Talking tests, instruments, and what’s best where

Christina Reita: Laboratories do face challenging decisions about when to centralize or decentralize some of their diagnostic testing. Our strategy positions us to provide value to our customers by consulting with them on when and how to do that. We have our Roche Healthcare Consulting service, which is made up of workflow consultants who can look at testing across the sites and help determine which testing makes sense to do at which site.

We also have invested in emerging IT solutions that can help laboratories and the health systems they are a part of. For example, Viewics delivers end-to-end health care analytics and provides insights to empower labs with the data required to improve operational and financial outcomes across the health care system.

We talk a lot about IT in our roundtables on instrumentation. First, the interface from the instrument to the LIS; we have a lot of middleware that’s important there. But then, importantly, reporting of the instrument result into the EMR. Dr. McCash, what has been your recent experience? I know you have an interest in the IT side of the clinical laboratory. Tell me about the challenges there, particularly as they affect instrumentation.

Dr. McCash: In terms of laboratory information systems, one of the issues is there aren’t many choices. There’s probably a handful of laboratory information systems out there that can handle large volumes in a testing laboratory. And these systems don’t necessarily push the boundaries of being able to do what you want them to do, to report how you’d like them to report. Part of that is because of the lack of competition. If laboratories want certain functionalities, they could put pressure on the laboratory information system companies, but that doesn’t always work. So to get the desired functionality, laboratories have to rely heavily on middleware and other systems from other companies.

A lot of what goes into what you want to bring in-house will depend on what the middleware can do and how it interfaces with laboratory information systems, maybe even with EMRs. That brings up the additional challenge of laboratories handling multiple systems for things like autoverification rules, quality control, critical value alerts, repeat testing, and reflex testing. There is also a challenge in organizing all of the data dispersed among the systems so that the laboratory can use it efficiently, with clinical results distributed appropriately to clinicians and patients.

On a scale of one to 10, with 10 being hugely satisfied and one being not at all satisfied, how would you rate your ability to put clinical lab results from chemistry and immunoassay into the EMR that your clinicians depend on?

Dr. McCash: There are always pros and cons, and I would say what we’re doing now is adequate. It is not ideal, especially since we do not have control of the EMR. We in the laboratory are trying to bridge that gap a bit more by communicating with the people who are in charge of the EMR to see what they can do for us. And we’re doing better in getting that communication and that teamwork going forward. There’s also a lot of effort in making sure we all communicate about these different systems that are in place. For instance, when we were bringing in our laboratory information system, we had talked to people who are in charge of the EMR, and we all had to come together to discuss our needs, what had to happen, and then come to a conclusion about which system to go with. And that relationship has been going well.

Christina, it’s well known that Roche has an enormous number of installs at some of the biggest core labs with high volumes serving large integrated delivery networks. Geisinger comes to mind. I’m sure those of you in centralized diagnostics live almost daily with some kind of IT issue.

Can you give me a sense of how that plays out and some highlights, if you will, of what kinds of problems customers need you to help solve, even though their real problems might be with an IT vendor?

Christina Reita: We have placements in large and small laboratories. Both the complexity and the resources of the IT systems that a site has will vary.

Our Roche Healthcare Consulting team works from a workflow perspective, and we have a strong IT consulting team that helps our customers as they operate in this new normal, where digital is critical to not just the laboratory but to the health care delivery system overall.

We have middleware solutions to help our customers solve some of their challenges, whether it’s basic connectivity all the way to sophisticated dashboards, because these labs are sitting on a mountain of data and expected to leverage that data to provide valuable insights.

We also move beyond middleware into our new digital suite, Cobas Infinity laboratory solution, which is designed to help our customers manage their sample and data flow across centralized and decentralized sites. We’ve got a workflow engine that helps determine the fastest route for every sample. It can negotiate changes—for example, when an emergency sample comes in. It’s a comprehensive workflow management tool designed to help the smallest laboratories to the largest with their biggest challenges.

Our diagnostics optimization solutions through our Viewics platform help customers solve the problem of what’s the right test to use at which time and whether all clinicians are leveraging the tests in the same way.

So while customers have a variety of information technology challenges, we look at these as opportunities to help them solve some of their most critical problems.

Mimi, tell us about the IT system challenge as you see it from your perch at Tosoh.

Mimi Dang: It is what’s been discussed thus far—everyone is trying to centralize their information to be able to distribute it to multiple channels. The LIS-LIMS providers are not always able to accomplish that in ways that are customizable to each laboratory’s needs.

Companies are offering middleware to address the challenges that aren’t able to be met through the LIMS or LIS. We have our teams and specialists for IT, where they work with customers to spec out what they need, the requirements they have with their LIS, and to be advocates to channel that conversation, if needed, especially if the laboratory doesn’t have the resources to have a specialist on board to advocate for it. We also offer the middleware solution from our end for laboratories that aren’t able to have a laboratory information management system within their labs or within their clinics. And we have inventory management and other solutions, through our middleware and other platforms, that would allow customers to centralize information to distribute it directly to where it needs to go.

Dr. Kiechle, what worries you the most about the next three to five years in clinical pathology? We have reimbursement pressures, staffing pressures, and pressures regarding adequate communication and understanding of the value or significance of laboratory tests on the part of busy clinicians who are taking care of patients, and not just physicians but nurse practitioners, PAs, nurses.

Dr. Kiechle: I would put on the top of the list the interface between molecular technology and anatomic and clinical staff applications. It starts with education of the physicians who are ordering these tests and education of some of the people in the laboratories. NGS is not a sodium measurement because the complexity of setting up next-gen sequencing to do tumor sequencing, for example, exceeds that of setting up a sodium as far as more bioinformatics and more understanding of complexities within the various platforms you have to choose from. Then the minute you make that decision, the next week someone else may have a solution that looks more tantalizing. But you’ve already just spent a couple hundred thousand dollars on something you’re now working with for a while.

I feel the most tension in that area because the area’s growing so rapidly, the information is so valuable, and the growth of immunotherapy may replace the need for that kind of technology.

Mimi, what do you have top of mind for challenges in the next three years?

Mimi Dang: The first one is, again, integrated health care—being able to help laboratories and laboratory tests transition to a digital world where connectivity is all important. With the consolidations occurring, the second challenge is being able to offer a menu that not only has some of the niche or esoteric testing but a standard menu too, to integrate all the immunoassays and chemistry onto one platform.

There’s a lot of consolidation going on with the custom menu itself, but also with the laboratory, and trying to get information into one place and being able to accomplish that seamlessly is going to be a challenge for the next couple years.

Christina, can you speak to this same topic?

Christina Reita: I agree with everything that has been said. To dive into one of those areas a little more deeply, I would say we are focused on continuing to drive those integrated solutions to help ensure that we are uniting what we’re talking about from a medical value perspective. We focus on the most critical tests that are bringing the right benefits to the patient at the right time.

As you think about the fact that the decisions are being made in a more centralized way, especially in integrated health networks, sometimes that medical value piece can get pushed to the side, so we focus on thinking about how we can ensure we are providing the solutions patients need.

People make decisions around these laboratory solutions, and the solutions are going to be in their labs for the next five, seven, or 10 years because reliability of systems has gone up dramatically. As an organization, we undertake things like looking at where laboratories are focused on answering the questions such as what will be the disease burden in 2030, and how can we ensure that our development pipeline and the solutions we have today are agile enough to meet those needs.

Dr. McCash, I’m going to give you the last word. What are the points of intense concern and interest for you?

Dr. McCash: My big concern right now being in New York State is that we have a lot of buyouts. Large hospital systems are buying out physician offices, many of which have their own laboratories to run CBCs and other tests. Now that they are bought and being integrated into these larger health systems, they’ve come under extra regulations they have to follow—for there to be a laboratory medical director, for example.

There’s a shortage of people who can be a director, particularly in New York State, maybe in some other states as well, but then these laboratories, when they can’t find a director, cannot use the same instrumentation they were using. So they’re moving more toward point-of-care and waived testing.

However, the doctors running these offices do not entirely understand what the difference is between their old analyzers and these new waived tests. They don’t understand that the results are not going to be as precise or as accurate, the reference ranges are going to be a little different, and that they need to apply more of their clinical knowledge to these laboratory results to make the interpretation.

I fear that they don’t necessarily have all the knowledge they need to put one of these together and to run it. I’m watching this from the sidelines, to see how things go, because I’m not sure how things will turn out. Will there start to be extra regulations on waived testing? I’m not sure. Is somebody going to get hurt? I hope not. It is important for physicians to understand that waived testing tends to have a higher degree of error and that assessing the overall clinical picture is essential for making medical decisions.