A panel’s take on instruments, connectivity, COVID

Sean Roberts (Beckman Coulter): Beckman Coulter has a long history of intellectual property in monoclonal development and production, and in our Chaska [Minn.] facility we grow many of these antibodies in-house, so they are in our control—both antibodies and cell lines for expansion. We can guarantee the consistency of the products we release through those production control processes.

Even though immunoassays have been around for some time, the technologies that go into antibody production, cell culture, molecular biology have all been capitalized upon at Beckman Coulter, such that we’re incorporating the latest and greatest technology. So even though it’s an immunoassay with an antibody, please don’t think that there isn’t new technology there. We remain laser focused on reproducibility and quality results.

John, what can you tell us about antibody sourcing from the Randox perspective?

John Naizer (Randox): Our line of immunoassay testing is specific to more the research side of things and specialty testing and esoteric biochemical markers. We grow a lot of our own monoclonal and polyclonal antibodies in our facilities in Northern Ireland and the Republic of Ireland, so we’re able to control what gets released, what gets put on our chips, for testing. We do take pride in making sure our system is foolproof at being able to keep the best antibodies in production.

I want to move to the next issue on the IT side—how we are getting these results into the EMR. We continue to see, in large systems, domination by Epic. There are a lot of Cerner EMRs out there. And yet we hear about the problems in populating the EMR lab data that the physicians have to access to make decisions. Chad, could you give us a bit of discussion about this?

Chad Meyers, vice president of product management and strategy, Sunquest Information Systems: Historically there had been the ability to view that data in the EMR in a more textual format. But as the technologies improve and there is more digitization, images, quantitative data, and other types of complementary information included on the report by the clinicians and the laboratory staff, we’re finding that the need to be able to display rich and formatted content in the EMR, such as hyperlinks or images, has grown.

We continue to collaborate across instrument and LIS vendors and EMRs to allow for as much rich content as possible on the report, using PDF attachments, so the clinicians can get the information they need. We continue to see evolution there, but there are still times when clinicians are frustrated because they’re not getting the fully rich content in the EMR or have trouble finding it.

Dr. Abel, from your experience at your institution, can you comment on that?

Dr. Abel (Lahey): It’s critical that the entire health care system is on the same EMR/LIS, and every health care system should focus on achieving that. It takes time to achieve that, so which EMR it should be is a big decision. No matter which EMR/LIS is used, a lot of work is required to get everyone under the same umbrella, but it’s critical to have easy access to the patient records from all parts of the health care system.

Communication between the analyzers and the LIS or the EMR can be achieved through innovative middleware solutions. Reliability is important for all of these analyzers, as is test menu, speed, easy operation, and low maintenance. But one of the competitive areas is the innovative middleware solutions to make these communications easy.

Standardizing across the system with the same one or two vendors is also difficult because when the health care system starts up there are various vendors, and it takes a lot of time and negotiation and looking at all the proposals to decide which is the right fit for a system.

These immunochemistry analyzers are big systems on which the majority of the tests are run. It takes a lot of money, full-time employee work and commitment, and even space to switch because you still need to maintain the operation with your old system. Most vendors come up with a new system every 10 years or so, and I would say much of the chemistry technology is settled. Every 10, 15 years, one might want to think about whether the system is still the right system to use. But switching from one vendor to another is difficult, so most laboratories do it only if they see something innovative or are unhappy.

I’d like to talk further about the display of chemistry and immunoassay results in the EMR. Dr. Grenache, are you satisfied at TriCore, as a reference lab serving many clinicians and nurses, that that is going smoothly and satisfactorily from your perspective? Or is there still room for improvement in the display of results?

Dr. Grenache (TriCore): There is still room for improvement and that’s not to say that what we’re currently doing—the collective all of us—is poor. It’s just that there are inherent limitations in HL7 messages. Chad was talking about how we have started to move beyond just providing discrete data. It’s no longer just a numerical result in a reference interval. Many times we’re asked to provide graphics, images, or tables. It’s not always easy, particularly in immunoassay for some steroid hormones, to provide adequate reference intervals for all the different partitions in terms of sex and age. That can be a challenge depending on the EMR that laboratory is connecting to.

How many PDFs do I get sent to me each day as an email attachment, yet I can’t send a PDF of an enhanced report of lab results—electrophoresis results, say, that have an image of the gel or the electropherogram. I can’t push that across an interface easily into an EMR. Or if I can, many times what we hear from our customer end is, “No, no, no. I don’t want your PDF because it’s just going to take up space.” Which I don’t understand because PDFs don’t appear to be that big.

So to answer your question, yes, there is still more to be done and I look forward to getting there. We still have, in some cases, to print out an enhanced report and put it in the mail to get to the client the information that certain clients want. Yet we have this amazing technology where we should be able to push it across a network and have it end up in the EMR. But there are challenges that are still difficult to solve. We’ll get there eventually, but we’re not there yet.

When we talk about chemistry being sort of routine and easily commoditized, is that in part because the clinicians themselves have routinized and commoditized the data they’re looking at? How often are you asked for an interpretive comment on the results you’re presenting to these clinicians?

Dr. Grenache (TriCore): I hate to think of lab tests as a commodity and we have to push back against that, because when something is a commodity you buy it at the lowest possible price. And there’s tremendous value in our laboratory data that we—again, the collective we—have to do a better job communicating and demonstrating. This is something that TriCore has been passionate about and has been working diligently toward. And I think it’s starting, slowly, to get recognized—the inherent value of these huge data warehouses.

I’m asked for an interpretive comment with some frequency. Usually it’s related to a confounding result, something that doesn’t make sense to them, and almost immediately they call me or they call TriCore and they find their way to me, but usually it’s around some sort of interference and they’re concerned about a result being compromised because of x factor. So it does happen, though maybe not as often as it should. I don’t think clinicians largely recognize that there are laboratory professionals they can turn to for help and consults. That’s been an age-old problem in our profession.

Dr. Abel, how often are you asked to add interpretive comments and field questions and consults on results, particularly from chemistry and immunoassay?

Dr. Abel (Lahey): I would like to first say that by no means did I mean that lab tests are commodities. I meant only that the most common high-volume tests are widely available on all of the systems and largely at the same quality. So it’s hard to find distinguishing qualities—which system measures better potassium or better sodium?

I am asked questions or to provide interpretive comments quite often. It is actually our main job now, in addition to, of course, safeguarding the patient’s safety and the high-quality testing in the laboratory. Our main job is to be available for questions and to look for opportunities where we can provide interpretation, advise the clinicians, participate in all of the committees in which order sets are made, and help clinicians optimize laboratory testing.

We want to have improved quality at lower cost and that’s possible if we decrease the use of tests that are outdated or over-ordered. We monitor that. We also have to increase the use of tests that are highly valuable and develop algorithms, order sets. I spend much of my time receiving and answering emails or pager calls about what to order or how to interpret critical tests, particularly in immunology and molecular testing but also in coagulation or just when they see an unusual result. They ask us what might be the reason for that unusual result. This is a big part of our job these days, and this is how it should be. It’s not about volume anymore; it’s about value, and we can provide it.

We are heading into an era that is more like managed care, where we want to provide optimal care and decrease health care costs. The laboratory can play a huge role, not just by lowering laboratory costs but overall by finding the more optimal management of patients.

Dr. Abel, to some degree, is alluding to the famous Dr. Michael Laposata, who is the chair at UTMB Galveston and who in many ways led the charge for optimizing test ordering and interpretation. And Dr. Grenache is involved at TriCore in the Clinical Laboratory 2.0 initiative. These are two important lines of thinking as we address the future. And of course there is a lot of discussion about what the proper test menu is, eliminating unnecessary tests, having testing algorithms to optimize care. Brittany, can you tell us briefly about Roche’s participation in this? And I’d like the others at companies to do the same.

Brittany Greiner (Roche): Viewics is part of our diagnostics and digital portfolio, and that is for test optimization and utilization. It is providing a broad portfolio of solutions to meet the needs of our customers.

Timea Zsiray (Beckman Coulter): I’m going to borrow from the Lab 2.0 initiative, where it was said that the lab is the first to know. The laboratory has tremendous insight and plays a critical role in patient care. It is important that we—industry partners—provide solutions that free up the time of the scientists, the medical technologists, and give them time back to collaborate with the physicians and to become part of the care team.

This is how we view it at Beckman Coulter: How can the various disciplines, the various parts of the organization—i.e. instruments, automation, and clinical informatics—be integrated and add to each other in terms of making the whole system more intelligent? We have a tremendous opportunity to expand the power of automation to the various sizes of the laboratories, to remove the mundane, non-value-added tasks from the daily routine, which will free up medical technologists’ time and ultimately translate into operational efficiency.

John Naizer (Randox): We always speak with customers and use the newest software and technologies to aim for the quickest and best results with all the supporting documentation.

Denise Pastore (Siemens Healthineers): In our existing middleware we have a lot of flexibility in our coding and algorithms that can be customized at the customer level so laboratories can avoid unnecessary testing and put in proper reflex testing.

In Clinical Lab 2.0, labs establish the value they bring not only to the institution but to the community at large. One of the ways we are trying to do that is by helping with data support software to help guide the physician when they get a set of results. What is my next step? Where do I take this from here?

Jeff Watson (Sunquest): We’re working on a module for Sunquest Laboratory called Clinical Validation, focused on the interpretation workflow. It automates the process of moving those noninterpreted results from the bench into a platform on which a pathologist, medical director, or supervisor can make that interpretation and get that information quickly to the clinician. It goes out not only with a numeric result but also with that interpretation attached.

How has the COVID-19 pandemic altered your thinking about the issues we’ve spoken about? When labs adopted Lean in the laboratory, they made supply chains skinny in the interest of efficiency, trying to consolidate on one system vendor. This has left some laboratories a bit short because they simply didn’t have a platform on which to run available tests. Has COVID altered your thinking or that of your customers?

John Naizer (Randox): It has changed the thinking of Randox customers in terms of what tests are the most important to run and the volume the lab is running. They’re thinking: We’re not seeing all these patients anymore, so how can we change our day-to-day operations to save money and be more efficient? Many customers we are talking to are looking at smaller kits. They say, “We used to buy this kit that does 1,000 tests but now we’re running only 100 tests before it expires.” So we are asking: How can we find ways to keep products as long as possible to be up and running? We are aiming to find them kits that have a longer shelf life. Or: “Once we have COVID-19 patients and they’re being treated, what requests are going to be increased for testing?” We’re trying to work with them to find out what’s the best way to get results to people and still run the lab efficiently and save time and money with limited staff.

Timea Zsiray (Beckman Coulter): It reinforces the need for thoughtful development of high-quality assays that provide meaningful insight clinicians can use, and the importance of strong partnerships with our customers and with strategic partners in terms of the supply chain. The pandemic has reinforced fundamental core values.

Sean Roberts (Beckman Coulter): I agree, and I would add that the pandemic is presenting the laboratory with an opportunity to prove itself at how it can be effective in managing patients and patient care and outcome.

It’s rewarding to see a company like Beckman Coulter, and Danaher, put their full weight behind this pandemic. It brings great pride that we can have that impact on patient care.

Denise Pastore (Siemens Healthineers): It was a pleasure to see all the vendors working side by side and talking with the administration to the public about the testing they’re providing. From a Siemens Healthineers perspective, one thing we were able to do is provide a pocket guide for physicians and nurses on what other tests you want to conduct once a patient tests positive for COVID-19, to help in furthering their therapy.

Because of the limitations in getting into the laboratory, we capitalized—both customer and Siemens Healthineers—on the remote support. Reliance on remote and virtual health has increased.

Brittany Greiner (Roche): The pandemic has been at the forefront of our thinking and our decision-making. We want to be there to support our clinicians, laboratories, and patients in the best way we can. That is where our focus is. We introduced two new tests quickly to the market, one molecular and one serologic. And we have worked with the government to develop an allocation strategy that prioritizes labs with the broadest geographic reach and highest patient impact. We also recognize that addressing a pandemic requires the contributions of all members of our health care community, so we are pleased that the FDA granted emergency use authorization to other companies’ tests as well to increase the testing capacity for our country’s health care system.

Dr. Abel, how has COVID changed your thinking in a big perspective sense?

Dr. Abel (Lahey): It gave us and everyone else a major challenge to deal with, but as a system we were able to resolve the initial supply chain and testing demand problems, and we have been doing well. COVID is a unique opportunity because it brought laboratory medicine and the diagnostic profession into focus. We are in the news much more than before and it is a momentum we should take advantage of by showing the impact of laboratory diagnostics, not only in COVID but also in all other diseases and conditions.

Many patients missed or postponed appointments and others just didn’t see doctors. Patients are waiting and at the end might be coming in sicker. On the other hand, some patients are not getting tests that they perhaps shouldn’t be getting because of overuse, and they may be doing fine without those tests. So in time we can mine the data on the general health situation of patients who were without health care because of COVID, partly or entirely. Are there more abnormal results, in proportion to all the results? In microbiology, is there a higher percentage of abnormal results or unusual cultures, and extreme numbers in chemistry? It may help us sort out what is necessary and what is not necessary. What did we do right and what didn’t we do right?

Telemedicine has been a phenomenal success during COVID-19, and it will not go away once the pandemic is over. And self-testing too—the use of continuous glucose monitors in the wards, for example, which the FDA permitted. The pandemic will bring into focus central laboratory testing versus point of care, and this new, COVID-driven dynamic will likely influence the manufacturers’ focus and efforts.