Negative margins, a shift to nontraditional care sites, and an increasingly complex logistics environment should prompt clinical labs and anatomic pathology groups to quickly evaluate shipping costs and data analysis
In September, American Hospital Association (AHA) leaders and Kaufman Hall healthcare analysts posted a particularly dismal status update for US hospitals, saying more than half are projected to operate in negative margins for the rest of the year.
As a result, hospital and healthcare leaders are likely facing difficult decisions around traditional operations while actively seeking new partnerships to increase reach and impact of their hospital services, including clinical lab and pathology testing.
Market pressures and revenue opportunities, including nontraditional clinical trial designs, hospital-at-home programs, and innovative care management for patient cohorts, are reshaping healthcare around the US. These and other ensuing shifts will add complexity on top of already burgeoning costs to the physical logistics of clinical laboratory testing and pathology services.
Traditional and Nontraditional: Conduct Assessments of Lab Shipping Costs and Logistics Management
Analyzing data of dynamic logistical inputs will support informed service line decision-making and can ultimately lead to cost savings for clinical labs and health systems, according to Jeff Ledbetter, regional consultant for Cardinal Health OptiFreight Logistics. Ledbetter monitors cost-per-shipment models and trends in service modes for a variety of healthcare providers, networks, and reference laboratories.
“What I’ve seen in the marketplace is that labs have historically built a reliance on physician offices across the country,” Ledbetter explained in an interview with Dark Daily. “What is changing is that labs have diversified their client base and who they now consider customers.” Some of the new inputs include individual consumers, corporations, and schools, in addition to integrated delivery networks (IDNs) and IDN-like entities.
For Dark Daily, regional consultant for Cardinal Health Jeff Ledbetter explained three data trends guiding cost-saving clinical laboratory logistics strategies and benchmarking. These will be important as labs diversify their client base and who they now consider customers. (Photo copyright: Jeff Ledbetter.)
The problem, Ledbetter said, is that lab executives are not able to see the profitability of their customer types and cannot achieve operational efficiencies because of the more complex and dynamic inbound and outbound shipment flow.
Ledbetter describes three ways to analyze lab costs:
1. Cost-per-pack benchmarking,
2. Ratio of test kit outflow to inflow, and
3. Visibility to shipments for workflow management and staffing availability.
With multiple transportation components for each test performed, “a hidden cost element is wasted test kits,” Ledbetter said. “We look at the ratio of specimens sent out but not returned to the lab. Each lab kit passes through multiple modes of transportation. Kits that are deployed but not returned to the lab become waste, resulting in sunken cost. When I talk to reference lab leaders, they understand this is an issue, but they don’t know how to manage it.” Ledbetter points to OptiFreight Logistics’ robust analytics as a critical element to help manage the waste. To increase profitability, the lab can adjust to whom and how it deploys kits to optimize the number of kits with specimens that return to the lab for testing.
A related issue is understanding the ratio of outflow to inflow for identifying profitability of customers. “Managing customers is now shaped by data points such as productive and profitable pickups,” Ledbetter said. For example, a returned shipment with five specimens is more profitable than a shipment with only one specimen.
“We also look at efficiencies that consider the number of lab employees needed to accession specimens, and how delivery timing can maximize efficiency of the testing operation,” Ledbetter said. “This is based on the mode of service and available delivery time.”
The starting point, Ledbetter said, is to gain continuous data-driven insights into the best possible service modes and specimen pack timing that will improve the lab’s operational efficiency, ease staffing constraints, and correlate with business-critical key performance indicators. Amid an ongoing shift to nontraditional care sites, this level of visibility is critical, he added.
Aggressive Adoption of Decentralized Clinical Trial Services Expected
Following a Clinical Operations Roundtable, global management consulting firm McKinsey and Company explored the acceleration of decentralized clinical trials post-pandemic. Experts there define that model as a clinical trial centered around patient needs that improves the patient experience. By design, decentralized clinical trials will use one or more “decentralization elements” based on suitability for their end points, patient populations, and treatments.
“Clinical-trial sponsors creating hybrid protocols are drawing from the menu of decentralization services and technology interventions, such as remote monitoring of vitals, mobile clinics, and home visits,” wrote Life Sciences Practice leader Gaurav Agrawal and others for the McKinsey and Company report, “No Place Like Home? Stepping Up the Decentralization of Clinical Trials.”
“Traditional site visits will still be needed for complex procedures and specialized assessments, such as screenings and magnetic resonance imaging. So smart, hybrid trial designs will make other touchpoints virtual or closer to the patients—for instance, through mobile clinics and primary-care physicians—whenever possible,” states the McKinsey report. The graphic below shows potential trends that will be of interest to hospital and IDN executives, clinical laboratory leaders, and anatomic pathology group administrators.
According to McKinsey and Company research, clinical trial investigators anticipate a threefold increase in remote patient interactions compared to before the pandemic, although that comfort level is lower than during the peak of the pandemic. (Source: McKinsey and Company and Nature Reviews Drug Discovery.)
Since specific laboratory tests mark key points within the care continuum, decentralization creates a more dynamic environment for specimen logistics, making visibility, data analytics, and predictive technology around lab deliveries essential for maximum profitability.
Hospital at Home and Moving Lab to Home
As the healthcare industry shifts to the home as a site of care, legacy patient-provider relationships and business will face disruption, executives at The Chartis Group wrote in a blog post published in September.
“Health systems would do well to consider how they are positioned to deliver care at home as an integrated part of their care models,” Chartis wrote in its blog. “This may include evaluating legacy home health assets and programs, while also rapidly evaluating the business case for launching a hospital-at-home program as part of their broader strategic and operational plans.”
Although outpatient services have taken to the flavor of innovation, hospital-at-home models may not be easy. “Simply extending the reach of hospitals into patients’ homes is unlikely to allow the promising scale or cost savings stakeholders hope for from home hospitalization programs,” according to a recent Health Affairs piece that simplifies many of the issues, such as top-down and bottom-up payment approaches and transformation challenges of which include diagnostics, monitoring, pharmaceuticals, and nursing services among many.
Regardless, changes to hospital operations in the coming year may be inevitable as a result of cost and payer pressures. In the meantime, patient cohorts appear to be a starting point for moving lab to home and potentially stopping the bleeding.
In Arizona, Sonora Quest Laboratories announced an “exclusive service” that is targeted to those living with chronic conditions and cognitive decline. Collaborating with remote healthcare service provider Getlabs in Los Angeles (for blood sample collection services) and Raleigh, NC-based uMETHOD (a precision medicine care plan provider), the service provides on-demand home lab collection, diagnostics, and individualized assessments to help slow early-stage progression of cognitive decline.
The Sonora Quest-Getlabs-uMethod triad is just one example of mobile and remote clinical laboratory services at work in various parts of the country, as The Dark Report recently explained. In a pilot trial of at-home phlebotomy services, laboratory order completion rates for patients jumped up 22.5%—this is significant because many factors can lead patients to discontinue lab orders, such a driving distances, time wasted sitting in a lab’s waiting room, or the inability to travel.
All of these moves describe strategic actions healthcare providers are taking to make existing and new services more accessible and possibly more efficient. Demand for shifting from traditional to nontraditional sites for care will continue to confront clinical labs and anatomic pathology groups with both opportunities and dilemmas. Forward-looking hospital, health system, and reference lab leaders will leverage logistics technologies.
Answers and effective solutions to the lab profession’s most urgent challenges will be front and center at the innovative ‘Lab Management Essentials Workshop’
Three powerful forces are slamming clinical laboratories today. One is the urgent need to cut costs. Second is the struggle to achieve and maintain full lab staffing. Third is the pressure to increase revenue and expand market share.
All of this is happening even as hospitals and health systems must deal with almost identical issues. Cost-cutting, recruiting more staff, and finding ways to increase revenue dominate the thoughts and actions of senior health administrators.
Most Hospitals and Health Systems Report Substantial Financial Losses
News reports about the financial losses at hospitals and health systems tell the story. For example, one report in Becker’s Healthcare described the financial damage at three major, multi-state health systems:
AdventHealth, a 48-hospital health system, reported a $417.7 million net loss in the first quarter of 2022. It reported that, because of inflation, costs had increased by 15% over prior year.
Kaiser Permanente, with 12.6 million members in seven regions of the United States, reported a net loss of $961 million in the first quarter of 2022. One major factor in these losses was the increase in expenses, which was 9.5%. For second quarter 2022, Kaiser Permanente showed a loss of $1.3 billion, most of that from a decline in the value of its investment portfolio.
Ascension Health, with 143 hospitals in 19 states, reported a net loss of $884.7 million in first quarter of 2022. It said its costs increased by 10.6% over the same period last year.
Most hospital-based clinical laboratory managers and pathologist are aware of these staggering financial losses. They also are watching how the shortage of nurses and other skilled personnel has hospitals scrambling to close that gap by paying more overtime, using temporary nurses who are paid at much higher rates, and increasing nurse salaries to prevent existing staff nurses from taking more lucrative offers from other hospitals in the community.
Clinical Laboratories Under Pressure to Cut Costs and Maintain Adequate Staff Levels
Hospital-based laboratories are on the frontline of these hurricane forces. Facing operating losses, hospitals ask their laboratories and other clinical service lines to cut costs below authorized budgets. Meanwhile, the labs themselves must deal with their own shortage of medical technologists (MTs) and clinical laboratory scientists (CLSs)—along with other skilled positions—that are required to provide the full menu of lab testing services.
This “perfect storm” of pressures to cut costs, keep staffing at authorized levels, and generate more revenue (that can offset rising costs of lab supplies and the higher salaries being paid to MTs and CLSs) is without precedent in the past four decades. To provide lab managers with the knowledge to resolve these challenges swiftly and confidently in their own laboratories, the team behind the Executive War College assembled experts to conduct a one-and-a-half-day interactive workshop.
Using Lab Case Studies to Teach Proven Solutions for Reducing Expenses
Each of the three important topics will be addressed in half-day learning modules. Following case study presentations on best practices, attendees at Lab Management Essentials will break out into smaller roundtable groups facilitated by lab industry experts. The groups will brainstorm how to apply these proven methods to cut costs, retain employees, and create revenue. They will then describe their findings to all participants.
Lab Management Essentials Workshop facilitators (clockwise from top left): Tafney Gunderson, Carlton Burgess, Dorothy Martin, Rick VanNess, Jane Hermansen, and Kim Zunker.
On the morning of day one, leaders of the lab cost-cutting module will be:
Carlton Burgess, Vice President of Laboratory Services at Prime Healthcare in Ontario, Calif.
Tafney Gunderson, Quality Systems Supervisor at Avera McKennan Laboratory in Sioux Falls, S.D.
On the afternoon of day one, leaders of the lab staff recruiting, hiring, and retention module will be:
Dorothy Martin, Regional Laboratory Manager at Dartmouth-Hitchcock Health in Lebanon, N.H.
Kim Zunker, MBA, MLS(ASCP), CAPM, Consulting Manager at Accumen in Scottsdale, Ariz.
On the morning of day two, leaders of the lab staff recruiting, hiring, and retention module will be:
Jane Hermansen, MBA, MT(ASCP), Manager of Outreach and Network Development at Mayo Clinic in Rochester, Minn.
Rick VanNess, Director of Product Management at Rhodes Group and TriCore Reference Laboratories in Albuquerque, N.M.
Delivering Essential Knowledge to Up-and-Coming Laboratory Managers
This Lab Management Essentials workshop is a first for the clinical laboratory profession. It brings together experienced, effective lab leaders to teach, guide, and coach your lab’s smartest up-and-coming lab managers. It accomplishes this in just one-and-a-half days, to minimize the time they are away from your lab.
To gain maximum benefits from this well-designed program, it is recommended that you send three or four of your front-line lab managers. Together, they will hear and learn at the same time, while working during the intimate sessions to identify the techniques and methods that will work best for your lab. This is important because, upon their return, they will have both enthusiasm and the knowledge to light the right fires under your lab staff and energize them into quickly deploying ways to slash expenses, attract top candidates to fill open positions, and even to tap new sources of revenue—all of which they learned during Lab Management Essentials.
Because the number of attendees to each workshop is limited, you are encouraged to click here to register yourself and your designated lab managers today.
Retail giant now has primary care clinics at stores in five states, but the rollout has not gone smoothly
Healthcare is increasingly being driven by consumerism and one clear sign of this trend is Walmart’s ambitious plan to open health clinics at its retail locations. The retail giant set its plans in motion in 2019 with its first primary care site in a suburban Atlanta store, however, the rollout since then has presented certain challenges.
Nevertheless, the trend of placing nearly full-service primary care clinics in retail locations continues. Clinical laboratories in these areas need strategies to serve customers accessing healthcare through these new channels, particularly as Walmart and the national retail pharmacy chains continue to expand the clinical services offered in their retail stores.
“Consumer engagement is a huge part of healthcare, [yet it is also a] gap for us in healthcare,” cardiologist and Walmart VP of Health and Wellness Cheryl Pegus, MD, told Modern Healthcare. “Healthcare is incredibly complicated,” she added. “And where we are in healthcare today is not in having great treatments. It’s not in having evidence-based medicine. It’s understanding how we engage consumers.”
The company also entered the telehealth business with last year’s acquisition of multispecialty telehealth provider MeMD.
“Telehealth offers a great opportunity to expand access and reach consumers where they are and complements our brick-and-mortar Walmart Health locations,” said Pegus in a Walmart new release announcing the acquisition. “Today people expect omnichannel access to care and adding telehealth to our Walmart healthcare strategies allows us to provide in-person and digital care across our multiple assets and solutions.”
Currently, Walmart Health centers only operate in Georgia, Florida, Illinois, and Arkansas. But telehealth enables Walmart “to provide virtual healthcare across the country to anyone,” Pegus said. With both offerings, “we’re really attempting to allow people to get healthcare the way they need it without disrupting the rest of their life.” Many users of these services are Walmart “associates,” she added, using the company’s term for its retail employees.
“In this country, about 25% of people don’t have a primary care physician,” cardiologist Cheryl Pegus, MD (above), Walmart’s VP of Health and Wellness, told Medscape. “So, your options for being able to solve in real time something that will help you, they’re quite limited. What we’re trying to do is give those options. We’re not trying to take away emergency rooms, or healthcare systems, or existing primary care. We’re asking, how do we expand that infrastructure so that people get care when they need it?” And this includes clinical laboratory testing, radiology, and telehealth services as well. (Photo copyright: Walmart.)
Large Portfolio of Healthcare Offerings
Pegus joined Walmart (NYSE:WMT) in December 2020 to oversee a portfolio that now includes more than 4,700 pharmacies and 3,400 Vision Centers, in addition to the telehealth operation and the Walmart Health centers. She was previously chief medical officer at Walgreens and Cambia Health Solutions and worked in private practice as a cardiologist.
The retail giant opened its first Walmart Health center in Dallas, Ga., an Atlanta suburb, in September 2019, followed by additional centers in Georgia, Arkansas, and Illinois.
Earlier this year, it opened five new clinics in northern and central Florida with plans for at least four more in the Jacksonville, Orlando, and Tampa areas, according to a press release. Each health center is adjacent to a Walmart retail location.
These centers offer a range of primary care medical services, including:
physicals,
injury care,
immunizations,
radiology, and
care for chronic health conditions.
Pictured above is one of the first health clinics established by Walmart. This location is in a western Atlanta suburb. Note that the services advertised include more than just primary care. Also offered are “labs and X-ray,” along with dental, hearing, optometry, and counseling. Clinical laboratory managers and pathologists may want to monitor whether consumers embrace primary care delivered from clinics located in retail stores. (Photo copyright: Georgia Health News.)
As Dark Daily reported in May 2020, the Walmart Health centers also offer clinical laboratory testing at cut-rate prices, such as:
$10 for a lipid test,
$10 for Hemoglobin A1c, and
$20 for a strep test.
On the Walmart Health website, patients can enter their Zip code to view a list of Walmart Health clinics in their area, including links to price lists.
Walmart’s Expansion into Healthcare Not Without Problems
However, the company’s expansion into healthcare has not gone smoothly. In 2018, the Walmart board signed off on a plan to open 4,000 health centers by 2029, Insider reported. By the end of 2021, Walmart expected to have 125 health centers in operation, but as of June 2022, the Walmart Health website listed only 25 locations, mostly in Georgia.
Citing anonymous sources, Insider reported problems that include “leadership changes, competing business priorities brought on by the coronavirus pandemic, and the complexity of scaling a massive healthcare operation.”
In Sept. 2021, Insider further reported that the clinics were experiencing operational difficulties including hidden fees and billing problems. One culprit, the story suggested, was the company’s electronic health record (EHR) software. That same month, Walmart announced it would adopt the Epic health records system, beginning with the opening of new clinics in Florida locations.
Pegus’ arrival at Walmart appears to be part of a management shakeup. In January 2022, Insider reported that she had assembled a new executive team, with David Carmouche, MD, Senior VP, Omnichannel Care Offerings, overseeing the health centers and telehealth operations. By then, the original executives leading the rollout of the health centers had all left, Insider reported. Carmouche was previously an executive VP with Ochsner Health in New Orleans.
Partnership with Quest Diagnostics
Meanwhile, in January, Walmart announced a deal with Quest Diagnostics that allows consumers to order more than 50 lab tests through The Wellness Hub on Walmart.com, which is separate from the Walmart Health website. The tests cover “general health, digestive health, allergy, heart health, women’s health, and infectious disease,” according to a press release announcing the partnership.
Consumers can order at-home test kits for certain conditions or set up appointments for tests at Quest Patient Service Centers. The tests on the Walmart/QuestDirect website include:
COVID-19 Active Infection ($119+)
COVID-19 Antibody Test ($69)
Cholesterol Panel ($59)
Complete Blood Count ($59)
Comprehensive Metabolic Panel ($49)
CRP Inflammation Marker ($59)
Diabetes Management ($69+)
Diabetes Risk ($99+)
Food Allergy Test Panel ($209)
Chickenpox ($59)
The website also offers a combined Basic Health Profile with CBC, CMP, cholesterol panel, and urinalysis for $149. “Each purchase is reviewed and, if appropriate, ordered by a licensed physician,” the press release states.
What does all this mean for clinical laboratories? “They need to recognize that the Millennials and Gen Zs are driving a consumer revolution in healthcare,” said Robert Michel, Publisher and Editor-in-Chief of Dark Daily and its sister publication The Dark Report.
“Walmart was early to recognize and respond to this, in part because it employs 1.3 million Americans, many of whom are Gen Y and Gen Z and quick to use telehealth and similar virtual health services,” he added.
Clinical laboratory leaders need to understand this trend and develop strategies to attract and serve new patients who are willing to access healthcare virtually, while still needing to provide blood and other specimens for the lab tests ordered by their providers.
Proof of vaccination, masking, and availability of on-site testing will continue to be measures taken at in-person events for pathologists and medical laboratory professionals
Organizers of in-person clinical laboratory conferences face an interesting dilemma as they plan events in 2022: Where do they draw the line with COVID-19 safety protocols?
On one hand, the surge of cases caused by the SARS-CoV-2 Omicron variant seems to be in its waning stages and large swaths of the population are vaccinated. On the other hand, clinical laboratory and anatomic pathology events want potential registrants to have confidence that it is safe to travel and attend the gatherings.
One lab industry conference producer who happens to be knee-deep in preparing for an in-person meeting this spring is Robert Michel, Editor-in-Chief of The Dark Report and Founder of the 27th Annual Executive War College on Laboratory and Pathology Management. This informative event takes place on April 27-28 in New Orleans and includes COVID-19 protocols to protect attendees.
The CDC chart above shows the daily number of new COVID-19 cases in the US for the six-month period ending Feb. 28, 2022. Clinical laboratory managers should note that the number of new cases is at its lowest level since the Omicron variant showed up early this year.
“It’s important for all those planning to attend this year’s Executive War College to know that screening COVID-19 protocols will be in place to ensure the health and safety of all participants,” Michel noted. “We did a large lab conference in the fall of 2021 that included protocols for COVID-19 and the attendees told us they appreciated the protection provided by those protocols.”
After a significant rise in COVID-19 cases in January 2022 due to the Omicron variant, current daily case levels now are lower than they were six months ago before the new variant hit, according to numbers from the federal Centers for Disease Control and Prevention (CDC).
The in-person 2021 Executive War College, which took place in San Antonio on Nov. 2-3, 2021, followed the CDC’s recommendations:
COVID-19 protocols included a daily set of questions and a temperature check for all speakers and attendees before they were allowed to enter the conference area.
CLIA-complex rapid PCR COVID-19 tests were available for individuals whose temperature and answers to the screening questions indicated the need for such testing.
Attendees used an app to answer the daily screening questions and upload proof of vaccination.
“At last fall’s Executive War College, approximately 400 attendees were screened on each of the three days before entering the conference area and not one rapid COVID-19 test was needed,” Michel said. “Not only is that an outstanding outcome, but a number of attendees also told us they appreciated our efforts to keep them safe and protect their health.”
The 2022 Executive War College will follow the CDC’s updated COVID-19 guidelines, along with any state and local directives in effect as of April 27.
Although 300 attendees were expected at the 2021 Executive War College, 400 registered and participated.
Proof of Vaccination Has Been Required at Other Clinical Lab Industry Events
Organizers of other clinical lab conferences also have dealt with COVID-19 safety protocols. For example, the American Clinical Laboratory Association (ACLA) will hold its annual meeting in Washington, D.C., on March 9. COVID-19-related requirements for attendees will include proof of vaccination uploaded to a vaccine verification vendor and proof of a negative PCR test taken within 72 hours prior to the event.
The annual meeting of the American Society of Clinical Pathology (ASCP) occurs later this year in September in Chicago—too early yet to publish protocols. Last year’s ASCP conference in Boston was a hybrid event, offering both in-person and virtual options. Those who attended in person needed to upload proof of vaccination to a third-party vendor and were required to wear masks. On-site COVID-19 testing was available.
Revived Corporate Travel Could Boost Clinical Laboratory Conferences
The path back to live events across all industries has not been easy given various COVID-19 surges, political divisiveness over masking, frozen corporate travel budgets, and corporate policies banning or limiting employee travel.
Conference organizers throughout the United States universally hope those barriers will lower as 2022 progresses.
“With the fast-spreading Omicron triggering another round of setbacks to start 2022, event planners now are betting on spring to finally mark a turning point for the hard-hit industry,” MarketWatch reported on Feb. 4. “Their hopes hinge on American corporations taking a note from the recovery already under way for domestic air travel for leisure purposes, with the linchpin being a robust revival of trade show attendance and other in-person business gatherings.”
For Michel, offering actionable advice through well-thought-out sessions has been a cornerstone of the content offered each year at the Executive War College. He believes that approach will continue to be the strongest drawing point for clinical laboratory and pathology executives now considering attending the event.
“Our reading of the tea leaves is that across the profession of laboratory medicine, a great many managers, administrators, executives, and pathologists want to return to in-person conferences,” Michel noted. “Registrations for our April event are running ahead of 2019, and people tell us that they recognize the changes in healthcare and the lab marketplace because of the pandemic. They want to understand what’s driving current trends, like greater consumer involvement in lab testing and how to get private payers to reimburse claims for COVID-19 and genetic tests, as well as how a growing number of clinical laboratories are incorporating artificial intelligence solutions in both clinical care settings and lab operations.”
By automating clinical chemistry and immunoassay testing, clinical laboratory leaders can improve throughput while reducing the stress on staff, laboratory expert says
The American Society for Clinical Pathology regularly conducts a vacancy survey of medical laboratories throughout the US. While the problem of lab department vacancy rates has been ongoing, the last survey reported showed increased rates for laboratory positions across all departments surveyed. Last year, burnout among healthcare workers reached a crisis level, reported Clinical Laboratory News.
As a result, staffing the clinical laboratory with qualified lab professionals resounds as a top concern—and at a time when expectations are perhaps the highest they have ever been for performance in healthcare operations, from general hospitals to the most complex integrated delivery networks.
Even in the midst of the clinical laboratory workforce shortage and chronic strain, laboratory leaders must still improve their labs’ processes and workflows; increase productivity; and expand routine and specialty testing to better serve patient populations.
Faced with unrelenting pressures to do more with less, lab directors are turning to automating certain departments of the laboratory as a way to:
Relieve the problems caused by an ongoing workforce shortage;
Improve workflows and processes through standardization;
Keep lab staff working on the most important tasks; and
Enhance the laboratory’s reach and grow the lab business in necessary ways.
How UMC Southern Nevada Prioritized STAT Runs, Consolidated Operations
One case in point highlights the University Medical Center (UMC) of Southern Nevada’s clinical laboratory. Located in Las Vegas, UMC is among the largest public hospitals in the United States. It is part of a recent master-planned Las Vegas Medical District (LVMD), and it is the only Level I trauma center in Nevada.
The laboratory needed to improve turnaround time and expand the test menu, among other goals, explained Scott Keigley, one of two General Laboratory Services Managers at UMC. While limited laboratory automation had already been applied broadly, the lab took its automation initiative one step further by connecting three high-volume automated clinical chemistry and immunoassay analyzers (CC/IA), an automated hematology line, and a coagulation analyzer.
The University Medical Center of Southern Nevada improved efficiency andstreamlined workflow by integrating a consolidated automated clinical chemistry and immunoassay analyzer (above) into the laboratory’s workflow. (Photo copyright: Siemens Healthineers)
An immediate benefit that UMC realized was consolidation of clinical lab operations. “Up until implementing our automated platform, we had a dedicated laboratory in our emergency room specifically to triage our emergency room tests,” Keigley explained. “You’re talking about not only a duplication of consumables, resources, and supplies, but also personnel.
“A big part of automating was showing our administration we were going to be able to eliminate that emergency room lab and still turn our results around as quickly and as efficiently without it,” Keigley added.
One of the ways that using an automated platform enabled consolidation of lab operations was by decreasing the turnaround times of STAT samples. “Our STAT turnaround times are way below many of the national thresholds or standards,” Keigley explained. “I’ll use troponin as an example. National threshold is 60 minutes from received to result, but we average about 30 minutes.
“Throughput definitely increased,” Keigley added, emphasizing that this increased throughput was actually accompanied by a reduced workload. “We’ve seen a reduction in the amount of hands-on time required to do the daily maintenance and quality controls. Once the daily maintenance and controls are completed, the chemistry department can usually be run by one person.”
Choosing a Consolidated Automated Chemistry and Immunoassay Platform
Described as flexible for adding components, modular, and scalable, a consolidated clinical chemistry and immunoassay analyzer (CC/IA) can run from 1 million to 3 million tests per year. Designed with innovative technological internal controls and sample handling—and other capabilities that include automated instrument calibration, maintenance, and quality control (QC) functions—the CC/IA platform also works as a standalone and is a first step toward implementing laboratory automation.
At UMC, multiple factors influenced the decision to add the platform, explained Keigley. “One reason was the increased productivity that it (the Atellica Solution) from Siemens Healthineers offers. This technology frees up our techs to do what we went to school to do. I can show anyone how to load samples on these analyzers in five minutes, but that’s not what it’s about.
“We were able to expand our test menu and our services. The platform allowed us to grow.” Keigley estimates that UMC’s test menu grew up to 20% after the change, both expanding the types of testing that could be offered and decreasing the number of send-outs. He estimates that the chemistry lab now processes about 2.6 million reportable results per year.
There were several (QC) features that Keigley believes UMC’s laboratory benefits from. The key QC features Keigley identified include onboard temperature-controlled storage, programmable run times, and barcode-labelled tube options from the control manufacturer that eliminate manual programming.
Operational Evaluation—Nexus Global Solutions, Inc. (Nexus), Plano, TX
While the primary driving factor in UMC’s decision to use the Atellica Solution platform was based on its individual laboratory’s needs, a recent study commissioned by Siemens Healthineers illustrated the benefits of this system.
An operational comparison report by Nexus found that there are multiple advantages associated with this integrated automation platform—as a standalone component—when compared to a similar offering.
Specifically, the Nexus report found:
Start-up and maintenance time was almost an hour and a half less;
Manual start-up time requirements were 28 minutes, compared to 46 minutes;
From 65% to 69% of samples had a faster turnaround time; and
A system footprint that used 20square feet less space and four fewer analyzers.
Clinical laboratory leaders can review the methodology and results of the Nexus Global report by clicking on this link: www.siemens-healthineers.com/operational.
This article was produced in partnership with Siemens Healthineers.
CDC advises clinical laboratories and microbiologists encountering C. auris to follow their own protocols before adopting federal agency guidelines
In July, the Centers for Disease Control and Prevention (CDC) warned healthcare facilities and clinical laboratories to be on the alert for Candida auris (C. auris) infections in their patients. An outbreak of the drug resistant and potentially deadly fungus had appeared in two Dallas hospitals and a Washington D.C. nursing home.
Since those outbreaks, researchers have studied with urgency the “superbug’s” emergence in various types of healthcare facilities around the nation, not just hospitals. Their goal was to discover how it was successfully identified and contained.
“Seeing what was happening in New York, New Jersey, and Illinois [was] pretty alarming for a lot of the health officials in California [who] know that LTACHs are high-risk facilities because they take care of [very] sick people. Some of those people are there for a very long time,” the study’s lead author Ellora Karmarkar, MD, MSc, told Medscape. Karmarkar is an infectious disease fellow with the University of Washington and formerly an epidemic intelligence service officer with the CDC.
“One of the challenges was that people were so focused on COVID that they forgot about the MDROs (multi-drug resistant organisms] … Some of the things that we recommend to help control Candida auris are also excellent practices for every other organism including COVID care,” she added.
According to Medscape, “The OCHD researchers screened LTACH and vSNF patients with composite cultures from the axilla-groin or nasal swabs. Screening was undertaken because 5%–10% of colonized patients later develop invasive infections, and 30%–60% die.
Medscape also reported that the first bloodstream infection was detected in May 2019, and that, according to the Annals of Internal Medicine study, as of January 1, 2020, of 182 patients:
22 (12%) died within 30 days of C. auris identification,
“This is really the first time we’ve seen clustering of resistance in which patients seemed to be getting the infections from each other,” Meghan Lyman, MD, Medical Officer in the Mycotic Diseases Branch of the CDC, told Fox News.
The graphic above illustrates how Candida auris is “spanning the globe,” The New York Times reported. Clinical laboratories that encounter this potentially deadly fungus are advised to contact the CDC immediately for guidance and to take proactive steps to prepare for the “superbug’s” arrival. (Graphic copyright: The Scottish Sun.)
Be More Proactive than Reactive in Identifying C. Auris, CDC Says
C. auris is a type of yeast infection that can enter the bloodstream, spread throughout the body, and cause serious complications. People who appear to have the highest risk of contracting the infection are those:
Who have had a lengthy stay in a healthcare facility,
Individuals connected to a central venous catheter or other medical tubes, such as breathing or feeding tubes, or
Have previously received antibiotics or antifungal medications.
It tends to be resistant to the antifungal drugs that are commonly used to treat Candida infections.
It can be difficult to identify via standard laboratory testing and is easily misidentified in labs without specific technology.
It can quickly lead to outbreaks in healthcare settings.
“With all this spread that we’ve been seeing across the country we’re really encouraging health departments and facilities to be more proactive instead of reactive to identifying Candida auris in general,” Lyman told STAT. “Because we’ve found that controlling the situation and containing spread is really easiest when it’s identified early before there’s widespread transmission.”
There continues to be concerns over this highly drug-resistant infection among hospital physicians and medical laboratories. “Acute care hospitals really ought to be moving toward doing species identification of Candida from nonsterile sites if they really want to have a better chance of detecting this early,” Dan Diekema, MD (above), an epidemiologist and clinical microbiologist at the University of Iowa, told Medscape. (Photo copyright: University of Iowa.)
Candia Auris versus Other Candida Infections
C. auris can cause dangerous infections in the bloodstream and spread to the central nervous system, kidneys, liver, spleen, bones, muscles, and joints. It spreads mostly in long-term healthcare facilities among patients with other medical conditions.
The symptoms of having a Candida auris infection include:
Fever
Chills
Pain
Redness and swelling
Fluid drainage (if an incision or wound is present)
General feeling of tiredness and malaise
C. auris infections are typically diagnosed via cultures of blood or other bodily fluids, but they are difficult to distinguish from more common types of Candida infections, and special clinical laboratory tests are needed to definitively diagnose C. auris.
Whole-genome Sequencing of C. Auris and Drug Resistance
The CDC conducted whole-genome sequencing of C. auris specimens gathered in Asia, Africa, and South America and discovered four different strains of the potentially life-threatening Candida species. All four detected strains have been found in the United States.
There are only three classes of antifungal drugs used to treat Candida auris infections:
However, 85% of the infections in the US have proven to be resistant to azoles and 38% are resistant to polyenes. Patients respond well to echinocandins, but more effective therapies are needed especially as some isolates may become resistant while a patient is on drug therapy, STAT reported.
“Even while it might be susceptible upfront, after a week or two of therapy, we may find that the patient has an infection now caused by an isolate of the same Candida auris that has become resistant to the echinocandins and we are really left with nothing else,” Jeffrey Rybak, PhD, PharmD, Instructor, Department of Pharmaceutical Sciences, St. Jude Children’s Research Hospital, told Infection Control Today.
Although relatively rare, C. auris infections are on the rise. The good news is that there may be further pharmaceutical help available soon. New antifungal agents, such as Ibrexafungerp (Brexafemme) show promise in fighting C. auris infections, but more research is needed to prove their efficacy.
What Should Clinical Laboratories Do?
The CDC stresses that clinical laboratories and microbiologists working with known or suspected cases of Candida auris should first adhere to their own safety procedures. The CDC issued guidelines, but they are not meant to supersede the policies of individual labs.
The CDC also recommends that healthcare facilities and clinical laboratories that suspect they have a patient with a Candida auris infection immediately contact the CDC and state or local public health authorities for guidance.
