CEO SUMMARY: Is the classic laboratory information system (LIS) morphing into a different information technology product? That’s the observation of one laboratory IT expert, who says that “best of breed” LIS products are becoming productivity tools that support improved clinical performance and give lab managers the comprehensive, real time information they need to closely manage laboratory work flow, including genetic and molecular testing.
PERFORMANCE DEMANDS on laboratory information systems (LIS) are intensifying, yet many products currently in the marketplace lack the full range of capabilities needed to help laboratories keep pace with unfolding healthcare trends.
“Legacy lab information systems are caught within the two jaws of an ever-tightening vice,” observed Gilbert Hakim, CEO of SCC Soft Computer (SCC), in Clearwater, Florida. “On one side is the constant flow of new technology in molecular and cytogenetics testing. This places more demands on existing laboratory information systems than in past years.
“On the other side, operational pressures and the unique needs of hospital laboratory outreach programs are putting equally powerful demands on the existing LIS,” continued Hakim. “Lab administrators need detailed flows of real time data to more tightly manage the laboratory. They also need an informatics solution to drive automation and provide the expanded range of functions required to support an outreach testing program.”
Just two years ago, Hakim made many of the same points in an interview with THE DARK REPORT (see “LIS Market Evolving to Serve New Needs,” May 30, 2005). “However, several key differences between the lab industry in May 2005 and the lab industry today are startling,” declared Hakim. “For example, the menu of tests offered by laboratories continues to increase and become more complex.
Sophisticated Lab Operations
“At the same time, lab managers are becoming more sophisticated in how they operate their laboratories,” he added. “Automation in the laboratory, along with the growing use of quality management methods like Lean and Six Sigma, require more sophisticated information technology.
“One reason so many laboratories are automating work processes and asking more of their laboratory information system is the shortage of skilled labor,” said Hakim. “To remain competitive, and to handle the constantly increasing volume of specimens moving through their laboratory, lab directors must find ways to make their laboratories more productive.
“Automation is one way to achieve that,” he explained. “Information technology can also be used to enhance specific work processes in the pre-analytical, analytical, and post-analytical stages.
“However, in many ways, laboratories are moving faster than their suppliers,” he stated. “LIS vendors are struggling to keep pace with the demand by their laboratory customers for more functionality, more reliability, and better integration of the LIS with the information systems used in their parent hospital or by their office-based physician clients.”
Supporting Lab Outreach
“Laboratory information systems grew out of the need to create a single data base to collect, store, and report lab test data being produced by the host of instruments and analyzers finding their way into laboratories during the 1980s and 1990s,” explained Hakim. “But most of these LIS products were never designed to support a hospital laboratory outreach program or act as laboratory automation software.
“Thus, during this decade, as more laboratories launched outreach programs, installed automated systems to boost productivity, and began to manage laboratory work processes in a more proactive way, their legacy LIS lacked the needed functionality,” he said. “Add to this the steady growth in molecular testing, genetics, flow cytometry, and anatomic pathology—all of which generate substantial quantities of data. The LIS industry has been challenged to keep pace with all the demands of their laboratory customers.”
Watching the changes unfolding in the laboratories of his customers, Hakim has come to view the design and function of LIS in a different way. “In today’s intensely-managed laboratory environment, laboratory informatics has become a productivity tool,” he said. “However, for any laboratory information system to succeed as a sophisticated, robust productivity tool, it needs to be capable of accepting and consolidating data from all the laboratory’s activities.
“This means accepting data from all different types of testing, from routine to molecular testing, genetics, flow cytometry, and anatomic pathology,” explained Hakim. “It also means having the capability to track the work processes in the laboratory, from pre-analytical to post-analytical, including storage and reporting.”
The business strategy at SCC has been to deliver a unified, comprehensive laboratory information system that can support all the lab’s IT needs. “Our goal has been to eliminate the need for a laboratory to go to an outside middleware vendor to get functions and performance that it needs, because its legacy LIS cannot deliver.
“All lab managers are familiar with the challenges,” he continued. “First is the shortage of medical technologists. Without adequate staffing, some labs must send out work to reference labs.
“Additionally, the shortage of technicians causes labor costs to rise, and because the genetics market is booming, some bench technicians are jumping into clinical and research settings for better jobs in genetics and molecular testing, cytogenetics, and flow cytometry,” added Hakim.
Shortage Of Skilled Labor
“As labs lose staff, they are forced to adopt automation and introduce robotics,” Hakim said. “Robotics becomes financially attractive when labs can’t hire enough technicians or processing people.
“Another factor in the acceptance of automation is that sophisticated laboratory information systems are using rules engines to verify results,” he continued. “In the past, every result had to be manually reviewed. Now, 60% to 80% of results that are normal can come from instruments and be posted without staff review because the rules engine validates and releases normal results.
“Robotics and rules engines allow labs to cut the volume of data they need to review,” Hakim noted. “But robotics and rules engines are also forms of automation, which are good for LIS companies. We connect robotics directly and we have a very robust rules engine. What’s more, all errors originating within instruments and robotics, along with patient diagnosis and history, is in one system. Therefore, our rules engine has direct access.
“For labs doing molecular testing and cytogenetics, the big issue is productivity,” he added. “These labs are desperate for automation because they already operating at capacity and yet the volume of specimens continues to increase. The right LIS can allow them to process more specimens, which means more income. And these tests don’t generate $5 or $10 per test. Some genetic tests start at $1,000 and it goes up from there. Genetic tests can be enormously profitable for laboratories.
Outreach Testing Needs
“Over the past few years, hospitals have added to the volume of outreach work they do,” Hakim said. “As volume increases, labs often find that their legacy LIS can’t support many outreach functions. About 90% of large hospitals today have outreach programs. But 10 years ago, only about 20% of large hospitals had outreach programs. They have added commercial outreach testing because they had extra capacity and they had high fixed costs for labor, instruments, and real estate. When they brought in outreach work, the incremental cost they had was for reagents, and that’s peanuts compared with their fixed costs. So, the profit on this outreach work is often more than 50% to 60% on every sample.
“However, with the larger scale of testing comes the need to more closely track and monitor that work as it flows through the laboratory,” observed Hakim. “If the lab’s LIS is inefficient, there is the risk of service breakdowns that could negatively impact inpatient testing and outreach clients.
“That is why any laboratory with a growing, successful outreach program needs a sophisticated and efficient informatics capability,” he said. “Continued growth from outreach specimens frequently motivates hospitals to upgrade their legacy lab information systems. Since the majority of LIS vendors do not produce the software needed to handle the most sophisticated work being done in labs today, that is one reason labs have often turned to middleware sources.
“At the same time that laboratories have become more complex and sophisticated users of laboratory information systems, the LIS product pipeline has failed to keep pace,” observed Hakim. “For instance, some LIS vendors have left the market and have gone into more lucrative areas such as hospital information systems. In other cases, LIS vendors have been acquired.
“These trends have been good for us,” he added. “The strong demand has allowed us to pioneer the development of the sophisticated modules that the market needs.
“For example, during the past three years, the market for molecular testing and cytogenetics has grown steadily,” explained Hakim. “Today, these tests are being done in tertiary care hospitals, in teaching hospitals, larger hospitals, and integrated delivery systems.
“In addition to doing cytogenetics and molecular testing, all of these large hospitals also have anatomic pathology, blood banks, and flow cytometry,” Hakim said. “The sci- entists in these large labs need a single data-base that can consolidate information from all of these different systems. Of course, they want everything at hand from the reporting side and from the diagnosis side. To render a diagnosis, they need all results from the same specimen across multiple departments.
“When the laboratory has an information system that consolidates data from all the different systems and sources, this increases the productivity of the scientists reviewing the information,” he added. “It means that the pathologists don’t need to jump back and forth among the different systems to determine the diagnosis.
“We have examples of well-known hospitals that selected our LIS solutions because our systems eliminate the need to go through separate systems (in pathology, molecular testing, and in hematology, for example) just to assemble the result to render the diagnosis. Our system makes everything available in one view.
“This can have a dramatic impact on productivity, since the most expensive labor is for those top scientists who use information from several systems to make the diagnosis,” stated Hakim. “An LIS that collects all the requisite information can save enormous amounts of time and labor costs.
“But, here’s another important aspect about these systems that is often overlooked in the outreach market,” Hakim added. “Systems that consolidate all the necessary data are saving a lot of time for outreach physicians too. These doctors don’t want to get five different reports for the same patient. They want everything consolidated into one report. They want integrated report modules, and that’s what our system does.
Turning Away Work
“Another dimension to using LIS as a productivity tool is the fact that many hospitals don’t have enough pathologists to handle the steady increase in cases,” Hakim continued. “I’ve seen laboratories turning away work because their pathology department was already at capacity. They have no choice because most molecular and cytogenetics labs are manual.
“In these situations, our integrated LIS can increase capacity because our software consolidates information from all the various departments, including cytogenetics, molecular, and flow cytometry,” he said. “This produces increased productivity at the same time that service to referring clinicians improves.
“I believe the market will be huge for laboratory information systems that can handle all the informatics needs of hospital laboratories, particularly where there is an extensive molecular pathology program and a thriving outreach business,” predicted Hakim. “Labs will see LIS products that collect data across all departments of the clinical and anatomic pathology laboratories.”
THE DARK REPORT observes that Hakim’s description of LIS as a productivity tool accurately reflects the changes taking place in hospital laboratories across the United States today. It marks another step in the evolution of LIS products.