Reports revisited—panel on preferences and pain points

November 2023—Reports—integrated or otherwise—were up for discussion when CAP TODAY publisher Bob McGonnagle convened online in October a group of informatics experts, who spoke of the need for simplicity in a time of growing complexity, ease of access, where Epic isn’t strong. The full conversation follows.

During last year’s roundtable, the panel was clear about three important themes that had emerged from the pandemic. We had a need for device integration in the world of lab information systems. We also had a need for report integration in the LIS and EHR. And ease of access was emphasized as things become increasingly complex and many more clinicians and others are interested in laboratory results. On the other hand, some people are more interested in a full report. Mark Tuthill, do those same themes remain important, and is there anything that has emerged in the past year you want to mention?
J. Mark Tuthill, MD, division head, pathology informatics, Henry Ford Health System: These are increasingly pressing needs, particularly in molecular pathology automation, where end-to-end solutions require device integration. With reports becoming more complex, viewability and usability are more essential than ever.

We have had at least three incidents in which people were viewing the HL7 data in Epic and made mistakes because they didn’t click the link to our full-featured PDF report. So I put in a push to Epic and said that our PDF report should be the primary view a clinician sees. Apparently Epic still cannot do that. So we may need to turn off our HL7 display in Epic and force all clinicians to click on the link that says “View PDF” because we’re having problems with people rushing through data. The PDF display is excellent; it’s a clean report. It will also allow us to do things in the reporting that we can’t do without that viewability.

Amjad Azizi, do you have customers who find that the display of data in the EHR is sometimes problematic?
Amjad Azizi, director, informatics strategy and solutions, Sysmex America: Yes. We have a cloud-based workflow solution [Caresphere Workflow Solution]. Still, we have customers who say they prefer a small-scale solution, which is our reporting solution, over an LIS solution because of the lack of data integrity. The data shows a solidity from one source and there is no consolidated view to get all the data from the same local LISs. That creates timing issues, especially when they must comment on special cases related to patients, and timely consolidated reports play a major role in ensuring patient safety and timely results.

Joe Nollar, what’s your reaction to the main themes we are rolling out here?
Joe Nollar, associate vice president of product development, XiFin: These are key themes in our industry now. Integrating with histology automation platforms is at an all-time high. We’re seeing another uptick this past year in digital pathology integrations where pathologists are contracting independently and want digital pathology to support their new business models. There’s also expansion into novel artificial intelligence algorithms for diagnosing cases. For example, running AI algorithms on prostate stain digital images to give insightful information to pathologists. AI and digital pathology are providing an opportunity for labs to offer new testing capabilities and insightful data to the marketplace.

I agree with the importance of having a PDF rendition of the report embedded in the HL7 message, as that is the ideal representation of the diagnostic data. We insist on that in all our integrations, unless the EHR is not able to accommodate a PDF.

Diana Richard, it seems we’re all living in the ocean of Epic, trying to make our business work. Can you comment on the dilemma of survival in that world or how we all have to accommodate it?
Diana Richard, senior director, pathology and strategic development, XiFin: As Epic has exploded over the past 10 years, they have continued to augment their solution by expanding on specialized modules, especially in the laboratory and revenue cycle spaces. As they have grown, the volume of experienced users increased exponentially and exposure to the pros and cons of their platform became more prolific. Through public and customer feedback, as well as our own experiences, we have gained considerable insight into the specific areas Epic has and has not been successful.

From a product development perspective, we are learning that delta to better support our Epic-based clients in areas we know Epic is not an ideal solution. A large opportunity exists in data aggregation and how we study the diagnosis, treatment, and cost of care of individual patient encounters and health care events. This is not something Epic does well today but something XiFin considers a pinnacle in the future of health care, particularly as the adoption rate of technologies like digital pathology and AI continues. Epic may be a wonderful EHR, but its users will continue to need infusions of outside solutions to drive innovation where Epic doesn’t have bandwidth or expertise.

Jonathon Northover, what are your thoughts on what we’ve discussed so far?
Jonathon Northover, vice president of product management, Compu­Group: We’re seeing demand for device integration on the clinical and anatomic sides, especially for interpreting PCR raw data, for example, in a way that can be consumed sensibly and used practically for a result, whether it’s urinalysis or HPV. Report integration is an ongoing theme but also balancing the need to make it easier on the patient to interpret a report while not relinquishing control on the physician side so they can provide interpretive help. We’re also getting requests for ease of access on the patient side and from reference laboratories.

One other challenge has been the constantly changing regulatory patterns in the states. For example, with regard to cloud systems that are fully managed as a service, Florida just implemented a law [SB 264] that says you can’t host data outside the country. In Canada two out of five provinces prohibit it and it seems others are likely to follow suit. Being able to preemptively support all models is key in this changing landscape.

Corey Stilton, these themes must be relevant to your business and your customers at Orchard. What’s your reaction?
Corey Stilton, chief information officer, Orchard Software: With molecular testing becoming more prevalent and the variety of bioinformatics solutions available, it has been a struggle to get the right amount of data from those companies to create the right report. For example, we work with a company that provides discrete data that we can use, put in the report, and transmit into the EHR. From other companies data comes on a PDF, not discretely. It is not filtered nicely into charts and does not go upstream well. You can’t track patient history that way. So we create aggregation strategies to standardize that data where we can, to create discrete data where it was not present through the PDFs. Smaller companies tend to have a small PCR instrument in their office and don’t have genetic counselors on staff. They rely on a third party to garner genetic information—it’s in a bioinformatics pipeline and comes down in PDF. They don’t interpret it, and they can’t necessarily support it. That’s where we see gaps in discrete results and reportability.

Ryan Stephens, Roche has an enormous footprint in laboratories in the United States and around the world and is important to clients big and small in what I’d call high-value diagnostics—cancer diagnostics, infectious disease, et cetera. With this variety of clients, does the pipeline of data become difficult because you’re serving a diverse audience?
Ryan Stephens, group marketing manager, automation and digital solutions, Roche: Yes. Data integration is even more critical with the complexity of the systems coming to market. I’ve been in this industry for 13 years and our system portfolio has advanced so much in what it can do. Middleware helps interpret the data and empowers the system to operate as efficiently as it can; without it, our products are hamstrung by the data. We’ve seen that in trying to do direct connections with Orchard, for example, and it shows that we need the software in between, which is a challenge for interoperability. We’re figuring out how to solve for that.

We’re also looking at ease of access. Some of our smaller clinics don’t have the infrastructure for an advanced IT solution. If you’re using a third party to support your data needs in a small clinic or rural community hospital, it might be difficult to implement a wide-scale IT solution. How do we solve for that and how do we leverage new technologies with cloud-based applications and understand the regulatory landscape for these products? For us to innovate at the pace we’re going, we need to think differently about how we handle the on-premise versus cloud conversation and can empower our customers and their customers—doctors and patients—to access the data efficiently from our systems.

Michelle Stoffel, you face all these complications in your health care system. And I’m sure Fairview Health doesn’t hand you a blank check to get everything done that you’d like to have done. What is your comment on this?
Michelle Stoffel, MD, PhD, associate chief medical information officer, laboratory medicine and pathology, M Health Fairview: Every day is an exercise in compromise. With an integrated Epic Beaker EHR-LIS, almost every action our LIS team takes to modify our build has a radiating effect on the non-LIS informatics teams. We have to take that into consideration. We also serve outreach clients, patients, and clinical end users. LIS build is a complicated process and requires coordination. Even if we had a blank check, keeping up with the changes needed takes time and deep expertise. That’s as big a constraint as raw resources.

Also, data display needs are moving in opposite directions from a laboratory and system standpoint. Laboratory reports are becoming more complex. We’re seeing more specialization in lab result reports. As testing gets more complex and drives therapy decisions, we need clinicians to be able to absorb the details.

On the opposite end, we are a big, integrated EHR-LIS, and the EHR system is moving toward having simplified laboratory data displays. If you are not able to see the individual data points that might represent legacy data or distinguish which data came from chemistry instruments with reference intervals that differ, clinicians can come to the wrong conclusion about a patient. So we’re trying to balance how we design our test codes to meet the needs of our stakeholders every day.

In the August issue of CAP TODAY was our roundtable on anatomic pathology laboratories. The upshot of that discussion is we’re in a perfect storm. There’s a splintered group of consumers of the data—splitters and lumpers. There are people who want an exquisitely interpretive report, which is difficult to have in a PDF and has to be portable and accessible. Suren Avunjian, what are you seeing along this line and what have you found useful in designing your system?
Suren Avunjian, co-founder and chief executive officer, LigoLab Information Systems: We have moved away from conventional external report generation methods like Word or Crystal. Instead, we’ve integrated the entire reporting functionality within our platform. This allows us to nimbly interpret and conditionally incorporate discrete data elements into a comprehensive report, resulting in an accessible PDF format. However, the challenge often lies in the transmission of HL7 messages. The silver lining is that more EHRs are actively seeking these discrete data elements, especially within anatomic pathology. This shift facilitates more intricate data representation in EHRs rather than just sending over a monolithic block of information.

The trend toward cloud-based EHRs presents a unique opportunity. We envision a scenario where we can establish a singular connection with cloud EHRs and manage the mapping to all our customers from our end. As customers join or evolve, activating these preconfigured cloud EHR connections becomes simple. This not only reduces implementation time but also cuts costs.

Ed Youssef, the cloud seems to be an essential enabler of solving some of the problems we face in laboratory computing. Do you agree?
Ed Youssef, chief strategy officer, NovoPath: Yes. That’s the direction for the future. Our cloud platform removes a lot of challenges and boundaries. With vendors working together, we can integrate without involving clients. Some clients don’t have the IT infrastructure to facilitate those integrations. By having cloud solutions, we’re able to bypass those challenges and work directly with industry leaders and have great connectivity. That makes it easier from a laboratory and health care provider perspective because they don’t have to get involved in the IT and can focus on providing quality care.

There seems to be debate about how to present final reports—do we have an interim report followed by an additional report when we get reference laboratory results? Some people wait to send a full report with the results of all ordered tests; some send a preliminary report. Do you see this across-the-board approach to how pathology reports are compiled in complex cases?
Ed Youssef (NovoPath): We’re having conversations with clients who want to have the individualized reports go out once they’re released. Their clinicians drive the preferences. Being able to cater to the clinician and make sure you deliver the results they’re looking for and can understand and interpret correctly is crucial. We strive to have a flexible system that can balance the speed of turnaround time, preferences of the clinician, and best practice of the industry. Aggregating results into a single report from disparate testing disciplines is a key challenge we have overcome, but we must also be able to provide interim reports at the provider’s discretion.

Mark Tuthill, do you have at Henry Ford a systemwide protocol for putting reports together? This is not just in anatomic pathology or cancer diagnostics; some infectious disease testing and reporting is also complicated. It’s in multiple sites and comes at different times and places. Can you comment on this question of serial reporting versus one consolidated report?
Dr. Tuthill (Henry Ford): Ten years ago clinicians were after us to have a consolidated report that would pull everything together. Now they want things broken apart. For example, we traditionally embedded our molecular testing for a surgical pathology case into the surgical pathology report as an addendum that’s integrated into the report. Clinicians don’t want that now. They want the molecular report to be a standalone report and the surgical pathology report to be a standalone report. Now we have to de-integrate reports that we spent a lot of time integrating. We’re working on how to cross-link reports so the surgical pathology report can find the molecular report and vice versa. With cloud-based solutions and Web-based platforms, hyperlinking becomes relatively easy.

We have traditionally used an integrated report, after the reports are done. When there is a final adjudication of the case, we issue an amended report. But this report is not to correct data; it integrates data from a variety of testing. This is classically used in hematopathology because it has a variety of disparate reports that we pull together.

We don’t use an interim or preliminary report, but we can issue a report and update it with an addendum. The report is published again. We consider it the primary report. Classic example: H. pylori on a gastrointestinal biopsy, where it will do the report and then we report the H. pylori subsequently on that same data point. It’s different than what we think about with microbiology, where we have a preliminary report of a Gram smear, a preliminary report of an organism, and then a final report with the Gram, the organism, and the antibiotic resistance profile.

Supporting the clinician’s need is the driver. The challenge is these needs are oppositional sometimes. As Michelle said, it’s an exercise in compromise and finding out what will help people do their jobs most effectively.

Ryan Stephens, does this all sound familiar?
Ryan Stephens (Roche): Yes. From the core lab and molecular side, we see this in how results are being transmitted from our instruments. We can get a lot of different targets on the molecular side, but the question becomes what is relevant. And with the complexity of multiplexing, we also need to understand what is useful for a clinician. We’re also trying to figure out how to influence clinical decision support by having cloud-based solutions that can pull data from multiple instruments and help risk-stratify patients and provide that to clinicians. If we can use data or an IT application that plugs into the LIS to help provide that, it could have value in the market and help our clinicians treat more efficiently.

It’s interesting to hear what Dr. Tuthill said about the compromise and integrating and de-integrating, because I assume we’re going to continue to see that as we push our products upstream.

Michelle Stoffel, what’s your reaction to what Dr. Tuthill said? It sounds to me like it calls for a lot of meetings.
Dr. Stoffel (M Health Fairview): It could take more meetings than there are minutes in the day, so we have to get creative. Everything Dr. Tuthill said is ringing true to what we’re working on in our system. An exciting opportunity around a current pain point now is rethinking the design of what have historically been considered parts of the AP exam—immunohistochemistry stains that are now being used as molecular biomarker tests, like PD-L1, BRAF V600e, et cetera. These are currently unstructured text in our AP reports. We’re working on how we can transform biomarker data to discrete form to make it more usable. Discrete data is easier to make visible within the chart so clinicians know the test is in process, for example.

When it comes to molecular testing, we’re also seeing blurred lines in terms of who orders it. Immunohistochemistry has historically been the domain of anatomic pathologists, but more and more we’re having clinicians request it. So we’re navigating these areas of decision-making turf using the constraints of our LIS to create solutions that will make clear who has ordered what and when.

Amjad Azizi, Sysmex America has a long-standing middleware that works well in your systems. Can you comment on that and the general topic of hematopathology and informatics?
Amjad Azizi (Sysmex): The main challenge for data integration is getting all disciplines reporting simultaneously. Our cloud-based solution has helped close the gap between getting the data and making it available for the LIS to provide consolidated reports to the physician. With AI and data migration, we can provide individual consolidated results, especially for hematopathology. But we need to get into more detail on data harmonization. We’re trying to close the gap with existing solutions to ensure we provide a full picture that helps physicians make decisions.

Suren Avunjian, can you comment on the need to help the clinician and the burden it’s putting on vendors?
Suren Avunjian (LigoLab): It’s imperative for vendors today to streamline and simplify the data integration process to support clinicians. The LIS or system of record should be agile, tailoring data collation and delivery to the clinician’s preferences, in format and frequency.

We’ve introduced what we refer to as the integrated or consultative report. This is not merely an aggregation of data; it’s an intelligent synthesis. The system dives deep into the data warehouse, collates data relevant to a specific disease state across various disciplines, and converges this with pertinent images and interpretations. This comprehensive report empowers the clinician to render their conclusive interpretation and recommendations, informed by a holistic view of the patient’s data. We present this as a distinct, standalone report rather than a mere addendum to the pathology report.

Corey Stilton, there are staffing shortages in all of health care, including many open positions in health care IT departments, which must be a crippling factor for someone who needs to service clients. Is that right?
Corey Stilton (Orchard): There are many vacancies. One of our largest struggles, especially with implementation of our solution, is the partnership with the client that we rely on heavily if they’re doing an on-premises install on their IT side, for example. We’ve been leaning on our cloud-hosting platform to get our implementation times down. If we can host the solution, we can leverage our staff’s ability to create VPNs for vendors, build out the system, set up a network infrastructure, and create a secure environment for their application. With lack of manpower, they may have a couple of people on staff but they may be leaving things in the background that are typically table stakes for an IT infrastructure, i.e. security. We’re trying to bridge that gap with our clients, but it’s an important issue.

Diana Richard, can you comment on the availability of adequate staff on the client side to optimize your offering?
Diana Richard (XiFin): Everyone is facing this compression of staffing, and the staff we are able to obtain and retain come at a higher cost. It’s a challenge that XiFin and a number of our clients face.

We are constantly challenging ourselves to develop more efficient processes with the goal of leveraging existing resources more effectively, organically reducing the need for new resources. This is largely driven by automation of workflows, in part or entirely. The concepts that drive development come from a routine retrospective and prospective assessment of what we improve upon ourselves. Other solutions are derived through external partnerships, such as leveraging relationships with ordering physicians and facilities. We have a number of clients who work with their hospital system, partnering on better outcomes in areas, like patient registration, that improve front-end information gathering and reduce back-end denials.

Several people at a recent meeting I attended said they were educated to be laboratory scientists and pathologists but instead find themselves to be process engineers and troubleshooters as a key component of what they do every day. Does that ring true to you, Michelle? And can you comment on staffing shortages at Fairview?
Dr. Stoffel (M Health Fairview): It does. In the past two years, since we’ve moved to an integrated EHR and LIS, we’ve had a lot of our lab staff and pathologists step up to the front line of process engineering, and they have been essential to getting our work done. The LIS is less an island than ever before, and that extends to our lab staff and pathologists being called on to engage in troubleshooting and design together with LIS.

We’ve been lucky that our LIS staffing has remained good, but we have faced the same shortages in lab staffing as many others have. And even in LIS, we are competing on the national market and beyond in terms of retaining staff who are now working predominantly in a remote environment. To make the most of what we have, we’ve focused on trying to get quick wins for efficiency. This depends on having robust communications and visibility between the LIS team and lab stakeholders—they know how to find you easily and can tell you where the pain points are so you can focus on that. It also depends on having a robust management system so we can, at a high level, look at the incidents coming in and detect patterns to home in on where the pain points are. That’s been a successful strategy for pinpointing the biggest workflow issues and trying to reduce inefficiencies one by one. We are also working to use automation wherever we can to reduce the burden on our lab staff and pathologists.

Jonathon Northover, talk about your perspective on the need for process improvements and adequate staffing process improvements to become a reality.
Jonathon Northover (CompuGroup): We’re expected to be experts way beyond how we might interpret a traditional LIS vendor to be on the IT side. We have a gamut of clients, from those who have robust IT engines that run within the client institution to those who lean on us for everything. It wouldn’t have been typical back in the day to have network experts on your team, but we have to be able to do that if we’re working for a client who has little to no IT infrastructure from a staffing perspective. Even when their IT is well staffed, they are expected to get up to speed with lab processes themselves. We help with that too.

In addition to being leaned on more to provide IT expertise, we are also seeing a high turnover in staff, especially with clients who have multiple point-of-care testing locations. As a result, they can struggle to keep current with competency assessments, the management process, and the paperwork. We’ve been pulled in to help those sites stay on top of their inspections and staff management, even though we’re not a staff management software provider. That’s ramped up significantly in the past 12 months and we don’t see it slowing down.

Corey Stilton, Orchard is known for paying attention to point-of-care testing. Does a lot of that burden fall on you for competency assessment and figuring out which testing sites will be open on a given day?
Corey Stilton (Orchard): Yes. We put a lot of emphasis on the inner development of our point-of-care application and leverage our middleware to communicate properly with the POCT1-A devices for those competencies, making sure we have the capacity across a vast array of locations to handle our clients’ needs. Competency is core to that, and it’s a tremendous amount of overhead on the system. It took a great deal of engineering to create a product that can span a wide-area network, integrate different devices, operate a range of protocols, and bring that together and not break the bank on the back end in processing that data.

As Ron Popeil said in his TV ads, “But wait, there’s more!” And the “more” is digital pathology, which is on a fast track now. Joe Nollar, what are your thoughts on that?
Joe Nollar (XiFin): We’re seeing a lot of interest in integrated digital pathology solutions in the LIS. We’re seeing interest in artificial intelligence solutions, digital pathology scanners, and image management solutions and how those are integrating with the LIS and driving new revenue models and new types of pathology practices and services. Even our largest laboratory customers who have tended to be more cautious with digital pathology are beginning to ramp up their activity and projecting that there may be shortages of scanners over the next two years as there’s a rush on the marketplace. Labs want to be earlier rather than later to the party.

Mark Tuthill, your comments on that and anything else we haven’t mentioned?
Dr. Tuthill (Henry Ford): It is ramping up and there is a shortage of equipment. I tell people who are interested to get in line early. I’ve heard cases of people waiting six to eight months for scanners. It’s not a problem we want, but it means we’re moving in the right direction. We need CLIA and the FDA to support these efforts and perhaps take a more open approach to deploying these solutions.

One of the most fascinating challenges is routing the images into the workflow and into AI and machine learning pipelines. Companies are starting to address this, at least verbally; I don’t know of many that have solved it directly. Most of it is still “pick up image, throw it to the analysis system.” We need to have pipelines, and the images need to be integrated into work lists and the laboratory information system.

There’s a tremendous amount of work coming at us, which comes back to the conversation on resources and human resources. Retention is a problem I find myself losing sleep over. And one of the ways to retain people is to have exciting projects like this for them to work on in these environments, which goes back to capital, et cetera. So we have a lot of work to do and don’t have enough money or people to get it all done quickly. But patience is the mantra in informatics. We’ve been waiting for digital pathology for 20 years.

Michelle Stoffel, is there reason to be excited?
Dr. Stoffel (M Health Fairview): I am excited. At M Health we have an integrated EHR-LIS workflow for our whole slide imaging. Even though we are currently doing limited use-case scanning in our daily workflows, it has been a game-changer for our pathologists in terms of being able to work how and when they prefer. Integrated digital pathology is a significant IT footprint every time there are upgrades and validations, and it requires a unique workforce to support scanning and quality workflows. It can be a challenge to figure out how to best scale digital pathology, but it’s a part of our future. I am looking forward to the day when pathology imaging data is as available and as useful in the chart as radiology data is today.