Close ties: instruments, middleware, and more

July 2021—Laboratory instrumentation from an IT perspective and as one solution to the labor shortage were the topics explored April 27 in a virtual roundtable of instrument vendors and laboratory medical directors, led by CAP TODAY publisher Bob McGonnagle. Part one of their conversation about core labs was published in the June 2021 issue; part two follows.

View CAP TODAY’s guide to chemistry and immunoassay analyzers for mid- to high-volume laboratories.

We include IT people when we talk about products and analyzers because for many lab directors and administrative heads of departments, the connectivity, interoperability, and ease of interface, not only to and of instruments and middleware but also electronic medical records, are top of mind. Jeff Watson, has Sunquest had a chance in the past year to look at that again and renew interest in serving that need in the laboratory?
Jeff Watson, MT(ASCP), MBA, senior director, product management for clinical solutions, Sunquest Information Systems: Integration to the EMR is core to our business so we have user groups that are dedicated to that. We have a Cerner special interest group that’s made up of users that have the Cerner EMR, and we have the Epic group, both of which we’re getting customer feedback from. But we also meet regularly with the EMR vendors, so we have an ongoing roundtable meeting with people from Epic. We sometimes talk about an issue that has come from that client special interest group, where they might say, “Why can’t you do X, Y, or Z?” and we say we need to talk it over with our partners at Epic. And we’ll sit down and hash through that and come up with solutions. While they have their competitive modules and want to put those in, they also are customer focused just as we are, and when we are servicing those joint customers, they’ve been good partners in working with us to solve some of the challenges we have around integration.

Curt Johnson, I’ll ask you that same question, and I know that in the Orchard user base there are many EMR systems you’re interfacing with all the time. Correct?
Curt Johnson, chief commercial officer, Orchard Software: That is correct. We’re not only looking at where the technology is today in regard to the interoperability, but we also have a strong focus on user interface design with a goal of making the user interface intuitive and easy for users to learn. Working closely with all the EMR vendors is also important. The laboratory information system serves a different purpose than the EMR but is a vital component of an integrated health care system. An important aspect of our role as an LIS vendor is to develop software that supports our end users, to make their jobs easier while simultaneously integrating with the EMR and the lab analyzers, and we work closely with many of the diagnostic vendors on the call today. I have monthly standing calls with them to understand where the analyzers are going, how the middleware they’re implementing for their analyzers not only benefits the end user but how that information can be integrated with us to give a more global view within the LIS. If these diagnostic vendors have integrated delivery networks, for example, and there are point-of-care analyzers throughout the organization and you’re putting middleware into the system to benefit the end user with your analyzer, the question is what can we add to that and how can we benefit not only the diagnostic vendor but also the end user and make sure that the information is easily transmitted upstream to the other systems. We are that vital piece that sits in the middle.

Looking at where integration is changing, we also have to start taking into consideration iPhones, iPads, handheld devices, and the patient and where data needs to go. That’s the next frontier for us from an integration point of view—how are we going to interact directly with the patient but also make sure we keep in mind the diagnostic vendors, the pathologists, the physicians, and the laboratory so that everyone who is involved in patient care can effectively use the data?

Dr. Faix

James Faix, do you have thoughts about this conversation on the importance of IT issues?
James D. Faix, MD, medical director, clinical chemistry and immunology, Montefiore Medical Center: I would add only that I think middleware is becoming so much more important than either the laboratory information system or the software on the instruments. Middleware has become a major place where we work. More and more you’re tied to the middleware version of Data Innovations that the company provides, so you’re sort of stuck with that version of DI if you want to use the power of the middleware.

Sunquest and DI are sister companies owned by Roper Technologies, and there is a great deal of coordination, as I understand it.
Jeff Watson (Sunquest): Yes, there is, and Dr. Grenache can talk to that relationship since he has DI and Sunquest together.

David G. Grenache, PhD, D(ABCC), chief scientific officer and medical director, core laboratory, TriCore Reference Laboratories, and clinical professor of pathology, University of New Mexico: I agree with Dr. Faix: Middleware is where we spend a lot of our time and it’s the engine that powers the output from our instruments. It goes through our middleware solutions and then out to various EMRs. But more than that, it’s powerful in that it allows us to do customized reporting. We can apply some logic rules so that if certain conditions are met, then we will be able to attach appropriate comments to results as needed. It’s powerful, and laboratories that aren’t leveraging it are doing themselves a disservice.

I’m sure all of our IVD participants would agree. Brittany, Roche has begun to tag itself much more as in the world of informatics. I also know Roche is an enormous customer of middleware vendors, not the least of which would be DI. How are the views of IT shifting at Roche if at all?
Brittany Greiner, U.S. marketing manager, Roche Diagnostics: It has been and will continue to be a focus for Roche. The one thing I’ll add is that it’s critical to have an overall picture of what’s going on—the holistic view from both the patient and laboratory perspectives. It’s a huge focus for us. This is where we’re investing heavily, with feet on the street as well as from an IT perspective, because it’s not just the solutions we’re bringing but also that partnership and the support for our laboratory customers. We want to be there hand in hand helping to implement and figure out the best solution. And we need that overall view so we can tailor our products to every laboratory. We all know if we’ve seen one lab, we’ve seen one lab.

Pastore

Denise Pastore, can you speak to the view of IT from the Siemens Healthineers perspective?
Denise Pastore, director of global marketing, laboratory diagnostics, Siemens Healthineers: It’s key for Siemens Healthineers as well with our Atellica Diagnostics IT platform for data management, program management, and inventory management because it’s important for our customers, the laboratorians, to be able to manage the patients, manage their data, manage their KPIs. We want to be able to bring that forth to them, even looking at the data and helping them troubleshoot, down to maybe “It was a phlebotomist and that’s why my samples are hemolyzed.” We can help with all of that with the Atellica Diagnostics IT.

Sean Roberts, automation is impossible without great information technology riding alongside. Isn’t that right?
Sean Roberts, senior product manager, chemistry/immunoassay business, Beckman Coulter: Absolutely. When I think of the middleware and how you run the automation, there is that level at the laboratory and the user, but there is also an administrative layer, and perhaps even an organizational layer, that’s necessary in terms of the information provided to various end users of these products.

Some of these implementations are becoming increasingly complex when hospital networks buy other hospitals. For example, in one implementation of 30 hospitals, we had four EMRs and about six lab information systems that all needed to connect and communicate because the chief of the system was interested in understanding the entire system as opposed to compartmentalizing in the network. So we’re also seeing a significant increase in the complexity of the implementation and the level of information our customers are expecting from our systems.

Mike Massei, can we get a comment from you on the IT issues?
Mike Massei, senior director, global marketing, core diagnostics portfolio innovation and strategy, Abbott: Our AlinIQ solution is a part of our total solution and will continue to be a focus as a value driver not only within the laboratory but also outside the laboratory with the clinicians. It can help the laboratory and institution deliver on their KPIs, and from an integrated clinical care and patient outcome perspective, its informatics tools can help the clinician so that collectively the health care ecosystem is working smartly.

I want to turn to the question of laboratory labor. I have heard more comments in the past year about the labor shortage than perhaps at any other time. The question I have for our IVD and IT vendors is: Do you still have a significant margin where your automation and your solutions can help with the labor shortage? For example, labor-saving automation, connectivity—do we still have a long way to go there or are we approaching a point where we’re going to say we can only do so much but then eventually we will hit a dead end and the labor shortage is just going to be severe and we’ll have to find other solutions? It’s a provocative question. Let me start with Sean Roberts.
Sean Roberts (Beckman Coulter): It’s not provocative. That is the feedback we get regularly from our customers—labor shortage, labor savings. At Beckman Coulter we recently launched the DxA 5000 Fit, which offers the full feature set of our larger automation systems for the central or core lab but more configurable and sized for the mid-volume and small-hospital laboratories. And one of the features of the Beckman Coulter line is to be able to incorporate clinical chemistry, immunoassay, hematology, and coagulation all on one line, so fewer operators are needed. We’re moving those high-end features available to central labs as far down market as possible to address the labor shortage.

Denise, do you feel you still have a good deal of runway at Siemens to improve the productivity of what laboratorians are doing and help to bridge some of this acute worker shortage?
Denise Pastore (Siemens Healthineers): I do, and we are still pursuing that. Automation used to be for the big labs, but now, as Sean said, the dynamic we’re living with is that we have to keep driving automation and automation features down within the midsize and lower-volume analyzers, and that’s what we’re doing.

Greiner

Brittany, I’m sure you’re in agreement with your colleagues on that one.
Brittany Greiner (Roche): Yes, and I think there are two parts to it. First is that Roche is unique in the market in that it is one manufacturer that provides your automation, analytics, IT solution, and reagents. We’re helping to simplify. Everything is designed to work together, and that means it is easier on your operators.

Second, we do market research frequently so we’ve been hearing this for years, and we have been funneling that back to our R&D globally. What we heard is ease of use and doing more with fewer people, and so we innovated with our Cobas systems and did a lot of self-operating things in the background while the system is running that help simplify the day-to-day for the operators—less maintenance, fewer reagent loading events, fewer calibration events, for example.

Dr. Grenache

Would anyone else like to offer a comment or ask a question as we come to a close?
Dr. Grenache (TriCore): Insurers have asked us to figure out ways in which patients could have access to laboratory services more easily than by the traditional routes, and I’m assuming we’re not unique in being asked to figure out how to facilitate home-based collections, at least for selected tests used to monitor chronic conditions. Does anyone on the call have a perspective on this, or has anyone heard something similar from customers or clients?

Curt Johnson (Orchard): Some of the unique efforts we have seen have revolved around the universities and campuses. How do you get college students, who are social animals and don’t necessarily use the health care system on a regular basis, to understand the need for testing and get it done? Some of the universities offered premade kits that were held in dorm rooms so they would be ready for the students. Others, if the university was small enough, had a barcode for that specific patient, with the whole kit ready to go. Others had to set up the testing and offered five or six different places across campus for it.

Other COVID testing labs joined in and tried to do near-patient testing, with different levels of effectiveness, but the colleges and universities had the most unique situations that we saw. Some of those are likely to stick as we move forward.