By Louise Lazear

Managing POCT in critical-care settings

io01.jpg (10308 bytes)From left: Philips Blood analyzer Portal, IL’s Gem Premier 3000, and the i-Stat System

The market for near patient testing in critical care settings continues to expand, as issues regarding connectivity and complexity move toward resolution. Factors fueling this growth include cost reduction due to faster results, leading to more immediate care and reduced length of stay, along with improved productivity by performing more work with fewer people. And with the move to improving the quality of patient care through outcome-based initiatives, it is likely that the need for POCT, especially in the critical-care setting, will be a front-burner issue that will further impact the roles of both laboratorians and clinicians in diagnosis and management of disease.

According to a recently published survey of the industry by the Enterprise Analysis Corporation, the U.S. market for POCT grew a prodigious 75 percent from $1.6 billion in 1999 to $2.8 billion in 2001. The largest percent increases by discipline occurred in clinical chemistry (18 percent) and blood gas and electrolytes (16 percent), followed by coagulation, hematology and urine chemistry, at about 10 percent. The smallest gains were observed in the use of cardiac markers in the point of care setting at a 2 percent increase; and blood glucose monitors came in at the same level, due primarily to the maturity of the market.

As the overall market experiences growth, the major players in near patient critical-care testing continue to dominate the field. Blood glucose monitoring, addressed by Abbott, Roche, Bayer and Lifescan among others, represents the most commonly available POC test in critical care, with a worldwide market of $2.4 billion. For blood gases and electrolytes, i-STAT, Instrumentation Laboratory, Radiometer, Bayer, Diamatrics and Roche represent 80 percent of the market share for this discipline, accounting for an additional $1 billion to $2 billion in revenues. In POCT coagulation, specialty firms including ITC and Medtronic have joined Roche and Bayer to address this $1 billion market. And for cardiac markers, drugs of abuse, chemistry and hematology, vendors including Biosite, Nova and Hemocue have established expertise and market penetration within these disciplines.

io02.jpg (10618 bytes)Enhanced software for Radiometer’s ABL700

Even while “traditional” vendors provide consolidation IA and chemistry platforms in the core laboratory, POCT products have developed along the lines of divergent philosophies, resulting in a mix of platforms and test menus for laboratorians and clinicians to consider. For example, i-STAT offers handheld technology with a broad menu for many applications, while Roche and Bayer have multiple products to address different disciplines. Some vendors, including Lifescan and Hemocue, define their market presence with proprietary products that target single applications.

Given this array of solutions, it is easy to see why in most settings moving laboratory testing closer to the patient is a challenging proposition. Even with the astoundingly swift development of POC connectivity standards and the availability of vendor-neutral data management systems, laboratorians still struggle with implementation scenarios and quality control of tests performed outside their purview. Implementation of POCT also involves a cultural shift in how caregivers perceive their roles within the healthcare system. However, despite the initially cool reception by the nursing community for POCT, recent evidence suggests that critical-care nurses have become more comfortable with the technology, as well as more reliant on the immediacy of results to improve patient care. “Initially, nurses typically view POCT as adding to their already overwhelming workload, ” says Michael Groves, Ph.D. and vice president at i-STAT, Inc. “However, as the unit converts to our system, the staff comes to realize that this change in process allows them to work more efficiently by eliminating the logistics of sample handling, which has a positive impact on the care of their patients.” He has observed other cultural changes, including a more cohesive relationship between the lab and the clinical departments as POC coordinators become more visible in their role as consultants and technology managers.

According to Groves, product acceptance has also been driven by consolidation of a number of tests onto one platform, which impacts ease of use, training, quality control and costs. “We realize the importance of having a platform that would allow us to provide a large, yet scalable range of tests at the point of care. We also strove to develop a simple system that nurses could become immediately familiar with, which is very important when you must train hundreds of people in the operation of new technology.” The company plans to expand its menu with the launch of PT for monitoring Coumadin patients, and the development of kaolinACT for heparin monitoring during open-heart  surgery, as well as cardiac markers.

io03.jpg (9261 bytes)Information management with Bayer’s Rapidlink

Multiple users in diverse settings prompted i-STAT to address early-on the issue of connectivity, which lead to the development of the Central Data Station POC data management system. i-STAT, like other vendors, also has formed a relationship with Medical Automation Systems, a leading provider of POC data management systems, to allow for a bi-directional interface between their analyzers and the vendor-neutral MAS system.

Cost also plays an important part in the adoption of near patient testing. i-STAT has performed several case studies involving hospitals of various sizes comparing costs of near patient testing with the i-STAT system to other stat scenarios. “At first glance, one might assume that POCT is more expensive than performing tests in the traditional laboratory setting because much of the cost of the test resides in supplies, that being the cost of the cartridge. However, compared with the total operating costs of the stat setting, including labor, equipment, reagents and other disposables including blood gas syringes, we’ve been able to show that the hospital can actually reduce costs and improve revenues.” Groves and others suggest that because of the way that the hospitals maintains profit and loss centers in their budgets, it is often hard to quantitate the exact impact of POCT on direct costs, and even more difficult to predict downstream savings that might occur from reduced length of stay in a critical care setting. “The key is to overcome the compartmentalized budget mentality that exists in any organization in order to understand the current cost structure,” adds Groves. Costs also may be impacted by changes in the way that physicians order tests once POC technology is implemented. “Because of logistics, physicians often ordered at prescribed times or intervals. With the availability of POC stat testing, many physicians now order tests only when required, which can actually help to reduce costs,” explains Groves.

While demonstrable cost savings continue to make headlines, simplification and ease of use are real-time features required for almost all POCT settings, and are key components in product development. “A driving force for this market is that these tests are, in fact, critical. And realizing that sampling handling accounts for most of the TAT, many hospitals are moving these tests closer to the patient,” says Patti Eames, director of marketing at Instrumentation Laboratory, which offers the GEM Premier 3000 for blood gas, electrolyte and metabolite testing in the critical-care setting. In POCT settings, healthcare providers are using different skill sets, with the primary focus being the immediate care of the patient. For that reason, says Eames, “we built our system with a focus on simplicity and standardization.” According to Eames, standardizing platforms inside and outside of the laboratory has immediate benefits. “Performing critical-care testing on a standardized platform throughout a hospital reduces personnel training efforts, eliminates correlation issues and simplifies inventory management.” With an easy-to-use system that requires only a change of cartridges to perform different tests, training for the GEM is easily accomplished.

To simplify the process even further, IL will be introducing an additional series of cartridges with an inherent intelligent quality management (iQM) component that will replace the need for daily external QC material. “The downside of extending testing beyond the laboratory is that many times you cannot ensure quality results. Because of workloads, QC checks every eight hours can become a major hurdle for many remote testing locations. With iQM, QC is performed automatically with no human intervention, including corrective action and documentation.” IL also has launched GEMweb, a connectivity solution that allows remote control of GEM systems from a central point of operation, and Web-based access to patient results.

At Bayer Diagnostics, information management and connectivity was a key factor in the development of their critical-care product line. “What we envision for point-of-care testing includes systems that provide laboratory-quality results, are easy to use and maintain, and allow our customers to monitor hospital-wide testing from a central location. The Rapidlink information management system, combined with Rapidpoint or Rapidlab systems, provides the laboratory or POC coordinator with direct access and control of our critical care products,” says John Sperzel, vice president of marketing and business development at Bayer. Instead of consolidation of all disciplines onto one platform, Bayer’s approach to critical-care testing involves optimizing distinct technologies for various applications. “A driving force in the critical-care market is the need for rapid turn-around of results. In terms of blood gases and electrolytes, these needs can be addressed in the central lab, as well respiratory therapy and POC testing sites. We understand that different areas of the hospital have different challenges and different needs, so we’ve developed a broad product offering to address site-specific needs” adds Sperzel.

Moving traditional testing platforms closer to the patient along with a focus on IT integration are cornerstones for Radiometer’s solution to the POCT in critical care. “The definition of point of care is really what makes sense for the hospital. And for most hospitals, this is not a one-size-fits-all proposition. Our company has developed a broad range of solutions to provide STAT analysis in many different settings, from the central lab to CVOR, ICU and the NICU. In a decentralized scenario, the integration of IT is key to this process,” says Alan Beder, senior product manager. Radiometer offers the ABL77, a portable whole-blood STAT analyzer, as well as the modular ABL700 series for use in high-volume STAT applications or where a broader parameter profile is needed. According to Beder, the majority of the 700 series systems in the field are in decentralized locations. These systems can be remotely controlled with the company’s bi-directional Radiance POC data management system. Radiometer also recently released a new software package for the 700 series that allows the operator to consolidate clinical information, such as ventilator data, directly into the laboratory report. The company also has expanded its menu with the addition of whole blood bilirubin for NICU applications.

One of the main propositions of “fast access” to biochemical data in the  critical-care setting is that this information impacts the immediate care of the patient. Imagine a scenario where results from POC diagnostics at the bedside are displayed simultaneously on a flat-panel patient monitor alongside a crashing patient’s physiological parameters, including blood pressure and oxygen perfusion. Imagine this is done with 125 to 200 microliters of blood, within approximately 90 seconds, and all while the physician and nurse are standing by, waiting for the results. This is reality, brought to the market through the Blood Analysis Portal and Philips Medical Systems patient monitors. “POC is an expansion of laboratory expertise directly into the critical-care unit. Laboratory professionals are still in control through information management functionality,” says Deborah Matthews, marketing manager at Philips.

Expanding POCT menus, integration of data with physiological processes, wireless connectivity and technologies for bedside measurement of biomarkers are providing new tools that impact the way in which clinicians care for their critically ill patients. What does this mean for laboratorians? More challenges ahead, as they assume an ever-expanding role in the management of these technologies, test results, and information.

Louise Lazear is a freelance writer based in Charlotte, N.C.