Just 5 years ago, the prospect of total

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1 F E A T U R E By Terri Yablonsky Stat, MA Laboratory Just 5 years ago, the prospect of total laboratory automation, a system in which all steps of the process are automated as opposed to just front-end automation, set many imaginations soaring. Administrators hoped to cut their bottom line by improving laboratory efficiency and quality. Technologists envisioned being freed from mundane parts of testing to focus on more challenging tasks. Technology Catches Up But Is Slow To Catch On In some laboratories, fantasy is now reality. Automation systems are performing routine tasks faster and with fewer errors. Patients, providers, laboratories, and health systems are reaping the rewards of reduced turnaround time (TAT), decreased cost per test, fewer errors, increased testing capacity, and greater productivity. But oddly enough, automation technology has been slow to catch on. Automation Boon or Bust? Photographs throughout this article have been provided by Beckman Coulter, Inc, Fullerton, CA. Section 3 Features JULY 2000 VOLUME 31, NUMBER 7 LABORATORY MEDICINE 3 6 9

2 At St Mary s Hospital Laboratories in Montreal, Quebec, preanalytic specimen processing is the most labor-intensive portion of the testing process. The 414- bed, acute-care hospital improved productivity by 17% in just 3 months by automating this process with the Beckman Coulter Power Processor. Mt Sinai Medical Center in New York processes approximately 4,000 specimens per day, with a future capacity of more than 25,000 specimens per day. Automation Sizzles Onto the Scene Only 35 to 40 laboratories in North America have some level of automation, says Rodney S. Markin, MD, PhD, professor of pathology and microbiology at the University of Nebraska Medical Center in Omaha. That s a lot less than we d hoped for 5 years ago, he says. One reason for the lackluster growth is the high cost of laboratory automation systems, which just a few years ago cost $5 million to $8 million a system. Laboratories that invest in automation systems need a large volume: around 2 million tests per year. Consequently, only a handful, such as commercial laboratories and large hospitals, can benefit from a large system. When people heard the historic cost of some large systems, the perception arose that the technology was too expensive, Markin says. But today s automation systems may cost $500,000 to $2.5 million, depending on the components a laboratory selects, says Markin. It s a significantly smaller number and more affordable. Some institutions chose not to buy new technology or to implement systems until after January 1, 2000, to avoid Y2K problems. Many institutions directed so many resources toward avoiding potential Y2K problems that they couldn t handle acquisitions of new technology, Markin says. Others agree that automation in the United States has lagged behind the success of Japan, which has installed more than 100 systems since 1979 and serves as a model for laboratory automation. There s been some reticence in the industry to move to automation, says Robin A. Felder, PhD, professor of pathology at the University of Virginia Health System, Charlottesville, and director of its Medical Automation Research Center. Felder is president and founder of the Association for Laboratory Automation in Charlottesville, VA, and editor of its journal. We re about 3 years behind what I predicted, Felder says, because many laboratories became focused on justifying the purchase of [total laboratory automation (TLA)] with substantive data showing its value. However, the investment in TLA is simply out of reach for many smaller hospitals. Some laboratories are opting for modular automation alternatives, Felder says. Modular automation consists of discrete automated work cells that support specific laboratory processes, such as front-end specimen processing or automated hematology or chemistry results production. Automation, it was hoped, would trim labor costs. According to Felder, the cost-effective automation systems in the United States have reduced staff by up to 20 full-time equivalent positions. That s nowhere near the savings experienced in Japan, which is better at standardizing every aspect of the process from phlebotomy to reporting, he says LABORATORY MEDICINE VOLUME 31, NUMBER 7 JULY 2000

3 Life in an Automated Laboratory From a Technologist s Point of View Susan Kokensparger, MT(ASCP), works the afternoon shift in an automated chemistry laboratory at Aultman Health Foundation, a 600-bed hospital in Canton, OH. Her laboratory purchased the LAB-Frame (LAB InterLink, Omaha) in May Kokensparger experienced the transition alongside 25-year veterans. It was exciting, she says. We were one of the first in the country to have this robotic system. The lab had to compromise, however, because undergoing automation meant losing half the staff. The system runs chemistry, immunoassay, and hematology, as well as routes specimens for additional testing. I come in each afternoon and find specimens missed from the day shift due to problems with the bar code readers, and I make sure that reagents on the machine are still working, Kokensparger says. As specimens sample from the track, she verifies results in the lab computer and performs necessary dilutions. In the US, we have too many nonstandard specimens to be able to easily and affordably automate the process, Felder says. However, sites that have made careful, informed purchasing decisions have experienced returns on investment of approximately 3 years. Return on investment is the driving force behind most systems purchased today. Many people believed automation would save laboratories significant money. After all, Japan operates with far fewer staff than US laboratories of similar size. With proper planning and a willingness to alter current processes, Markin says, a facility can realize a payback of its investment in about 3 years. Markin believes laboratory automation will continue to evolve. Since 1995, the cost has dropped dramatically, and now that Y2K issues are resolved, I believe we ll see significant purchases of automation technology in The cost is down, the technology is better, and Y2K is over. Kokensparger spends more of her time performing quality control on the instruments. We look at patient results, things that don t look right. We do much more interpretation. It s a challenge, and I think we re a step ahead of everybody. She and her colleagues encounter hardware and software problems, she says. When it works, it s the best thing in the world, but when it doesn t, it s stressful. You have to spend time on the phone with technical support and can t work. If the system is down for any length of time, priority and stat specimens can still be run on the system s front end. Automated systems start with a central computer. Kokensparger had worked with laboratory computers but not with a PC. It was rough at first, she says, but after some on-the-job training, I m comfortable working on a PC today. l Felder is less optimistic. There s been little money in everybody s budget to buy all modules at the same time, so people upgrade their systems piecemeal, he says. Problems arise in linking the modules. Conveyer belts have been effective, he says, but are difficult to install. A bigger issue is whether to retain the central laboratory concept at all. According to Felder, point-of-care (POC) testing is beginning to provide affordable alternatives to centralized laboratory testing. In the future, we will dismantle core labs and start using a greater percentage of POC testing, he says. Section 3 Features JULY 2000 VOLUME 31, NUMBER 7 LABORATORY MEDICINE 3 7 1

4 Preparing Your Laboratory for Automation Successful automation requires understanding the challenges of laboratory architecture and engineering. Structural Capacity Most hospital structures are designed to accommodate the structural loads imposed by new automated equipment. The Building Officials and Code Administrators building code requires hospital laboratories to be housed in structures capable of supporting at least 60 pounds per square foot without appreciable stress. Live-load capacities of 80 to 100 pounds per square foot are adequate for most laboratory installations. It s important to verify the load capacity of the floor system in any space about to be converted to a laboratory, because codes often allow lesser load capacities for private rooms and wards. Similarly, equipment that imposes concentrated point loads of more than 1,000 pounds can produce loads that exceed the code minimum design standards and will require verification of the load-bearing capacity of the floor system. Minimize Vibration Because most clinical laboratories use sensitive microscopes, vibrationdamping requirements should already be met in existing laboratory spaces. However, when relocating a laboratory, avoid locations near major vibration sources such as mechanical rooms or elevator machine rooms. Plan for Flexibility Large open laboratories with limited fixed benches around the periphery offer the greatest flexibility for new analyzers and techniques. Develop a plan that maintains the separation of primary reagent, waste, and sample flows and allows for expanding and revising building systems without disrupting spaces outside the laboratory. Consider flexible wiring and data management strategies, with ample room for expansion. In addition, the laboratory air conditioning system must be designed with enough cooling capacity to accommodate future equipment. The plan should accommodate utilities such as flexible deionized water lines, waste lines, and materials-handling equipment. It should allow for new systems and the rearrangement of existing systems. Staff should be able to move safely through the laboratory. There should be a means for disconnecting and reconnecting equipment from waste and water supply lines without major disruption.l Alexander K. Wing, RA, is an associate and project architect with Burt Hill Kosar Rittelmann Associates in Butler, PA. Felder predicts an explosion in the prevalence of POC analyzers that will change the landscape of laboratory testing, he says. Several groups, including ours, have demonstrated that POC testing costs about half as much as core laboratory testing. POC will replace the need for laboratory automation in many cases. But in the near future, automation will hold its own. We ll see far more front-end systems, Felder says. Preanalytical processors are almost versatile and fast enough to significantly impact the most labor-intensive and error-prone part of laboratories. Is There Room for the Medical Technologist? One misunderstanding was that automation would make the medical technologist extinct, Markin says. But this isn t so, he says. As automation is implemented, technologists will be employed in areas that need human intelligence and interpretative skills, such as microbiology, molecular biology, and blood banking. Markin isn t worried about technologists having enough to do. Each time we develop a new hightech approach to health care, there s a significant laboratory component, he says. I hope that the implementation of automation technology gives technologists a chance to use their skills in new and challenging ways to eliminate mundane tasks and do the fun stuff. Technologists are being reassigned to different areas of the laboratory, Felder says, but not as many as he expected. Even in automated laboratories, he says, technologists are necessary for handling exception samples. Some are being trained to service and operate automated systems. Only those who are unwilling to adopt the new technology are having a difficult time, he says LABORATORY MEDICINE VOLUME 31, NUMBER 7 JULY 2000

5 Still, some institutions have reduced core laboratory staff. Displaced technologists are performing phlebotomy, interpreting results, and conducting research. They may also help physicians and nurses understand the role of the laboratory, Felder says. They are our best ambassadors, and we must find roles for them as information specialists. A Seamless Operation The Mount Sinai Hospital Center for Clinical Laboratories Ask Elkin Simson, MD, whether he s pleased with his totally automated laboratory, and he ll say that once everything s in place, he ll be very pleased. Simson, medical director of The Mount Sinai Hospital Center for Clinical Laboratories in New York, leads the team that recently implemented one of the largest and most comprehensively automated laboratories in the world. The Mount Sinai Hospital is an 1,170-bed full-service tertiary care university hospital in Manhattan. The automated core laboratory now processes 4,000 specimens per day, with capacity to handle more than 25,000 specimens per day with no additional equipment. The laboratory is open 24 hours a day, 7 days a week, with 11 technicians and supervisors per shift. When the system was installed in 1998, the goal was to reduce costs and improve quality. Because of the test volume generated by the hospital and the potential for more tests from the Mount Sinai Health System, the team chose TLA and the IDS system (Beckman Coulter, Fullerton, CA). The system consists of 5 automated robotic tracks 1 each for hematology, coagulation, and urinalysis, and 2 identical tracks for serum analyses. Tracks move specimens from the time of receipt to sample preparation, including serum separation, then to automated analyzers on each track, and finally to storage areas. The automated core laboratory performs hematology, coagulation, and urinalysis, as well as chemistry, immunoassay, serology, endocrinology, and therapeutic drug monitoring. Of the specimens received, 65% are inpatient, 20% are outpatient, and 15% are from outreach programs. Elkin Simson, MD, medical director of the Mt Sinai Center for Clinical Laboratories, with a portion of the Beckman Coulter total lab automation system recently installed by Mt Sinai Hospital in New York. The system greatly improves testing and reporting, while also enhancing worker safety. A state-of-the-art laboratory information system (Soft Computer Consultants, Clearwater, FL) controls the operation of the automated system. Physicians may access results from any hospital desktop workstation, as well as from their medical center offices, remote offices, and homes. The automated core lab has greatly improved speed of testing and reporting of results, Simson says. It provides enhanced accuracy of analysis, reduces specimen identification errors, improves efficiency of operation, provides greater capacity, and increases worker safety, all at reduced costs. We re accomplishing what we set out to do. Staff is being reduced by 25% to 40% over 3 years. Staff now devote more time to quality control by verifying results and evaluating results that do not appear to be valid. We have fewer technologists and technical staff transporting specimens in the laboratory and doing mundane tasks such as aliquoting and specimen relabeling, Simson says. The new system improves worker safety, because specimen tubes are untouched by human hands once they are placed on the line. In addition, the hospital is now using plastic tubes, rather than glass, to reduce the chance for injury. Section 3 Features JULY 2000 VOLUME 31, NUMBER 7 LABORATORY MEDICINE 3 7 3

6 Laboratory information systems (LIS) at St Mary s Hospital Laboratories in Montreal, Quebec, provide a seamless process in line with automation. Ralph Dadoun, MBA, oversees the laboratory at St Mary s Hospital Center in Montreal as administrative director of Diagnostic and Pharmaceutical Services. Dadoun was able to increase test volume by 25% without a staff increase, while cutting costs, by implementing frontend automation. Simson says the system needs some upgrades and improvements. Plans are in place to improve patient identification by implementing bar coding on the patient floors. The bar code on a patient s wristband and the specimen tube label must match before blood is drawn. Front-End Automation Some laboratories automate the preanalytic parts of testing. Front-end, or preanalytic automation, removes the most labor-intensive and redundant tasks of the process, such as sorting samples, loading and unloading the centrifuge, decapping tubes, and sorting samples to the appropriate analyzers. This part of the process accounts for 60% of laboratory labor costs. Ralph Dadoun, MBA, vice president of corporate and support services at St. Mary s Hospital Center in Montreal, Quebec, Canada, oversees the core laboratory of this 414-bed acute care facility that implemented front-end automation in October 1998 (Beckman Coulter s Unisyn system). Prior to implementing automation, Dadoun and colleagues revamped St Mary s laboratory to deal with budget cuts and an increase in test volume when nearby hospitals closed. The facility evolved from a noncomputerized traditional department-based laboratory to a fully computerized core laboratory. The transition to the core laboratory was intended to streamline the process and to standardize procedures before implementing automation. We increased our volume by 82% and decreased staff by 15% once we went to a core lab, Dadoun says. Two years later, they implemented automation. The system consists of an 18-foot linear track with an inlet unit, a centrifuge, a decapper, and an outlet unit. It can process 300 specimens per hour. Within months, workload efficiency had increased by 17%, as measured by the College of American Pathologists Laboratory Management Index Program. The laboratory operates 24 hours a day, 7 days a week, and processes 2,200 specimens per day. The greatest benefit of front-end automation, Dadoun says, is the consistency of the TAT from the time the tubes come into the laboratory until validation of results. In stat chemistry tests, the TAT decreased from 35 ± 23 minutes to 25 ± 6 minutes. The longest response decreased from 81 minutes to 37 minutes. Daily phone calls from physicians waiting for stat results decreased from 28 to fewer than 5. The decreased variability in TAT and its consistency are among the most important aspects of automation, Dadoun says. It means the doctors waiting for results are getting them much faster and with fewer mistakes. Future plans include increasing volume by at least 30% while continuing to reduce labor costs. We re far from having reached our peak, Dadoun says.l Terri Yablonsky Stat is a freelance writer in Evanston, IL LABORATORY MEDICINE VOLUME 31, NUMBER 7 JULY 2000