS, you should settle for nothing less than the best solution for your Anatomic Pathology Department. More often than not, this may be either a Best-of-Breed approach, or an Enterprise-Wide Solution augmented by a robust “Best-of- Breed” AP LIS.
Whole slide digital imaging
Whole Slide Imaging Systems (WSI) rapidly scan and produce fully digitized 3D images of slides. In a perfect world, pathologists would not be relying on the microscope and the AP LIS as their primary tools. They would use combinations of WSI technology—Anatomic Pathology LIS and other software programs to aid in making “microscopic” diagnoses and to rapidly transmit and archive relevant information.
The concept of whole slide digital imaging could be viewed in light of the revolution of computed radiography (CR). In CR, digitized images, previously captured on X-ray film, radically changed the workflow within the Radiology Department. This new digital technology replaced X-ray film, view boxes, developing rooms, and chemical waste, while at the same time improving turnaround time, accuracy of diagnosis, workflow, cost, and patient safety. Eventually, this led to the development of “Radiology PACS,” permitting radiology departments to expand to a virtual environment that enabled radiologists to remotely access images for diagnostic purposes (teleradiology). Capturing a 2D black and white image of a body part and transferring the information across the world, is, however, very different from capturing and transmitting 3D, full-color microscopic images of cells.
The bandwidth challenges to WSI
The vendor-based impediments to WSI adoption are both technological (scanning time needs to be dramatically reduced to seconds per slide) and fiscal (scanner costs must plummet) in nature. The bigger challenge, however, is outside of the control of WSI vendors.
This larger issue must address the technology needed to transfer large amounts of information from one facility to the next. As the WSI technology matures, image resolution (amount of detail captured) will increase. With increased resolution (in this case measured in gigabytes/image), the amount of information to be transferred will proportionally challenge the capabilities of the existing pipeline technologies (Fiber, DSL, Cable, T1 lines, Wireless, etc.). In addition, other departments such as Radiology and Cardiology are generating increasingly more image-intensive data, forcing WSI to compete for limited pipeline “space.” Thus until bandwidth capabilities are addressed, WSI will be used within local area networks (LAN) with dedicated pipeline capability, but sparingly elsewhere.
Aside from the cost and technological issues, a recent ruling by the FDA categorized WSI Systems as a Class III device. This ruling will dramatically delay the widespread adoption of this technology.
Over the decades, pathologists have become extremely proficient in diagnosing from glass slides. Until costs come down, technological advancements are made, pipeline bandwidth explodes, and government regulations are addressed, WSI will remain a niche technology with exceptional potential. Even when Whole Slide Imaging Systems' technology hits “prime time,” it will co-exist alongside the AP LIS and the microscope. Until such time, the microscope and the AP LIS will remain the dominant tools of pathologists.
The future? Diagnostic clinical hubs
Stimulated by healthcare reform and other government initiatives and programs, technological advancements related to the exchange of large amounts of information, (cloud technology, medical software, digital medical imaging capture, computer-aided analysis and diagnosis, etc.) are anticipated. As a result, it is likely that in the next decade or two we will be implementing the concept of Diagnostic Clinical Hubs as the cornerstone of healthcare organizations. A case could be made that by having all diagnosticians and clinicians in one centralized “hub,” either virtually or face-to-face, with complete access to subspecialty expertise and comprehensive patient information, outcomes would dramatically improve and costs would be substantially reduced. The ACO concept is a model that ties healthcare providers to both the delivery of quality care and the reduction of total cost of care. Moving to Diagnostic Clinical Hubs will provide the infrastructure to benefit all in achieving the overarching goals of an ACO.
No matter how these trends unfold, it is evident that the more flexible and robust your anatomic pathology LIS is in meeting the increasingly complex needs in healthcare, the more competitive your pathology lab will become. Now is the right time to make certain that your AP LIS is flexible and forward-thinking.
Rick Callahan, Vice President of Sales and Marketing at New Jersey-based NovoPath, Inc., has 15 years of experience in medical IT solutions, particularly regarding pathology and radiology.
