CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
July 2019—One vendor or two. Automating esoteric testing. The desire for more smart systems. The need for analytics. Seven people spoke with CAP TODAY publisher Bob McGonnagle in May about chemistry and immunoassay testing. They are David Alter, MD, DABCC, of Emory University; Nina Babic, PhD, DABCC, of Medical University of South Carolina; Denise Pastore of Siemens Healthineers; Timothy Lenz, PhD, of Randox; Delena Carite of Roche Diagnostics; and Jessica Tubman, MPH, MT(ASCP), and Stephen Ishii, MT(ASCP), of Beckman Coulter. What follows is what they told us.
Dr. Babic, what is a top-of-mind concern for you in your job dealing with the high-volume demand of chemistry and immunoassay in laboratories?
Nina Babic, PhD, associate professor of pathology and laboratory medicine and director of clinical chemistry and point-of-care testing, Medical University of South Carolina: Aside from quality, flexibility and footprint are two important things I consider. By flexibility I mean the adaptability of instrumentation to the size of the laboratory and needs of the patient population. While the MUSC central laboratory is a high-volume, fully automated lab, there are smaller laboratories at associated clinics and hospitals within our system. So we are always looking to consolidate test menus and harmonize tests across different sites. Interoperability between systems and support services, in terms of both IT and instrumentation, are also important.
Jessica Tubman, I believe this is a fairly common concern among the customers Beckman Coulter interacts with, not only in the United States but also around the world, namely they want to be on a single system and they want to have a system that has the flexibility to provide test results in a huge core lab with high volume, but then also to be dispersed within a health system network. Is that correct, and how are you approaching this?
Tubman
Jessica Tubman, MPH, MT(ASCP), global product management, immunoassay, Beckman Coulter: Yes, we hear that quite a bit: the scalability of results, having the same results for your patient and network whether the patient has visited a small or a large hospital, having the same reference range and quality of results no matter what platform is used. At Beckman Coulter, as we pursue new product development, maintaining the same reagent in our immunoassay product line is important. So we are making certain to use the same reagent no matter if the lab uses a small system or a large system within our portfolio. We do believe we have better solutions if we offer low- to high-throughput systems using the same reagents to meet various customer needs.
Dr. Alter, can you give us your reaction to my first questions and the answers?
David Alter, MD, associate professor and director of clinical chemistry, Department of Pathology and Laboratory Medicine, Emory University School of Medicine and Emory University Hospital, and chair, CAP Clinical Chemistry Committee: First, hospital systems can manage multiple platforms and different vendors provided they’re savvy enough to keep in mind the way the results are reported. If you’re a multi-hospital system that has two or three different vendors, it’s important within the result field to note that this result was performed on this analyzer, and you can standardize reference intervals, but I do think it’s important to indicate that even for something as common as a sodium, you want to specify that this sodium was performed on your Beckman and this sodium from hospital B was performed on your Roche Cobas, and so on.
Dr. Alter
However, with certain assays where it’s not practical to standardize the reference interval, it forces, I hope, my counterparts and Dr. Babic’s counterparts to push their IT departments for separate reporting fields. So if you’re in a system that has troponin I and troponin T, or two different troponin Is, you should try to recognize that and to have your vendor A troponin I and your vendor B troponin I reported out separately.
My broader view of the big platforms is that every one of them has pros and cons that cancel each other out, and that when it comes to deciding what to do through an RFP process, the weight falls on the end users, the technical services staff, and what they feel in terms of usability of the instrument and how the vendors respond with service.
I’m sympathetic toward the vendors of the instrumentation because in many cases, they can only do so much and then the customer and instrument vendor end up dealing with IT, and often that’s now centralized IT. Delena Carite, how would you deal with this question that Dr. Alter puts so well, which is: We would like to be able to show our physicians and others who’ve been ordering tests reference ranges that are specific to a particular kind of analyzer. That’s not easy to accomplish with centralized IT systems, is it?
Delena Carite, group marketing manager, centralized diagnostics, Roche Diagnostics: I’m not an expert in centralized IT networks from an LIS standpoint, but you can certainly integrate or notate specific parameters about an assay, for reference by the clinician. But I find Dr. Alter’s response interesting because we hear the contrary most frequently. Laboratories seek standardized result reporting with common reference ranges for ease of interpretive accuracy and trending of results over time. Therefore, our focus is delivering one result for the physician, hospital, long-term care, nursing home, clinic.
We also continue to see increased interest in standardization beyond common reference ranges and reagents. Specifically, when it comes to software interface, it’s important to have a common platform across a health system with one user interface that allows flexibility to shift staff from one lab to another, reducing training time to equip your staff to be confident using a common platform interface, no matter the location. It’s certainly a benefit from that perspective.
Dr. Babic, what are your thoughts on this? Do you find yourself in a position where you’re sending chemistry or special chemistry technologists to different sites within your network to operate instrumentation daily or weekly?
Dr. Babic
Dr. Babic (MUSC): I would first like to touch briefly on Dr. Alter’s comments. Being part of an integrated health system, we do have a situation where two different vendors are used in different laboratories. It’s absolutely possible to maintain different vendors for the same tests, and I would argue it’s much easier to do so for chemistry assays than immunoassays. This is because immunoassays are not very well standardized and, no matter how hard we try, it’s difficult to communicate methodology differences to the physicians. I have encountered numerous situations in which I would speak to a clinician who was not aware that a particular test was performed with different methods, even though it’s clearly stated in our EMR.
Regarding staffing challenges, as we are expanding our services and shifting toward an integrated patient-focused model of care, we are opening additional labs with limited test menus and having to rotate technologists between those sites. A limited staffing situation makes platform synchronization and streamlined user training highly desirable.
Dr. Lenz, what are you hearing at Randox as you talk to laboratories?
Timothy Lenz, PhD, regional sales manager, Randox: The lines between chemistry and specialty chemistry are becoming increasingly blurred. We are finding more diversity, especially in larger hospital labs that are starting to function as reference labs for their system. They may be trying to bring tests in-house that are not traditional acute care hospital tests but rather assays that may be ordered by various physician offices within the system—cardiologists or endocrinologists, for example. We are seeing an uptick in labs that are looking to third-party vendors such as Randox for niche reagents and small analyzers as specialty chemistry instruments, to bring some of those more esoteric tests in-house.
Stephen Ishii, can you weigh in on what you’ve heard?
Stephen Ishii, MT(ASCP), global strategic marketing, chemistry, Beckman Coulter: To the statement Dr. Alter made about having different platforms, it is possible with the information technology that exists today, with the software that’s available, to be able to do that in a network situation. But we’re also seeing plenty of requests from laboratories that want to be able to standardize reference ranges, assay methodologies, and so forth as much as possible.
Dr. Alter, if you could have your druthers and budget were not a question, would you like to see the Emory network on one platform or do you still believe there’s a sort of best-of-breed approach not only in special chemistry or immunoassay but also in chemistry, where you like to have the flexibility of different platforms to optimize individual test results for your patients?
Dr. Alter (Emory): Emory had already standardized automated chemistry prior to my arrival in December 2018. In addition, my prior institution [Spectrum Health, Grand Rapids, Mich.] had, over the last three years, obtained funding through the hospital and put together an RFP to standardize automated chemistry across their entire system. They were able to do so, and it behooved the hospitals not currently on the agreed upon platform to move to the new platform when their current contracts expired. So they now, systemwide, have a common EMR, common chemistry analyzer, and a mostly common hematology analyzer.
I’d like to echo Dr. Babic’s comment about immunoassays being harder to standardize. More chemistries than not can be standardized but there are others that cannot be. There are certainly chemistries that can’t be standardized very well.
If I’m at a conference and in the coffee queue during a break, I hear people say, “What kind of line do you have?” meaning do you have a Roche line, a Beckman Coulter line, a Siemens line. We’re in at least the third generation of lines. Denise, Siemens Healthineers has an important new line, Atellica Solution, but before we talk about Atellica, tell me where we are in the evolution of these high-volume, highly automated lines from your perspective.
Denise Pastore, director, global marketing, lab diagnostics, Siemens Healthineers: You’re right: We are in our third generation of automation and our premier product in that line is our Aptio automation line. Featured with the Aptio automation is our Atellica Solution. They were designed together so they could keep up with the throughput that each laboratory demands.
I agree with Dr. Babic that consolidation and footprint are a need and a priority. In addition, we have to look at the lab requirements for workflow and turnaround time, and to do that you need a rapid transport system, and that’s what we can achieve with the Atellica Magline Transport. The Atellica Solution has a lot of flexibility—more than 300 configurations—suitable for a midsize or high-volume or mega-size laboratory, and then we can offer standardization because all of the instruments would use the same reagents, consumables, and hardware.
To meet turnaround times, we make sure stat assays are done within 10 minutes. That would include all cardiac tests such as high-sensitivity troponin I as well as hCG and intact PTH, just to mention a few.
Delena, can you too comment about where we are in generations of lines and how the demands of customers are affecting Roche’s approach to these large centralized laboratory lines for immunoassay and chemistry?
Delena Carite (Roche): I agree with much of what Denise said about what customers are saying—they need standardization and common reagents and consumables, and the ability to share that across network and the efficiency of doing so. Roche began the modularity rage in the early 2000s offering laboratories the ability to scale up due to consolidation or scale down when testing is decentralized. Because of the decline in skilled labor, the instruments must become, in a way, more skilled. Lab optimization is an important piece of our R&D spend at Roche. But these smarter instruments and automation also allow highly trained, highly educated personnel to focus on their practice of laboratory medicine.