Lab Management

Analyzers faster, simpler in 2010

By Richard R. Rogoski

The start of any new year gives vendors the opportunity to take stock of their industry and to "crystal ball" new trends and development goals. For manufacturers of clinical laboratory analyzers, 2010 promises to be a year when their instruments will be expected to meet the ever-growing and changing demands of labs and lab professionals. According to Luis Tapanes, global marketing manager for the Hematology Business Center at Brea, CA-based Beckman Coulter, the trend is toward faster turnaround times (TAT) and analyzers that are easy to use. Dave Kolesar, ELISA marketing manager at Waltham, MA-based Inverness Medical, explains that labs are looking for analyzers that can process more specimens faster but are simple to operate.

What is fueling these trends appears to be an increase in the number of tests being ordered by physicians, coupled with the shortage of qualified laboratorians. Not only are many laboratory technicians nearing retirement, but there are fewer entering the field, says Ralph Taylor, vice president, marketing and medical affairs at Sysmex America in Mundelein, IL.

"According to the Bureau of Labor and Statistics, the U.S. graduates fewer than half the number of clinical laboratory personnel needed to staff the country’s clinical laboratories. It is reasonable to assume then that the nation’s medical staff technologists’ shortage is not going to change in the near term. Therefore, one can predict that any laboratory procedure requiring manual intervention is an appropriate candidate for automation."

Doing more with less

The buzz words today are "multiplexing" and "automation." Kolesar says multiplexing represents a quantum leap in analyzer development. "With multiplexing, you can look at a hundred different antibodies from a single well." Pointing to his company’s development of the DSX line of analyzers, he says that while a single run is limited to four microplates, there are 70 autoimmune and infectious-disease assays in the analyzer’s menu that can yield 384 patient results from a single batch. Plus, he says, these analyzers feature an open system and use universal reagents.

Another breakthrough for his company is the development of both the AtheNA and AIMS (automated immunoassay multiplexing system). "What we have done is to optimize a large number of assays in order to process the results faster." The company claims, for example, that its AtheNA Multi-Lyte system represents a high-performance step-saving alternative to indirect fluorescent, or IFA, and enzyme-linked immunosorbent (ELISA) assays. It also claims that this multiplexed, fluorescent, bead-based system is designed to perform simultaneous multiple assays from a single sample in one well, thereby providing improved clinical sensitivity and comparable clinical specificity in a labor-saving, automation-friendly format.

Another vendor in the multiplexer market is Beckman Coulter. Tapanes says the Unicel DxH 800 hematology analyzer can also run other body fluids such as spinal-fluid samples. In addition, the DxH 800 is scalable, allowing two or three to be connected. "In this case, you have built-in automation, so you do not need to add tracks." And with the specimen-transport module, there is a handoff between analyzers, he adds. Additionally, the integrated software and data-management system allows results from connected analyzers to flow into a single, consolidated database.

The buzz words today are “multiplexing” and “automation.”

This new analyzer also can run up to 100 CBC differentials per hour and has a feature that automatically repeats any specimen test necessary, Tapanes says. Part of Beckman Coulter’s innovation process also has led to a standardization of software so that the operating system, with its touch-screen capability and intuitive icons, is the same for hematology or chemistry analyzers. Tapanes says slide making will soon become easier. "We have automated the process of making slides. Doing cell counts is still a manual process, but we have focused on the extended differential." Still in development, this product will use the DxH platform to automatically count and classify cells.

Software development is becoming increasingly important in the multiplexing and automation fields. "We are getting ready to release a software package to go with our glucose and lactate analyzer, the YSI 2300," reports Jamie Lussier, product manager at Yellow Springs, OH-based YSI. The new software will configure data from the analyzer into a spreadsheet so test results can be analyzed at a workstation," Lussier says.

Although he does not foresee many breakthroughs in the glucose analyzer field, Lussier says the complexity of analyzers, in general, needs to come down, including the methods used to calibrate and recalibrate instruments. "You need to make sure the operation is as simple as possible," he says, adding that in many of today’s hospitals, nurses — not certified lab techs — are being asked to run the equipment.

Key to simplifying and automating procedures was the development of the Bioplex 2200, says Ginger Weeden, the analyzer’s senior product manager at Hercules, CA-based Bio-Rad Laboratories. Launched in 2006, the Bioplex 2200 is a fully-automated multiplex platform that analyzes multiple disease markers from a single patient sample. Weeden said her company is currently adding more reagents for this analyzer and working toward being able to use whole-blood specimens. Using the Bioplex 2200 as an example, Weeden says using multiplexing and automation technology allows the analyzer to run 12 different tests in one reaction vessel using only a 5-microliter sample. And since the laboratory information system (LIS) tells the lab tech what the physician ordered, all the tests in the reagent pack are performed, and the results of only those tests are released to the physician. There is a caveat, she says. "As we automate traditional assays, there are others being introduced. So, it is difficult to keep up with what will come next."

Looking ahead

Keeping up with technological advances also means planning for the future, says Taylor. "We see analyzers with greatly expanded reporting capabilities but without additional costs and complexity. For example, the Sysmex RET-He (reticulocyte hemoglobin equivalent) is an established parameter that is recognized by the National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative guidelines. RET-He directly measures the mean hemoglobin content of red blood cell precursors (reticulocytes) and assists with early recognition of functional iron deficiency — critical when caring for patients with end-stage renal disease, a common and costly diagnosis," he says.

Sysmex’ seven-part differential (a traditional five-part differential plus nucleated red blood cells and immature granulocytes), offers automated parameters that assist physicians with disease management of anemias, leukemias, platelet anomalies, infections, and bone-marrow transplants," he continues.

"These newer parameters have been enabled by the use of fluorescent flow technology — by quickly permeating, tagging, and optically measuring light transmission and scatter in circulating cells to more finely discriminating cell types."

Advanced software also is crucial, he says. "Clinical laboratories will look to middleware to fill important needs such as autovalidation and improved TAT, enterprise-wide solutions and single-source data management and storage." Bio-Rad’s Weeden agrees that software upgrades are needed.

While most manufacturers tend to guard their own research and development efforts from others, Sysmex and Bio-Rad have entered into a collaborative agreement, says Taylor. "In a recently released article, the American Diabetes Association has recommended the use of HbA1c in the diagnosis of diabetes. In aligning with the nation’s new present-on-admission, or POA, healthcare initiatives for evidenced-based, patient diagnosis on admission, and in keeping with healthcare reform’s overall aim to cut cost while improving efficiency, Sysmex and Bio-Rad have collaborated to introduce an ‘island’ that automates diabetes and hematology testing.

This first-of-kind solution combines the Sysmex HST-N hematology automation platform and the Bio-Rad Laboratories’ VARIANT II TURBO Link, which enables automated, on-demand, diabetes testing in a random-access setting. This integrated testing solution points to an emerging trend toward clinical laboratory automation and testing/platform integration or ‘islands of automation,’" he continues.

Traditionally, automation involved consolidation of testing platforms from ‘like’ disciplines within the core laboratory (e.g., chemistry/immunochemistry). This trend is re-emerging with a new ‘twist’ that involves quality-testing areas across disciplines (e.g., HPLC HbA1c testing [chemistry] with hematology [CBC differential, reticulocyte count], and driving both data and sample management through ‘intelligent’ software."

Sysmex has been developing its own line of products independently. "The Sysmex XE-2100D automated hematology analyzer was recently cleared by the Food and Drug Administration (FDA) for use in blood-processing centers for quality-control release testing. The system will be used to test post-processed red blood cell and platelet components collected using a variety of anticoagulants," Taylor says.

Another recent development was the release of what the company calls lavender-top management, "which enables laboratories to realize virtually hands-free analysis of the lavender-top tube, providing >90% of tests compatible with EDTA samples (i.e., erythrocyte sedimentation rate, or ESR, CBC differential, reticulocyte count, Hb A1c, and other esoteric tests) through sample re-routing and archiving, with as little human intervention as possible."

According to Taylor, the benefit of this system begins with reduction of draw volume and the avoidance of sample splitting and aliquoting, where a single tube can be used to analyze >90% of high-volume tests offered within the core laboratory, such as CBC differential, reticulocyte count, ESR, sickle screen, and Hb A1c. "With reduced draw volumes, laboratories and hospitals can improve quality and provide higher levels of service and efficiency to their patients," he says.

Facing challenges

There are a number of challenges facing analyzer developers, aside from the shortage of qualified laboratorians. According to Rich Bohlmann, senior instrument product manager for ELISA at Inverness, cost has become a major challenge. "Labs cannot afford to acquire these new instruments because of their prices," but he points out that design and development costs and those associated with quality control and regulatory compliance need to be figured in when discussing the final cost to customers.

Murray Rosenthal, PhD, manager of reagent technology at Alfa Wassermann in West Caldwell, NJ, says another challenge is the time and effort it takes to get a new analyzer through the FDA’s regulatory process. He also says the industry needs to work on standardizing analyzers so that those from different manufacturers yield the same results. He would like to see is the establishment of a central laboratory that sets gold-standard certifications. "But," he notes, "there has to be some kind of coalition. Maybe the American Association for Clinical Chemistry could take the lead and bring manufacturers together."

Taylor at Sysmex sees yet another challenge: a shift in diagnostics. "The role of the clinical laboratory in the care pathway has become increasingly important, as hospitals nationwide brace for tougher regulatory oversight aimed at quality and cost transparency," he says. "The restructuring of diagnosis-related groups (DRGs) to medical-severity DRGs used in the inpatient prospective payment system and the new POA requirements will impact how hospitals code patients and, consequently, the way in which hospitals are reimbursed. This, coupled with an aging population, increasingly complex cases, and diminished human and financial resources, makes accurate patient diagnosis and instrument capability critical elements to adequate reimbursement and hospital survival. "As we shift from the use of traditional diagnostics to the use of additional, personalized disease diagnostics and treatment, the value of laboratory testing in healthcare will continue to grow."

Richard R. Rogoski is a freelance journalist based in Durham, NC. Contact him at rogoski@aol.com .

Gearing up for the automated lab

By Richard R. Rogoski

The increasing number and complexity of tests needing to be run in today’s clinical laboratory, coupled with a shortage of qualified laboratorians, helps bring more automation to the bench. Other factors also are having an impact, says Pete Manes, vice president of sales at Troy, MI-based Integrated Laboratory Automation Solutions. Manes points to concerns about patient safety, a push to reduce errors, and financial constraints as contributing to the automation trend. "In order to survive, labs need to automate," he states.

Pete Van Overwalle, group marketing manager for lab automation at Roche Diagnostics in Indianapolis, IN, says, "The evolution in lab automation over the past decade has been driven by the lab’s need to reduce complexity and increase flexibility. Those factors will continue to drive future innovation in lab-automation systems. For example, we will see increased integration among instrument systems, middleware, and the LIS, with enhanced functionality to cover gaps with information flow from bar-coded primary samples to multiple aliquot tubes. As labs pursue more aggressive outreach programs, their automation systems will likely have to accommodate different types of sample tubes and caps. Finally, there is an increasing trend for labs to link additional types of instruments, such as coagulation or hematology analyzers, to automated platforms.

"A large part of the evolution in automation is due to increasing economic pressures and the changing nature of the lab’s business," he says. "For example, until the recent economic downturn, many hospital labs were experiencing an increase in testing volumes because they are being viewed as a new source of revenue for the health network. Their outreach programs provided a substantial and fairly quick return on investment. Another factor driving the evolution in automation is the labor shortage, which requires labs to make their processes ‘LEANer’ — which is an effort to remove non-value-added tasks in order to focus more on what the customer is actually willing to pay for.

"Automation can help labs address both issues by enabling them to expand their capabilities without necessarily having to hire more people," he continues. "An effective automation system can eliminate the need for highly skilled med techs to be performing the repetitive, manual tasks that other staff can do — which frees them up to be performing the high-level diagnostic analysis that other staff cannot do — and, thus, the lab can handle a higher volume without increasing staff. By matching the right kind of person to the right kind of job, the lab can improve both the efficiency and the profitability of its operations. With labor accounting for roughly 65% of the operating expenses in a typical lab, those improvements can make a significant impact on the bottom line."

From hardware to software

Manes says his company developed a track system consisting of a process-control software that uses specimen-specific data from the LIS, and the track hardware on which the specimen travels from analyzer to analyzer. While not the only track system on the market, Manes says the Lab Automation Efficiency Series is an open system, which allows it to interface with instruments from different vendors as well as with a wide variety of laboratory information systems. Because its track is 36 inches wide, the system can accommodate wider containers, he adds. The system also allows the lab tech to remove any specimen from the track and run it manually on any analyzer, then return it to the track.

The ultimate in automation is the robot. While they do not look like the type of robots most people envision, the AutoSorter II and AutoSorter III from Motoman in Irvine, CA, do qualify as robots, says Craig Rubenstein, the company’s life-science technology leader. Rubenstein, however, is quick to assuage the fears of most lab techs. "We are not heading toward replacing lab techs with robots. We are automating the mundane, repetitive tasks so lab techs can do important work."

AutoSorter II (designed for high-volume reference labs) and AutoSorter III (for moderate-volume hospital labs) are flexible specimen-processing platforms whose specimen grippers can handle tubes within a 7-millimenter diameter range and a 40-millimenter height range. A reader mounted on the gripper reads bar codes as the tubes are rotated within the grippers. Specimen loading and unloading is managed by continuous-flow conveyors.

Roche also is developing new products aimed at specimen tubes, says Van Overwalle. "Roche is planning to launch the cobas p 501 and cobas p 701 post-analytic storage units," he says. "These are high-capacity systems with a relatively small footprint that automatically store and retrieve bar-coded sample tubes to and from an environmentally controlled, refrigerated storage space. They can be customized to automatically dispose of samples after a pre-determined period of time, and they are fully integrated into the LIS, which means they deliver a sample automatically when a re-run or re-test is ordered.

"They are designed to connect directly to Roche pre-analytics and analytics, giving the lab comprehensive automation for the entire sample-management process, from receipt of the patient sample to automated disposal," he continues. "This helps eliminate manual labor tasks and can reduce the time it takes for sample retrieval, which in the average lab could be 20 minutes or more. It also helps prevent quality degradation of the sample by sending tubes into storage within minutes of being aliquoted."

According to The Binding Site’s Faranak Atrzadeh, marketing manager for serum proteins, "Laboratory testing continues to move toward automation on larger analyzers for higher throughput, ability to run more variety of assays, and better accuracy. This trend includes the migration of nephelometric and turbidimetric testing to big chemistry analyzers as well. However, the challenge in transitioning to large analyzers is that not all the assays can be switched over to these platforms. An example is Serum Free Light Chain (sFLC) assays which are used for assessing monoclonal gammopathies such as Multiple Myeloma and AL Amyloidosis. Currently, sFLC assays are run on many automated nephelometric and turbidimetric instruments which are getting old and most likely will not be supported going forward. This presents a great opportunity for the SPAPLUS system in labs to run the sFLC assay. sFLC is a rapidly growing test. We recently introduced Hevylite in Europe which includes assays specific for IgA kappa/IgA lambda. The goal is to automate these assays on the SPAPLUS. We foresee the use of sFLC and Hevylite tests to be important and critical diagnostic tools to clinicians in assessing multiple myeloma and AL amyloidosis and managing patients with B cell dyscrasias."

Work yet to do

While Rubenstein applauds advances in automation, he says work still needs to be done in the area of data management in order to achieve true connectivity between systems. "We have written middleware to allow our systems to connect to other systems and LIS," he says."

Another area that needs work, according to Van Overwalle, is addressing misconceptions about automation and efficiency. "There are two common mistakes that labs can make when they try to use automation to boost their efficiency," he says. "The first is the unintentional attempt to automate a bad process. The right way to approach it is to first look at the lab’s processes and see if there are wasted efficiencies. For example, the lab might be able to streamline its workflow by standardizing its tube types. This is where the lab can adopt LEAN techniques to study its workflow and identify potential sources of wasted efficiency, such as process delays, hand-off points, and other process gaps.

"The second common mistake is to assume that implementing automation in the lab will make every result come out faster. While the average TAT typically drops, it is due to the reduction of the outliers on the upper end. What automation does do is to provide a more consistent and predictable TAT. Like most other processes, diagnostic-testing TAT falls into a bell curve. The outliers on the upper end — in other words, the unusually long test times — are what skew the curve up. Automation helps eliminate those outliers on the upper end and bring the average test time down. That does not necessarily mean every test will come out faster, but a reduction in the average TAT is a more significant factor in terms of the impact on the lab’s overall profitability and customer satisfaction. Labs that implement automation successfully enjoy the benefits of a highly predictable workflow."

So, what should labs do? "The single biggest piece of advice I would give to someone looking to boost overall laboratory efficiency is to look at boosting efficiency as a two-step process," Van Overwalle recommends. "The first step is to make sure your lab has a LEAN workflow. Look at your processes, and evaluate to see if there are wasted efficiencies. The second step is to look at automation solutions to standardize your lab’s operations and eliminate wasted labor.

"Remember that not all automation solutions are created equal. Make sure you carefully consider the product-quality aspect of the proposed solution. For example, ask about ‘mean time to failure’ metrics so you can evaluate the potential for interruptions from unplanned downtime. Overall, the best automation system for your lab is one that is reliable and flexible enough to accommodate your changing needs. This will allow you to reduce complexity, enhance your level of patient care, and facilitate your financial growth."

Richard R. Rogoski is a freelance journalist based in Durham, NC. Contact him at rogoski@aol.com.

Elevating patient care at University of Michigan Hospital

By Sue Stern, MS, MT(ASCP)

At a busy tertiary-care academic center where the clinical lab churns out 8 million test results a year — 7 million just in chemistry and immunodiagnostics — effective deployment of automation and information technology to maximize productivity and cost efficiency is a given. Such is the case at the University of Michigan Hospital (UMH). At the chemical pathology department, productivity gains are only part of the story. Indeed, the lab has been able almost to double its volume over a period of almost four years, without adding staff or instrumentation. Just as important are quality improvements that have made a positive impact on patient care. From 2004 to 2009, the number of errors was reduced by half while volume almost doubled. Turnaround time also kept dropping. Today, 97.3% of in-patient STAT samples are delivered within the targeted TAT of 45 minutes, while 99.8% of routine samples are on time for the 120-minute goal. Last but not least, the lab was able to reduce the number of SST tubes per patient, by as much as 60% in the outpatient area — a welcome change that benefits patients and their caregivers.

Powering productivity through workflow design

Chemical pathology at UMH provides chemistry, special chemistry, immunology, and toxicology testing services for all three hospitals on campus, with a total of 865 beds and 1,600 physicians, as well as 30 health centers and 120 outpatient clinics within a 60-mile radius. To accommodate the consistent annual growth rate of 3% to 5%, a mix of inpatient and outpatient, STAT, and routine testing needs, the lab designed and implemented a new automation line in 2006, including three immunoassay systems, three chemistry systems, two centrifuges, and two sample managers that handles 100 different chemistry and immunoassays, all managed by networking solution. Six instruments took over the workload of eight analyzers used prior to the redesign and have supported the volume growth over the last four years. Today, the automation line runs 24/7.

Automating previously manual tasks: The networking solution can be programmed to execute tasks that are often performed manually. At UMH’s chemical pathology lab, it handles automatic repeat testing for some tests. The lab also takes advantage of specialized algorithms for infectious-disease testing; for example, when duplicates of hepatitis or HIV tests are required, the system will run the duplicates automatically. This saves technologists time since, by the time they review the results, the necessary dilutions and/or repeats have been performed already. Similarly, when there is an add-on, the system will locate the patient sample on the automation line with no manual intervention, run the test, and report the result (or flag it for technologist review as appropriate). Turnaround is faster since there is no delay waiting for the technologist to locate the specimen.

For labs looking into lab-informatics solutions, the starting point is a list of what the lab wants to accomplish.

Autoverification streamlines results reporting: With autoverification, each result is classified based on criteria programmed into the system, flagging only those results that require technologist review. This means there are fewer results to review — at UMH, 80% of test results are reported directly without technologist review. It also means that the same rules are applied, consistently, to review the results.

A backup for the LIS: When the LIS is down, the networking solution provides a computerized backup, alleviating delays.

Measurable gains in quality care

Even more important than the improvement in productivity is the impact of automation and information technology on patient care.

Improved TAT expedites clinical decisions: Auto-verification and the automation of typically manual processes have reduced manual steps and decreased TAT. Routine samples classified as "on time" based on the 120-minute goal increased from 98.4% in August 2007 to 99.8% in August 2009. Using a 60-minute benchmark for all STAT samples, on-time STAT-sample TAT increased in the same time period from 89.9% to 99.8%. Furthermore, inpatient STAT samples meeting a 45-minute goal advanced from 66.7% to 97.3% in the same period, while 95.6% of outpatient STAT samples were reported within the 45-minute goal, compared to 77.6% two years ago. TATs such as these support timely clinical decisions and specific clinical guidelines in some cases.

Delta checking by both absolute value and percentage is important, as is quality control (QC) and the ability to stop results if QC is out.

Reduced error rates enhance patient safety: Error rate is an important benchmark of quality and safety. At UMH, standardization of the results-review process, automation of error-prone manual tasks (e.g., locating specimens for add-ons), and the reduction of the number of results requiring staff review have contributed to a reduction of the number of reported errors.

Fewer blood draws: The consolidation of more than 100 different tests on the automation line has significantly reduced the number of SST tubes required. In the past, for example, a basic profile, lipids, and thyroids might require three different blood tubes. Now, only one tube is needed. In the outpatient group, this means a 60% reduction in number of SST tube draws.

Pointers for middleware evaluation

For labs looking into lab-informatics solutions, the starting point is a list of what the lab wants to accomplish. In the case of UMH, considerations such as reducing staff stress and handling the ever-increasing volume were the primary concerns. And middleware needs should be reviewed in the context of the current LIS, with the goal of complementing LIS capabilities. With autoverification, one important feature to look at is the ease of rules writing and the flexibility to build rules, as needed, for special circumstances. Delta checking by both absolute value and percentage is important, as is quality control (QC) and the ability to stop results if QC is out. Technical support is a factor, as is the vendor’s commitment to product enhancements on an ongoing basis.

Sue Stern, MS, MT(ASCP), is administrative healthcare manager in the Chemical Pathology Department at the University of Michigan Hospital in Ann Arbor, MI. From Siemens’ ADVIA line, Stern used its LabCell Automation Solution, three Centaur Immunoassay Systems, three 2400 Chemistry Systems, and the CentraLink Networking Solution.