Is there anything new under the sun in the world of laboratory information systems? Compared to some other areas of health information technology, the LIS may have been slow to change. But federal mandates; the development of molecular and genetic tests; a growing reliance on mobile devices; and the profit-driven strategies of hospitals are causing LIS developers to reconfigure their systems in order to meet the specific—and evolving—needs of today’s laboratorians.
From LIS to EMR
The far-reaching effects of the federal American Reinvestment and Recovery Act/Health Information Technology for Economic and Clinical Health Act (ARRA-HITECH) are just starting to be felt.
For many physicians, the adoption of an electronic medical record under meaningful use requirements is changing the way they collect and use patient data—including laboratory test results. “Much of the LIS marketplace is revolving around meaningful use,” says Curt Johnson, chief operating officer at Carmel, Indiana-based Orchard Software Corp.
However, transferring relevant lab data from an LIS to an EMR can present a challenge. “Lab data is a critical piece of a patient’s portfolio,” Johnson states. “But data needs to be structured so it can be easily integrated into an EMR.”
John David Nolen, MD, director of laboratory strategy at Kansas City, Missouri-based Cerner Corp., agrees, saying that when moving a pathology report from an LIS to an EMR it is important to retain the report’s format. But given the traditional way of transferring these reports, Nolen notes, “You’ve locked down the data using a PDF.”
As the adoption of EMRs becomes more widespread, the role of the LIS may drastically change, says Gary Yancich, president of LabSoft, Inc., in Wesley Chapel, Florida. “Lab results are now being sent to EMRs, and the EMR is doing the charting. The EMR is the central repository for information.”
The growing number and use of point-of-care (POC) tests in hospitals and physician offices also is adding to the amount of lab data that has to be stored and managed in a central data base. But Yancich asks, “Do you want all that information in the LIS?” In other words, if all that data is eventually going to be sent to an EMR, why upload it to the LIS first? With the EMR becoming the central data repository, Yancich says, “it pushes the LIS into an isolated corner. The LIS is becoming just a lab tool.”
The need to transfer lab data to an EMR again raises the question of systems integration. “Lab information that is stored and retrieved is entirely different from other information,” says Yancich. “And different EMRs have different capabilities in communicating with an LIS.”
John Yount, vice president of the Laboratory Solutions Group at Alpharetta, Georgia-based McKesson Provider Technologies, acknowledges that meaningful use and the push to establish regional health information exchanges (HIEs) is driving a renewed interest in connectivity and interoperability among systems.
But so is the growing number of connections between physicians and outside labs, says Lisa Jean Clifford, CEO of Milford, Massachusetts-based Psyche Systems Corp. “A lot of physician offices are increasing their connections with regional labs and hospital labs. And some regional labs are even paying for the interfaces,” she says.
For years, best-of-breed systems were pitted against single-vendor solutions. While a more expensive alternative, installing all major hospital information systems, including the LIS, from a single vendor, ensured total integration among systems and a seamless transfer of data. Best-of-breed systems, which are praised for features that are best suited for specific departments, often require either an HL7 (Health Level Seven International) or Web-based interface in order to connect to another vendor’s system.
However, the recent trend toward a single-source solution may be waning. Yount, who says McKesson’s LIS is an example of a best-of-breed system, reports that he’s not seeing his customer base trending toward a single-source solution. “As they grow into a mid-sized or larger hospital, they’re still holding firm on the idea that they need best-of-breed solutions.”
Accommodating new technologies
This reemphasis on a best-of-breed LIS also is being fueled by the introduction of new tests and advances in the field of pathology.
Johnson says he expects the best-of-breed trend to continue. “You’re going to see a return to best-of-breed because of molecular testing. With molecular testing, I have to have a data base that integrates all tests into an EMR.”
Clifford says the growing use of molecular and genetic tests is definitely steering labs back to a best-of-breed LIS. She continues, however, that “a lot of labs are combining specific testing into one facility and all under one application.”As a result, anatomic and clinical pathology, as well as molecular and genetic testing, are able to share a common data base within a single system.
Johnson agrees, adding that this convergence is leading to the establishment of a single diagnostic laboratory. “But this means you have to have an LIS that handles all modalities,” he says.
The advent of molecular and genetic testing is even changing the business model of some independent labs, says Clifford. She is already seeing labs that specialize in a few “boutique” tests such as those that target genetic markers for specific cancers.
Given the amount of data generated by traditional and new tests, laboratorians need an LIS that helps improve workflow, says Clifford. “They need to maintain efficiencies in the lab in the most cost-effective way with the resources they have and the existing infrastructure they have in place.”
Adds Nolen: “You need to pull data from multiple sources to make a decision or create a report.”
Improving efficiencies and workflow also can include the use of mobile devices. While most POC tests are run on a mobile device, the growing popularity of iPhones and iPads is providing physicians with another connection to the lab. “With the increased need to gather and exchange data electronically, there’s no doubt that mobile computing will fill a larger role,” said Keith Kaplan, MD, informatics director and CIO of Charlotte, North Carolina-based Carolinas Pathology Group and Celligent Diagnostics LLC—an outreach laboratory.
Although not yet approved by the FDA as a diagnostic tool, the iPad and a handful of apps available to pathologists allow for the viewing of specimen slides and for the inclusion of these digital slides as part of the pathology report.
According to Clifford, while these devices may someday become an integral part of the diagnostic lab, at present the vast majority of smartphones and iPads are simply being used to view test results and reports.
Adjusting to change
For laboratorians, the changing face of healthcare presents both challenges and opportunities. For many, the LIS they have relied on for years can no longer meet the demands and must be upgraded or replaced.
Kaplan says he had been using one vendor’s LIS for his pathology group and another for his outreach labs. By the end of this year, however, both sets of labs will be running on a single-vendor system. This, he says, will allow him to “build the system from the ground up, as we feel it should be built.”
The six to eight months Kaplan says he spent looking for a new system gave him insight as to what LIS developers should focus on. “Add more intuitiveness, like type-ahead functionality,” he says. “All the requirements of a report should be there. On the front end, there is a huge need to be more flexible and customizable, like handling split samples and creating a synthesized report.” He adds that “most off-the-shelf LIS do not have that capability.”
Jeff Shepard, MD, administrative director, Laboratory Transfusion Services and Outreach in Dothan, Alabama, says he is currently upgrading his LIS that went live in 2008. These upgrades will add more functionality, he says, and will include order and results monitors that track the status of every sample—from transport to the lab until the final tests on that sample are done. Shepard also has some advice for LIS developers: “There’s always a need for better integration and data mining of information.”
Another laboratorian who is getting ready to expand his system is Simeon Schwartz, MD, president and CEO of Westmed Medical Group and CEO of Westmed Practice Partners in Purchase, New York. Set to open a new clinic in Brooklyn, NY, Schwartz says he currently runs about five million lab tests a year and does a lot of tests in the area of cytology.
While staying with the same vendor, he says, an LIS should be able to “handle complexity without being complex” and should also help to improve workflow in the lab.
Reed Chamberlain, system administrator at Genetics Associates in Nashville, Tennessee, says his privately-owned lab specializes in cytogenetic testing. He admits that before going live in 2009 with an LIS from a major vendor, he had been using a custom-built one. However, he says, he needed an LIS that was more robust and modifiable and that would fit his lab’s specific needs. Finding a customizable system is one thing Chamberlain says he would recommend to anyone looking to replace their current LIS.
The learning curve
Given the stiff competition among vendors and the costs associated with rolling out a brand-new system, many labs have decided to stick with the LIS they have and look for ways to add functionality.Those who have upgraded their existing system or installed a new one have learned a lot in the process.
Chamberlain notes that establishing a link between the LIS and an EMR, as well as interfacing it to other information systems, can be problematic. “Do your research,” he says. “Look at all your options.”
Also remember that setting up a new system takes time and a lot of attention, says Shepard. “It can be a little overwhelming, especially during implementation. And you can’t learn everything immediately.” In offering advice to others, he says, “Think about how the LIS will fit into your hospital information system and that what you want can talk to everything else.” He also advises that those who are setting up a new system “understand inbound and outbound applications and inspecting agencies’ requirements.”
Kaplan also stresses the importance of systems integration, but he notes, “You want your LIS to adapt to your workflow, not have to adapt your workflow to your LIS.” He adds, “Do your homework. Talk to current users and make lab site visits.”
Ultimately, you have to make a choice, but the decision should be made by senior management, and only after establishing a clear vision for the future that takes into account both the workings of the lab and the health of the patient, says Schwartz. And it should be a system, “that will bring real value within that vision.”
Looking ahead
E-mail, smartphones, tablet computing, and the “cloud” may have been mere visions in the minds of some entrepreneurs when the DOS-based “green screen” ruled the lab. But with today’s ever-changing technologies, the LIS is rapidly becoming part of an interconnected repository of data on every patient seen by every doctor.
Whether it gets shoved into a corner of the lab, only time will tell. But for now, at least, the LIS is evolving to meet the demands of new tests, newer technologies, and changes in the healthcare delivery system.
Richard R. Rogoski is a freelance journalist based in Durham, North Carolina. Contact him at [email protected].
