By Louise Lazear

     Laboratories have relied upon laboratory information management systems (LIS) for more than twenty years to help automate and track operations. With the development of new assays and point-of-care testing, laboratory workloads have increased in the face of a shrinking workforce and growing regulatory burdens. At the same time, some laboratories must shoulder the additional burden of using an LIS that does meet the needs of the current business environment. For example, the expansion of laboratory outreach programs and the potential for direct access testing have propelled the need for web-based order entry and results reporting. Also, healthcare quality improvement initiatives utilizing clinical decision support systems require that laboratory data from all sources be moved into the hospital information system. To help laboratorians address these issues, LIS vendors now offer products designed to create workplace efficiencies as well as integrate laboratory data into enterprise-wide information solutions.

io01.gif (14919 bytes)
graphic courtesy of Jay B. Jones, Ph.D. DABCC, Geisinger Health System

    As a mature market, sales of new LIS usually target replacement of existing systems that do not meet requirements for functionality or accessibility to data. LIS are also replaced as healthcare facilities revamp their IT infrastructure to move toward an electronic medical record (EMR). Major LIS vendors include Meditech, Inc., Misys Healthcare Systems, Cerner Corporation, McKesson Corporation, SCC Soft Computer, Siemens Medical Solutions Health Services Corporation, Creative Computer Applications, Inc., and Triple G Systems Group. “We believe that this market is pretty well saturated, and is a replacement market at this point,” said Ralph Reyes, Jr., MT, and senior vice president at KLAS Enterprises, a research and consulting firm specializing in monitoring the performance of healthcare information technology providers, including LIS vendors. Based upon input from over 3500 healthcare providers that voluntarily submit objective ratings, KLAS monitors and reports the performance of about 200 vendors and 300 different products. According to Reyes, despite market saturation some new entrants have made suprising inroads, including Triple G Systems, Molis (France) and NetLIMS (Israel). What clients look for in an LIS product varies, but integration seems to be emerging as the primary criteria. “From the CIO’s perspective, a key strategy is to achieve integration in order to provide clinicians with all data to give them the best possible view of their patient’s condition. From the laboratorian’s perspective, an LIS must not only retain all current functionality, but also be able to interface with other clinical systems so that proper test-test and test-drug checking can occur, and clinical alerts can be generated,” he said. Billing components, the ability to have multiple ways to access and report out operational information, the flexibility to handle data from various instrument manufacturers and the ability to serve outreach markets are also features deemed important by prospective buyers. While purchasing decisions and administration of LIS appear to be moving to IT departments especially in large client-server operations, Reyes feels that most CIO’s realize that the laboratory must retain an ownership position. “LIS is such a specialized clinical system that the lab must always be involved. However, we are seeing a symbiotic relationship between the laboratory and the IT department that reflects the need to couple technical expertise (based around the client server) with the clinical expertise needed to reach integration objectives. This is quite a bit different from the past, where LIS independence was common,” he added.

     “Laboratory managers and directors need not only functional, but also operational relationships with the IT group, and that’s a change from the past,” echoed Ken Kark, director of marketing at Misys. Kark has also seen different buying patterns over the last few years. Today, CIOs and CFOs are driving lab IT purchasing decisions and system configuration, especially in situations where a single vendor has been selected to provide enterprise-wide information solutions. While initial purchase price, cost of ownership and return on investment are becoming major considerations in purchasing decisions, new features that help improve overall lab management and workflow are important as well. “Laboratory managers usually are our champions, because they know the features and benefits that will make them successful,” added Nancy Addie, product manager for Mysis Laboratory, the company’s LIS offering. Some of these new features demanded by lab professionals include billing and statistical reporting components that reflect their changing roles as business managers. “The laboratory has turned into a real business. It has become a profit center, where managers must justify their expenses… Our clients are demanding the right types of ad hoc reporting to allow them to analyze their business and focus on areas of opportunity,” Addie said.

     Within the last several years, laboratories have sought to bring in additional revenue by expanding outreach programs. Most legacy LIS were not designed to support situations where a hospital also functions as a reference laboratory. New LIS provide higher levels of customization and integration that allow hospital laboratories to offer more services to new customers. “Hospitals are now competing against commercial laboratories and other healthcare systems,” said Jeff Watson, MBA, MT ASCP, product marketing manager for Horizon Labs at McKesson. “However, they will never be able to obtain customers on price alone. An LIS can allow them to compete on turn-around times, and to tailor services to physicians by customizing the way results are reported. And by integrating an LIS into enterprise-wide information systems, hospitals can provide clinicians with laboratory data from all patient encounters, including ER and office visits, “ he added.

     Automation of processes that streamlines the laboratory workflow is also an important feature of today’s LIS. “The laboratory staffing shortage has reached critical levels, and clients are now focusing on features that can automate functions that have eluded them in the past,” said Watson. While many existing LIS have separate software systems that allow the user to define rules to automate certain functions, new products have imbedded software, termed “expert technology”, that permits functions to directly interact with each other. For example, based upon rules selected by the user, an LIS can automatically reflex to additional testing, and subsequently correct the order to capture the proper billing. According to Watson, one Horizon client uses close to 150 separate rules to automate virtually every process in their laboratory, including regulatory and compliance functions. Because of this higher level of automation, Watson sees the focus of laboratorians changing from routine and repetitive tasks to more clinically relevant and scientific work. “I think IT will become an enabler. It was necessitated by the staffing shortage, but the end result is that the laboratorian will be able to focus on the work that drew them into the field,” he said.

     With a new emphasis on healthcare quality and medical error incidence and reduction, patient safety-related features have also become important to LIS users. Through automation of processes, LIS can reduce levels of human interaction and consequently improve accuracy. For example, close to 68 percent of all laboratory errors occur during the pre-analytic phase. Connectivity to barcode technology at the bedside to positively identify patients and correlate tests with specimens is now offered by some LIS vendors.

     “We are addressing ways to reduce risk in all areas of laboratory processes,” said Donna Roth, MT ASCP and product marketing administrator at Siemens. “Today, hospitals require LIS features that not only handle data, but create information vital to all aspects of patient care,” she added. Customers are also looking for LIS data integration in order to generate clinical alerts, including drug-test and drug-drug interactions. “A laboratory can contribute to medication safety by providing timely, accurate results to ordering physicians and to the pharmacist, as well as other clinicians. This requires integration into the pharmacy information solution, as well as being able to deliver results to physicians especially at the time of placing additional orders,” said McKesson’s Watson.

     Information integration and implementation of an electronic medical record is a critical business strategy at Geisinger Health System in Danville, PA. Here, physicians are required to perform all patient management functions, including charting and ordering diagnostic tests, on PCs connected to an enterprise-wide information management solution provided by Epic Systems Corporation. According to Jay B. Jones, PhD and director of regional labs at Geisinger, physicians are offered training in “Epic Etiquette”, where they are advised on how to interact with patients while entering data into the system. “The EMR is central to our mission at Geisinger, and the laboratory must fully understand the EMR strategy of the Health System,” he said. The EMR will also fuel the further development of evidence-based medicine, a megatrend in which laboratories provide key information. “Evidence-based medicine is derived from outcomes analysis, which evolves out of the clinical database. Laboratory data will be mined very heavily to produce evidence for outcomes,” he said.

     Jones’ particular area of expertise is in POCT integration, which he feels is a “great stimulator for out-of-the-box thinking”. While POCT connectivity issues have largely been resolved with the development of NCCLS-approved standards, POCT to LIS connectivity is just the first step. “Our product is information, and all information, including POCT, must be passed into the information mainstream,” he said. Using EPIC’s EMR, POC lab tests are reported over internet and intranet platforms that shuttle all data into a single clinical respository. Geisinger’s EMR hardware facility houses over 200 client servers on a firewalled wide area network accommodating over 30 applications, including LIS.

     Jones sees POCT as being at the “front-end” of the EMR, where a new age of new consumerism will propel POC into the home and patients will demand access to the EMR via the internet. Curt Johnson, vice president of sales at Orchard Software agrees. “I believe that we will see consumer ordering of laboratory tests sometime within the next five years,” he said.” A LIS that has a web-based browser will have an advantage, because consumers will have access to order entry and be able to receive their own results. Front-end order-entry and results reporting are key components to an LIS,” he added.

     These features will also come into play as genomics, proteomics and pharmacogenomics move from research into clinical settings. “In the case of genetic testing, the instrumentation and results are to a large degree manual. A LIS vendor must be in a position to integrate results from these devices, and to make the results easy for a primary care physician to understand,” said Johnson. “What we will see in the future is an explosion of molecular testing in the laboratory,” agreed Thomas Meyer, MT ASCP, product marketing manager for Cerner Lab Enterprises. “It is very important to determine the future vision of the LIS vendor and what level of importance they place on being able to store detailed genomic, proteomic information, and how that information is represented to the appropriate care provider,” he said. According to Meyer, heightened awareness of the potential for bio-terrorism will also require LIS vendors to offer surveillance systems that alert the appropriate public health entity of potential outbreaks and epidemics.

     As both information and diagnostic technology evolves, so will the function and structure of the LIS. Integration of laboratory data from all points within the healthcare continuum and the ability to generate workplace efficiencies are key features of new IT products. While the future for the LIS industry appears robust, other solutions may soon become available. According to industry observers, instrument vendors that have developed laboratory automation managers (LAM) may eventually provide LIS functionality as well. While automation remains too expensive for many laboratories, more competition may help to drive down the cost of laboratory data management. For now, as the gatekeepers of laboratory information, LIS vendors are looking to expand their roles as specialty IT providers by designing solutions for use outside of the lab, and by developing tools to help caregivers improve outcomes and healthcare quality.

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