By Marleen and Gary Wolfe

Recent years have seen a remarkable evolution—some might even say a revolution—in laboratory information systems (LIS). These changes have led to capabilities far beyond fundamental inpatient/outpatient record keeping and report generation.

 Schuyler House’s SchuyLab is an easy-to-use icon-based program that interfaces with instruments, monitors QC, maintains worksheets and daily logs for compliance purposes, and prints consolidated patient reports.

Contributing factors to this evolution are many and diverse. One reason is that hospitals and laboratories are tasked to comply with federal and state mandates on record keeping, data reporting, and patient privacy. In addition, these facilities are striving to find new and better methods to make patient information more portable and accessible to health care providers who must serve a mobile population.

Adding to the challenges, the continuing public outcry for more timely patient treatment and better patient safety must be balanced by ever-present requirements for better financial performance and accountability in the face of soaring medical insurance and malpractice insurance costs, coupled with the reality of hospital consolidations and closings.

Fortunately, many advanced technologies can enable the high level of functionality demanded from modern LIS solutions. Some examples include more powerful, yet easier to use databases; lower cost computers and networks; easily accessible Internet and wireless communications; and higher throughput, automated laboratory systems.

Here, leading LIS vendors offer assessments on where the industry is today and where it may be headed.

Laboratories Must Reach Beyond Hospital Boundaries
As clinical laboratories find themselves adopting new business models to make themselves more competitive, cost efficient, and responsive, they face a number of information technology (IT) challenges that are heavily influencing the development of next-generation LIS solutions.

 Using bar code technology and wireless networking, McKesson’s Horizon MobileCare Phlebotomy helps laboratories ensure positive patient identification at each step from ordering to specimen collection to lab processing to reporting.

According to Jeff Watson, director of marketing for McKesson Provider Technologies (formerly McKesson Information Solutions), “The prevalent business model for hospital laboratories today is hybrid in nature. This means that many labs serve all the traditional areas of the hospital, and also serve as community-based reference labs, selling services to physicians in the community, other hospitals, other labs, and other health care providers, such as nursing homes, and long-term care facilities.”

To enable this hybrid business model to succeed, “the laboratory’s IT infrastructure is rapidly evolving from stand-alone legacy systems (including manual paper-based procedures) that deal only with inpatient and outpatient testing,” Watson says. Instead, laboratories are migrating to more broadly applicable real-time solutions that take advantage of cutting-edge technologies, such as the Internet and wireless bar-code reading.”

By leveraging these technologies, LIS companies are providing hospitals and laboratories with effective new ways to integrate lab information into the workflow of ERs, physicians, nurses, pharmacists, and other health care professionals. “This helps bridge the gap between the financial and the clinical aspects of the lab, facilitates clinical decision-making, and enhances both patient care and patient safety,” Watson says.

Additionally, “Laboratory data will be intensely integrated with most health information applications. A perfect example is the current interest by clinicians in CPOE (computerized pro-vider/physician order entry) systems that provide them with real-time connectivity to the LIS,” says Steve Hawn, M(ASCP), director of marketing for LabSoft.

“Lab information systems will have to be even more user friendly,” says Hawn. “To a greater extent than ever before, future caregivers, who have access to laboratory results, will include physician assistants, nurse practitioners, nurse specialists, registered nurses, therapists, pharmacists, and other technical personnel.”

Internet Is a Key Driver of New LIS Development Work
Considering how all-pervasive the World Wide Web is, it comes as no surprise that LIS vendors are leveraging Internet technology to expand the usefulness and reach of their products.

 Centricity Ultra is GE Healthcare’s high-end customizable UNIX-based LIS solution designed to meet the needs of high-volume, multi-site, multi-entity laboratory workflow environments.

“Access to inexpensive Internet technology is playing a big part in changing the relationships between patients, physicians, and the hospital environment,” says Patrick Herguth, general manager for laboratory and medication management, GE Healthcare (previously GE Medical Systems). “The entire digital environment is driving consumer health care toward more personal access to more medical information than ever before.”

Sharing a similar view, William Shipley, president of Schuyler House, says, “As both the medical professional and the patient become more comfortable with the Internet, the speed of information transferal and access to data become more commonplace. Today, many doctors expect to log on and get lab results quickly, even while away from the office or hospital. Similarly, patients expect to receive their results from their doctors, look up the significance of the results, double-check the diagnosis, and send emails to their doctors with questions.”

Portable Health Care Information for More Personalized Medicine
Looking at the current technology trends, Hawn concludes, “The Internet may easily become the tool of choice to distribute laboratory and other medical information in the future.”

Herguth’s colleague at GE Healthcare, Robert Dale, marketing manager for laboratory management, says, “Thanks to the ability of the public Internet and secure, private intranets to tie different Web portals together and to provide links to various hospital systems, data is easier to access, regardless of where it resides. Add wireless technology, and physicians and clinicians become completely untethered; free to have data flow to them as they go between the office and the hospital. This represents a significant move towards increased portability of health care information.”

“When we look at using the Web and Web technology,” says Dale, “the lab is key to the decisions that are being made, since lab results already affect 60%–70% of treatments. As we move into the realm of genetic testing, the LIS will become even more critical for all decisions regarding treatment and diagnosis. So, we see in the laboratory the ability to drive greater personalization of medicine.”

LIS Market Growth Tempered By Conservative Attitudes
Despite the undeniable advantages presented by advanced technologies and LIS solutions, there is no denying that the adoption process is, to some extent, captive to a test of wills between the progressive and conservative elements of the health care community.

Expanding on this point, Jan Chennault, vice president of Schuyler House, says, “Many seasoned health care professionals are still hesitant to adopt and use mainstream technologies, such as PCs, the Internet, and information systems, which have been commonplace throughout the general business community for years. The real challenge for the LIS industry is to get more health care professionals comfortable with the technology tools available to them.”

Consumer pressure is one powerful factor that is forcing a shift toward the adoption of new technologies. GE Healthcare’s Herguth says, “Patients want the same kind of responsiveness that they get from online banking and Internet searches, but they are frustrated because the information is not necessarily available in today’s health care environment. This is putting pressure on physicians, laboratories, and hospitals to adopt new technologies, implementations, costs, and management changes that can provide the type of services the consumer wants.”

Other Technologies of Interest to LIS Users
Beyond the Internet, other new technologies are expected to influence the LIS market and the ways in which LISs are used.

 LabSoft’s Velocity Web-based software package works with the LabNet LIS, enabling users to order lab tests, access patient demographics, schedule patient draws, and review results via a secure Internet connection.

LabSoft’s Hawn says, “Not only will laboratory information demands expand as access to lab data increases, but new laboratory technologies will emerge. For example, bioinformatics, starting with genomics, is a potentially very large growth area for clinical laboratories. Following completion of gene studies is an even larger growth area, proteonomics (the study of proteins, their function and control in relation to specific genes). These fields will generate vast amounts of data that will lead to some clinically relevant applications.”

GE Healthcare’s Herguth says, “We’re very interested in a new tracking technology, RFID (radio frequency identification), that promises to have major impact on hospitals and labs in the future, and that can easily be tied into information systems. The use of RFID is currently being driven on the consumer side by WalMart and Gillette to tag razor blades for automatic tracking and identification throughout the distribution system. In time, we envision that RFID will be phased into the LIS world in the same way that bar coding was. We are looking for ways to adopt RFID into the health care workflow within 12 to 18 months, where it could be used for everything from patient tracking to lab specimen tracking to hospital asset tracking to OR management.”

LIS Costs Becoming More Favorable
For years, many common arguments against LIS have been cost related. The growing availability of LIS products that carry lower price tags without sacrificing performance are helping to overcome these objections.

Schuyler House’s Shipley says, “Although larger institutions have been computerized for years, the country is full of small hospitals and physician’s offices that still run their labs without a computer LIS and enter lab results manually. In many cases, it appears that this is because they erroneously believe they can’t afford an LIS or that investing in an LIS will somehow reduce what they can invest in patient care.”

Despite the hesitancy, Shipley sees the potential for a huge and growing market for PC-based LIS, even though the current growth is slower than he or his industry counterparts would like. He says, “CFOs and CEOs of medical facilities all over the US are awakening to the fact that they are no longer locked into a choice between a mainframe LIS costing hundreds of thousands of dollars or no LIS at all. Most small to moderate-size facilities can now buy an LIS that costs $10,000 to $50,000 and does more than the old mainframe systems did.”

Governmental Impact on LIS—Mountains of Mandatory Paperwork
Much of the rationale underlying the ongoing development and deployment of LIS continued to be justified by requirements for clinical laboratories, hospitals, and other components of the health care industry to comply with government regulations.

“The federal government, and in many cases, state governments have recognized the necessity to advance information technologies further into health care as a whole,” says LabSoft’s Hawn. “However, it is quite apparent that our current health care system lacks economic incentives to invest the massive amounts of time and money necessary to climb the mountain from paper to full digital automation. The past few years have not been conducive for governing organizations to allocate funds to facilitate this change. However, the idea of providing grants in support of such efforts seems urgent to some key governmental leaders.”

“There are always issues involving compliance and medical necessity,” says McKesson’s Watson. “For example, last February, the FDA issued a mandate requiring manufacturers of medications and blood products to add bar-code labels on their products. This is directly resulting in more hospitals and laboratories recognizing that they can improve their own patient safety initiatives and processes by taking advantage of the same tools and technology that manufacturers have used for years.”

In a similar vein, Schuyler House’s Chennault points out, “Among the things that are motivating change are the new HIPAA requirements. Even though these requirements are not directly oriented to patient care, they are causing more hospitals and labs to adopt computers to ensure compliance.”

LIS Providers and Products
GE Healthcare
GE Healthcare, headquartered in the UK, is a global organization that provides transformational medical technologies in medical imaging and information technologies, medical diagnostics, patient monitoring systems, disease research, drug discovery and biopharmaceuticals. The company’s Technologies Division, which provides LIS, is based in Waukesha, Wis. GE acquired LIS provider Triple G Systems Group Inc, Markham, Ontario, Canada, in August 2003, and Laboratory Information Management Systems (LIMS) provider Amersham PLC, based in the UK, in April 2004.

GE Healthcare offers Centricity® CIS, an enterprise-wide clinical information system that enables providers to raise the standards of care, institutions to optimize costs, and patients to experience a comprehensive and integrated care delivery process. It also empowers health care providers to optimize workflow in each clinical care area and, via their common architecture, disseminate that information seamlessly through the enterprise to support a longitudinal electronic medical record on each patient. This data is accessible on demand for clinical decision-making, helping to reduce the potential for medical error, improve clinician productivity, and control operating costs.

Centricity Laboratory is available in two versions: Centricity Ultra is a high-end customizable UNIX-based LIS solution designed to meet the needs of high-volume, multi-site, multi-entity laboratory workflow environments. Typical installations range from large single facilities to distributed facilities with 10 to 15 or more laboratories. Some labs run more than 20,000 orders per day with this system. The latest iteration has added Web order entry, and a digital imaging component of interest to pathologists. The system operates on a variety of UNIX hardware platforms.

Centricity TriWin is a Windows NT–based LIS solution for smaller, less complex multi-site environments with standardized workflows. This system uses an SQL-type database called Advantage. This LIS operates as a client-server implementation of Windows NT or Novell networks supporting PCs running Windows XP.

LabSoft Inc
LabSoft Inc, headquartered in Tampa, Fla, provides laboratory information system solutions to leading hospitals, reference labs, clinics, and physician-office labs located throughout the United States.

LabSoft LIS solutions are available for labs of all sizes. At the upper end, LabNet LIS, a Windows-based system, offers comprehensive capabilities, including unlimited expandability; remote connectivity; reference lab interface; quality control; medical necessity checking; reflex testing; support for normal, critical and panic ranges; bar coding and labeling; easy order entry; and print/autofax components. Additionally the system can upload lab activity to electronic medical records, billing, health information systems and/or practice management systems. At the lower end, the company’s Beethoven II is an easy-to-use single workstation LIS that provides features comparable to those on LabNet LIS.

Velocity is a Web-based software package that works in conjunction with LabNet LIS and enables users to order lab tests, access patient demographics, schedule patient draws, and review results via a secure Internet connection.

EZLink, a cost-efficient networking system for smaller labs, connects up to three workstations in the same facility without sacrificing the functionality or performance available in larger networks. For creating a paperless laboratory, the network can be linked bidirectionally with an HIS (hospital information system) or PMS (practice management system), reference labs, and instruments.

McKesson Provider Technologies
McKesson Provider Technologies, an Alpharetta, Ga-based business unit of McKesson Corp, provides health care organizations with comprehensive software solutions and services to improve patient safety and reduce the cost and variability of care and to better manage their revenue stream and resources. The company’s newest program, Paths to Patient Safety, helps health care providers take advantage of POC, pharmacy, and lab integration to enhance patient safety, quality control, and financial performance.

McKesson’s flagship LIS, Horizon Lab, is a comprehensive, integrated, enterprise-wide solution that automates central laboratory processes and workflow, facilitating such activities as specimen ordering and routing, medical-necessity checking, and result reporting and tracking in full compliance with HIPAA requirements. Horizon Lab fully integrates with the company’s Horizon Blood Bank information system, which is used to manage the internal workflow of the transfusion service, providing complete control over blood inventory, transfusion histories, documentation, and patient data.

Integrated, add-on modules expand Horizon Lab’s capabilities beyond the central lab. The following modules all employ a combination of bar-code reading, wireless networking, and workflow automation technologies: Horizon MobileCare™ Phlebotomy for preanalytic tracking and positive matching of patients, specimens, and test results; Horizon MobileCare™ Transfusion for the point-of-care bar coding for patient identification when administering blood products; and Horizon Admin-Rx™ for medication administration.

In all cases, small, handheld computing/bar-code reading devices travel with caregivers on their rounds and communicate in real time over the hospital’s secure wireless network to provide up-to-date information and eliminate preventable error. Adding to the versatility of this approach, the phlebotomy, transfusion, and medication applications can all coexist on the same handheld devices.

Schuyler House
Schuyler House, based in Panorama City, Calif, provides an inexpensive full-featured LIS called SchuyLab, which is currently employed in installations as small as a single station handling 10 specimens a day up to 40 station networks handling thousands of specimens a day. Heavily graphical in its implementation, this LIS is intuitive and easy to learn, even for those who don’t speak English. Installation time is as little as 1 to 2 weeks for the smaller configurations.

SchuyLab runs on any Windows-based operating system, and provides an easy-to-use icon-based program that interfaces with instruments, monitors QC, maintains worksheets and daily logs for compliance purposes, and prints consolidated patient reports. The LIS can also communicate with the user’s office system or HIS using the HL7 protocol. Auto faxing, remote printing, dial-in results, and medical necessity modules are available, as are direct Medicare/Medicaid billing and the SchuyNet Internet module.

SchuyNet gives laboratories and physicians the ability to review current and archived patient test results, and to generate and print custom graphs and reports instantly via secure Internet connections. The company is currently releasing an Internet Ordering module that works in conjunction with SchuyNet to allow users to order tests and check medical necessities remotely. SchuyNet and SchuyNet Ordering are distinguished from most laboratory Internet modules in that the laboratory itself hosts and controls the Internet access, keeping its data locally and assigning security to its clients. Schuyler House also offers many other compatible utilities including: QC, custom reports, graphic reports, and management tools.

Marleen and Gary Wolfe are contributing writers for Clinical Lab Products.