Summary

Laboratory leaders from various health systems discussed strategies to navigate competition and ensure growth. Key themes included the importance of strategic planning, partnerships, and leveraging technology like AI. While some systems are expanding their outreach programs, others are focusing on internal growth and improving clinical quality.

March 2026—How to stave off the competition for laboratory services—that’s what Compass Group members talked about when they met online on Feb. 2 with CAP TODAY publisher Bob McGonnagle. For what they’re doing, thinking, and advising, read on. The Compass Group is an organization of not-for-profit IDN system laboratory leaders who collaborate to identify and share best practices and strategies.

Clark Day, tell us what’s happening at IU Health.

Clark Day, VP of system laboratory services, Indiana University Health: We have a conversion underway from Cerner to Epic; it will be done by mid-2027. I have a systemwide, 16-hospital conversion of the core laboratory platform to Roche for clinical chemistry and to Sysmex for hematology. We’re opening a hospital in Fort Wayne in spring 2027 and a consolidated downtown Indianapolis hospital in December 2027.

The health system is doing well. Our CEO describes it as facing headwinds but also making progress. Nursing recruiting is going well and our clinical quality remains strong in spite of the headwinds. ED patient satisfaction, which is a focus, is improving.

We’re also focused on longer-term strategic planning, which I’m taking to our laboratory as well. We’re making a concerted effort to put a five-year plan in place. We’re calling it Lab 2030—what our lab needs to do to set our operation up for success over the next 10-, 15-, 20-year run. We’re trying to think bigger picture and section by section. We have what I call big rocks in the river that can’t move—the Epic and Roche conversions—and all things have to flow in and around that. How do we piece in our path toward digital pathology or staging for next-generation sequencing testing? We need to map that over the next one, three, and five years.

Mike Eller, do you have a comment on what Clark said and what is happening at Northwell?

Mike Eller, assistant vice president of business development, Northwell Health Laboratories, New York: We’re going live with Epic systemwide. The laboratory is staying on Cerner, so we’re integrating with Epic. Our first wave went live in November and was pretty successful, and now we’re looking at lessons learned and trying not to make the same mistakes for our next wave in April. When we’ve completed all four waves we’ll work on integration with our new partners, Nuvance Health.

We’ve been taking on strategic planning exercises ourselves because everything is moving so quickly and we’re experiencing the same headwinds Clark described. We have to take a look at what we want to be when we grow up. Ten years ago the answer was different—sell the outreach, bring money into the health system, help it expand, and be a financial contributor. Though those pressures will always be there, we’re more focused on supporting our clinical programs, growing our cancer programs.

If we look five, 10 years down the road, we have to explore opportunities for partnerships because I don’t think we can build it alone. It’s too big, and our competition in the outreach world is too big. If we’re going to compete, we will have to partner and become innovative and creative on different models so we can keep supporting our clinical programs and driving revenue into the health system.

You’re talking more partnerships with other systems, part of consolidation, and your outreach will become increasingly in-reach if you’re focused on pathology and laboratory medicine. Is that a fair characterization?

Mike Eller (Northwell): Yes, pretty much. We’re fortunate that our outreach business expands as our health system expands. We purchase other practices, but about 40 percent of our outreach are nonaffiliated physicians, so we’re still a strong competitor in our market.

Consolidation seems to be the order of the day. I don’t see much that argues it won’t or cannot happen or can be avoided. Clark Day, what are your thoughts about that? You’re a sprawling mega system as it is.

Clark Day (IU Health): We are, and that sprawl continues. Our CEO has taken the idea of selling the lab to an outside entity off the table. We continually get reassurance that we are an integral part of the health system and a strategic front door. “A great health system deserves a great laboratory” is a phrase our CEO has used.

We are investing in and growing our outreach business. When I crafted that strategy eight years ago, our revenue was $3 million to $4 million. We reached our 25 by 25 aspirational goal, which was to be at $25 million in revenue by 2025. We’re at about $27 million, and that’s pure outreach—non-IU Health hospitals and physician laboratories. That helps us keep costs per test low. I think we can double that business in the near term, but we’re trying to manage the growth as well.

Because of our footprint, breadth, and courier capabilities, we can rapidly deliver tests locally. We can perform highly sophisticated reference lab testing for our clients in state. Our strategy is to make Indiana one of the healthiest states, not just where our footprint is, and our outreach lets us do that.

Guillermo Martinez-Torres, what is your reaction to this? Your system has grown, but you also face competitors coming into the market that are also consolidating provision of care.

Guillermo Martinez-Torres, MD, president and chief physician executive, NorDx, Scarborough, Me.: Yes, that is correct. That’s the new normal. We’ve been in a highly competitive environment since I’ve been here, and we have to react accordingly. I’m working with Dartmouth and University of Vermont to form a Northeast collaborative to find ways to wall off the competition. We have the same threat in Vermont as we have in New Hampshire and Maine. It’s the same set of players. The more we work together and collaborate, the tighter the wall we can build.

I remind the team that we have to demonstrate our value to the health system every day, and luckily we’re able to do so. We have an aggressive growth strategy to demonstrate value and continue growing that value.

Gaurav Sharma, Henry Ford has been involved in significant expansion. Getting bigger, beyond just increasing the number of lab tests you’re performing, seems to be key to all this. What are your thoughts?

Gaurav Sharma, MD, system vice chair of clinical pathology, division head of regional laboratories, and medical director of the outreach laboratory, Henry Ford Health: I agree. The key phrase is “It’s the economy.” We can’t lose sight of the broader economic forces around us or where those trends are headed. There are three things to keep in mind beyond the lab.

One is we are increasingly living in uncertain global economic conditions, which makes it strategically important to work with fewer, more reliable diagnostic instrument partners.

The second is demographics. In Southeast Michigan, demographics are changing. Population out-migration in Michigan has slowed. The population is aging. We have employees who live across the border, so changes in border logistics and other external factors may affect our operations.

The last is AI. AI will be both transformative and disruptive. It will change existing roles while creating new ones. When I think of a lab in 2030, we have to plan for an economy and a demographic that will be different from what we have now. We may have leaner teams, but with AI those teams will be able to do much more. The question is whether we are preparing now to accommodate that shift.

Michael Shepherd, what is happening at UAMS?

Michael Shepherd, MBA, service line administrator, University of Arkansas for Medical Sciences: At UAMS in Little Rock we’re seeing big growth intrinsically. There’s a lot of surgery; there’s a big push to make sure we’re getting patients in in a timely manner. That has pushed up our volumes on histology, IHC, some AP-driven items. We’re still trying to grow our outreach volume. One challenge is space: Finding more places to put people, equipment, and tests in our older building is challenging. We’re embarking on a journey to find space that will work for what we need not just right now as we think about outreach, but in the next five to 10 years to position ourselves from a financial and patient care perspective. Arkansas is one of the lower-rated states from a health perspective, so we’re beginning to grow our outreach and see where we can expand and bring in other volumes and tests.

Greg Sossaman, space can be a major expense, but most systems that have presented sound planning and convincing futures have, on the whole, seen space accommodations made for them. Is that true in your experience?

Greg Sossaman, MD, senior medical director, pathology and laboratory medicine, Intermountain Health, Murray, Utah: In general, I would agree that where you can show increasing volume and work, particularly with outreach, you’re able to keep up more easily with space needs.

Given your experience as a recent past president of the American Society for Clinical Pathology and your roles involved in planning and national oversight for the development of labs, does this ring true to you in those settings? In other words, we have to get bigger and better and solve labor and space shortages to survive.

Dr. Sossaman (Intermountain): Yes. We have to be aware of the economic realities and health system environments we’re in. I was in a medical leadership meeting recently and an executive team member was talking about where we are with Medicare Advantage plans now. Many of us have significant Medicare populations in our areas, and Medicare Advantage is going to be very challenged in the next couple of years. There may be changes for us. We still play a volume game with fee for service, but we also are in the risk-based area. We have to have an eye on both and be attuned to and able to react to the health system economics as those change. It’s still very much a volume game for labs in whichever way we’re talking about compensation coming in.

The government proposal to fund Medicare Advantage plans managed to tank a few stocks of providers, particularly at UnitedHealthcare. The volume game may not succeed if there’s stingy funding for programs like Medicare Advantage, which is a difficult insurer, usually, when you’re trying to run a pathology practice. Stan Schofield, can you comment on that?

Stan Schofield, VP and managing principal of the Compass Group (formerly of NorDx/MaineHealth): It’s true. The government is cutting back everywhere. With the current administration, the idea of health care charity and rich benefits is in the crosshairs. We’re going to have Medicaid and Medicare Advantage problems. This is the first of two or three more years of the government trying to rebase the cost of health care and reduce its balance sheet. It was not well received by the stock market. UnitedHealthcare was under investigation the past three years for upcoding, code jamming, and inappropriate utilization codes overcharging the government. This is one avenue where the government will say, “If you’re going to keep playing these games and we can’t catch you, we’ll cut the money off the top.” It’s similar to what insurance companies have done to us in the lab. You get 10 viruses in a respiratory panel, and they say you can run all 10 but they’re going to pay you for only three. Same thing with flow cytometry codes and markers—they take it off the top. It’s going to be a strong effort by the federal government not to raise the deficit or to improve the position on the balance sheet on the number of dollars spent per person in this country. It wasn’t just UnitedHealthcare that took the hit. Humana and Cigna took a hit. Everyone that has a significant Medicare Advantage program is taking a hit.

Chris Scanlan, how are you seeing this financing drama play out in your system?

Christopher Scanlan, director of laboratory administration, BayCare Health System, Clearwater, Fla.: The population growth in our region has fueled much of our growth. We’re adding another hospital and other ambulatory sites in the next couple of years. The great part about the growth plan is that our organization values the laboratory. Lab is at the table when these conversations and developments are taking place to make sure there’s a laboratory service center on the campuses for patients in the community. Establishing a laboratory presence on these campuses ensures continuity of diagnostic services as the community grows and care delivery evolves. It affirms the laboratory’s role as a strategic asset—enabling access, supporting clinical decision-making, and advancing our system’s long-term growth and mission.

Sterling Bennett, what are your thoughts about the immediate and more distant future?

Sterling Bennett, MD, MS, senior medical director, pathology and laboratory medicine, Intermountain Healthcare: People have expressed well the challenges we have now and looking forward, but there are substantial opportunities. We recognize better than we ever have as a laboratory community how important it is to be connected with the senior leaders of our organizations. The laboratory services that are best connected with their senior leaders will be the most prosperous into the foreseeable future.

Can you flourish if you’re a freestanding lab provider not connected to anyone except your lab work?

Dr. Bennett (Intermountain): A freestanding laboratory that is closely tied with a health care organization could theoretically prosper, but the connection needs to be strong and secure. Organization leaders need to understand the value that a laboratory service line brings to them. On the one hand, laboratories are responsible for only three or four percent of total health care costs, so it would be easy for health system leaders to think they have bigger fish to fry than worrying about a lab and may lean toward outsourcing it. But the impact laboratories have on total delivery and cost of care is significantly greater than the financial impact. If we don’t help our leaders understand that, we’re enabling them to make bad decisions.

Adam Loftesness, tell us about Sanford and what your thoughts are on these issues.

Adam Loftesness, MLS(ASCP), director, laboratory support services, Sanford Health, Sioux Falls, SD: We have incredible expansion going on right now. Joining with Marshfield Clinic Health System was the big one last year, but we’ve also accumulated several independent practices in the Black Hills and Rapid City areas, and in Watertown the Prairie Lakes Healthcare System is joining with the Sanford shingle.

We are trying to grow our lab outreach business while also internalizing many of the state’s health providers. We’re also building a $300 million hospital in Rapid City. Our outreach business is still strong, but we’re trying to keep pace with the rest of the health system while monitoring and working to understand all the other things we’ve been discussing about government spending. I feel like I’m drinking from a fire hose right now with all the requests I have for trying to expand and build and do as much as possible with as little as possible.

Sanford is throwing a fairly wide loop. Moira Larsen, it strikes me that everyone ought to get a good atlas of the United States to be a winner long term in the lab pathology business.

Moira Larsen, MD, MBA, physician executive director, MedStar Medical Group Pathology, MedStar Health, Columbia, Md.: Absolutely. I was struck by Sterling Bennett’s comments—you need to sell your services. You need not think of outreach as a global process but instead to identify specific service lines, whether it’s AP or specialty lab testing, where you offer something that makes a profit. By having a relationship with leadership, you can bring that to them and let it be the start of something bigger, because once they see that laboratory is not a cost center but can bring revenue, you begin to get a response. That’s why I’m building an external anatomic pathology laboratory.

I have found that by talking with people and explaining our services, our turnaround times, our expertise, and the ability to talk to a pathologist about a case and not spend hours on hold with a customer service line—that level of customer service will often tip the scale and help you grow in ways that allow you to continue to show and increase your value and thus stave off that search for the outside, quick answer that some systems appear to go for.

At the CAP, there’s emphasis on what pathologists themselves need to do from an attitudinal and even a skills perspective to flourish in the new environment. Dr. Sharma, can you comment on that?

Dr. Sharma (Henry Ford): I was part of the CAP advocacy training program and went to Washington. The Wayne County Medical Society recently organized a daylong conference, at which I was able to spend time with Senator Elissa Slotkin of Michigan. While we were getting ready for her speech in the green room, there was a conversation about why health care is important. The Affordable Care Act had a lot of changes, and many people who are impacted by those changes may not even know it. The senator’s concern was that many Michiganders’ premiums went up, or the out-of-pocket limit went up and coverage went down, and those bills will start coming now.

We are already thinking about reducing reimbursement but also looking at a possibility in which many people may forgo preventive service because it is partially or less covered or no longer covered.

I am hearing increasing anecdotal discussion of patients going to see physicians, getting lab orders, and then not getting drawn for the lab test. People get busy and it can be a hassle to get drawn, but I also think there’s growing concern about the copays for those tests. Dr. Sossaman, do you see that in your area in Utah?

Dr. Sossaman (Intermountain): Not as much, but I’ve heard a similar concern from others in different areas. It has to do with how patients get billed for hospital outpatient services—for example, a copay in addition to a hospital-based facility fee. That can influence patients’ decisions on whether they should get lab draws, particularly if they’re having to go to a Coumadin clinic or have a chronic disease that requires frequent testing. It impacts people’s willingness to go in.

Clark Day, a final comment from you?

Clark Day (IU Health): I agree with what others have said. Connectivity to executive leadership is key, and once you deliver on something successful, that builds credibility and more support and trust to invest in you. The laboratory’s story and that connectivity need to be about the patient-oriented value the laboratory’s services bring. Even patient experience. The lab at IU Health is 10 percent of our health system’s patient experience score weight. So you don’t have to put together a big financial presentation—at least we haven’t had to—to justify how much you’re worth. It’s about that patient benefit the laboratory provides.

Summary

A University of Washington study analyzed HCV testing costs across its system from 2017 to 2024, focusing on the public county hospital ED where one-third of diagnoses occur. The study compared the costs of implementing point-of-care HCV RNA testing versus the traditional two-step algorithm. While point-of-care testing offers faster results, it significantly increases laboratory costs, prompting the need for policy changes to support reimbursement for this approach.

Meredith Salisbury

March 2026—A University of Washington study analyzed hepatitis C virus testing across the UW system from 2017 to 2024 to inform the use of HCV RNA screening and to estimate laboratory costs associated with five testing approaches (Helm EW, et al. J Clin Microbiol. 2026;64[1]:​e0125925).

The current recommended HCV screening algorithm begins with antibody testing that is followed by reflex HCV RNA testing if the antibody result is positive, but confirmatory testing generally cannot be completed during a single emergency department visit.

A multicenter randomized clinical trial consisting of 147,498 ED patient visits found that while many patients had been newly diagnosed with HCV infection, clinician referral from the ED resulted in only 20 percent who were successfully linked to care and 16 percent of patients beginning treatment (Haukoos J, et al. JAMA. 2025;334[6]:497–507).

The Food and Drug Administration in 2024 granted marketing authorization to Cepheid for its Xpert HCV test and GeneXpert Xpress system, the first HCV RNA test for use at the point of care, including in EDs.

“Our clinicians are very excited about this new test from Cepheid,” says Alex L. Greninger, MD, PhD, MS, MPhil, coauthor of the UW article and head of the Division of Infectious Disease Diagnostics, Department of Laboratory Medicine and Pathology, and the Larry Corey endowed professor of laboratory medicine and pathology. The test, which provides results in about an hour, has “a lot going for it,” he says, “but it doesn’t necessarily scale super well.”

There are three UW hospitals: an academic medical center, a public county hospital, and a community hospital, each with its own ED. HCV antibody and viral load tests are performed in the off-site UW virology laboratory. HCV antibody testing volumes increased from 26,188 tests in 2017 to 45,010 tests in 2024.

The analyses performed in the study were largely focused on the county hospital ED, where viral load testing rose 6.6-fold between 2017 and 2024 and the positivity rate for detectable viral loads was high: 31 percent in 2024.

“The part that stuck out to me was that one-third of our diagnoses now come from the ED at our public county hospital,” Dr. Greninger says. The HCV screening program the UW had set up was outpatient oriented. “We didn’t have to have the result while the patient was in the office, but it doesn’t work in the ED population when you may never see the patient again.”

The median collection-to-RNA result turnaround time was 84 hours for reactive screening tests from January 2017 to October 2024. In November 2024 viral load testing was switched to the Hologic platform, enabling three runs per week and reducing the median TAT to 45 hours.

The authors examined various scenarios for using point-of-care HCV RNA testing instead of initial antibody testing, using 2024 data: 1) for all HCV testing, 2) for inpatient and ED testing only, 3) for ED testing only, 4) for public county hospital ED testing only, and 5) not using it and remaining with the traditional two-step algorithm for all HCV testing. To estimate costs, they used the 2025 Medicare reimbursement rates for HCV antibody testing ($14.27 per test) and viral load quantification ($42.84).

The findings were as follows:

• If all testing remained as a two-step algorithm, the total laboratory cost was $704,848.
• Implementing single-step point-of-care HCV RNA testing for all screening would add $1,172,744 to the laboratory cost.
• Limiting single-step POC HCV RNA testing to inpatient and ED settings would raise laboratory cost by $211,703.
• If single-step POC HCV RNA were limited to the EDs at the three hospitals, laboratory cost would increase by $135,450, and if limited to the public county hospital ED, by $94,051.
• Costs per HCV infection detected would be $4,210 for universal single-step RNA testing, $2,055 for inpatient and ED testing, $1,884 for all ED testing, and $1,791 for the county hospital ED.

A second round of laboratory cost projections using internal UW cost accounting data for HCV antibody and traditional RNA testing, combined this time with estimated reagent and staffing costs for POC RNA testing, revealed these figures, which more fully capture laboratory expenses:

• Total laboratory cost for HCV testing in 2024: $1,103,127.
• The added costs if all screening were shifted to POC HCV RNA testing: $2,871,634; if it were only used for inpatient and ED testing: $555,123; for all ED testing: $350,397; and for the county hospital ED only: $246,143.

For POC HCV RNA testing, the cost was modeled on the Cepheid test and estimated to be $90.69 per test inclusive of reagents and staffing.

What might UW do with the insight it uncovered in its analyses? “We would probably look at bringing this test on just for the public county hospital emergency room,” Dr. Greninger says. “The positivity is high enough to warrant it, and they already have the equipment. But it’s about $250,000 a year in new laboratory costs with no clear mechanism to pay for it.”

Absorbing the higher cost isn’t the only challenge. “We would have to change the algorithm to go straight to RNA,” he says, “and we need to show that it works—that paying this extra money leads to higher cure rates of hepatitis C.”

No HCV antigen tests are FDA approved, though they are used in other countries to confirm active HCV infection. Dr. Greninger and coauthors wanted to understand what the different cost profile of antigen testing would mean for clinical laboratories. They therefore modeled the same testing scenarios using up-front combination HCV antigen/antibody testing or reflex antibody-to-antigen testing. They write, “These approaches resulted in much lower laboratory costs, and if on-site chemistry line testing is available, could potentially provide turnaround times equivalent to or better than POC HCV RNA testing.”

Their data indicate that antigen testing would miss two percent of infections based on reflexed HCV viral loads. To avoid missed infections, they modeled an algorithm by which all positive antibody but negative antigen tests are reflexed to HCV RNA testing, making it possible to identify the few missed cases but adding to the TAT.

Among the study’s limitations is its focus only on laboratory costs; it did not include clinical care costs associated with the testing.

One of the aims of the study, Dr. Greninger says, is to open the conversation. “Our overall intention is to move the policy environment—we need to get a new reimbursement to support direct one-step RNA testing.”

He says he hopes to see other laboratories’ analyses of their own testing data. “It’s helpful to have the numbers out there,” he says. Until now, “most of this has been reserved for economists, just looking at it from an overall health system standpoint.”

Dr. Greninger calls the story of HCV “one of the greatest in clinical virology.”

“We called it non-A, non-B for years,” he says. “A lot of basic science work went into figuring out how to culture it. After that, we were able to get antivirals very quickly.” The direct-acting antiviral treatment results in virologic cure for most patients who complete treatment. “You can basically cure a cancer-causing virus. That’s an incredible story.”

But once you have a curative drug, Dr. Greninger says, “it’s all about the diagnostics. You have to find the cases and get people to take the drug. You can’t cure it until you find it.”

Each health system will have to assess its own test volumes and costs to determine whether point-of-care testing is feasible. “There are trade­offs and you have to make choices,” he says. “We want to find hepatitis C cases, and we want to cure people. We don’t want to take our eye off the prize.”

Meredith Salisbury is a writer in the New York City area.

Summary

Rapid advances in genomic sequencing are reshaping microbial classification and nomenclature, creating challenges for clinical microbiology laboratories. While some updates improve patient care, others disrupt established workflows. Laboratories must carefully evaluate the clinical relevance of proposed name changes to ensure accurate and consistent reporting.

Isabella W. Martin, MD

March 2026—Rapid advances in genomic sequencing are reshaping how microorganisms are classified and named. While these changes improve scientific accuracy and deepen understanding of infectious diseases, they also create practical challenges for clinical microbiology laboratories and the patient-facing health care providers who rely on clear and consistent laboratory reports to diagnose and treat patients. A group of members of the CAP Microbiology Committee recently published an opinion paper to spread awareness among nonlaboratory health care providers about the complexities of this situation and to urge collaboration around adoption of new nomenclature in the clinical laboratory (Dien Bard J, et al. Clin Infect Dis. Published online Sept. 23, 2025. doi:10.1093/cid/ciaf474).

Taxonomy is the science of grouping organisms based on shared traits and genetic relationships, while nomenclature refers to the official names assigned to those organisms. Each major group of microbes follows its own international naming rules. As genetic technologies such as whole genome sequencing become more common, basic scientists are discovering that many organisms are more—or less—closely related than previously thought. This has led to frequent updates in microbial names.

For clinical laboratories, these changes have direct downstream effects. Updated nomenclature may appear in organism identification systems before clinicians are familiar with the new names, creating potential for confusion in result interpretation, antimicrobial decision-making, and recognition of recurrent infections. Inconsistent adoption of nomenclature changes across diagnostic platforms and electronic health records further compounds this challenge.

In some cases, nomenclature updates clearly benefit patient care. Recognition of newly defined species has improved the understanding of antimicrobial resistance patterns and supported the development of species-specific susceptibility testing criteria. For example, description of Staphylococcus pseudintermedius as an important and often multidrug-resistant veterinary pathogen enabled not only its recognition as a cause of opportunistic infections in immunocompromised patients but also the development of species-specific antimicrobial susceptibility testing breakpoints to optimize treatment. In other cases, however, name changes driven primarily by phylogenetic data may offer limited clinical value while disrupting established diagnostic and treatment workflows. An example of this can be found in the proposed change of the genus name Candida into multiple different teleomorph names such as Pichia, Debaryomyces, Torulopsis, and Kluyveromyces.

Complicating the nomenclature landscape is that the “rules” for nomenclature vary by organism group. Bacterial nomenclature is governed by the International Code of Nomenclature of Prokaryotes, which regulates naming but does not designate an “official” taxonomy. As a result, both older and newer names may remain valid, requiring laboratories to make deliberate choices about which names to report. Fungal nomenclature, governed by the International Association for Plant Taxonomy, has undergone particularly extensive changes following the adoption of DNA-based classification and the “One Fungus, One Name” principle, sometimes outpacing clinical guidance and patient-facing provider familiarity. Parasite nomenclature, governed by the International Commission on Zoological Nomenclature, has been less disruptive to routine laboratory practice, while viral taxonomy, overseen by the International Committee on Taxonomy of Viruses, is structured in a way that largely preserves clinically familiar virus and disease names despite taxonomic reclassification.

New expert groups, including international committees focused on prokaryotic and fungal nomenclature, are working to provide clearer guidance for clinically relevant name changes. For example, an ad hoc committee focused on the nomenclature of clinical fungi was formed in 2023 under the auspices of the International Society for Human and Animal Mycology, European Confederation of Medical Mycology, and Fungal Diagnostics Laboratory Consortium, with the goal of creating a consensus guideline for fungal name changes for clinical use. These efforts aim to balance scientific accuracy with the need for stability, clarity, and effective communication in laboratory reporting.

Members of the CAP’s Microbiology Committee and Checklists Committee have recognized the challenges associated with changes in nomenclature in the clinical laboratory as well as the varied potential impacts to clinical care. The CAP checklist requirement pertaining to taxonomy and nomenclature (MIC.11375), first implemented in 2014, has evolved over the past decade in response to these challenges. In its current form it emphasizes consistency and thoughtfulness in nomenclature adoption, rather than mandatory adoption of every taxonomic update. Laboratories are encouraged to evaluate whether a proposed name change is scientifically valid, clinically meaningful, and operationally feasible before implementation. Additionally, the CAP’s microbial proficiency testing challenges and their associated educational material foster accurate and adequate organism identification, reinforcing best practices in patient care.

As microbial taxonomy continues to evolve, clinical laboratories play a critical role in translating scientific advances into actionable clinical information. Careful, coordinated adoption of nomenclature changes—aligned with laboratory capabilities and clinical impact—will remain essential to maintaining high-quality diagnostic services and supporting safe, effective patient care.

Dr. Martin was vice chair of the CAP Microbiology Committee through 2025. She is medical director of the clinical microbiology laboratory at Dartmouth-Hitchcock Medical Center, Lebanon, NH, and associate professor of pathology and laboratory medicine, Dartmouth Geisel School of Medicine, Hanover, NH.

Summary

A roundtable discussion focused on improving workflow efficiency in urinalysis, highlighting the potential of AI to enhance reflex testing by integrating test results with EHR data. While progress in implementing AI-driven reflex testing has been gradual, there is optimism about its ability to elevate urinalysis from a screening tool to a more diagnostic discipline. The discussion also touched on the underutilization of existing urinalysis analytes and the need for improved sample preservation methods.

March 2026—Workflow efficiency in urinalysis, sample preservation, the impact of new pharmaceuticals, and automation were front and center in a Jan. 26 roundtable on urinalysis, led online by CAP TODAY publisher Bob McGonnagle. The conversation begins here, and CAP TODAY’s guide to urinalysis instrumentation starts on page here.

Jason Anderson, in last year’s roundtable we talked about reflex testing and the potential usefulness of artificial intelligence in streamlining the process. What progress has been made in implementing reflex testing in urinalysis as you look across the board?

Jason M. Anderson, MPH, MT(ASCP), senior product manager, urinalysis solutions, IVD product marketing, Sysmex America: From my perspective, progress has been gradual, and many laboratories are still relying on the same traditional reflex rules. Reflex rules inherently aim to produce improved outcomes more efficiently. The opportunity lies in leveraging AI to integrate urinalysis test results with EHR data such as age, sex, other laboratory findings, prior antibiotic use, previous culture results, and other relevant clinical information. We’re just beginning to tap into how this combined data can drive more precise reflex testing pathways. It’s a promising frontier. By applying AI with advanced urinalysis methods, we can elevate what has traditionally been a screening-focused discipline into one with stronger diagnostic power, and that’s an exciting evolution for the field.

Matt Rhyner, many people would be thinking about using AI applications to define whether to go to a microscopic urinalysis, automated or otherwise. Does Beckman Coulter have initiatives in this area?

Matthew N. Rhyner, PhD, MBA, vice president and managing director, hematology and urinalysis business, Beckman Coulter: Our microscopic analysis and technology use AI to analyze and classify particles. The trend I see is more people are doing almost 100 percent reflex on these. When people obtain a workcell, there’s a high desire to do the chemistry and microscopy portions of the analysis. I see AI using those two pieces of information and providing something more definitive. A practicing physician colleague told me recently that he can no longer order a separate urinalysis chemistry and microscopy because it is one order now at his health care system.

The holy grail would be to skip microbiology urinalysis, though susceptibility testing will still be required for antimicrobial stewardship. That would be impactful, and we’re a long way from it, but I think that’s where the field will ultimately go.

You’re talking about the chemistry of urine and then using an automated visual interrogation to identify the particles?

Dr. Rhyner (Beckman Coulter): Yes. When the particles and chemistry are together, you can make an informed clinical decision to support the diagnosis, or if it’s a UTI you can recommend a specific antibiotic.

Mariann Amador, what do you think about the idea of reflex testing and interrogating the particles that are discovered and pairing them with the urine chemistries?

Mariann Amador, marketing manager, Arkray USA: When I first started working in the lab, the criteria that were positive in the urine chemistry would get reflexed to a urine sediment. Then I started working outside the U.S. market, first in Latin America, and my question to lab directors there was, “What’s your reflex rate?” The question surprised them because for them a urinalysis consists of a urine chemistry and a urine sediment, regardless of whether the chemistry is negative. I think it is good practice for labs to do almost 100 percent urine chemistry and sediment.

I agree with Matt about the urine culture because there are devices now that can identify the bacteria, for example, and do a quick susceptibility so you don’t have to give a broad-spectrum antibiotic from just the urinalysis result. It would be great in the future if we could, based on the bacteria or WBC count, gauge whether it’s a pure culture or a contaminant and then incorporate susceptibility testing into the urinalysis process.

Meagan Seeger, what are your thoughts on what you’ve heard so far?

Meagan Seeger, MLS(ASCP)^CM, hematology and coagulation supervisor, Wisconsin Diagnostic Laboratories, and member, CAP Hematology/Clinical Microscopy Committee: We recently transitioned to a similar process and changed many of our reflex orders. Clinicians used to be able to order the macroscopic, microscopic, everything separately or together, and now we have initiatives with our CAUTI [catheter-associated urinary tract infection] group, especially inpatients, to make sure they get the correct order for the proper reflex testing to determine if an associated UTI was from the patient’s hospital stay. We’ve reduced our urinalysis orders by using reflex testing with what we offer to people because we’re doing extra testing that doesn’t seem helpful.

We’ve been utilizing AI and reflexing to help with staffing metrics. For example, “I don’t have to look at that urine; it’s going to go through and will autoverify.” Or, “I have to spin this down and look at the sediment to determine what I’m looking at.” It’s been useful for us to do the reflexing so we’re not spinning down every urine we look at to look at the sediment.

When you say you’re using AI, is this an algorithm your laboratory developed based on certain values?

Meagan Seeger (WDL): Yes. We are using the Arkray Iris system, so we use the pictures from what it determines to also decide if we need to look at it under the scope.

Rob Fratino, tell us your thoughts on what you’ve heard so far and where Siemens Healthineers is with AI and the efficiency of testing urinalysis.

Rob Fratino, global product manager, centralized urinalysis, Siemens Healthineers: I agree with what was said about reflex rules. Today reflex testing still depends on site-specific and population-based-specific implementation of rules. On a global level, many of our customers had been performing 100 percent microscopy for a long time, but because of the changing headwinds they’re facing, whether it be reimbursement or resources within the lab to perform site microscopy, there has been a stronger desire to cut down on review rates. We’ve been working hand in hand with customers on validation studies to get them to a point where they’re comfortable with what they’re seeing from the chemistry side and what is ultimately going to the microscopic side.

There’s always interest in AI. My focus today would be on the under­utilization of urinalysis in the marketplace. A number of existing analytes have significant value, whether it be kidney disease or cardiovascular, and are not applied at the same level of urinalysis tests being performed today. A disproportionate amount of information is being left on the table.

Urinalysis is such a high-volume test, but it doesn’t always get the respect for the clinical value it can yield. Meagan Seeger, are we maximizing the value of our urinalysis efforts?

Meagan Seeger (WDL): We have talked about whether we are maximizing preservation and the volume of tests we can do. We’ve brainstormed different systems we could use so more outreach clients have the ability to use urinalysis, because 24 hours in the refrigerator isn’t always the best, especially with clients all over the state. It feels like it is underutilized given the amount of problem specimens we get and the number of people who want to order it but are hesitant because they might not be able to get it to us in time.

Jason Anderson, have we made progress with the underutilization of preservatives in urine samples from your perspective and that of your customers?

Jason Anderson (Sysmex): There’s no single preservative capable of consistently maintaining clinically significant urine particles under all conditions. Urinary casts, for example, can carry substantial diagnostic value but are inherently fragile. We still have a long way to go in optimizing urine sample preservation to maintain particle integrity. Continued research is essential to developing improved preservatives that can provide greater confidence that we’re getting accurate results in all cases. Advances in AI‑driven analyzer algorithms would be welcome, particularly those that can more reliably recognize and flag suboptimal or degraded specimens.

Mariann Amador, what is your recent experience with not only preservatives but also collection tubes? Several readers after last year’s roundtable was published said the tube itself may be as important as the preservative.

Mariann Amador (Arkray): Sometimes you do not get much volume of urine in the lab, which is why the urine tube is important. It’s quite delicate to be able to preserve the urine so that you are able to analyze it as if it were just voided.

Matt Rhyner, is there an effort underway at Danaher to solve these problems of urinalysis through a process improvement and the business systems you specialize in?

Dr. Rhyner (Beckman Coulter): We’re focused on improving the field of urinalysis but not only through core analysis. You talked about sample storage and handling, automation connections, and things that optimize the overall workflow because the analysis is not the whole story. With our broad portfolio and expertise, we can start to optimize and connect to total lab automation as well as other pre- and postanalytical tools that will help. We want to innovate on the core analysis, but also middleware and other tools that can combine with other testing modalities to give a clinical diagnosis. We view urinalysis as an important node in the overall data flow.

There are different ways of imagining urinalysis within total lab automation. Would it be on one central line with chemistry and hematology or separate? What are your thoughts on that and what is your experience with your customers?

Dr. Rhyner (Beckman Coulter): In an ideal world you would offer both­—a standalone high-volume urinalysis workcell and the ability to connect to an automation track, in which blood and urine are on the same TLA track. Some customers have figured it out on their own with bespoke connections.

Meagan Seeger, where should urinalysis be in total lab automation?

Meagan Seeger (WDL): In the grand scheme of things, it should all be attached, everything on one line, including chemistry and hematology. That would improve lab efficiency because we’re still doing manual pour-offs and walking them to the bench. Being able to place them directly on our line would help efficiencies between every department in the lab.

Right now you have a dedicated urinalysis automation that’s off the main line?

Meagan Seeger (WDL): Yes, but putting it on a main line would streamline workflows.

Many high-volume labs have a dedicated coagulation track, and then it can be worked over to all the manual needs there are for esoteric testing and coagulation. Can you see urinalysis doing something similar?

Meagan Seeger (WDL): Yes, I could see urinalysis going in a similar direction. Having an entire cell dedicated to urinalysis would also likely streamline workflows.

Rob Fratino, there are many options, differences among customers, countries, reimbursement schemes. What are you taking into consideration as you look at centralized urinalysis at Siemens?

Rob Fratino (Siemens Healthineers): It’s the variability—different geographies, different sites. The conversation on TLA unearths that different sites take different approaches where urinalysis is more tied to a microbiology department versus the core lab and other facilities. Having high-volume workcells as opposed to a total lab automation track might make more sense for a more decentralized lab rather than for a community hospital, which may have everything consolidated in a single location.

There’s variability too in automation and test menus. We’re still seeing increasing calls for albumin and creatinine testing outside the U.S., particularly in Japan and Western Europe. We continue to monitor those trends, including what the pharma industry is doing and how the emergence of new drugs or the application of existing drugs are having a trickle-down effect on urinalysis testing in terms of interferences or overall demand. I’ve seen the pharma industry in the U.S. advocate for urine albumin-to-creatinine ratio screening on daytime television, which I never thought I’d see. Changing dynamics are at play, particularly with the pharma industry and its interaction with urinalysis.

Is that because of side effects from drugs that are affecting the urinalysis?

Rob Fratino (Siemens Healthineers): Yes. We’ve been getting more and more inquiries about the potential for GLP-1 interference in urinalysis samples. On the flip side, GLP-1 could also be used to prevent kidney disease, so you’re potentially seeing a higher degree of screening to determine if a patient is a candidate for a GLP or other pharmaceuticals on the market.

I assume GLPs are a significant new breaking front in urinalysis and other chemistries?

Rob Fratino (Siemens Healthineers): Yes, and it’s a bit uncharted. We’re in a reactive standpoint now as more data are collected and more of the population is brought online with these new pharmaceuticals. It is a critical point and one that we have to continue to monitor to ensure our customers have the full information they need to perform urinalysis at the expected standard.

Jason Anderson, what are you seeing in terms of increasing orders, changing orders, or changing protocols?

Jason Anderson (Sysmex): I don’t see any seismic shifts in urinalysis ordering patterns or protocols at this time. However, some forward‑thinking laboratories have expressed interest in investigating and potentially refining reflex rules for specific patient populations to optimize test utilization and improve outcomes in those populations. With new therapies entering the market, the ability to accurately monitor treatment protocols, for example, in IgA nephropathy, will become increasingly important. Accurately detecting small red cells or dysmorphic red cells in a standardized way may provide improved guidance in assessing glomerular health and limiting further degradation.

As labs begin to consider evaluating particles like atypical cells and analytes not currently routinely measured through automated methods—such as those relevant for bladder cancer treatment—there is growing potential for new analytes to emerge in the future, which could positively impact urinalysis ordering patterns.

Matt Rhyner, the world of oncology and clinical laboratory testing that’s not directly related to oncology are getting closer together because of the interrelated analytes and procedures that clinicians and patients need. Can you comment on that?

Dr. Rhyner (Beckman Coulter): There’s definitely tie-in. I think of core lab diagnostics as the first line of defense before we want to do a biopsy—molecular, chemical, or protein indicators are much better for the patient than a biopsy. But if biopsy is to occur, there are many AI-powered tools. AI-powered image analysis is helping to advance oncology analysis. Networks are starting to make those decisions, looking for a total solution, and we can offer that. With the integrated EHR, there’s better dialogue and sharing of results. Molecular genetic analysis, which is a direct marker for cancer biology, could be added to the main analysis as a reflex test, but it’s still not cheap or rapid enough for a screening tool.

Rob Fratino, same question to you.

Rob Fratino (Siemens Healthineers): I’ve seen early studies, particularly for bladder cancer, where urinalysis is not the main driver of the diagnostic pathway but can potentially serve a role in refining an AI algorithm that provides data from urinalysis alongside emerging biomarkers in the immunoassay sphere. We have to take a step back and look at it from a practical implementation standpoint—if studies are promising, I see challenges on the workflow implementation, combining analytes and parameters from multiple disciplines.

Jason Anderson, Sysmex is a global company that is beginning to introduce instrumentation and other solutions into the United States. There must be times when you ponder a grand combination that would be useful for patients in the clinical setting.

Jason Anderson (Sysmex): I agree there’s still significant research needed in bladder cancer and developing robust algorithms will take time. However, the strength of urinalysis lies in its ability to screen for disease even before symptoms emerge. By screening for specific particle types and reflexing to additional diagnostic modalities, such as immunoassays and molecular testing, urinalysis can play a more pivotal role in early disease detection.

Sysmex is well positioned to implement advanced flow cytometry to deliver accurate, precise urine particle identification as a screening tool. This capability can, for example, potentially help reduce unnecessary cystoscopies or better target the patients who would most benefit from them. Ultimately, the goal is to enhance workflow efficiency while improving diagnostic and screening capabilities to detect and monitor these conditions more effectively. That’s where I see Sysmex having a meaningful impact in the future.

Meagan Seeger, what are the most important practical considerations in running urinalysis now in the clinical environment? Do you have enough staff?

Meagan Seeger (WDL): Staffing is an issue. Even at a large facility such as ours, we have multiple shifts that share the urinalysis bench; it’s not always a singly staffed bench. If we bring extra tests onto the bench—an extra analyte or reflex—and don’t have a staff member to sit and watch it all night, that could be a concern for keeping samples preserved. The urinalysis bench gets left behind in terms of staffing. It’s perceived as an easy bench—we can get through it quickly; we don’t need to staff it. As things change, that may not be the case.

Within your network, because you serve many sites and a lot comes to the main laboratory, do you find you’re doing urinalysis at fewer sites but with greater volumes, greater concentration, and sophisticated technology?

Meagan Seeger (WDL): We aren’t necessarily doing it at fewer sites. Sites that don’t have enough staff to run a large analyzer will run point-of-care chemistries and send the sample to a larger lab for the microscopic.

Would it be more efficient to avoid that?

Meagan Seeger (WDL): It would be better because of preservation to complete testing at the same time. When they run a chemistry at a smaller site, it is not always known what time it will arrive at the lab that’s performing the microscopic. Then your chemistries and microscopic results may not match.

Mariann Amador, what are your thoughts about this?

Mariann Amador (Arkray): I agree with Meagan on what is better because then your results are not disconnected. Arkray is working on offering a remote classification service in Asia-Pacific. In other areas of the world with smaller labs, there is a remote microscopy service. If some of the satellite clinics perform the urine chemistry and do a subscription for remote microscopy, then there’s no need to transport the urine to the main lab.

Rob Fratino, tell us about remote service.

Rob Fratino (Siemens Healthineers): This conversation fully aligns with what I’m seeing outside the U.S. Over the years, Siemens Healthineers and other vendors have brought right-sized microscopy solutions to smaller laboratory settings and gave them automated technology. The challenge that still exists for many of these labs is having the resources and microscopy expertise within those settings. We’re getting more and more calls for remote capabilities. You wonder if we’re trending toward what we see in large geographically dispersed pathology networks. Hematology has gotten into that sphere as well, where the centralized expertise is in a hub and the spoke satellites perform the testing. There are general, practical limitations to this, like internet bandwidth or sharing of large file sizes. We’re having to be cognizant of these restraints, especially in developing nations.

Meagan Seeger, what is at the top of your wish list for vendors?

Meagan Seeger (WDL): The top of our wish list is better identification of Trichomonas in the urine. Especially with still images, we can’t tell if we’re looking at a white cell or if it has motion. We run a large STD clinic, so we end up putting a lot on slides. Classification is harder when you’re using still images.

Matt Rhyner, what could customers better understand about urinalysis as they look to solve their laboratories’ problems?

Dr. Rhyner (Beckman Coulter): We are constantly trying to improve our offerings, and we partner with our customers. We greatly value our customers’ input and how we can make our solutions better fit their workflow.

Mariann Amador, what would you like customers to know about your offering?

Mariann Amador (Arkray): The customer experience is first and foremost because Arkray is fairly new in the market. Now that we are slowly building our urinalysis portfolio, we value when customers have a good experience with us and give feedback.

Rob Fratino, what do you wish customers would know?

Rob Fratino (Siemens Healthineers): We want them to continue to push the boundaries of urinalysis. It’s been a staple of the core lab for decades, but there’s still a ways to go. I love when customers ask me, “Why can’t we measure dysmorphic RBCs?” It’s a challenge based on sample collection and analytical capabilities, but we’ll wrap our heads around it. Keep trying to explore different avenues for urinalysis and giving us feedback. It’s an opportunity for us to reach that untapped potential.

Jason Anderson, what would you add?

Jason Anderson (Sysmex): My advice to our laboratory customers is be vocal in helping vendors understand what you’re trying to achieve. What outcomes are most important to you, and which ones aren’t meeting your expectations today? When we know that, we can partner with you to reach those goals over time.

March 2026—Exa Capital has acquired StaffReady, an SaaS platform for managing clinical workforces in health care. The platform supports hospital ancillary departments such as laboratories, pharmacies, physical therapy, rehab, and support services as well as standalone bioscience, pharmaceutical, and commercial laboratory test design corporations. It enables health care organizations to streamline compliance, staff scheduling, inspection preparation, and workforce readiness.

StaffReady will continue to operate independently and its existing leadership team will remain in place.

StaffReady, 877-229-5230

March 2026—Agilent Technologies launched the Agi­lent S540MD slide scanner system, a whole slide imaging digital scanner available for sale in select European markets. The system offers a capacity of up to 540 slides, continuous loading, and standard rack compatibility and features automated scanning modes and AI-assisted tissue detection.

The scanner is the Agilent-branded version of the Hamamatsu NanoZoomer S540MD slide scanner system. It will initially be available as an in vitro diagnostic in Germany, France, Belgium, Spain, Austria, Luxembourg, Italy, the U.K., and Switzerland, with plans to expand into additional European countries this year.

Agilent Technologies, 800-227-9770

March 2026—Arlington Scientific has completed its acquisition of Awareness Technology’s EIA/ELISA product line. The assays will be part of the SeraQuest line and aim to strengthen ASI’s FDA-registered serology platform, which includes agglutination, latex, and ELISA methodologies.

Arlington Scientific, 801-489-8911

March 2026—New England Biolabs released the Monarch Mag cell-free DNA extraction kit. The magnetic, bead-based workflow is compatible with biofluids including plasma, serum, urine, and cerebrospinal fluid across input volumes from 1 mL to 4 mL. The kit design and format offer versatility across sample number, input amounts, and sample types. Users can expect consistent recovery of concentrated cfDNA across the full range of fragment sizes, down to 50 base pairs in length, according to a company press release. The kit pairs with NEB’s downstream amplification and library prep products, including the NEBNext portfolio for next-generation sequencing library preparation.

New England Biolabs, 800-632-5227

March 2026—Cepheid received FDA clearance for its Xpert GI panel, a multiplex PCR test designed to detect gastrointestinal pathogens from a single patient sample. The panel simultaneously detects and identifies 11 important bacterial, viral, and parasitic pathogens directly from stool specimens in Cary-Blair transport media.

The test delivers results in about 74 minutes and runs on Cepheid’s Gene­Xpert systems.

Cepheid, 408-541-4191

March 2026—ARUP Laboratories has launched an innovation central laboratory to facilitate collaboration with pharmaceutical, biotechnology, and other industry partners. ARUP says the new laboratory will serve as an ecosystem for validating technologies and accelerating next-generation diagnostics from concept to commercialization.

“The innovation central laboratory represents a bold step forward in diagnostic medicine,” Tracy George, MD, chief scientific officer of ARUP and president of its innovation business unit, said in a press statement. “By building and validating tests that are truly commercial ready, we’re not just accelerating innovation, we’re ensuring that groundbreaking diagnostics can be adopted in real-world laboratories to improve patient care globally.”

Other initiatives of the laboratory include developing assays for rare and under-recognized diseases, improving genomic sequencing technologies, operationalizing artificial intelligence and digital pathology solutions into laboratory workflows, and facilitating biomarker discovery and development of new assays for neurodegenerative diseases.

ARUP Laboratories, 801-583-2787