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.”

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