Lab consolidation drives technological advances and platform integration
By Elaine Sanchez Wilson, MPP
Under the emerging integrated health model, the clinical lab is but one strand in a complex web of healthcare partners. From the emergency department (ED), to physician’s offices, to the specialty clinic, patients are often treated at multiple points of care. Achieving reliable test results across the spectrum of healthcare settings, therefore, is not just desirable, but crucial.
Nevertheless, as testing demand surges, laboratory administrators also face budgetary pressures and staffing shortages. This article examines why and how labs are turning to automated technology to accommodate increases in testing volume. Specifically, advances in clinical chemistry analyzers have enabled labs not just to meet ever-growing workloads, but even to improve turnaround times while achieving consistency in results and minimizing labor requirements. Additionally, the influx of integrated analyzers, which combine chemistry and immunoassay testing on a single platform, has provided labs with an opportunity to consolidate testing and streamline their workflow even further.
MATCHING LAB GOALS
“Right now, laboratory consolidation is the challenge of the day, and the core lab is increasingly being viewed as the solution,” says Joseph Crowley, senior vice president for centralized and point-of-care solutions at Roche Diagnostics Corp, Indianapolis. “As more and more testing is being driven to the core lab from across the healthcare network, capabilities such as reliability, scalability, and turnaround time—especially for stat assays—are no longer regarded as merely ‘nice to have.’ These are critical, fundamental capabilities that drive the metrics by which labs are measured.”
Manufacturers of clinical chemistry analyzers have designed their devices to offer a growing number of automated features, all to enable their users to achieve optimal productivity. As they consider equipment for purchase, customers can select from systems that offer everything from intelligent sample management and remote system diagnostics, to automated dilution, calibration, and quality control (QC)—and a host of other advanced features.
Although such high-end features go a long way toward offering laboratories the level of testing sophistication they have come to expect from current clinical chemistry analyzers, manufacturers agree that their customers often share goals that are much more basic.
“At Siemens Healthineers, we often engage with our customers to understand the desires, needs, and demands that they consider important when determining which laboratory vendor to partner with,” says Jack Kenny, senior vice president for North America diagnostics at Siemens Healthineers, Tarrytown, NY. “The overarching feedback that we hear from customers is they are looking for control, outcomes, and simplicity.”
At Beckman Coulter Diagnostics, Brea, Calif, recent voice of customer surveys have confirmed that lower total cost of ownership is an important checkmark for prospective purchasers of clinical chemistry analyzers. “With today’s healthcare reform, laboratories are looking for ways to reduce the total operational costs of owning a new instrument,” says Stephen Ishii, senior marketing manager for global chemistry at Beckman Coulter. High on the list of priorities for Beckman Coulter customers is proven uptime—“an analyzer that can demonstrate minimal failures, is easy to maintain, and provides continuous operation to meet the workload demands,” Ishii says. Lab professionals also demand the ability to produce highly accurate and clinically relevant results to satisfy physician demand, he adds.
Debbie Whitehair, vice president of marketing at MedTest, Canton, Mich, agrees that customers are searching for robust analyzers with the lowest total cost of ownership, including “the highest yield per kit, minimal downtime, lowest mean-time-between-failures, and low service contract costs.” Customers seek minimal hands-on time spent on scheduled maintenance procedures, as well as a broad chemistry testing menu with a few open-channel applications, she adds.
Offering a broad test menu shows that an instrument is adaptable and has the technology to accommodate newer assays that may require three- or four-part reagents, such as vitamin D, explains Phil Shugart, chief executive of Carolina Liquid Chemistries Corp, Winston-Salem, NC. The company’s installation base also values cost-effectiveness, especially for post-sales support and maintenance costs. “Newer analyzers have newer electronics and fluidics,” Shugart says. “Maintenance is ‘plug and play,’ and downtime and service costs are substantially reduced.”
A BUSTLING MARKETPLACE
In the past year, Carolina Liquid Chemistries has launched a new FDA-cleared family of three clinical chemistry analyzers designed to match the needs of clinical laboratories of different sizes. For moderate-volume labs, the CLC800 sports a small footprint and user-friendly software with built-in troubleshooting, and produces up to 400 photometric tests per hour and 800 tests per hour with ion-selective electrode (ISE). For high-volume clinical laboratories, the CLC1600 produces up to 900 photometric tests per hour and 1,200 tests per hour when including electrolytes. These two analyzers accommodate reagents with up to four parts. And for large hospitals and reference labs, the CLC6410 is a modular clinical chemistry analyzer that allows throughput to expand from 1,600 tests per hour to 6,400 tests per hour.
“We offer a ‘one-size-fits-all’ reagent cartridge for the new CLC800, CLC1600, and CLC6410 modular analyzer,” Shugart says. “This allows economy of scale for purchasing. It also means the same normal ranges, operator training, and quality control ranges from the smallest to the largest laboratory in the healthcare system. Our new family of instruments offers up-to-date software, microelectronics, fluidics, and robust hardware. The efficient design increases productivity.”
Beckman Coulter offers analyzers that are matched to an individual lab’s workload, whether the load is 50,000 tests a year or 5 million tests a year. The company’s AU480, AU680, and AU5810, AU5820, AU5830, and AU5840 analyzers were developed to be highly reliable, easy to maintain, and operational when users need them to be. They also seek to be consumable-efficient, using efficient reagents and minimal consumables, and therefore contributing to a lower total cost of ownership. “Successful healthcare delivery today is where operational and clinical excellence intersect,” Ishii says. “Beckman Coulter chemistry analyzers allow the laboratory to work efficiently and cost-effectively, and to produce results they can trust.”
Other companies focus their development efforts on a specific market segment.
For mid-volume laboratories, the MedTest 480 chemistry analyzer produces 400 photometric test results per hour and 240 ISE tests per hour, with an overall throughput of 560 tests per hour. Advanced features include automatic processes such as automatic start-up, ISE calibration, quality control, automatic sample dilution, interior and exterior automatic probe cleaning, probe collision recovery, reagent blank checks, and rerun, among others.
“The Medtest 480 chemistry analyzer has an intelligent probe system that checks for sample clots, sample volume, reagent volume, and reagent bubbles, ensuring that the appropriate amount of sample and reagent are combined to produce an accurate test result,” Whitehair says. The analyzer’s full menu includes drugs of abuse reagents for urine drug screening and a range of chemistry tests, including specialty tests such as HbA1c and vitamin D.
The SK500 clinical chemistry system from Sekisui Diagnostics, Lexington, Mass, is suited for low- to moderate-volume laboratories that aim to provide efficient reagent usage. “The small footprint can fit in labs that are challenged for space, such as upgrading from a benchtop system,” says Timothy Lynch, senior global product manager at Sekisui Diagnostics. The analyzer’s ability to perform tests with small reaction volumes reduces the volume required in patient samples, and also increases the number of tests available in a reagent kit. It also accommodates reagents with up to four parts. As a result, “consistent throughput is not negatively impacted by two-reagent assays,” Lynch says. The open system allows novel or esoteric assays to be added by users, he adds.
With more esoteric and specialty testing now being performed at smaller laboratories, Ishii says, lab professionals are increasingly considering integrated analyzers, systems capable of processing both clinical chemistry tests and immunoassays.
At Beckman Coulter, the UniCel family of analyzers is suited for mid- and high-volume laboratories. All systems in the portfolio use standardized assay reagent packs and similar assay protocols, to ensure confidence in consistent patient results.
“The selection criteria for integrated systems are often similar to those applied to standalone chemistry analyzers,” says Ishii. “Laboratory professionals still desire improved uptime, lower total cost of ownership, and quality results. Lower cost benefits all laboratories.
“Often times, laboratory floor space is a deciding factor on whether standalone or integrated chemistry and immunoassay analyzers are the best choice,” Ishii adds.
Scalability has been a prime development objective at Roche, which has spent the last two decades investing heavily in its test menu and portfolio standardization. For example, the company’s Cobas series of analyzers utilizes standard instrumentation, reference ranges, and consumables to allow for extensive modular flexibility. “Our commitment to driving advances through this research and development investment has resulted in the broadest test menu of any integrated platform, and true lab standardization,” Crowley says. “Plus, our analyzers deliver industry-leading instrument reliability across low-, mid-, and high-volume segments. Our scalability allows labs to remain agile and adaptive when testing volume is uncertain, without compromising on quality.”
“All of this allows patients to move through an integrated health network to multiple points of care—such as the physician office, ED, specialty clinic, and other inpatient and outpatient settings—getting reliable, consistent test results regardless of location or instrument,” Crowley continues.
In its Dimension product line, Siemens Healthineers provides a scalable family of integrated systems that do not require sample sharing, or splitting. “The key features that enable our systems to meet the demands of existing and prospective customers would include their quick turnaround times for processing a basic metabolic panel, a comprehensive metabolic panel, or cardiac assays,” Kenny says. In addition, he says, “the benefits of the onboard QC and calibrators have been exceptionally differentiating in the marketplace.
“In addition to marketing the instrumentation itself, Siemens Healthineers has also supported customers’ needs with the Aptio automation system and CentraLink middleware, combined with the expertise to implement this solution in their laboratory successfully,” says Kenny.
Integrated platforms offer a number of benefits: a vast menu of assays, avoidance of maintenance costs associated with operating separate systems, elimination of multiple quality control protocols, and streamlined record-keeping. Still, several companies cited their wariness of the consolidated technology.
“Integrated systems have their advantages, but they have been known to slow down getting results out,” Shugart says. “That is why it is important not to sacrifice getting patient results out timely, if your laboratory is in a critical care situation. Electrolytes should not be sacrificed for a thyroid test.”
“The challenge is to make sure that integrated platforms are really delivering the labor savings they set out to provide, and getting patient results out timely,” Shugart continues. “A laboratory in a critical care setting should watch that the speed of critical tests is not sacrificed, and that they really see the anticipated labor savings, because these systems can be quite complex.”
“Integrated systems customers are focused on performing as many assays as possible on a single platform, even though some concessions might be necessary,” says Lynch. “Some integrated systems do not offer as broad a menu as a standalone clinical chemistry system in conjunction with a standalone immunoassay system. Integrated systems also often lack open-system capabilities.”
Crowley acknowledges the possible shortcomings of some integrated platforms, however he points out their potential to consolidate testing, improve turnaround times, and minimize footprint. “Some of the hesitancy regarding integrated systems may be based on a lab’s prior experience,” Crowley says. “Not many companies offer reliable integrated systems, and if you’re running on subpar instrumentation and, say, the chemistry side goes down, the whole system goes down.” This is not the case with Roche systems, he adds, citing the Cobas systems’ average uptime of more than 98%.
In addition to gaining access to technological capabilities and state-of-the-art features, at the end of the day customers also expect to have confidence in their results.
According to Kenny, Siemens Healthineers places an emphasis on confidence early on in the design process. “It starts with the research and development that drives the instrumentation and assays that we offer,” he says. “Of the six assays in the industry considered compliant with contemporary cardiac guidelines, for example, Siemens manufacturers four of them. Additionally, we employ a number of intelligent autoverification rules in our middleware systems to help create sophisticated filters to drive the automated release of normal results.”
At Carolina Liquid Chemistries, consistency can be expected across its entire new family of analyzers. “A potassium test result on our smaller CLC800 is the same potassium test result you will get from the high-throughput CLC6410,” Shugart says.
To achieve operational efficiency and clinical effectiveness, Beckman Coulter offers Six Sigma quality assays, which Ishii says “ensures the system is producing highly accurate and precise results.” In addition, the company’s Danaher Business Systems offering and suite of clinical information management tools serve to improve lab productivity and patient care, he says.
MORE WITH LESS
Responding to the testing needs of customers who are also facing pressures such as budgetary constraints and staff shortages, manufacturers have their work cut out for them. “Today’s challenge to laboratory management is how to replace aging chemistry instrumentation at the same time that laboratory budgets are decreasing or being frozen,” Whitehair says. “Laboratories will be forced to produce more test results with less resources—fewer operators and reduced budgets. Test reimbursements are decreasing year over year, thus adding more pressure on the laboratory management team.
“To help our customers keep their operations running smoothly,” she adds, “MedTest offers never-before-seen acquisition options so that customers can acquire volume-appropriate instrumentation.”
According to Crowley, the biggest assets and opportunities in labs today center on data. “In any given core lab, you may see 10 to 20 pieces of equipment by various manufacturers, and all of those products are creating and collecting data,” he says. “But how do they communicate with one another?
“Issues related to data collection, integration, use, and even ownership are the topic of the day,” says Crowley. “With rapid advances being made in science, disease detection, and therapy monitoring, testing needs will change as well,” he adds. “All in vitro diagnostic vendors are being challenged to continuously grow their test menus while improving the assays already available. Here, too, Roche is pushing the envelope, and we are well positioned to do so thanks to our long-time commitment to standardization and connectivity.
“When you talk about unmet need, another key piece is simply optimizing what labs currently have,” says Crowley. “The process is anything but simple, and that’s why Roche has also invested in lab process analysis led by internal experts in our instrumentation and assays. We work one-on-one with customers who need to refine and elevate their offerings and operations to address common lab challenges such as staffing shortages.”
DOWN THE ROAD
What does the future hold for the market in clinical chemistry and integrated analyzers? To meet the shifting needs of clinical laboratories in a variety of settings, manufacturers anticipate that the trend toward greater platform consolidation will continue.
Manufacturers will continue to expand the immunoassay menus of their integrated systems, to match the menus offered by standalone clinical chemistry systems combined with standalone immunoassay systems, says Lynch. But while additional assays may migrate from immunoassay systems to integrated systems, he says, an increasing prevalence of proprietary reagent formats may negatively affect customers by limiting open-channel flexibility.
There will likely be a “rapid advance in the number of immunoassays available on the market, which will put pressure on IVD manufacturers to deliver integrated analyzers that can accommodate the growth,” Crowley says.
Shugart agrees that applications for unique tests may find their way onto integrated platforms—especially those with high throughput capabilities. “We are seeing laboratory consolidation, hence a need for larger platforms,” he says.
“The trend we see today is laboratories looking for a ‘total’ solution that involves a suite of products and services beyond just chemistry and integrated systems,” Ishii says. “Diagnostic companies that are positioned to offer the broadest suite of advanced diagnostic instrumentation, automation, and advanced information technology will best meet the needs of the future.”
Elaine Sanchez Wilson, MPP, is associate editor of CLP. She can be reached via [email protected].