Volume? Space? Automation decisions in coagulation

January 2023—Automation and point-of-care, reflex, and viscoelastic testing were some of what came up when a group spoke with CAP TODAY publisher Bob McGonnagle in late November about hemostasis testing. Also tossed in: Results reporting to the EHR, which “can always be improved,” said Eric Salazar, MD, PhD, of University of Texas Health San Antonio. And D-dimer, one of the pandemic’s “health care heroes,” said Nichole Howard of Diagnostica Stago.

Here’s what they said about all that and more.

CAP TODAY’s guide to coagulation analyzers begins here.

Dr. Russell Higgins, what is top of mind as you look at the field of hemostasis now? I put this in two parts—the routine, high-volume, largely heavily instrumented side and then the specialty assay areas.
Russell Higgins, MD, professor, clinical, University of Texas Health San Antonio, and medical director, University Health System Pathology Services: If we’re talking about instrumentation, it’s automation—track systems, integration into larger track systems, and the automation that goes in the box of coagulation analyzers, like HIL [hemolysis, icterus, lipemia] modules. Those are changing. Coagulation is late to the game in terms of incorporating HIL into the workflow compared with chemistry, which has been doing this for some time.

Dr. Eric Salazar, I’m going to ask you the same question. I know you have a specialty in the more esoteric components of the coagulation cascade.
Eric Salazar, MD, PhD, associate professor, clinical, University of Texas Health San Antonio, and member, CAP Hemostasis and Thrombosis Committee: My top three answers are automation, automation, and automation. In addition to what Dr. Higgins said, we’re talking about ease of use. The pandemic taught us that we’re going to have shortages of workers—we currently have shortages of medical laboratory scientists—and supplies. There were crunches during the pandemic such that the easier the device was to use, the more sustainable the whole process. And that’s why we think about automation not only for routine tests but also for some of the more esoteric tests that require manual processes. Can we get these tests automated in the event you need an esoteric test more rapidly? The more automated it is, the better it is for us so we don’t need specialized medical laboratory scientists.

As Dr. Higgins and I explored—we recently wrote a chapter on automation and coagulation—when we talk about automation we’re talking not only about connecting the track systems or the inside of the box, but also about middleware and what the software can do to make running the tests easier.

Matt Modleski, what’s top of mind as you look to coagulation testing and the laboratory and in the networks and systems you work with?
Matt Modleski, executive vice president of corporate/business development, Orchard Software: As these tests become better at the point of care, we see a lot of testing moving closer to the patient. Our two jobs as a software company are, one, be ready when a new test comes to market so we can integrate it smoothly into the lab. We need a little advanced warning if there are new analyzers coming so we can work on interfaces and the things that make bringing the new test and new analyzer to market easy.

The other is the location of testing, point-of-care tests. That trend will continue because it makes sense from the perspective of the cost of other health care. The closer we can get a test result to the patient, when the clinician wants it, the better the chance of that patient getting the care they need in a timely fashion and staving off downstream costs. When we think about coagulation, we’re looking at the same four things we look at with almost all testing, which is: Is it going to move to point of care or is it already there, and how efficient is it? If there’s new technology coming, are we ready for it? And as those trends move, where is the biggest bang for the buck from a reimbursement or a patient treatment perspective? Are we ready to help that area of testing and treatment?

Ken Huffenus and Nichole Howard, both of your companies offer a dedicated track and automation for coagulation. That seems to be efficient because if it’s all in one place, it’s convenient for the medical laboratory scientists. On the other hand, I suppose some laboratory directors long to see coagulation tied into the main core line and have coagulation essentially imitating hematology, chemistry, and immunoassay. Ken, you probably hear from customers who want both solutions. Give us your thoughts about this question around automation.
Ken Huffenus, MBA, director of marketing, hemostasis, Werfen: Dr. Higgins’ comment about coagulation being late to the automation game is correct. Experts in the field were concerned about what would happen to the sample when it travels along a total lab automation track to the analyzer and where the centrifugation would be performed. In 2014–2015 we talked to customers about automation for coag testing and found many were against any form of it, other than automation within the instrument itself. But that started to change, even before the pandemic, when we saw the shortage of well-trained medical lab scientists. Then the question was, how do we automate in the right way? That’s when our hemostasis workcell concept gained momentum. We said, let’s make it dedicated and ensure that we treat the sample the right way. With HemoCell, we have only as much automation as we need to get the samples from entry into the lab to the analysis, and the data back to the laboratorian as quickly and efficiently as possible.

Nichole, do you agree that the workstation automation dedicated to coagulation is the preference of more customers rather than another solution?
Nichole Howard, MBA, director, SNA marketing, Diagnostica Stago: To your point earlier, there’s two paths. There’s the high-volume, hyper-focused on coag path, for which customers want a dedicated solution. We have that solution—it’s turnkey, built in-house, and we service and manufacture it. It’s tailor-made, you can design it, and it’s powered by digital solutions. It’s the challenges Ken mentioned of coag being the last added to the line and the coag blue-top tube moving down the line, getting shaken up. In that case, you have sites that want the track, the automation in the instrument, and digital solutions that help automate processes. And Dr. Salazar or Dr. Higgins can sit in their office right now and look at results and review QC and be empowered where they are.

On the flip side, we’ve also seen double-digit growth of our automation installs on TLA lines over the past few years. So we’re seeing both and making sure we’re sensitive to meeting customers where they are and have the connections in place so when a customer says I’m ready to go, their analyzer can connect to that line.

Dr. Salazar, as a coauthor of a recent chapter on the subject, did you come down on one side or the other? Or do you recognize there are two viable paths for automation in coagulation?
Dr. Salazar (UT Health): The approach is individualized. It depends on your situation at your facility. What are your volumes, what is your space? Is your space set up to put the analyzer where it needs to be? That’s a huge limitation—was the design appropriate from the beginning? We’re designing a lab now for the new UT Health Hospital and coming across this question of whether we go toward TLA or keep analyzers separate. Do we keep hematology and coag separate from the chemistry line? It’s a difficult question to answer, highly individualized. With the shortage of medical laboratory scientists, the preference in general is to move toward automation, including coagulation.

While we’re talking about shortages, where are we with blue-top tubes these days? Where are you, Dr. Higgins, in terms of your supply chain for coag tubes?
Dr. Higgins (UT Health): Blue-top tubes never hit my shortage list. But we have had shortages of EDTA, purple-top tubes, and on and on. It depends on where you are in the country and who is taking care of your supply and how closely they’re looking at it. For instance, our outpatient laboratories and hospital were getting their supplies from central supply, where the tubes are managed. And they didn’t always have a day-to-day communication mechanism that could tell us how much they had in stock and available. We had to ask every week, how many tubes do you have? And they had to check in several systems to give us a number, and then we had to translate that to how many days, weeks, or months of supply we had. We monitored that during COVID and are still monitoring some of those tubes.

Nichole, can you tell us what the situation is now nationally for blue tops?
Nichole Howard (Diagnostica Sta­go): For a while we were having almost weekly calls with BD to coordinate efforts. Right now it’s pretty calm; we’re not hearing much.

Ken, when we have the shortage we have of phlebotomists or the situation in which systems are telling their nurses to stop drawing blood because they’re too busy, is that having an effect on the quality of draws, specifically for coagulation studies?
Ken Huffenus (Werfen): We have not heard of any recent changes in the quality of draws. From my perspective, one of the reasons we focus on preanalytics in hemostasis testing is to make sure that regardless of what happened to the sample before it reached the lab, we have a way to assess the quality of it during the analytical process and flag it if there is an issue that may impact the result. That preanalytical test-specific assurance is really important.

Dr. Salazar, are you happy with the draw quality and the arrival of the specimens?
Dr. Salazar (UT Health): During the pandemic when there were crunches on nursing staff, we did not notice a decline in the quality of the specimens.

Improving the quality of the specimens where I worked previously was a major effort, especially in the ER. There was a lot of effort to try to reduce, for example, hemolyzed samples coming from that area.

Right now if you don’t have an HIL module with your coagulation analyzer, it’s a manual process. You’re looking at the sample, checking for hemolysis, comparing it to different pictures of a level of hemolysis or lipemia, et cetera, and trying to determine if it is a sample you can reliably run. The more that analysis can be automated, the better it is for the lab.

From the perspective of the lab, however, it is important to understand, independent of what the vendors tell you, what hemolysis, lipemia, et cetera, do to the tests you’re running. You probably should do in-house validation to make sure you understand how important it is. For example, if I have a bleeding patient in the OR and I get a hemolyzed sample and need to run a PT/INR and a fibrinogen, how important is it if it’s a moderately hemolyzed sample? You need to know that for your individual assays.

Nichole, do you have further comments about specimen quality and preanalytic guarantees coming from you and other vendors of coagulation equipment?
Nichole Howard (Diagnostica Sta­go): Dr. Salazar’s point is well made in terms of understanding the impact with your local patient population for each of your assays. At the core of every Stago analyzer is the viscosity-based detection system with the mechanical clot. So knowing that we’re not outside of the sample looking in, whether you have H, I, or L, you are able to actually live in that sample and not have the interruptions that may come from preanalytical issues.