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Diagnostics Digital and computational pathology

Global Referral

Rajendra Singh. Credit: Supplied by Interviewee

Matthew Hanna. Credit: Supplied by Interviewee

Healthcare was brought to its knees in the initial months of the pandemic. With few hospitals focusing on the provision of acute care, patients struggled to access regular services, leading to a noteworthy increase in the number of requests for second opinions in the field of pathology. Since then, that demand has continued to increase.

PathPresenter, an image viewing and pathology workflow management platform “created by pathologists for pathologists,” has always sought to fill in gaps in the use of digital pathology. Driven by pandemic need, the team set out to create a seamless solution for second opinion consultations. The goal was to integrate this new tool with already existing workflows in a manner that allowed institutions to provide their expertise without disruption and create a compelling return on investment for implementing digital pathology.

With that goal in mind, PathPresenter decided to partner with the Ohio State University Medical Center (OSUMC) Hospital to pilot and validate a fully digital, remote solution. This tool enabled OSUMC pathologists to receive, view, and sign out cases uploaded from referring institutions around the world – directly into OSUMC’s existing laboratory information system (LIS). That was back in April 2022. 

To learn how the process of securing second opinions has changed post-pandemic and what effect digital pathology has had in that transformation, we talk to Matthew Hanna, Director of Digital Pathology Informatics at the Memorial Sloan Kettering Cancer Center, and PathPresenter co-founder Rajendra Singh.  

How does pathology’s use of (digital) remote consultations differ from other fields of medicine, such as radiology?
 

Rajendra Singh: Pathology remote consultations involve the sharing of multiple large files. When comparing radiology and pathology files, the latter are usually 10–20 times larger and, in addition, one consultation case could have multiple H&E slides as well as additional immuno slides. Sharing large amounts of data for each case and ensuring a good user experience while viewing these images needs sophisticated technology, good bandwidth, and solid infrastructure. 

Matthew Hanna: From a regulatory perspective, it is worth noting that, historically, pathology departments were limited by state and federal regulations – for example, the Clinical Laboratory Improvement Amendments of 1988 (CLIA) or state licensure requirements – in terms of remote consultations. Other domains in medicine have state licensure requirements but are not governed by CLIA. With the declaration of the public health emergency in 2020 and regulatory enforcement discretions, pathology was finally able to provide remote care in certain settings with validated systems. 

What is driving the demand for remote second opinions?
 

RS: Broadly speaking, cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2023. Each year, approximately 400,000 children develop cancer. A little over 1.9 million new cancer cases are expected to be diagnosed and approximately 609,820 deaths from cancer are expected in the US in 2023. Despite all our advancements, the number of cancer cases is on the rise. Cancer diagnosis has become more complex and specialized. Each cancer has many subtypes and an ever-expanding list of features and new findings that decide prognosis and treatment. The kind of expertise required to treat cancer appropriately is not available everywhere, which leads to patients seeking second opinion consultations from the few experts sitting at various locations around the world.

MH: In my view, there are three main areas that drive the demand for remote second opinions. 

First, during the pandemic, remote review became almost essential to keep operations and provide patient care. Requests have not gone back down to pre-pandemic levels. 

Second, as Raj mentioned, and we see this domestically, remote consultations are mostly driven by lack of subspecialty expertise where, for instance, a local hospital does not have a neuropathology specialist but the hospital performs neurosurgical procedures.  

Third, globally, remote consultations are quite important for resource restrained countries or locations where pathologists are scarce. Democratizing pathology knowledge is critical to supporting global health initiatives where patients need the expertise and we have an opportunity to support our pathology colleagues.

Additionally, pathologists may use second opinion as an informal consultation to a colleague or for consensus review between multiple colleagues, which can also be very useful in the digital format.

Please briefly describe the traditional and digital remote consultation workflows…
 

RS: Currently, remote consultations in pathology are either done by mailing glass slides or uploading whole slide images (WSI) to the cloud and sharing with the expert. Mailing is a time consuming and expensive affair. Glass slides need to be assembled and shipped with paperwork with extremely reliable carriers to ensure safety. Once the slides reach the institution, personnel are needed to track and ensure delivery, open the packages, document the paperwork, register in the LIS and assign them to the right expert. Connecting everything to billing and ensuring payments is a separate chore. 

If one is sending WSI via the cloud, current methods include Dropbox, Box, OneDrive, and other similar technologies. Personnel at the receiving hospital need to download the slides and enter all the metadata, ensure the slides are uploaded in the right location so that the assigned pathologists can view them in the LIS along with associated metadata. Of course, if the sent file is in a format that is not functioning in the current viewer, the file may need to be converted to a compatible file format.

In general, primary diagnosis workflows are actually much simpler to implement because the patient is first registered in the hospital electronic medical record (EMR) and then in the lab information system (LIS), which now has their metadata. Only after that is the glass slide produced. As the patient metadata is already available, it is easier to connect the produced glass slides and digital slides to the metadata. For remote cases, the slides come first and then the metadata needs to be entered, which entails creating a new case, most likely only in the LIS.

What are the main barriers to digital remote consultation?
 

RS: From a technical perspective, the main barriers are:

  1. Multiple file formats coming from various institutions based on the scanner they have
  2. Insufficient technological infrastructure and bandwidth for transmitting large image files over the cloud and allowing remote viewing in a seamless fashion
  3. Data security issues in transferring patient health information (PHI) and slides, privacy and HIPAA compliance. 
  4. Different LIS in different hospitals

MH: Overall, not having implemented the pre-requisites of a digital pathology system (barcoding tracking, LIS integration, and scanners/viewing software) is a big barrier. The lack of standardized protocols for digital pathology workflows and quality assurance to allow seamless experiences in the sharing of patient data is also a challenge.

Another barrier is quality control. One underserved area in digital pathology is related to quality control of the digital slide. Glass slides reviewed on a brightfield microscope can be much more forgiving than a digital slide that has air bubbles, pen ink markings, overhanging coverslips, labels, and other pre-analytic artifacts. As these slides have likely already been handled by many hands in the process of slide review, storage, retrieval, shipping, unpacking, collating, distribution, and scanning, they are not as pristine as they might have been if scanned directly after staining and coverslipping.

Digitizing remote second opinions
 

Vice Chair and Director of Anatomical Pathology at OSUMC Anil Parwani and PathPresenter co-founder Rajendra Singh reflect on how the pilot performed and explore what may be next for the partnership.

Anil Parwani. Credit: Supplied by Interviewee

OSUMC is a pioneer in digital pathology – one of the few institutions that have deployed digital pathology for primary diagnosis. The institution also receives many consultation cases from other parts of the country and abroad. The was very aware of the issues when receiving glass slides or WSI. Thus, the main goal of the collaboration between PathPresenter and OSUMC was to create a seamless end-to-end digital workflow that was vendor agnostic and that would allow any patient in any part of the world to connect with an expert pathologist for second opinion reads. An additional goal for the PathPresenter team was to create a scalable model that could be extended to other institutions.

PathPresenter created a web portal that allows OSUMC to invite referring hospitals to register. Once approved by OSUMC, the referring hospitals can upload patient slides and metadata on the secure cloud portal. This can be done manually or through APIs. Uploaded information was brought into the EPIC Beaker system at OSUMC through a proprietary HL7 engine built specifically for this purpose by PathPresenter. Once the integration was completed, referral cases became automatically available for the pathologists in their LIS queue. Once cases were signed in the LIS, OBX messages allowed the PDF report to be sent back to the referral hospital for downloading. 

The interface was designed to keep simplicity in mind and offer intuitive ways to operate a virtual dashboard with all cases listed per specialist/pathologist and all the necessary tools to create consultation reports.

This setup provided many advantages. First of all, it was a scanner agnostic system. Slides were made available in the LIS, so pathologists would see them in their routine workflow. In-built communication channels allowed pathologists at the referral hospital and OSUMC to communicate as well as OSUMC pathologists to discuss cases among themselves. Integrated AI modules through API/FHIR allowed pathologists to use them in the viewer used for reporting cases, rather than using a separate viewer provided by some AI companies. Everything the pathologist needed – reporting issues, adding macro codes, case discussions, and more – was possible from the viewer, making it easy for the pathologist to quickly complete their cases.  Reports generated were automatically available for download thus completing the loop.

This process was fully automated, ensuring that many of the typical pre-analytical errors could be avoided, including mistakes in the patient name or other metadata, linkage of the wrong patient with the slides, and so on, resulting in cost and resource savings. Other big advantages are that the portal can provide access to all types of images – from WSI to gross images and even images from other specialties, such as radiology. 

The main challenge we encountered was integration with EPIC Beaker LIS. The current LIS is well suited to handle internal cases that are first registered in the EHR and then brought to the LIS. However, remote cases are not registered in the EMR, but need to be registered in the LIS. Workaround solutions needed to be created to make this a seamless and true integration, which is the cornerstone for a streamlined workflow where the right pathologist can connect with the right patient for the right diagnosis.

Plenty of work still needs to be done. Issues related to uploading different file formats and huge image sizes need to be worked out. PathPresenter has worked with each LIS vendor separately as they are all unique and come with a different set of issues and requirements. However, each integration has been easier and less complex than the previous one. The goal is to create a network of institutions that are working in the same ecosystem and can share expertise easily.

In the future, we are hoping to create infrastructure that goes beyond faster and easier second opinion consultations from expert pathologists, extending into research organizations and pharma companies who want to match patients with the right drug using AI models. Patients could upload their slides, allow AI to look for specific mutations and changes, and match them to the right clinical trials or companion diagnostic drugs.

Disclosures: Matthew Hanna and Anil Parwani both serve as advisors to PathPresenter.

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About the Author
Patrick Myles

Path Presenter

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