Hematology panel: bridging gaps, staffing, Lab 2.0

I appreciate that nuance on the usefulness of the CellaVision depending on the site and patient population served. Danette, can you comment on what we’ve just heard from two sophisticated laboratories with excellent medical direction? How do the rates of manual review strike you in the wider context? Does this sound like something you wish many other laboratories could achieve, and if so, would realize even greater efficiency from their hematology automation?

Danette Godfrey (Sysmex): I would have to agree. And it’s refreshing to hear the close alignment with the solutions that are coming to market today, and to hear the new value laboratories are able to achieve through integrated technology solutions. I also have an appreciation for the need to provide more efficiency solutions, whether that’s through image analysis, middleware, or through digital solutions in general. We mentioned the BeyondCare Quality Monitor to help laboratories manage quality through modernized innovations. Providing solutions to laboratories to be able to address these staffing challenges is something that struck me as critically important to our customers and also remains a focus of Sysmex. Sysmex is now providing quality and operational data to laboratories through new dashboards and digital solutions to manage productivity of their teams and their solutions, instruments, and analyzers.

Matt and Rachel, please comment on what you’ve heard from Dr. Sever and Dr. Pozdnyakova with reference to what they have achieved in terms of manual review rates and the other points they raised.

Dr. Rhyner (Beckman Coulter): Those are good rates. We think about the manual review as a function of three different parameters. One is the patient populations, oncology centers, for example, where I’d expect a significantly higher manual review. Pediatric hospitals, also much higher. Then there is what would be termed the rate due to instrumentation or flagging due to instrumentation, and coefficients of variation. Then there would be consideration for the rate that is taking care of the second reflex on a lot of instruments. We’re proud of having a high first-pass yield. While we have some cancer centers that are in the 30 to 40 percent range, we’ve seen labs, especially outside the United States, where they have maybe more aggressive decision rules, in the single digits in terms of review rates. We have one webinar regarding our partner in New Zealand where it’s about 3.8 percent.

A lot of it gets down to the decision rules, their comfort, the patient population, how the instrumentation is performing, and leveraging the technology. What it comes down to is manual touches. We do have a flow cytometry product outside the U.S. that also dramatically reduces these reviews. So, I can see a future where there are single-digit-style reviews in a broader segment of the population, and in which the cost and staffing pressures are going to force us into that range.

We recently launched the DxA 5000 this year, which is our next-generation total lab automation solution, currently pending FDA clearance, that integrates seamlessly with our DxH hematology platform. That’s another way in which you can reduce the rate: have an entire lab fully automated with integrated middleware. The DxA 5000 works with our middleware and total lab automation for what we refer to as multidiscipline reflex. This could be where follow-on sepsis care bundles with tests like lactate or procalcitonin. It could be run after an initial flag. Beckman Coulter is looking at the total lab perspective with hematology being a major piece of that.

You would reflex from a hematology result back to a tube to put on the chemistry analyzer for an add-on or a follow-up?

Dr. Rhyner (Beckman Coulter): Yes, you get one draw and we refer to it as multidiscipline reflex. It works with our DxOne Clinical Informatics Platform.

It seems to be in everyone’s interest to optimize the efficiency of the instrumentation and then the laboratory site—the instrumentation in combination with the professionals who staff that laboratory. Rachel, would you like to add anything?

Dr. Burnside (Beckman Coulter): I would agree with Matt with respect to what drives manual reviews. I see this not just as something related to individual institutions but across the country with respect to technical staff aging and there not being enough workforce. This is not unique to core labs. I was in a cytogenetics laboratory for many years as a director and we experienced the same thing. It’s just high-complexity testing as opposed to moderate-complexity testing.

This is industrywide across health care. So, I think you’re going to see more focus in the future on development of technologies that reduce the manual burden on people, and that would include a reduction in the need for making a slide and/or improvement in image analysis where cells can be analyzed in real time or on a slide without human intervention. This is the way of the future. We’re not there yet, but it’s exciting to participate.

In some ways this is a race between the technology advancing fast enough to keep pace with an accelerating labor shortage. Dr. Pozdnyakova, is that how you see this?

Dr. Pozdnyakova (Brigham and Women’s): I don’t know. I do not want to see or continue to see the reduction of medical professionals in the laboratory. We could use more people but maybe redeploy them to different tasks. I would hate to see all the labs being replaced by an automated process that does everything from start to finish. There is a lot of value in what we do. In addition to patient care, there is a lot of interaction between providers and technologists, between pathologists and technologists. We have to be more efficient, given the shortage, and use lab professionals in other areas and train them to do other things.

Dr. Sever, at TriCore you have been part of the Santa Fe Project that’s sometimes now called Clinical Lab 2.0. TriCore is a founding member, and Sysmex has been highly interested and involved in it. Many in the industry, in labs and in companies, are looking at this. Can you talk about how improvements in the operation of the hematology laboratory can lead to a greater appreciation of the laboratory endeavor and to some assurance for those who work in laboratories and service laboratories that the future is bright for them?

Dr. Sever (TriCore): It’s a comprehensive approach to everything, more or less. And again, for me, it’s important to realize what patient populations you serve and incorporate values across different disciplines into actionable clinical data.

We are taking baby steps in hematology; in other areas we already have some 2.0 running. One of our initiatives was offering an anemia screen for outpatients. The intent is to have patients come only once to the lab draw site and diagnose two-thirds of anemias in the outpatient setting. You can order a CBC with reticulocyte count, reticulocyte hemoglobin content and immature retic fraction, which has all the information to diagnose uncomplicated iron deficiency. We are rolling that out to leverage some of the new capabilities.

The other big arena is in the oncology field where we are asked to guard utilization and we are taking on a lot of tasks that in many traditional environments are done by the oncologist—bone marrows, for example—the pathologists order everything from flow to molecular to cytogenetics. We often trigger action right away based on CBC results. We perform a lot of bone marrow procedures ourselves and order ancillary tests as appropriate. There is even a little publication from our hematopathology fellows. We are saving the system to the tune of an entire pathologist FTE by guarding these resources. And those are the most highly valued activities.

We have the same problem with replenishing our technologists. We believe they are on the frontline and it would be a disaster not to have them at night and on weekends. To get efficient, we are shifting things to moderate-complexity tasks, where we can have less-skilled personnel run these machines. Sysmex has a new machine that does five-part differentials and is moderate complexity. We are experimenting now with freestanding ERs—putting them in the ERs and having them run by the ER techs with supervising laboratory technologists and with integrating that into our entire hematology workflow. That saves a lot of technologist FTEs.

There are a lot of CBCs; it’s the number one test ordered. So we have shifted an entire population out of the high-intensity, technologist-driven scenario into point-of-care, moderate complexity, with supervision by trained technologists. So those are the other approaches as a system where we can preserve our precious resource of trained hematology technologists and expand the pool of people who can run the machines.

They have to be robust machines, and there has to be software that works with the point-of-care scenario. They have to automatically prompt the operator to do the right thing and then remotely enable the supervising technologists to audit, edit, and manage this. Sysmex has a remote calibration verification system that hopefully gets approved in the budget. It’s in the works. So that’s another approach to preserve our resources and get more efficient in our more difficult shifts.

Dr. Pozdnyakova, how does the laboratory demonstrate and preserve its value in the face of what we all know are enormous pressures on technology, on cost and spending, on labor? Do you see it as part of your job to make sure that the value of your service to the entire system—clinicians, patients, and others—is top of mind?

Dr. Pozdnyakova (Brigham and Women’s): Yes, it’s very important for us to promote our services and to educate clinicians so that they fully understand that our services are probably one of the most important contributions to the patient care.

Dr. Sever brought up important points—that we, as pathologists and as laboratorians, should be the keepers of the test ordering. This is something we’re doing also, somewhat successfully, at Brigham and Women’s Hospital. Deciding what tests are appropriate and inappropriate for each patient saves not only the dollars but also the valuable time of technologists and pathologists. I agree this is one of the efforts we should continue to drive and that we must continue to educate not so much clinicians in this case but laboratorians and labs themselves—how to make sure all tests ordered are appropriate in a particular clinical setting.

We are trying to be creative in how to retain our technologists and how to make do with fewer of them in the current shortage, and one way is cross-training so each technologist can efficiently work in many different lab areas. This is also one of the ways to keep laboratorians interested, because they appreciate rotating through several areas of hematology. It has paid off in our situation.

Danette, would you like to share impressions or thoughts you had as we’ve been through this discussion?

Danette Godfrey (Sysmex): It’s inspiring to hear the feedback from our pathologists and it’s something we at Sysmex hold dear to our hearts—the value of laboratory scientists. So as much as we continue to push digital solutions, automation, we can’t let go of the importance of the clinical decisions and the value of the medical scientists.

The summary of my impressions is that we as manufacturers of instrumentation can do our best to provide the right hardware and software solutions for the laboratory, but our goal is to empower our clinical experts to use the efficiencies we can provide to them through automation solutions, not in an effort to replace them but to empower them and take away that busywork that can be replaced with automation so they can focus on what is important to drive clinical decisions.

Dr. Rhyner (Beckman Coulter): I can’t agree more. For a long time, the laboratory has been viewed as a cost center. And part of what we hope to do is to bring labs biomarkers with real demonstrated clinical value, like our Early Sepsis Indicator, to turn the lab into something that the C-suite can see as a benefit to the entire health care network. Not just a cost center to squeeze as much as possible, but something that has real health, economic, and clinical benefits and has the potential to reduce the overall cost burden to the entire hospital operation.

So, I agree, and what we need to do is provide solutions that allow the clinical information that saves patient lives and reduces the cost of care to shine through.