Looking into the short term, laboratory information system (LIS) vendors are focused on refining their products, adding the connectivity and flexibility that allow the systems to meet the varied needs of the laboratories that use them. At the same time, LIS vendors with a long-term view are also preparing for a radical change, developing a next generation of LIS that will meet the needs that even today’s systems perfected cannot provide.

“Exactly what that system is going to look like is still a little ways out,” says Curt Johnson, vice president of sales and marketing for Orchard Software Corp, Carmel, Ind. Even users aren’t really sure what it is they will need over the next decade. But manufacturers are thinking about it, and it’s likely that the next generation of information system designed for use in the clinical laboratory will be broader, encompassing all the diagnostic disciplines.

“I don’t know if I would call it a revolution or an evolution, but I think you will really see a convergence of radiology, digital pathology, and molecular biology potentially cause the need for a whole new information system,” says Johnson, who estimates this new information system category will debut within the next 5 to 10 years.

SCC Soft Computer, Clearwater, Fla, has termed this future system the “pre-diagnostic EMR,” according to CEO Gilbert Hakim. “This is a concept of the system that will play the role of an agent for the physician in the ever-growing mass of information pertinent to the overall health of the patient. That agent’s role will be to monitor all disease-specific events, such as test results, medication metabolism, and so on, and will alert physicians to patients in need of intervention,” Hakim says.

The new system will fit into a framework of personalized medicine, another trend that will likely continue into the future. Subsequently, the LIS, both that of today and tomorrow, will need to connect to a number of other people, devices, and systems, not the least of which is the electronic medical record (EMR), aka electronic health record (EHR). That integration is occurring now as hospitals upgrade or replace legacy laboratory systems and/or implement enterprisewide software, such as an EMR.

“The laboratory providers are going to have to have information systems that will integrate with EMRs or they will lose work to other providers that have that capability. We’ll also want to have the ability to integrate not only clinical pathology, but also anatomic pathology and radiology testing,” says Vicki Downing, product manager of Horizon Lab for McKesson Provider Technologies in San Francisco.

Vicki Downing
Andy McLean
Jim O’Neill
Joseph Stabile

Information In

The convergence of diagnostic disciplines into one information system mirrors the convergence of data that currently occurs at the level of the diagnosing physician. The clinician compiles all of this data to make the appropriate diagnosis and treatment decisions. But because this information is pulled from different digital databases and physical sources, the process can be inefficient, increasing time to diagnosis and decreasing the quality of care.

Moving the process to an electronic system can help to solve these challenges. “Today’s pathologists use a lot more information to render a diagnosis. So the LIS, or whatever application they are using, will need the opportunity and the ability to reach into other systems to get that data,” says Joseph Stabile, McKesson product marketing manager for Horizon Lab.

That includes POC and waived analyzers. “Larger facilities may not have a moderately complex laboratory, but they have small point-of-care or waived analyzers throughout the facility. The important thing is to get the results from their analyzers to the EMR. We’ve done several large jobs where all we have done is interface with waived analyzers,” says Sandy Laughlin, MT (ASCP), product manager for LabDAQ at Antek Healthware LLC, Reisterstown, Md.

As more disciplines come online, this will be achieved more easily. Both pathology and molecular biology are becoming increasingly automated and digitized as solutions become more economically viable due to rising volumes. “As pathology continues to move toward the digital age with more imaging and more instrumentation and computerization—digitizing their slides—it’s fueling growth in that part of industry,” Johnson says.

At the same time, molecular and pathology labs are experiencing the same challenges that LIS has addressed in chemistry, hematology, and blood banking: shortages in qualified personnel, broader testing menus, higher volumes, and greater demands for improved quality. Personalized medicine creates a special demand for diagnostic aid from these laboratories. “With the need to support personalized medicine will come an increase in molecular testing,” Downing predicts.

When it reaches a critical mass, more targeted information systems or specific modules will debut to handle these areas. Currently, few LIS vendors offer products that are specifically designed to handle molecular diagnostics. “Today’s traditional laboratory information systems do not really allow for the expansion in molecular biology testing, given the complexity of those tests as well as a need to control preanalytical steps in those complicated workflows,” Hakim says.

Laughlin describes molecular diagnostics “as a whole different world: The workflows are different. The data storage requirements are different. There are numerous steps that need to be documented and lots of data generated that needs to be stored,” Laughlin says. LIS vendors are challenged to understand this workflow and design a useful system for all the stages of testing, including postanalytical reports.

Some vendors are approaching these needs through enhancements; others are creating entirely new solutions. “We made a conscious decision to introduce a new design in order to accommodate those challenges,” Hakim says.

Whatever the new solution looks like, key elements will have to include connectivity and flexibility. “The LIS has to have the flexibility to incorporate whatever workflows and features any given lab has. Honing the software to support those procedures, document them, and facilitate them is really the name of the game,” says Andy McLean, western marketing representative for Computer Service & Support Inc (CSS), Linwood, NJ.

Information Out

Connectivity is essential to achieve this flexibility, both with incoming and outgoing data. And just as the number of sources for incoming data is growing, the number of outgoing channels is also increasing. Many LIS systems now have the capability to connect with EMRs, physician management systems, and other databases, such as registries (eg, cancer and infectious diseases).

With the passage of the American Reinvestment and Recovery Act of 2009 and its subsequent incentives for EMR adoption, the medical digital network is expected to expand, particularly into physicians’ offices where the incentives are most expected to speed adoption. Patient portals will also increase, in some instances as a function of the EMR and in others through the LIS. “If we are talking about a group practice, it might very well be a function of the EMR. If we are talking about a reference lab, it almost certainly will be a function of the LIS,” McLean suggests.

Some systems permit laboratories to give patients direct access to their results through the LIS. “Patients can log in, access their own lab results, and do some trending,” says Jim O’Neill, Jr, CSS vice president of sales and marketing. Other functions, particularly in portals that encompass the entire EMR, can include scheduling, prescription refill ordering, and bill payment. The capabilities support patients’ desire to better manage their own health care as well as the government’s desire to increase the efficiencies in delivering that care, and patient portals are expected to become more common.

“I think there are many benefits to this, from helping a patient better manage their own health care and costs, to helping the clinicians serve the patient by providing the physician with a more complete and accurate patient history. To an extent, hosted PHRs [personal health records] become data warehouses and could even trigger alerts to government agencies, which could, in turn, help stop a major outbreak or alert a government to a potential terrorist act,” Hakim says.

Naturally, with more people accessing the information and with more information to be stored, reporting must be flexible but also integratable. “Interestingly, there has been a steady increase in demand for electronic reporting interfaces,” Hakim says, attributing the need to state and federal initiatives, such as infectious disease and cancer agency reporting, growing EMR investment, and ad hoc reporting.

New diagnostics also impact reporting needs. The digitization of anatomic pathology and molecular results demands more sophisticated reports that incorporate alphanumeric data, text, images, graphs, scatterplots, and other information. “All of this data now has to get to the end user via the electronic medical record in a useful manner. So it’s changing the way we are interfacing and displaying images and data, and that will continue to evolve as that part of the market continues to evolve,” Johnson says.

Vendors have gravitated toward web-based reporting systems that increase accessibility but keep things simple for users. Data storage is treated similarly. For many users, this task occurs behind the scenes and often seamlessly. The need to archive data and the frequency with which this must happen differs with each system, but has gradually been reduced as the cost for storage has come down.

“With the cost of storage ever decreasing, I think archiving may not be necessary. For example, most laboratories store results in the LIS indefinitely because the cost of maintaining the data is minimal. But the type of data that is being stored must be considered … there has to be a balance based on economy of scale,” Hakim says.

So while cancer-related images should be saved for the life of the patient, decades-old CBC data may be deemed deletable—if necessary. “We can purge information from our system, but our customers often just increase their disk storage,” Downing says, noting it’s cheaper to add disk space than to archive.

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The bottom line does not—or should not—typically influence health care decisions, but the efficiencies created by the LIS help to justify its expense and will continue to justify new development and institutional upgrades. “Ultimately, the LIS must continue to support the basic principles—what we’ve always done—and that’s to provide quality information for achieving better outcomes for the patient while always increasing efficiency and productivity,” Downing says. With more information coming in and going out that ever before, the LIS can help clinicians to understand the data coming in so that outcomes turn out right.

Renee Diiulio is a contributing writer for CLP.