Chemistry and immunoassay testing: Standardizing platforms, ranges, interfaces—panel weighs in

Jessica, can you speak to this question about the need for the large high-volume centralized lines where chemistry and immunoassay are combined? I’m sure you’ll agree this is a new demand. What is new in the setups Beckman Coulter is asked to evaluate as you replace new instrumentation or lines or come in for the first time?

Jessica Tubman (Beckman Coulter): Ultimately, we believe laboratories are looking for overall end-to-end productivity to produce repeatable, high-quality results. There is a need for smart systems to free technologist time to focus on high-value–add tasks. They are looking for systems that automate various tasks including quality checks, which account for a significant amount of preanalytical errors. For example, checking the sample label, the sample tube type, and sample volume versus tests ordered to prioritize critical tests and performing serum indices to alert staff when a re-draw is required. Additionally, standardizing workflow—regardless if a stat or routine request—with the ability to manage a large variety of tube types and sample sizes. These steps all add up to drive productivity and efficiency to produce high-quality results and preserve valuable tech time. These are our top priorities as we deliver our next-generation scalable automation systems to bring the benefit of automation to any size laboratory.

Dr. Babic, is there a limit past which we cannot go just with automation?

Dr. Babic (MUSC): We are fairly close to that point where you strike this balance of the technologist’s time versus automation. As we are increasingly utilizing artificial intelligence to automate instrument diagnostics and result interpretation and reporting, there will always be exceptions that require human judgment, so there’s definitely a limit to what we can automate. To learn and improve, we will still need human intervention.

One area of improvement possible today is preanalytics. To assess specimen integrity and suitability, it would be nice to have a camera installed at the beginning of the automation line to capture the volume and color of specimen before it reaches the analyzer. But how do we solve the problem of add-ons? You still have to have that human intervention where the specimen has to be retrieved and reloaded. Then there is the instrument maintenance. Unless we completely automate that particular process, we will always have to assign a technologist to tend to the instruments. Finally, someone still needs to review calibration and QC data.

What we’re seeing now, as our test menu and volumes expand, is the need to add a third party to the automation line, such as, for example, allergy testing or an automated mass spec platform. The need for more flexible and open automation systems is growing. I see that as a challenge in the future.

Dr. Lenz, if we’re going to create these large core labs that have all the volume of a network pouring in, and there are esoteric tests that optimally we’d like to have on a line, that almost implies the need for open lines. As you look through your crystal ball at Randox, is that something that’s top of mind for you as you plan for the future for labs?

Dr. Lenz (Randox): Absolutely. Our newest and largest chemistry analyzer, the RX Modena, is built to adapt to open line systems. We have not yet implemented this, but it is something we were conscious of when initially designing the system. This also ties into the idea of third-party reagents on open channels or developer channels, depending on the lab’s core instrumentation. We are seeing more and more interest in adding third-party assays, which many instrument providers do not offer on their main systems. In that way labs can keep those niche tests automated without having to bring in an additional instrumentation vendor. They just require parameters from the reagent provider for those esoteric tests on their current instrumentation.

Dr. Alter, can you comment on what you’ve heard and offer insight into what your plans are as you direct these activities at Emory?

Dr. Alter (Emory): I’d like to offer one piece that was not touched on in terms of expanding automation. To the best of my knowledge, none of the major lines have set up good solutions to managing the small-volume tubes and microtainers. It is largely manual and a big issue if you’re with a large pediatric hospital.

Looking forward, I hope we stay with one line across the system. It’s economically efficient and, in my opinion, is a quality laboratory practice that improves patient care. The holy grail is to be standardized to one platform across the system, and my comment at the beginning of the discussion would reflect that not everybody has the resources to do that.

Isn’t that also in some ways a phenomenon of consolidation? In other words, if I’m doing 3 million billed tests a year, I may not have the heft to demand some of the things I can demand if I’m doing 8 or 9 million billables per year. And doesn’t that all feed into this sort of nuclear consolidation, you might say?

Dr. Alter (Emory): I would hope so. It depends on how much the administration of your institution values what the laboratory can bring to the table.

I want to end on an important topic that Dr. Alter raised. What is the value of the laboratory? We all live in this world in which there are a lot of pressures—PAMA, the difficulties with health care economics, not only in the United States but everywhere in the industrial world. And an important part of all laboratory enterprises are the results that come out of these automated lines in chemistry and immunoassay. Dr. Alter put his finger on an important point, which is we have to be able to articulate and express the value of these lab results. Denise, how does Siemens help folks in the laboratory articulate the value of what they do?

Denise Pastore (Siemens Healthineers): We’re looking at the pressures that are on the laboratory in terms of PAMA and what the reduction in reimbursement means and the way the laboratory can address that challenge so it can remain a profit center versus a cost center. That would be done through our team of consultants. We can work with the laboratory to provide the right solution so we’re not overcapitalizing or undercapitalizing, so we can enable them to meet the demands their service has to provide in terms of turnaround time for routine specimens and stats. That has to be seamless and help them meet their metrics daily. We also want to provide consistent quality, so we have to make sure there are checks and balances—that there are built-in reliability metrics, and, for consistency of results, make sure ours are solid. We want to make it as simple as possible to future proof the laboratory. With the more than 300 configurations we offer, we can handle all sorts of specimens.

To get back to a point Dr. Alter made earlier, it’s hard to put microtainers and pediatric specimens on an automation line. However, we were able to successfully do that on the Atellica Solution with both tube top sample cups and also microtainers, and all within the same racks. You don’t have to have specialty racks, which saves time and labor. And, as a result, there are better outcomes, which is exactly what the lab is meant to do.

Let me invite Jessica and Stephen to talk about the activities at Beckman Coulter, in particular in support of laboratories sustaining and even demonstrating their value to the overall health care system.

Stephen Ishii (Beckman Coulter): We agree it’s important that the laboratory be able to show value. We consider ourselves partners with the laboratory in providing products able to do that, in increasing the lab’s efficiency, for example. Being able to handle their future desired state is also important, whether it’s going to be consolidation or growth. We want to be able to accommodate either one. And to the Siemens point, it is also important to be able to offer the right menu for current health issues. Cost is always an issue, so we’d like to be able to minimize that for the laboratory and address its budget concerns.

Jessica, what would you like to add?

Jessica Tubman (Beckman Coulter): One of the main goals of our organization is to elevate our customers’ performance. What can we do to add benefits around automation for laboratories of all sizes, accelerate their care pathways by focusing on the right menu that’s going to help in the most critical situations, and help through clinical insights. We talked about informatics as well and how that can tie the whole picture together, and how we can partner with them to do all of that.

Dr. Lenz, what can Randox do to help the labs demonstrate and even improve their value to the system?

Dr. Lenz (Randox): I would echo what the other vendors have said: It is important not just from a financial standpoint but from a clinical standpoint to be able to get reliable results to providers quickly, along with any required interpretation so they can act on that information in a timely manner. Randox is known for providing high-quality reagents and reliable results on our analyzers so that there are no questions about the quality of the results. The ability to expand testing on existing platforms via third-party reagents allows delivery of critical results to patients and clinicians more quickly than when sending those tests out to a reference lab. Even if these may be lower-volume tests, they often provide critical bits of information in diagnosing an acutely ill patient, and time to result can be crucial.

Delena, how is Roche working to help laboratories define and promote their value within health systems?

Delena Carite (Roche): We strive to help our customers build a sustainable solution for the future. One way is encouraging laboratory professionals to have long-term vision, to create and build a solution in the laboratory that’s sustainable for the future. We also focus on enabling the laboratory management team to articulate to its leadership the value the lab provides far beyond its walls. For example, the lab plays a huge role in readmission rates, improving the standard of care, reducing costs, and patient satisfaction. It’s also important for labs to take that long-term view so they are consolidation and integration ready. That’s where that standardization piece becomes critical—bringing all these different labs together in an integrated health network.

Lastly, Roche is committed to driving the future of digital diagnostics. We offer a suite of software solutions that enable labs and health care providers to drive the future of care delivery, which in turn benefits the patient and demonstrates the value of laboratory medicine to health care.

Dr. Babic, would you like to make a few final comments?

Dr. Babic (MUSC): It’s very important that we work as a team in having the robust product, having good manufacturing processes that will minimize variability between different product lots, and optimizing the assays with minimum interference and turnaround time. All of that helps our service, but we are also looking for help with the clinical decision support needs and the capability to educate the clinician and to provide the consultation.

Which tests are appropriate? Which tests are not appropriate? We need real-time data analytics to help us not only monitor our analytical processes but also monitor different trends and be able to come up with predictive pathways to help our clinicians manage the patients and be preventive, not reactive. I’ve seen attempts and shifts in industry in trying to get this real-time analytics data incorporated, and it’s important, because if we are going to make sure we are active participants in clinical care, we do need to have that data and the ability to communicate effectively to a clinician.

Dr. Alter, how would you sum up for us what your thoughts are on these topics?

Dr. Alter (Emory): I can’t do better than Dr. Babic, but I have to double down on usability for the technical staff and service from the vendors in real time. I realize communication is key among vendors and that in the corporate universe, it’s important not to reveal everything until it has approvals and been verified, but I sometimes have wished over my 20 years that the vendors would have been more transparent regarding an issue identified by the lab by admitting to it and addressing it, as opposed to the standard mantra of “Please recheck your calibration or do another comparison study,” or something. I’ve had handfuls of times across multiple vendors where we’ve identified issues and pulled our hair out and had to collect reams of data, only to have the scientific staff tell us, “We knew about this issue but we had to validate it from your end.”