Urinalysis: Efficiency, utility, and the ‘movement in the field’

Megan, have you seen improvement in the availability of good collection tubes with preservatives?
Dr. Nakashima (Cleveland Clinic): We’ve been doing the majority of our sample in preservative for a while, and that’s why it was an issue for me. FDA approval was the big issue because you have to make it a laboratory-developed test when you’re using an unapproved sample type. At this hospital we have the resources to do that type of validation, whereas at some of our smaller sites, they don’t have the manpower or it’s difficult for them to get the manpower together to do that type of study in addition to the usual FDA-approved analyzer validation.

Just to underscore for our readers, in the interest of our industry representatives here, they cannot help with LDTs. That has to remain at the laboratory level for legal and regulatory reasons.

Megan, how have your volumes in urinalysis changed in the last year or so, if at all?
Dr. Nakashima (Cleveland Clinic): In the beginning we had a dip, but since then most of our volumes have been back to normal.

Jason, what are you hearing from your customers in terms of volumes?
Jason Anderson (Sysmex): Our customers did see dips initially, but those volumes are back to pre-COVID levels in a lot of cases. We have customers who, based on staffing challenges and increased workloads in urinalysis, want to automate and get away from the subjectivity of and time required for those manual, hands-on processes, so we’re seeing an increased interest in our automated urinalysis solutions.

Matt, same question to you and, in particular, I would like a comment about people in lower-volume labs and their interest in and appetite for greater automation in urinalysis.
Dr. Rhyner (Beckman Coulter): For the labs, getting back to normal happened a while ago. For our business, it’s been that way most of 2021. Starting in late winter or early spring, testing volumes spiked and have been strong ever since.

The budgetary, workflow, and workload concerns in labs are driving the desire for more automation or more efficient processes that require less interaction with the machines. It comes down to a cost-benefit analysis of how much the automation will cost versus the number of samples run. Beckman Coulter just released the DxA 5000 Fit, which is designed for mid- and smaller-volume labs to offer them automation features seen more commonly on analyzers made for higher volumes. That’s where it becomes a financial consideration—balancing workload and sample volume and the capital investment to get more automation.

Since the first of this year, the staffing issue in laboratories has become acute. Megan, are you facing some of those same problems in your practice?
Dr. Nakashima (Cleveland Clinic): Yes, we’re like everyone else. At the beginning, we had to shift resources, including personnel, into COVID testing. That has flexed back, but we’re still dealing with those same challenges and trying to train as many new medical laboratory scientists as we can and to get young people excited in the field. Also, a lab that’s doing a lot of automated urinalysis is frequently a 24-hour-type lab, and you have a lot of attrition and turnover in some of those off shifts. That’s always been an issue.

Is it your opinion that automation will come to save the day? Or are we approaching an era in the lab where the shortage cannot be answered by anything—whether it’s more money for technologists and technicians or more automation? Are we at that crisis level yet?
Dr. Nakashima (Cleveland Clinic): I think there are different ways to flex that. If you have a really small site, then hand-dip your urine if you have to. Other people are going to the other extreme and consolidating practices over four states. There are different ways to approach this problem depending on what type of situation you’re in. We’re not breaking quite yet.

Jason, are you hearing a lot from customers about the staffing challenges?
Jason Anderson (Sysmex): Absolutely. The aging of staff, the lack of highly trained staff, the use of traveling technologists who may not be as familiar initially with lab processes and instrumentation—these exacerbate the challenges.

At Sysmex, we recognize that with our urinalysis solution, simple things like having software that’s similar to that of our hematology instruments, which are widely used in the field, can shorten training times and learning curves so techs can quickly become proficient and productive on our system. Sysmex has introduced the TH-11, an optional integrated automatic urine tube decapper—a first in urinalysis. The TH-11 eliminates the nonvalue-added manual process of removing caps and minimizes repetitive stress and biohazard exposure risks to lab personnel. For labs with staffing challenges, the UN-Series is a game changer—tubes are loaded on the system and staff can walk away to complete other critical lab tasks and return to review only those samples that require further subclassification.

Matt, I’m sure this is resonating with your customers and potential customers.
Dr. Rhyner (Beckman Coulter): Yes, demand for all of our products has been extremely high since the pandemic. Customers have started to see the value for all the reasons we’ve addressed, in urinalysis, hematology, lab automation, chemistry, immunoassay, and in clinical informatics. Compensation increases are part of the solution, but we as manufacturers also have to make new products for the new reality in which labs exist. Fewer and fewer people are entering the field.

Dr. Nakashima (Cleveland Clinic): Increased demand during the pandemic has been mentioned, but I have experienced and heard people talk about the fact that you can’t get capital to buy an instrument right now. Are people buying instruments or are they reaching out and doing exploratory questioning?

Dr. Rhyner (Beckman Coulter): We’ve seen orders increase. A lot of institutions ended up with extra capital that they’re trying to burn off, either through government assistance or reduced costs through the pandemic; that’s been our experience.

Jason, would you like to comment on that demand and the availability of capital?
Jason Anderson (Sysmex): We have seen a lot of demand for urinalysis equipment. Every month it seems to be increasing, so there’s capital available to labs. Whether they’re reallocating it from other needs, they’re coming up with that money and are able to secure the automation, especially in urinalysis and hematology, from the Sysmex perspective.

I will close with questions around data handling and the nuts and bolts of IT in urinalysis. Matt, are you satisfied with the level of software and middleware support and reporting of urinalysis data into EHRs for Beckman Coulter users?
Dr. Rhyner (Beckman Coulter): With the release of the DxU Iris, we added several new clinical informatics tools, one of which is ProService, which allows remote monitoring of the instruments for the first time on our platforms. We do offer the Remisol Advance platform for middleware.

As I said, our analyzers produce more information than doctors will perhaps use. I’ve spoken to several MDs, particularly about sediment analysis, where a lot of information is produced about different particle subtypes, and they might look at only two or three of them or only if there’s an abnormal chemistry correlate, for example. What we have today is more than adequate for the clinical information derived. There could always be more, depending on where the field goes, but all the parameters we report are easily available in the middleware.

Megan, how satisfied are you with the IT hook­-up to and from your urinalysis laboratory?
Dr. Nakashima (Cleveland Clinic): I think it’s good—I hear no complaints from my laboratories.

Touching on what Dr. Rhyner brought up about the amount of information we get for particles, and I discussed this with Mr. Anderson at AACC—I think there’s a shift now in what laboratory technologists are trained or competent to do in terms of picking out the billion different types of particles and knowing how clinically useful they are or if we need to quantify, semiquantitate, fully quantitate those things. In my experience with asking some of my colleagues in the clinical sector, the responses vary immensely. Some people say they could not possibly live without X and other people say they don’t know what X is.

Keri, do you want to comment on this last question?
Dr. Donaldson (Solvd Health): I experienced this a few years ago when I ran a lab that did urinalysis. We moved from a manual-based to an automated system, and we had to correlate historic reported results to new data that had more granularity, making sure the granularity not only mapped appropriately, which is part of the instrumentation verification, but also that the clinicians understood the granularity and could make decisions from it.

What Dr. Rhyner and Dr. Nakashima are saying is part and parcel to being a good laboratorian—making sure the information the lab is putting out is used in a way that makes a clinical impact. That’s a challenge as you change practice, but there is opportunity—for different types of sediment analysis and flow cytometric analysis. I often use a crawl before you walk, walk before you run analogy. With urinalysis particulate analysis and being able to distinguish things we couldn’t before, we’re still in that crawling phase because we have to put it in front of folks and make sure they understand it before they can walk and make a decision or eventually run and improve patient care.

Matt and Jason, would you like to make a closing comment?
Dr. Rhyner (Beckman Coulter): We’re excited by the response to the DxU Iris launch at AACC; it’s been overwhelmingly positive. The early adopters are happy, and it makes me proud that the team worked on the project throughout the pandemic and hit the product launch at AACC.

We are investing in the area and will bring new products to the market that are clinically and workflow differentiated. The next few years in urinalysis will be an exciting time.

Jason Anderson (Sysmex): We’re proud to offer a robust, accurate, and efficient urinalysis solution that can be configured and scaled to meet the needs of different sized labs. For labs that want to fully automate and standardize their urinalysis testing process at the highest levels, the UN-Series can facilitate this through a combination of technologies and capabilities.

As Dr. Nakashima said, the full power of fluorescent flow cytometry has not been tapped. There’s a lot to look forward to in the discipline of urinalysis. There is a continuing need to take a closer look at best practices and the expansion of the clinical utility of urine particles and parameter detection and measurement. We look forward to continuing our work with customers to enhance our understanding as well as participate in urinalysis best practices evolution.

Keri, a final comment from you.
Dr. Donaldson (Solvd Health): Increased standardization is important, and having scalability to different laboratories and harmonization are some of the strengths these companies have been working on. I would advocate, Matt and Jason, that as you’re looking at additional pieces of information, always keep it patient-centric because at the end of the day, the information that’s being provided is used to steer patient care. When a urine sample is positive, defining what is there and what the appropriate clinical decision could be—this is the next five to 10 years of this analyte.

And Megan, what are your final thoughts?
Dr. Nakashima (Cleveland Clinic): It is an exciting time for urine. There has not been movement in the field for a while and we’re getting more interest. People are not only seeing the advantages we can have clinically and diagnostically but also workflow-wise. The new partnerships that have been made especially in the past couple of years are really interesting.