Coagulation tests and COVID: inside labs, industry

Nichole Howard, early on there was a falloff in the demand for many standard clinical laboratory tests, as they relate to elective and other procedures, and then we went through the period, which I don’t think is over, of patients being reluctant to come into clinics and hospitals for testing. How have you seen this up and down of demand over the past few months as it’s reflected in your work at Stago?
Nichole Howard (Diagnostica Sta­go): We did see ER and ICU beds being the focus, and there were mass cancellations of routine and elective procedures. Then, as things started to come back, the laboratory had to maintain its COVID testing but also ramp up and try to deal with the backlog from the cancellations as patients started to return. We’ve seen a steadying of that.

We talk to our care networks about the importance of having diversity in the type of instruments and type of setting. For instance, using a smaller automated platform in a clinic setting, rather than a point-of-care device, to measure PT/INR, where you get a comprehensive treatment of the patient. Let’s say the patient is going in to get their PT/INR done. They are able to get the result they need at that time that they’ve been out of the house. There’s no risk of their having to return to be redrawn or having to go somewhere else to get a laboratory test performed. By keeping those patients close to home in smaller settings that are separated from COVID patients, it’s building the confidence that they’re making sure they’re taking care of their regular checkups that are fundamental to being sure we don’t add stresses at other points in the health care continuum.

Jason Lam, tell me about what the ups and downs have been of demand for tests and where you think we are now. Are we back to normal? Are we back to 90 percent of normal?
Jason Lam (Siemens Healthineers): Back to normal—I smile, because is anyone normal now? When the D-dimer volumes were going up drastically, we also saw routine testing drastically decline, and it was happening fast.

It started to come back but routine testing is still affected. As you shut down routine labs and start running the testing only in some of the larger hospitals, volume capabilities are becoming increasingly important. Hospitals want to know whether they can take on more volume without having to replace current instrumentation. That’s making these facilities re-evaluate when they bring in new instruments and whether they are bringing in the right fit with the ability to grow quickly. Economically, with the routine hospitals shutting down, it does come down to financing and how they are able to get the equipment into their facilities.

I’m seeing a lot of change in the market, at least from acquisitions of instrumentation, partnerships, and how they are doing the hub and spoke of the independent network hospitals.

Curt Johnson, you have a good feel for how systems are working, with centralized flagship hospitals but then in clinics, doctors’ offices, and the important smaller hospital that is under siege in nearly every respect. Tell us about this health system environment and the testing within it.
Curt Johnson (Orchard): The challenge we are seeing now in the reference labs that are associated with the large institutions or large IDNs that have their own core labs is: How do I ramp up the volume for COVID testing along with the other tests I need to do? At the same time, if you have a nursing home or senior living care facility within your organization or as a client and you are the expertise they rely on, some of that testing needs to move out into those organizations. So point-of-care testing is moving not only toward the patient within the hospital, but also out of what we would consider traditional laboratory space. How do you get everything connected in that scenario?

The question is: How will this process change when the vaccine is widely available? We’re working with all the manufacturers to support rapid point-of-care testing to manage hot spots that will pop up once there is a vaccine. We believe that the high volumes of COVID testing won’t substantially go down by this time next year, but that testing will expand dramatically in different settings, and that shift will take place throughout all of health care. As we move to a more preventive care, value-based model, while the cost per reportable might be higher for low-volume point-of-care analyzers, the cost to the whole episode is dramatically lower, and we believe that’s where the need for information and testing will shift. So we’re preparing for both the high volumes we’re seeing now and the disbursement and distribution in the future.

Dr. Harris, do you, as medical director of the core laboratory at UF Health, have a few thoughts about how the distribution of testing will be affected by the experience we’ve had in the past year? And do you have personal views about what would be most desirable?
Dr. Harris (University of Florida): The core laboratory was never much involved in virology until about a year or two ago when we started doing more virologic tests, and that happened to coincide with the pandemic. So this has become a main thrust of the lab, but I don’t think it has affected the coagulation that much, but there’s been a restriction of the workforce—a move of the staff to the COVID testing. There’s a shortage of people on the bench.

Prior to the pandemic, we had a number of specialized tests available. For many years we’ve been running the anti-Xa assay for unfractionated heparin and low-molecular-weight heparin. We have assays available for some of the newer oral anticoagulants. So thus far, we haven’t had to introduce new assays.

I agree with Dr. Volod that viscoelastic testing is important. I had mentioned earlier that our nonmalig­nant hematology group has taken the lead in guiding the hospital. At the moment, though, most of the interest in the viscoelastic testing has come from anesthesiology and the intensive care unit.

In terms of COVID, although we do many viscoelastic tests, it has not yet become a mainstay or main criterion for assessing the COVID hypercoagulable state at our institution. The nonmalignant hematology group has used the more traditional methods, and by that I mean the D-dimers, factors, and fibrinogen.

I’d like to talk about the lessons we may have learned over the past year and how they might shape the future. I’ll give you an example. Many for years have promoted Lean, standardization on one standard analyzer, not wanting to keep excessive reagents or supplies on hand. We wanted just-in-time scheduling. And that has caught many labs short, not just for COVID testing but for other testing, as has been pointed out. Nichole Howard, are you seeing a shift in the planning philosophy among some of your customers?
Nichole Howard (Diagnostica Sta­go): Even in our personal lives we’re seeing a lot of people do this. We wouldn’t have run short on toilet paper throughout the year if that were not the case. But you make a good point. When it comes to things like D-dimer, anti-Xa, yes, our customers are wanting to have more of a sort of security blanket. We’ve worked with our customers to determine precisely what they need and to build confidence. We’ve been happy that no one has gone into backorder. For us, the focus has been on education and confidence-building for the customer, that we can make it through this and don’t need to stockpile. We’re worried about the collective health, so we’re each doing our part to take the things we need and not stockpile.

I don’t see customers turning away from being lean. In fact, the need to play catch-up on canceled elective surgeries and things of that nature, and the shortage of people on the bench as Dr. Harris said, may have reinforced the need for lean work environments, the right care pathways, and making sure you have the right tests onboard. A good example is anti-Xa and not using the PTT to monitor heparin. I think it makes the laboratories stop and reflect on how to partner most strategically with their vendors to be sure they have the right tests at the right time for any patient.

Jason Lam, same question—what are the long-term implications, and what are you hearing directly from customers as they’re planning for next year?
Jason Lam (Siemens Healthineers): Things came to a halt last year; future planning was delayed. We have all come to find that COVID-19 will be with us for the foreseeable future. Hospitals, labs, will have to continue to be lean because of the economics of all those routine surgeries and everything else going on. They don’t have a choice but to be lean in their solutions going into the future.

I can’t predict if it changes the mindset of how we move forward as a health care system, but I can tell you that over the past six months, the partnership and communication between the manufacturer and the hospital facilities and medical directors only grew stronger because we as manufacturers heard what was needed and were able to deliver. The FDA cleared tests quickly to meet these needs through emergency use authorization. D-dimers were always available, heparins were available. I hope the partnerships and collaboration continue in the future.

Dr. Winkler, would you like to comment?
Dr. Winkler (IL): I agree with Nichole and Jason regarding the partnerships. We’ve seen that as well. We are working closely with our customers and have been able to be there for them, sometimes on site if applications teams were needed to assist with installing or helping to validate new tests.

The other thing that has come up is automation for coagulation, which historically has been behind other areas of the laboratory. As the workforce may be challenged, the question is what is the opportunity for increased efficiency with automation and hemostasis.

That’s an important point, and I’m going to ask Curt Johnson to comment on it. Lately, I’ve been hearing a lot of worry about staff burnout and staff shortages. At first, quite a few people were furloughed and now they’re recruiting retired technologists and others, trying to bring them back into the laboratory. Curt, how do you see the labor issue affecting us going forward?
Curt Johnson (Orchard): Pre-COVID, the value of the laboratory was never fully understood. The value of laboratory information in health care and in treating patients is astronomical compared with the cost, yet the lab does not normally get the recognition it deserves—until we started seeing press conferences on the White House lawn and the president talking about point-of-care analyzers and the volume of daily testing. As we move forward, I think the country will notice the value of the laboratory, and when you have a spotlight on the laboratory’s value, you may see more people interested in joining the force.

Now in the interim: For the past 25 years we’ve had a labor shortage in the lab. Between the scientists, the diagnostic companies, the automation, and the information systems, we have managed to offset labor by automation, and I think you will see that continue.

Dr. Harris, we know historically that public diseases and problems like AIDS and hepatitis have had an effect on willingness and desire to go into the laboratory field—I’m talking now of technicians, phlebotomists, and medical technologists. Do you fear a similar effect from COVID?
Dr. Harris (University of Florida): I’ve actually been encouraged, even prior to COVID, by the number of young people we’ve been getting in the lab—certainly not enough, however. But when I first started in Gainesville in 2002, 2003, there was a large cohort of medical technologists who were about to retire, and the prediction then was that there would be no replacements ever. I think there has been a growing interest in it.

To some of the points others made, yes, the status of the lab has been elevated by the testing available during the COVID crisis, and I think there is a growing interest among graduates in laboratory medicine.

In my own situation, we’ve had a much better relationship with the hospital administration regarding equipment and support. This is surprising because a few years ago I would never have predicted it.

But the crisis in terms of the staff shortage is far from over. We are chronically understaffed. We use travelers—people who are semi-permanent, going through the lab. I wish there were more medical technology programs throughout the country. A number have closed over the years. I’m hoping that this current situation could reverse that.