Critical Features of the LIS

Molecular diagnostics, analytics and integration characterize the up-and-coming elements of the LIS.

Vol. 24 • Issue 8 • Page 14
Cover Story

It’s been said that the field of healthcare has changed more in the past 5 years than in the preceding 50 years, and one of the best illustrations of this is the evolution of the modern laboratory information system (LIS).

“What you need in today’s LIS is not relevant to tomorrow’s LIS,” explained Curt Johnson, chief operating officer at Orchard Software. “One example that everyone can relate to is Polaroid vs. digital photography. It doesn’t do any good to address improving the Polaroid today because we’re moving to digital. If companies are telling you how to make the instant picture better, they’re already done and just don’t know it. In the new healthcare arena, the aim is to improve overall healthcare, not just the lab, because the lab is not a freestanding profit center anymore.”

Business Intelligence

One major area of interest in tomorrow’s LIS is analytical data and dashboards. According to Dennis Winsten, MS, founder of Dennis Winsten & Associates, the most successful 3rd party suppliers are providing tools to extract data from the LIS, as well as the EMR and pharmacy databases.

“Business analytics are important because financial and operational efficiency issues are in the spotlight, and every lab needs to see trends in utilization,” he remarked.

In addition to business analytics, molecular diagnostics and cytogenetics, interoperability with EMR systems, companion integrated diagnostics capabilities and outreach client business growth are among the most requested features of the LIS, confirmed Winsten.

Johnson speculated that deeper analytics exploring turnaround time may be in demand in the coming years. Hal Weiner, president of Weiner Consulting Services, considers business analytics to be the most critical component of the LIS of the future.

“Real-time productivity, access to multiple data pieces and turnaround times all allow a different kind of lab management,” he noted. “There’s an amazing amount of interest because laboratorians are being pressed to change their whole delivery model.”

Molecular Diagnostics

No change to the lab has been more profound than the introduction of molecular diagnostics, and it cannot be ignored in the LIS.

“The ever-changing face of molecular technology to accommodate specific workflows means massive amounts of data are being collected, some of which may not be used today,” remarked Johnson. “But we’d better be collecting the data now for the medical breakthrough of the future. We’ll be able to go back, run the analytics and improve patient care.”

Nancy Stoker, director of product management at Orchard Software, said batch management for molecular workloads is becoming more essential. But the molecular-related LIS tasks are more complex than ever.

“Nobody’s 100% sure what molecular diagnostics will look like within the LIS,” clarified Johnson. “There’s a portion that comes with large analyzers. In those cases, the workflow is familiar and has already been designed. There’s another third that’s assay, therapeutic or disease-specific. Based on the degree of automation, the role of the LIS makes workflow as efficient as possible to make up for the deficiencies. Reporting is critical and the LIS must be capable of adding interpretive data to the output to make diagnosis more beneficial to the end user. The next third is R&D, where laboratories are manually manipulating DNA and chemicals and receiving pieces, pipettes or plates throughout the system using specific readers. It’s still very manual, and the LIS will need to help where it can, aiding in tracking, communication, reporting, interpretation and storage of molecular data.”

The Interoperability Equation

Every LIS company knows all too well the challenge of integrating the LIS with the EMR. Some of the larger medical records companies, including Epic and Cerner, have their own LIS offerings so the LIS companies are under unique pressure to compete.

“It is critical to have an integrated system capable of communicating with other healthcare information systems with discrete and structured data,” rationalized Johnson. “If you’re trying to keep a healthy patient healthy, run preventive testing to alert to any outliers. For unhealthy patients, the focus is on getting a diagnosis as quickly as possible so we can develop a treatment plan. Both cases involve lab. Once the patient is diagnosed and put on a wellness plan, you need testing to monitor disease progression and treatment efficacy. In all cases, you need discrete data that can be analyzed, put into formularies, algorithms or combined with other data sets like radiology and pharmacy to get a complete picture of the patient’s health status.”

It’s also important to distinguish the difference between interoperability and interfacing. Currently, there’s no industry standard, although the large EMR companies offer differentiation. Health Level Seven® (HL7) is accepted by the lab community, but still lacks any conformity as far as data structure. Though interoperability is becoming more common, the industry has yet to reach its goal of operating at the plug-and-play level.

“More and more, procedure and user manuals as well as testing protocols are electronic and part of a quality assurance tool,” noted Weiner. “Entire electronic lab notebooks that integrate testing protocol are available from non-LIS vendors. The line is blurring because LIM vendors are now capable of LIS and vice versa.”

Testing Environment

The final consideration for the LIS is anticipating the future patient environment. No longer will all testing be conducted inside hospital laboratories; testing will move to the patient point-of-care, or even near the patient or bedside.

“For accurate analytics, all discrete data must be captured, and the LIS not only has to accommodate various workflows of different areas, but also different ways instruments communicate,” explained Johnson. “Not all instruments outside of lab are sample ID-specific. POC devices may be patient ID-­centric. Also, we have to consider certification of users and their qualifications. Right now, the industry is using middleware and Band-Aids to handle POC testing. That has to change to incorporate POC, bedside and near-patient testing and get ready for home health testing.”

It’s unknown if the LIS will use the same tools for near bed, bedside, POC and home health. Patients may communicate with smartphones and tablets or have home monitoring devices that have output data needing to be captured.

“Home health is here today. What’s different now is lab data used to be 70 percent of patient’s record, but as patients move to the Apple watch, the amount of data in the record will be immense. Patient testing in the home will be a question mark. Will it be useful in the LIS? Home health vs. a phlebotomist sent to patient’s home to draw a test is different. There will be more patient-directed home testing and questions whether repository should be in a patient’s chart vs. LIS. I think the chart should be the keeper of the medical record, but the LIS should know to do trending or analysis.”

Johnson anticipated that, if LISs concentrate on discrete data, analytics, lab workflow, POCT and molecular diagnostics, it would be a 4 to 10 year process for many in the industry. In addition to that, LIS manufacturers have to stay abreast of changing regulatory requirements like meaningful use Stages 2 and 3. What Johnson feels is crucial is not current features in the LIS, but focusing on the critical features necessary to succeed 6 to 18 months from now.

Though daunting, he is confident the lab is well suited to the task. “Laboratorians, not the LIS, are critical in making positive changes in healthcare. The LIS just needs to be designed to support them and give them the tools to support the organization and benefit the evolution of the healthcare system.”

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