Automation in coagulation was the topic of a Nov. 11, 2024 roundtable led by CAP TODAY publisher Bob McGonnagle. Put it on a line or on a dedicated automation platform? Seven participants talked about that and about cybersecurity, viscoelastic testing, and the labor shortage, among other things. Their conversation starts here, and CAP TODAY’s guide to coagulation analyzers begins here.
Brian Knight, can you recap the hemostasis-related news Sysmex announced in 2024?
Brian Knight, director of urinalysis and hemostasis strategy and solutions, Sysmex America: Siemens and Sysmex have a global partnership. It creates local competition, but the philosophy is that globally we can better address individual markets together. Sysmex America has been actively promoting hemostasis in the United States since April 2024. We are marketing our Sysmex CA and CS analyzers with Sysmex-branded hemostasis reagents. With the service organization we’ve built through our hematology and urinalysis portfolios, we’re confident we’ll be able to support customers well based on the relationships we’ve curated over the past 20-plus years.
Ashley Sanchez, the relationship between Siemens and Sysmex is longstanding, and much of it remains in other parts of the world. How does that look from your side of the relationship?
Ashley Sanchez, BS, MT(ASCP), marketing manager, hemostasis solutions, diagnostics, Siemens Healthineers: Siemens Healthineers and Sysmex have been in partnership for more than 25 years. Together, we bring a broad hemostasis portfolio to everyone worldwide and it creates local competition. We now sell the Sysmex CA and CS analyzers under the Siemens Healthineers brand to allow our customers to have a more simplified partnership on a local level with one vendor for hemostasis.
Laboratorians and institutional administrators like a simplicity of contracting and so on. It’s becoming a complicated world. Eric Salazar, can you comment on that?
Eric Salazar, MD, PhD, clinical associate professor, University of Texas Health San Antonio: It makes things easier for the laboratory, budgets, contracting, et cetera. The more you can bundle, the smoother the process is likely to be. At UT Health San Antonio, we’re getting ready to open our new hospital and recently went through a lot of contracting and figuring out where we can bundle. Coagulation often stands apart as a separate contract from chemistry or other elements of the laboratory, so it will be interesting to see the opportunities for more bundling.
LaShanta Brice, I’m hearing from many people in instrumentation about the cybersecurity checks that come with bringing new instrumentation into laboratories. Are you experiencing that at Diagnostica Stago?
LaShanta Brice, DCLS, MLS(ASCP)CM, SH(ASCP)CM, scientific engagement and clinical education scientist, Diagnostica Stago: Yes. Cybersecurity has always been an issue, and it comes from different angles. It’s usually several issues at one time, having to do with patching. With the reports of more cyberattacks within large integrated delivery networks, hospitals have become more strict. Going forward, we should expect we’ll be more restricted on what our middleware and software can and cannot do.
I’m hearing this often delays installations that labs regard as critical, and models of analyzers are being approved one by one. In other words, if you were going to bring in a second analyzer, it goes to the back of the line for cybersecurity clearance. Holly Wiles, is that true in your experience?
Holly Wiles, MBA, MLS(ASCP), national automation manager, Werfen: I said in a recent lecture that IT rules the world, and there were a lot of nodding heads in the crowd, most of whom were laboratorians. We see it with the IT involvement with our middleware solution, HemoHub, and our remote diagnostic software, ProDx. Hospitals don’t always have sufficient resources and there’s competition between projects. So this can cause installation delays.
An advantage of HemoHub is that when you add another analyzer to your lab or within your network, you can add it to HemoHub; it doesn’t add another interface. If it were another interface or different analyzer, it would mean a longer wait for customers. The other point is standardization. Because our instruments are developed on a standardized platform, there’s no difference between any of the models when it comes to interfacing. We can get a blanket approval from an IT cybersecurity perspective. But there are still challenges, and we’re having to be agile as an industry to support our customers and their patients.
John Friedl, can you provide a comment on cybersecurity?
John Friedl, MSM, director, global marketing, HemoSonics: With the Quantra viscoelastic testing system, we don’t use a server. We connect directly within the secure hospital network and pass through Telcor, RALS, and UniPOC, which are point-of-care middleware, and through Data Innovations, which is a lab-based middleware. This way we can be scalable securely throughout the institution. Due to our secure light footprint, IT assessments usually go quickly with the Quantra system placed at the point of care or in the lab. It’s a light lift in deploying our system to get results securely into the LIS but also through the remote viewing system into the points of care.
Dr. Oksana Volod wrote a wonderful book published by the CAP on viscoelastic testing. Where do we stand today with viscoelastic testing?
John Friedl (HemoSonics): With viscoelastic testing, three players are using cartridge-based systems, and it’s ready for prime time. It’s now being adopted more broadly in the United States and is already well adopted in Europe.
The Quantra system is an automated, cartridge-based ultrasound system that has a new way of displaying results by using a dashboard style with dials versus a traditional curves screen. It’s easily deployed and delivers fast results that are simpler to interpret. Viscoelastic testing as a technology has crossed the chasm. Now with actionable information provided quickly, clinicians can make informed decisions and transfuse blood products appropriately.
Dr. Salazar, what is the status of viscoelastic testing in San Antonio?
Dr. Salazar (UT Health): Viscoelastic testing is here to stay. It’s integrated into our testing processes. Clinicians tend to like it. Anesthesiologists, liver transplant anesthesiologists, ICU doctors, trauma doctors especially, use viscoelastic testing. It can add a lot of value from different perspectives. Turnaround time can be better in a point-of-care viscoelastic platform versus sending to a core lab, if that core lab is far away. Viscoelastic testing can give you actionable information quicker, which is what we’re trying to get at—actionable information we can acquire in the quickest way to inform transfusion.
We’ve seen a transition toward more automation and point-of-care-type platforms with cartridges instead of cup-and-pin mechanisms, where we’re doing manual pipetting of reagents and samples. That’s good because it allows for standardization, ease of use, and a little easier point-of-care implementation.
We as a field have had to transition to understanding the implications of viscoelastic testing. For example, the CAP Hemostasis and Thrombosis Committee, along with Dr. Volod and her efforts to create that wonderful book, has looked at what risks are associated with viscoelastic testing and what new standards were needed. An effort led by Dr. Geoff Wool on that committee has led to new accreditation requirements for viscoelastic testing. The first is related to remote viewing. Many viscoelastic platforms have remote viewing capabilities. As far as I know, it’s the only test in the lab where a clinician can remote in to the platform and see a test develop over time before the lab has had a chance to check the reliability of the test. Do we understand and agree with the results? Can we verify the results before they go out? Viscoelastic platforms allow for the viewing of those results before verification, which means there’s risk, and the committee has implemented standards to account for those risks.
Lance Trewhella, can you comment on the standards-related point Dr. Salazar made on behalf of the CAP committee?
Lance Trewhella, regional sales consultant, HemoSonics: I’m an advocate for having standards, especially in the area of remote viewing. HemoSonics’ Quantra system clearly shows that when the test is still running, values are “evolving” and not yet final. Once the result is final, Quantra’s dials show a solid color, indicating the test is complete.
I’m pleased to see the interest in standards so we’re all operating on the same page and eliminating misinterpretations and the potential of having to issue a corrected report.
With some of the regulatory requirements for releasing test results to patients, we’re going to see more about preliminary results, results that need final release, or amended reports. It’s becoming a daily occurrence in surgical pathology. Dr. Brice, what are your thoughts on that now and reflecting on your tenure in laboratories?
Dr. Brice (Diagnostica Stago): It’s long overdue to have the guidelines for remote viewing, primarily because physicians aren’t used to having information they have to interpret as preliminary in different forms. I’ve seen this with the LIS and the release of results. Sometimes they’re misinterpreted as not preliminary. I would encourage developing a way to educate large groups to make sure they understand what preliminary results mean and what they can and cannot do. That education then has to trickle down to the laboratory so they understand that if they receive a request while a report is preliminary, those results are not acted on, especially in transfusion medicine.
John Friedl, can you comment on this?
John Friedl (HemoSonics): It’s important to set standards, and that needs to be assessed and addressed with the viewing of evolving results. With the Quantra system, we’re able to release the results quickly so they’re then passed to the remote viewer in their complete form and into the LIS.
Holly Wiles, where’s the ideal place for automation in coagulation and hemostasis? Do we want to put it on a line? Many people tried that early on versus putting it on a dedicated automation platform.
Holly Wiles (Werfen): It’s a loaded question and much of it centers around the delay in bringing coagulation to automation because of its specialization. Instead of comparing coagulation to core lab automation, it makes more sense to compare it to microbiology automation because of the level of specialization. Putting coagulation on a line, if you don’t have a strict turnaround time requirement or a high volume, can perhaps be a good fit. There’s a place in the market for total lab automation and it provides a single point of entry. However, many of our customers need a better turnaround time, and they lean toward specialization.
With HemoCell Specialized Lab Automation, we’ve seen customers go from a 45- or 50-minute turnaround time on total lab automation to a 21-minute turnaround time and reduce the standard deviation and inconsistency. The other thing is providing one process. If you go from a nonautomated process, that’s one process of doing things manually. Oftentimes when people go to a total lab automation line, they end up with two or more processes—one for routine testing and the other for specialty or traumas with stroke designations needing quick turnaround times, all being handled off the line. With HemoCell, we’ve seen that customers can do all of that with one entry point for coagulation. Everything that’s blue goes on there. They can receive it in the lab and process it, whether it’s special or routine, and still get a standardized, reliable turnaround time.
Ashley Sanchez, Siemens Healthineers is famous for the quality of its automation and engineering. What are your thoughts on this?
Ashley Sanchez (Siemens Healthineers): Siemens Healthineers, in understanding the need for a specialized automated process for hemostasis, is able to offer the hemostasis island by customizing the FlexLab X track, which is now launched in the U.S., to behave as a hemostasis workcell, if that’s the way the customer needs to go. In many labs there’s not much space, and maybe a lack of staff, and they want a total lab automation solution—FlexLab X allows the hemostasis specialty to be customized with the smallest footprint. We’re able to offer integrated specialized hemostasis automation when customers need total lab automation, or if they want a hemostasis island, we’re able to customize that as well.
Dr. Brice, how do you lead customers through decision trees in terms of automating coagulation testing?
Dr. Brice (Diagnostica Stago): This year about 30 percent of my scientific presentations have been on laboratory automation. I’ve had TLA projects go well and others less so. Stago has the Workcell Max, which offers a hemostasis-only solution. In addition, the current platforms in the middle and high segments connect to all current TLA vendors in the market. We offer both options and each has advantages and disadvantages. Sometimes chemistry wins the battle in making decisions for the core laboratory, and that means we have to find a TLA solution.
I encourage laboratorians to use their voice as the hematology-hemostasis section and ensure they are involved at the beginning of a TLA project. Scientific literature shows that hematology and hemostasis analyzers should be in the front of a TLA; however, we find that hematology folks tend to wait in the background until chemistry finishes, and then it’s added at the end, which causes preanalytical issues. When automation comes up, laboratories need to look at coagulation automation and decide if they have the space. From a preanalytical side, do they have staff who understand what preanalytical factors have to be taken into consideration? Some people think it’s just a blue top, but it’s much more than that.
Brian Knight, what are your thoughts on this now that you’re looking at coagulation?
Brian Knight (Sysmex): The comments from the team here ring true. Customers are leaning toward TLA, but it’s crucial that everything is considered and brought up front in conversation before the decision is made. We have not moved forward with TLA yet, although the CS-5100 can be integrated. There will be instances in which it makes sense given customer requirements or testing practices. But an island of automation or a workcell makes sense in many cases. Coagulation is a unique animal. We’ve been at it full force for about six months, but we’ve learned that very evidently. It’s a weekly conversation on my team.
We’re now getting a second or third generation of large core labs as the IDNs seem to get bigger and bigger. Dr. Salazar, how do the newest generation of large core labs and core labs that are remote from the flagship hospital or institution affect your thoughts about automation and coagulation in San Antonio?
Dr. Salazar (UT Health): Each decision is an individual risk assessment and benefit assessment in terms of the best way to set up automation. One great development we’ve seen is dedicated coagulation automation, which offers a solution for certain labs. You have to think about quite a few factors. What is the required turnaround time? Where are you doing coagulation testing in proximity to the automation line? What kind of automation line do you have? Is it compatible? Who do you need to bring into the conversation to answer these questions well? Pathologists can try to answer these questions, but it’s really an engineering question. How do you engineer the line so it meets all the parameters you need it to meet? Industry members can include in their services engineering solutions that the lab probably doesn’t have the resources and skill set to fully address. Laboratorians are smart people and can tell you the parameters that need to go into the equation, but what the equation looks like and how the equation is solved probably needs engineers, which industry can help us with.
Ashley Sanchez, as you see IDNs developing and reference labs taking on ever bigger parts of ambulatory testing and taking over management of outreach from labs, is this still a moving target in terms of where coagulation automation will need to live three or four years from now? It could be an entirely different site, could it not?
Ashley Sanchez (Siemens Healthineers): Absolutely it could. Many large reference labs and IDNs struggle with knowing where to put coagulation. Will it be standalone? Will we incorporate it into TLA? Is the automation up to par for hemostasis? I still see reference laboratories that have two different processes, almost two different labs. Hemostasis is on one side, or it has a separate process, and then there is the rest of the lab, all TLA, everything incorporated into one track. Those laboratories are faced with trying to integrate these processes into one. What that will look like is going to be interesting, and it’s very much a topic of conversation at Siemens Healthineers.
Holly Wiles, I’m assuming that’s also true at Werfen, which has a global footprint and is keenly aware of developments in the North American laboratory world.
Holly Wiles (Werfen): Absolutely. I came from the laboratory and implemented our automation solution along with other TLA lines. We need people who are laboratorians but also have Lean Six Sigma certification and workflow training and understand automation. We’ve put those types of teams together and expanded our consultative services. There’s been a huge demand in the market for workflow analysis and additional continuous process improvement and change management activities.
Where to put the testing to optimize patient care and laboratory operations seems to be an eternal question. It’s still in flux, it seems, and what we thought was going to work two years ago appears to be breaking down now, and we need a different solution or thought about where different tests in the menu belong optimally. Brian Knight, do you see that in your work at Sysmex?
Brian Knight (Sysmex): Yes, it’s still developing and changing. It’s about partnership and understanding and, from a vendor standpoint, investing in the resources to provide a consultative approach so the right solution is developed. Each customer is a little different.
Viscoelastic testing is another case in point, where we have a developing technology that seems to offer value for near-patient testing but also requires education for and collaboration with laboratories to realize the solution. We see that on the hematology side because we pride ourselves on automation and how these all work together in an ecosystem and for the laboratory. We need to be the experts at the right time to walk alongside and partner with laboratory professionals.
John Friedl, what are your thoughts on what has been said here?
John Friedl (HemoSonics): These same opportunities apply to viscoelastic testing in terms of the placement of devices. The key is to take a Lean Six Sigma mindset to deployment and look at where the volumes are and where tests are being performed to optimize placement. Secure connectivity is critical as well—having a connectivity ecosystem because it’s about workflow and data flow.
Dr. Brice, we have labor shortages in laboratories, particularly among veteran, high-level people with experience in laboratory operations and on the technical side. What are you seeing and what needs to be provided to help laboratories?
Dr. Brice (Diagnostica Stago): That is a loaded question. I keep my ear close to the ground as an educator in university programs, and I’m seeing a loss of coagulation knowledge from the beginning. Students are being taught less and less about the operations of coagulation and are unaware of what their vendor is. They treat their vendor as a vendor and not as a partner. It’s our job as vendors to highlight through education what we offer as a partnership.
From an automation standpoint, workflow services are important. Stago offers MyOptiLab, but if people don’t know about it, then they don’t know to ask until it’s too late—the TLA decision has already been made. It’s part of our job as vendors to make sure we’re in the educational space and offer things in a partnership format as opposed to a more scientific format. As we shift toward this education model of getting out professionals quicker, as vendors we’re going to see a larger gap in the skills that were first obtained by the veterans. As they retire, we’ll have to step in and start filling the gaps much quicker by providing different services or with educational presentations.
Ashley Sanchez, Siemens Healthineers at a press conference at ADLM 2024 presented work it did regarding shortages in the laboratory, the squeeze on personnel. I don’t see that changing dramatically anytime soon, do you?
Ashley Sanchez (Siemens Healthineers): No. The “Do less” campaign points to laboratories not having enough staff and possibly not having enough resources to do their jobs, and that will not change in the near future. How can we design analyzers, reagents, et cetera, to optimize workflow and allow the laboratory to do more with less? How our technology integrates with the FlexLab X, by Inpeco, was showcased at ADLM, and the unique features that can be tailored to each discipline, including hemostasis, are the driver of the “Do less” message.
Holly Wiles, Werfen’s breakthrough in hemolysis detection for some of its point-of-care devices and critical care testing is a good example of a company helping its customers.
Holly Wiles (Werfen): Our Gem Premier 7000 system is a breakthrough. We understand at Werfen that preanalytical variables are largely unavoidable within laboratory testing but vastly important to the accuracy and reliability of results. Just like our ACL Top Family 50 series systems were groundbreaking when it came to hemolysis, icterus, and lipemia detection, the Gem Premier 7000 addresses preanalytical variables, now including hemolysis detection in blood gas analyzers at the point of care.
Dr. Salazar, can you talk about the value of having approved reflex testing protocols such that no one has an ethical or legal worry?
Dr. Salazar (UT Health): I’d like to first comment on our messaging when it comes to automation because I don’t want two things to be at odds with each other. When we talk about automation with our medical laboratory scientists, I often encounter fear that automation may take someone’s job. Automation should not be perceived that way. It should be viewed as an augmentation of one’s job. It will make you better at your job. It’ll help you take care of other higher-priority and higher-payoff tasks in the lab and even help you take care of patients in a better way. We need to be careful about that messaging.
With respect to reflex tests, it’s important we think of automation not just from a hardware engineering perspective but also a software reflex test perspective—the middleware. Middleware is also automation, in my opinion. A colleague in the industry wrote a paper about how middleware can be used to automate dilutions in factor assays, which is a huge help [Riley PW, et al. J Pathol Inform. 2017;8(1):25]. If you were to look at the algorithm that many labs use for how to interpret dilutions in one-stage factor assays, it’s mind-boggling. It’s complex. The more we can automate that, the safer the test is, the quicker the turnaround, the easier it is for medical laboratory scientists.
It is important we get our reflex tests—especially if they’re going to lead to a new CPT code, if it’s a new orderable test—approved in some way for their medical necessity. Oftentimes labs approach it by getting those reflex tests approved by the medical executive committee. We have to be careful in industry and in the laboratory that we understand the rules around reflex tests and billing.
Would anyone like to make a final comment?
Holly Wiles (Werfen): To Dr. Salazar’s point, middleware and IT solutions are forms of automation. It’s critical that we’re able to be agile and manage reflex testing. Instead of vendors saying, “This is the workflow the lab has to adopt to work with us,” it’s, “What are your policies and procedures, how do your algorithms work, and how can we automate those?” We’ve had great success from automating factor assay algorithms and various lupus anticoagulant testing algorithms. We’re hoping technologists gain more confidence around those algorithms. We know they’re complex, and training people to be confident in those areas takes time and effort. By automating them, a visual is still provided, but standardization and patient care are also optimized.
Dr. Brice (Diagnostica Stago): I agree. Algorithm development needs to be flexible among the vendors, if they provide them in middleware. It also needs to keep up with scientific guidelines. As we progress, it’s important that algorithms remain editable as new guidelines come out.
As we move forward with staff members coming out as more polyvalent as opposed to discipline specific, we need to adjust to that. Educators will be teaching polyvalent skills—skills that are applicable to all disciplines in the laboratory. It would do vendors well to assist in those educational endeavors by making things easy to understand for staff members and those who oversee the laboratory. Our PhD clinical directors can also benefit from that ease of use.
John Friedl (HemoSonics): I agree with the comments about middleware. With viscoelastic testing systems, middleware enables the technology to be fully operationalized and standardized throughout the hospital, whether the devices are at the point of care or in the lab. Now we’re often seeing hybrid setups, and our product is designed for use in lab and point-of-care settings. We’re not just driving Quantra systems out to the point of care; we’re finding there’s an optimal balance as we talk about Lean Six Sigma and engineering workflows. We’re attuned to the adaptability and how the systems are laid out to cover all our indications and prepared to scale as future indications come online.