A panel’s take on instruments, connectivity, COVID

July 2020—Has the pandemic changed your thinking or that of your customers? That’s one of the questions CAP TODAY publisher Bob McGonnagle put to seven representatives of five companies and two other panelists in a May 13 roundtable on chemistry/immunoassay analyzers and testing. But first up were other topics: scalability, connectivity, standardizing platforms across health systems, consistent sourcing of antibodies, and open automation.

The panelists were Gyorgy Abel, MD, PhD, of Lahey Hospital and Medical Center; David Grenache, PhD, D(ABCC), of TriCore Reference Laboratories; Brittany Greiner of Roche Diagnostics; Denise Pastore of Siemens Healthineers; John Naizer, BSc, MSc, of Randox; Timea Zsiray and Sean Roberts of Beckman Coulter; and Chad Meyers and Jeffrey Watson, MT(ASCP), MBA, of Sunquest Information Systems. Here is what they had to say. (CAP TODAY’s guide to chemistry/immunoassay analyzers)

Dr. Grenache, in past roundtable discussions the topics that have been top of mind and seem to emerge consistently when we talk about instrumentation are matters of menu. We talk about the scalability of analyzers from a given vendor; in other words, can the same analyzer and test method be accommodated to all the various sites, large or small, that the analyzer needs to serve for the hospital or health care system? Connectivity comes quickly into these instrumentation discussions, not only for the laboratory but also result reporting into the EMRs. We have talked about consolidation and about labor shortages in the labs and how instrumentation can help with shortages.

Can you comment on whether these topics are top of mind for you as you think about chemistry and immunoassay instrumentation?

David Grenache, PhD, D(ABCC), chief scientific officer, TriCore Reference Laboratories; medical director, core laboratory; and clinical professor of pathology, University of New Mexico: They are critical for TriCore Reference Laboratories. We’re a system laboratory. We operate everything from a high-volume reference laboratory in Albuquerque, to large medical center laboratories, to laboratories that are in small critical access hospitals in rural New Mexico. We need to stay on a single platform as much as is practicable because all of our data goes into a central repository and we don’t want differences due to different platforms to complicate that data.

Scalability is critical. Our critical access hospitals have very small laboratories, yet we are expected to operate a full-service menu. So we need instruments that can fit the space yet have comprehensive menus, as comprehensive as they need to be for a small hospital. And in the reference lab we need a greater number of instruments to accommodate the volumes, yet consistency with the platform and the menu. So scalability is essential.

If you were to walk into my core laboratory now, you would see instruments from a variety of vendors, with one vendor’s platforms predominating. That’s not desirable for all of the obvious reasons. It’s important that we consolidate to a single platform, as much as possible, to gain economies of scale.

And then there’s the personnel issue. New Mexico is not unlike many other states; we are challenged with having access to an appropriately educated and trained workforce. The more we can do with fewer staff because of ease of operating instrumentation or the consolidation that can be enjoyed with some platforms, the better it is for our operation, which means it’s better for our clients and ultimately better for the health of New Mexicans.

Denise, what are your thoughts on what I mentioned in my opening question and on what Dr. Grenache has put succinctly and eloquently around his needs at TriCore? I assume you’re hearing similar things from not only your customers but also your potential customers around the world.

Denise Pastore, director of global marketing, laboratory diagnostics, Siemens Healthineers: Absolutely, and especially in the United States, where diagnostic laboratories combine into networks to thrive. As Dr. Grenache said, the customer needs a range from a low-volume solution all the way to a mega-size solution; many technologists and technicians are retiring now, so the basic skill sets may not be as sophisticated as they were previously.

In answer to that, we need to produce instrumentation and user interfaces that can meet those customer needs, and that’s what we’re doing at Siemens Healthineers, with a range of instrumentation that will be compatible regardless of the size of the laboratory. Scalability is one of the key metrics of our Atellica Solution because it comes in multiple configurations—greater than 300.

Being able to consolidate all testing is also important, and strong IT can help laboratories accomplish that goal and standardize information across all of our available laboratory diagnostic platforms. The Atellica Data Manager and Atellica Process Manager from Siemens Healthineers help to accomplish that standardization.

Jeff, at Sunquest you’re dealing with all kinds of instruments and instrument vendors. Can you comment on what you’ve heard so far, in particular the importance of connectivity in the systems and the management of the workflow?

Jeffrey Watson, MT(ASCP), MBA, senior director of product management and clinical solutions, Sunquest Information Systems: It’s very much the same set of drivers that we see coming from our clients. They look to have connectivity. It really is around consolidation. A lot of our clients are in the acquisition mode, so they’re acquiring new health care facilities, and as they do that, typically they look to standardize the instrumentation.

We also are seeing that even in our clients in the U.K., where they’re moving into laboratory networks the NHS Trust hospitals that in the past operated kind of independently. We’ve got a large client in London that has about seven hospitals where they are just standing up this past year a new centralized automation line to manage the immunochemistry and chemistry testing that doesn’t have to be done on a stat basis. So even there they’re driving for consolidation and economies of scale.

The ask from our clients is how we can help them from the LIS and connectivity perspective to manage complex rules around autoverification. As they consolidate, they’re looking to drive an 80, 90, 95 percent autoverification rate across the organization. We’re able to do that with our LIS product proper but also in conjunction with our sister company, Data Innovations.

We’ve been doing a lot of work, in combination with Data Innovations, where a number of Sunquest customers—TriCore being one of them—have moved to have all of their instrumentation run through Data Innovations and then connect into Sunquest Laboratory. That gives them that combination of a powerful data set that you have in Data Innovations, as well as what you have in the LIS so you can much more fine-tune that autoverification and drive those numbers into the high 90s.

Timea, what are your thoughts on these topics, and in particular about the need for autoverification solutions not only to foster productivity in labs but also, to some degree, to make up for labor shortages?

Timea Zsiray, senior director, global marketing, Beckman Coulter: There is a lot of similarity with what has been said. We at Beckman Coulter believe that instruments, automation, clinical informatics, and menu should form a comprehensive, harmonized solution that is tailored to the needs and size of the specific laboratory. In our view, the need for automation as a productivity tool is absolute, but we don’t believe in one size fits all, and that starts with instrumentation. Labs of different sizes have different needs, as Dr. Grenache pointed out, so it’s important that we bring solutions to fit the operation. An instrument that is best suited for a medium-size laboratory will not optimize the workflow in a high-volume laboratory just by virtue of “multiplication.” Therefore, it is important to consider the right instrument specifically designed for the size of the laboratory and then integrate it with the right automation solutions.

At Beckman Coulter we believe that every laboratory should be able to harness the power of automation. Historically, automation was the privilege of the large-volume laboratories, but if you look at the laboratory workflow, 70 percent of the work is happening in the pre- and postanalytical phases and those parts are labor-intensive, so the need for automation is universal—independent of the size of the laboratory. Solutions that will fit in the different size laboratories but help with the physical automation of the processing of the tube will continue to be vital for the industry.

Lastly, we need to rethink automation to be inclusive of not only the physical movement of the tube but, to your point, Bob, of autoverification, automating data flow. Automating the physical movement of the patient sample is only half the solution. There are lots of manual data-processing steps that can be automated with clinical informatics solutions.

Dr. Abel, we know there is much consensus around these topics. Would you like to add to the consensus or react to what you’ve heard so far?

Gyorgy Abel, MD, PhD, medical director of clinical chemistry, molecular diagnostics, immunology, and point-of-care testing, Department of Pathology and Laboratory Medicine, Lahey Hospital and Medical Center, Burlington, Mass., and instructor in pathology (part time), Harvard Medical School: For the most part I will be in consensus. First, as everyone pointed out, the key change has been the formation of health care systems. Laboratories had to adapt to the health care systems, and some players in the systems with bigger hospitals have large laboratories. Others have smaller laboratories but sometimes with bigger analyzers that could do almost the same menu as was available in the larger hospitals.

This is not sustainable, and as my colleagues pointed out, the manufacturers needed to adapt to this and they did respond well. Most of the manufacturers now have larger and smaller modular instruments so there is scalability. Even if many of the smaller hospitals don’t lose the laboratory entirely, they are delivering testing only for their OR, ER, and inpatients, but they still need to maintain a 24/7 laboratory with basic chemistries, hematology, and coagulation testing. The bigger hospitals’ labs can do all the specialty and nonurgent chemistry and more complex testing.

Clinical chemistry tests, and with no disrespect to any of the manufacturers, are commodities to some extent, because probably 80 to 85 percent of the test menus of the major manufacturers overlap with some specialty tests and with certain innovations. But most of them measure all the cholesterols or enzymes, electrolytes, and so forth and the basic immune assays for liver disease, heart disease, and so on. So it’s hard to differentiate between them. It’s like selecting between a Honda Accord and Toyota Camry. Both are good but you need to look at your own specific needs. Where they can distinguish themselves is in areas that emerged over the past decade—for example, middleware, connectivity with the LIS and EMR, and the modularity. There are areas where they can make themselves stand out from the others.

On one point I would disagree. Dr. Grenache mentioned that you want to have one system, and in general I agree. But it is good to have a second vendor, at least in the larger laboratories. I say this because if the FDA pulls out one test from one vendor and if everyone is on that same vendor, you have all eggs in the same basket and you will be left without the test and have to scramble to bring on another vendor. It’s much more convenient if you already have another vendor, an alternative or supplementary vendor, that provides much the same or a similar test menu, and they can be harmonized. It’s quite a bit of work, but at least in the health care system, it’s good if at least two vendors are present.

Another situation would be like the COVID-19 situation. One by one the vendors will have a COVID IgG or IgG plus IgM or total antibody test, but over time we will learn that some of these are better than others. If you have a choice between two vendors, you have those systems at least in your health system in one of your hospital laboratories, then you will have a choice. You can choose the better one or you can choose which is first available. So it gives you flexibility and protection against certain disastrous events that may happen with the systems or some tests of one of the vendors.

Brittany, Dr. Abel has put his finger on one of the challenges we have across the board in a lot of areas of diagnostics, but maybe specifically in the core lab and chemistry and immunochemistry, and that is product and company differentiation. Please give us your thoughts on that.

Brittany Greiner, marketing manager, systems, Roche Diagnostics: From a Roche perspective, we’re always collecting and gaining feedback from our customers and that’s where we put our focus. We have heard a lot already about standardization. We see a lot of consolidation in the market and the need for standardized solutions, and there is benefit to that inside and outside the four walls of the lab. Within the lab, having one system to train your staff, one user interface, one analyzer to maintain, one IT solution—you can quantify the savings as the benefit of having a standardized solution. Outside the lab’s four walls, there is benefit in having common reference ranges for interpretive accuracy, in the physician being able to trend the results over time, in one result for the physician, the hospital, the long-term care facility, et cetera.

The second is the menu. Roche takes pride with its R&D in being able to provide and give its customers access to an often first-to-market menu. We invest regularly in new claims for existing tests to put actionable information in the lab and in the physician’s hands.

We are also focused on shaping and driving digital diagnostics. We provide a suite of software solutions that will enable laboratories and health care providers to drive the future of care delivery. At the core of every health care decision is diagnostic data, and with Roche Digital Diagnostics, health care professionals are empowered to leverage this data with our broad portfolio of solutions that are designed to work together with our systems.

John, as a sales manager for Randox, are these the sort of things you hear in the list of asks that potential customers have?

John Naizer, regional sales manager, Randox: A lot of people ask how many tests can be performed on our machine in regard to how large the menu is, because Randox specializes in having a large esoteric clinical chemistry test menu. Often their interest comes down to their being able to run all these tests on one instrument. Maybe there is one specialist in a hospital or clinic who wants to run a highly esoteric test like lipid subfraction, and we’re able to offer that type of thing. It can save them time in bringing on a third-party assay. That’s the way we have been able to help and assist customers, along with making sure to be up to date with the most recent software and operating systems.

It used to be that many people in laboratories had a particular liking for one vendor’s immunoassay for a given analyte. Perhaps they thought one immunoassay company had a better fertility panel or anemia panel, for example. Sean, do you still see some of this desire to mix and match depending on the feelings about the individual assays?

Sean Roberts, senior manager, chemistry/immunoassay business, Beckman Coulter: What we see with our customers is a balance between two points in terms of consolidation and being able to standardize across a network and those customers that would prefer to keep each of their existing laboratory instruments within their network. We’re able to integrate either approach. We can convert laboratories to Beckman Coulter systems, again offering a scalable solution of what I’ll call small, medium, and large solutions, offering common reagents across those platforms to provide standardized results, middleware that will integrate all results across the network, and rules writing and control. We can add in an instrument simply for specialty testing. We have open automation systems that allow connectivity of other systems, so we can enable the construction of multi-vendor laboratories if the customer so desires.

Dr. Grenache, based on what you’ve heard, is there something you’d like to add or highlight at this point?

Dr. Grenache (TriCore): Open automation—larger laboratories, reference labs, large academic labs really need solutions like that. There are a lot of things I want to add to our automation line but I can’t do it. So open automation is like a Christmas gift under my tree.

The other thing I have in mind hasn’t been mentioned. We talk about standardization and maintaining consistency, especially with immunoassay. What often goes unrecognized or is unappreciated is the need for consistent sourcing of antibodies. I get the sense that not every company sources its own antibodies or manufactures them or has the ability to do so, so they rely on other parties to do that. And maintaining consistency in immunoassay is something we all recognize as important. When I have the opportunity, I ask, Where do you get your antibodies for your immunoassay? I want to understand that because I need to guarantee, as much as possible, consistency in our immunoassay methods.

Denise, can you comment on Dr. Grenache’s comment about the consistent sourcing of antibodies for immunoassays? We don’t have to work too hard to find a considerable literature now on immunoassay performance, and it’s not always flattering. So tell us what Siemens is doing to ensure the performance of the Siemens immunoassay products.

Denise Pastore (Siemens Healthineers): Yes, we know the criticality of antibody consistency. When you shift antibodies, sometimes you will see that the results have shifted, and this has an impact. It is important at Siemens Healthineers that we make sure to keep antibody pools consistent. And we are making strides in our Walpole [Mass.] facility, which we have just expanded, to do just that. We’re making sure we have continuity from lot-to-lot production so that we can provide customers with a product that will drive consistency regardless of a lot change.

Brittany, what is the Roche Diagnostics perspective on this?

Brittany Greiner (Roche): At Roche we manufacture all of our reagents, but we do allow for third-party vendors or partner channels. Our longtime partner is Hitachi; that is our manufacturer for our instruments and all of our digital portfolio. Everything is designed to work together. That means a better customer experience of our total solution.

And then there is the benefit of our quality. We have our patent in electrochemiluminescence and it’s unique to Roche. It provides a broad measuring range, low-end sensitivity, and lot-to-lot consistency, which also comes from our standardization process to deliver a quality reagent from the launch of a test through each subsequent lot release.

Sean, would you like to comment on the importance of consistent sourcing of antibodies for the immunoassay business?