IT in a pandemic year, now and what’s ahead: interfaces, analytics, telepathology—seven weigh in

And because I have been involved in digital pathology, on or about March 17 I said to the other pathologist who was going to do the COVID cases with me, Do you think we should stand up a digital pathology repository for COVID autopsies? He said yes, and three weeks later we launched a COVID team with about four cases that we had obtained in consultation from COVID autopsies. As I sit here in early September, six months later, we have in process more than 101 autopsies that we’re presenting to our community in digital format, so pathologists across the United States and the world can understand the pathology they’re going to encounter [COVID19pathology.nih.gov].

We’ve been developing these technologies and talking about them. Now we’re deploying them to help our community.

Just as Roche and Sunquest prepared years ago to be well prepared for this, to some degree, so too are the people implementing digital pathology. And it’s nice to note that the autopsy gets renewed respect whenever something new and unknown enters the sphere of illness, health, and death.

Bob Dowd, you’ve just heard considerable discussion about anatomic pathology. My first question is not to necessarily talk about autopsy but just to clarify: Most of NovoPath’s surgical pathology customers are now back running at about normal capacity, correct?
Bob Dowd (NovoPath): That is correct. The business has picked up and we have gone to the digital age, where we’re doing a lot of digital reporting, whole slide imaging. And some pathologists who normally would go to multiple sites are now staying in one site and getting the work distributed and the whole slide image sent to them.

We’re getting a lot more inquiries from our existing clients about what else they can do to further automate their own systems by using our workflow enhancements or new modules with added functionality. They’ve found differences with staffing changes—not all furloughed employees have returned, for example—and want to know what they can do to enhance workflow. So there has been interest in our workflow solutions.

We’ve also received inquiries from potential new clients about demos for those digital and workflow capabilities. We’re starting to see now that people have realized this is more of the atmosphere and environment we’re going to have to deal with, so they’re questioning how it can be accommodated more efficiently. They need to have a much more efficient workflow.

Mark Tuthill, Henry Ford has been a longtime leader and enthusiast for digital pathology. Did the relaxation of CLIA during the pandemic, allowing surgical pathologists to do remote sign-outs, have a big effect this year on the operations at Henry Ford?
Dr. Tuthill (Henry Ford): Not really, but it has given us incentives and opportunities to continue to expand what we have been doing. We’re at the beginning of our digital pathology journey for whole slide imaging in terms of primary diagnosis. We mainly use whole slide imaging for frozen sections, clinical conference, and so on, and all of that is in place. Digital pathology was used more extensively and we had fewer concerns about CLIA compliance, but again, we are not doing primary diagnosis.

We did make extensive use of our digital pathology tools to integrate pathology sign-outs between residents and pathologists virtually. We’re already doing a lot of virtual microscopy, screen sharing, et cetera, and that went on steroids from the pathologists’ offices and homes to the resident room. So we were making more use of what I would say is digital pathology 1.0, live dynamic camera viewing through screen sharing technology, as opposed to whole slide imaging. But whole slide imaging was used to move around our diagnostic controls for immunohistochemistry, which is just part of how we work now.

Dr. Hewitt (NCI): We have had much the same experience. We put cameras on every pathologist’s microscope, and we were able to move our resident education online effectively. The one place we virtualized everything was molecular pathology, and suddenly much of what had been on paper and in in-person meetings, where we would have the team review all the cases together in one room, we completely moved virtual. A number of our staff haven’t been on the campus in more than six months, and it’s had no negative impact on performance and being able to do our molecular pathology. In some ways this experience is going to take some technologies and move them much more virtual and much faster.

James Harrison, what is the experience of your surgical pathologist colleagues in Virginia? Did the relaxation on sign-out have a positive impact?
Dr. Harrison (University of Virginia): All the surgical pathology sign-out is still being done on site. We’re in a situation similar to what Mark described at Henry Ford. We have a whole slide imager that’s used for research but that’s not been integrated into the clinical workflow. So we’re not doing routine imaging with sign-out from home.

On the clinical lab side, we do serum protein electrophoresis with gels, and we were looking at capillary electrophoresis when COVID hit. We haven’t brought those instruments in yet, although it is planned. I am part of that clinical service and we sign out gels on site. We decided not to go to remote sign-out of gels because we found literature suggesting that unless you have purpose-built equipment, scanning and displaying gels on commodity hardware reduces sensitivity. Our hemoglobin electrophoresis is already capillary, and those tracings can be reviewed on any display.

All of our quality control sign-out and laboratory management is done remotely by online meetings. And we have a pretty good ability to access the LIS and EHR from multiple remote sites, so that has gone smoothly.

Michelle Del Guercio, I think Stephen Hewitt was hinting at something that is broadly applicable to laboratories across the country, namely that molecular may still be paper based and not necessarily as well integrated into a digital or LIS type of workflow as are the more common tests from a core lab. Have you seen at Sunquest additional interest in getting the molecular component well suited to the LIS environment, and the EMR environment for that matter?
Michelle Del Guercio (Sunquest): Yes, we have seen quite a bit of activity around molecular testing, with our LIMS for molecular diagnostics, and just dealing within the laboratory itself and with instrumentation. We developed what we’ll call a rapid deployment to help support these labs that all of a sudden are saying they need a LIMS. Manual workflow was no longer working for them and they required something quick to get started so they could bring RT-PCR testing and order workflows in-house. To get them going quickly, we developed a starter package that integrates both with the external for the order entry and then internal with Data Innovations’ Instrument Manager to support the instrumentation on which they’re performing the tests.

Brian Gunderson, since you represent much of the molecular technology that needs that connectivity, can you comment on the increasing need for informatics connectivity for molecular?
Brian Gunderson (Roche): It has had a huge impact. In the past the workflows were manual. Very little IT was deployed within the molecular labs, and with COVID it’s accelerated the need for the IT connectivity back into the LIS and the EMR systems.

Curt Johnson, we are all coping with COVID, so it can be hard to think about future plans and capital budgets and what may happen next year. How is the market looking for Orchard from a sales perspective as you go into next year?
Curt Johnson (Orchard): It’s looking to be one of our best years. A couple of things are playing out, one of which is the laboratory getting the spotlight for testing. It depends on how far you’re looking into the future. Molecular testing is becoming more mainstream. It has been rapidly deployed more clinically than it would have been in the past, and it has forced a lot of information systems to react versus being proactive. As you’re reacting you must look proactively at where things are going and what the future is going to hold. Where is COVID-19 testing going to go? It’s moving now into the senior living areas and nursing homes, and the government is working with those homes and equipment manufacturers to deploy point-of-care testing analyzers throughout the country. These point-of-care systems will require connectivity to rapidly communicate results. How will all of that get connected?

Point-of-care testing is going to explode, and that kind of workflow can be thought of as a different flavor of molecular. It’s different than the normal laboratory information we’re used to seeing, and the connectivity to those analyzers uses different interfacing specifications and has different requirements, different certifications, different types of users. It’s another level of testing, and once you get into the point-of-care area, the next step is into patient homes. All of these ideas have to be in your blueprints today or you’re going to be behind when those times come.

COVID-19 benefited Orchard in some ways. We were in the process of introducing our point-of-care enterprise solution and our enterprise LIS, both of which are cloud based. We had many more deployments than we probably would have had in a traditional year, so it’s been a bridge for us into the future. It has taught us a lot about where we’re going and it enhanced our development.

An example within COVID-19 testing in molecular is pooling of samples. It’s much more than putting a few extra patients in a well. How are we going to handle the reflex testing? How are we going to identify patients? How are we going to make sure the testing gets back to the EMRs and is electronically correct? How are we going to make sure that information gets to the state department of health? All of this has to be managed proactively.

What is the school system going to look like in two years as far as testing goes? Will they have point-of-care analyzers where they can test for flu, COVID-19, and strep in the nurse’s office? Who is going to want that data? How will the data be used? What kind of data is the NCI or NIH going to need? How can we benefit by capturing that data and providing it to people? All of that is on our roadmap.

Michelle Del Guercio, are you hearing and feeling some of the same things at Sunquest?
Michelle Del Guercio (Sunquest): Yes, we are. The continued growth with molecular, for example. It is becoming more mainstream, and there is more demand. We continue to focus on that within the Sunquest suite. Interoperability between systems—the pandemic may have slowed down some of the large EHR implementations. So we’re helping our customers focus on interoperability within their own health systems and then external to that as they look to connect multiple EHRs and multiple LISs.

We’re seeing synergy between the public health world and the standard clinical world, as we see people return to universities and to work. It’s the connection between the population and the patient. We will see that trend continue and a little overlap of those industries and then support them on that. We support the disease surveillance and outbreak management side, and we support the clinical pathology molecular side.

Brian Gunderson, you mentioned at the top of our discussion the increase in consolidation, particularly among providers. For those labs that are not yet consolidated and may be on older, even legacy-type operating systems, is now a good time for them to consider what they’re going to need in IT for the future?
Brian Gunderson (Roche): My advice would be that you, as a laboratory, have a digital strategy and know where you want to go with it. Laboratories have become much more visible, and traditionally we’ve been seen as a transactional service, but going forward, and especially pushing through COVID and going into value-based health care, it’s going to be critical that you look at all of that data and holistically determine how you can provide more value to health systems. It’s a challenge because understanding that digital strategy hasn’t been a focus, but if we’re going to survive all of the consolidations that are coming, you have to have that in place so you can react quickly, like we did through the pandemic.

Stephen Hewitt, what is your take on that last question? Do labs not yet in the process of getting prepared need to step up for the future?
Dr. Hewitt (NCI): Yes, they do. There is a challenge for them now and it is that many institutions are suffering an economic hit from the pandemic. The institutions that were marching down this way and had already implemented this are seeing the rewards of having been ahead on these technologies. But for institutions that had not started moving toward clouds or integration or anything else, suddenly they have less coin in their back pockets to help them get there.

Data integration is going to be critical to the future, even on the research side. I am participating in the National COVID Cohort Collaborative, known as N3C, and that’s through NCATS, the National Center for Advancing Translational Sciences. N3C will make it possible to rapidly collect and analyze clinical, lab, and diagnostic data from hospitals and health care plans [COVID.cd2h.org]. These are heavy, complex efforts that require an enormous amount of bandwidth with sophisticated IT departments. And a lot of organizations have been taking baby steps toward this. If it was not on their roadmap, it is now. Unfortunately, the economics are such that they will have to push this off two to five years, and that’s concerning.

Some of the large, academic labs in metropolitan areas were surprised when they realized that many of their suburban hospitals and the labs connected with them were understaffed and didn’t have adequate technology, and that accelerated the flood of testing and patients into the flagship institutions.
Dr. Hewitt (NCI): No one was prepared for the flood of testing. For pooled testing, for example, you couldn’t even get a robot on the open market to pool the samples. All of a sudden we noticed how thin the infrastructure really was.

We have been obsessed with being lean, with saving money, with just-in-time inventory, and a lot has changed and may change in the future. Mark Tuthill, would you like the last word?
Dr. Tuthill (Henry Ford): One of the things we have not brought up was the need for analytics capabilities to show how the lab was performing. This was critical for our laboratory leadership and the health system at large. For example, “What’s your turnaround time on your OB/GYN patients coming in in labor?” “Are you getting 100 percent of those tests back in three hours?” We were able to provide these metrics rapidly for a variety of scenarios.

Business analytics tools were critical to our success and added to the visibility of the laboratory because you just could not get that level of detail out of the EMR in real time. We could produce that information up to the minute with our LIS and the tools that we have worked to develop with our vendors in that capacity.

That was the one gap we have not talked about and it is critical. We deliver a curated report showing our throughputs, our turnaround times, our just-to-the-minute positivity rates for a variety of cohorts every day. Our chair personally curates and delivers it to the leadership of the organization. This underscores what we said earlier, that people have finally realized that the laboratory is critical to patient care and that having a hospital-based laboratory is very important for your service delivery. What a fascinating lab 2.0 opportunity, experiment, and demonstration we have all just put on.