Dennis Winsten and Hal Weiner predict the future of laboratory information systems
Vol. 25 • No. 3 • Page 14
Cover Story
Over the past decade, the functions and utilization of laboratory information systems (LIS) have changed dramatically. The advent of enterprise-wide computerized physician order entry (CPOE) systems and electronic medical records (EMR) systems have usurped many of the roles that used to be played by the LIS. At the same time, systems that previously only acted as instrument interfaces have added extended capability to overlap with many features previously only in the LIS. Additionally, lower cost laboratory information management systems (LIMS) have added patient centric capabilities. So, what functions will be left for the LIS to do in the future and what form will the future LIS take?
At one time, the LIS was the basis for entry of patient demographics, ADT data, orders and results printing and distribution. With the advent and proliferation of electronic medical records (EMR) and hospital information systems (HIS) systems, many functions previously performed by the LIS have been assumed by the EMR or HIS. Today, rarely-and usually only in the case of outreach operations-does the LIS enter patient demographics, ADT, orders and billing transactions. In many cases, this outreach function is accomplished outside of the LIS with CPOE systems. The EMR now provides this information via interfaces or directly in the case of integrated enterprise-wide systems (EWS), where the LIS is simply an application module within the EWS. Further, results display, printing and distribution have fallen largely into the EMR/HIS domain. For many laboratories, even providing patient access to laboratory results is being accomplished through the EMR/HIS system.
Given the rapid acceptance and proliferation of EMR/HIS systems throughout the hospital market, what will the future hold for those independent “best-of-breed” LISs that have been the primary source of laboratory computerization over the past five decades?
Integrated Workflow
Essentially, we predict that the LIS will evolve into a laboratory internally-focused system. It will support the operational aspects of the laboratory including instrument automation and data acquisition, quality control and quality assurance, business intelligence related to laboratory operations, quality, service and outreach financials. The LIS would be “inwardly” focused. The future LIS would become more specialized and modularized with components to specifically service core lab, microbiology, anatomic pathology/cytology, blood bank, molecular diagnostics, etc.
The emphasis of the LIS will evolve to serve as specific work area managers (WAMs) that optimize operations and workflows within a particular laboratory area or even a workbench. There might be a HWAM histology work area manager that coordinates gross specimen recording, slide preparation, staining and processing or a HEMWAM hematology or MICWAM microbiology, etc. There would probably be a MGMTWAM that supports a business intelligence model and obtains operational and statistical data from all the other laboratory WAMs, and serves to receive and transmit data to/from external systems (e.g., CPOE and EMR). In fact, these products exist today and are offered by many vendors around the world. The future LIS will be more closely coupled with the technologist’s comprehensive and integrated workflow including both automated and manual processes. The LIS will be a component of a more integrated hospital or enterprise-wide information system.
Scope of FunctionalityOur long-term prognosis: LIS scope of functionality will become more specialized and inwardly (laboratory) focused. Functional emphasis will be placed on new diagnostic technologies, including molecular diagnostics and cytogenetics. Operational focus will be placed on optimizing laboratory operations by serving as highly specialized WAMs designed to focus on the workflows of each unique laboratory department or section. Outreach support may be offered as a unique module encompassing integrated courier services, specimen tracking and management, customer service (CRM), client reporting, client billing and business intelligence with interfaces as necessary to the LIS application for obtaining requisite data. There will still be some laboratories that perform significant research and customized test protocol activities that may still require a full featured, independent LIS or LIMS.
For some of the EWS LIS systems, there will still be a need to purchase separate interfaced products for blood bank transfusion and donor modules, HLA and other FDA 510K regulated systems. Additionally, as new quality assurance regulations come into place, more systems may be required to comply with several ISO and CLIA standards, which may also reduce the number of vendor products in the market.
Another factor that will dictate how the LIS of the future is shaped is the increased use of more sophisticated point-of-care testing, patient-directed and in-home testing. As technology further evolves, use of cell phones and tablets coupled with new IVD devices will enable complex lab testing and monitoring to be performed at home or anywhere. The results generated will need to be included and maintained in the patients’ EMR and the result quality monitored. This will require access to results via cellular or wireless networks. This may become the purview of a future LIS or simply be part of the EMR functionality.
The Pace of Change”Times, they are a-changin” and if anything, the pace of change is increasing. The C-Suite acceptance and support of EWS has led to proliferation throughout the hospital market. EWSs that include integrated LIS-like application modules will put pressure on best-of-breed LIS companies to differentiate their systems and provide justification for their continued use. The challenge for best-of-breed LIS companies to continue to be successful will be to justify their existence on the basis of proven benefits to the hospital and health system-not just to the laboratory.
Healthcare legislative reform will put further pressure on laboratories to increase operational efficiency, collect and report more types of performance data and ensure ongoing compliance with existing and new regulations. Further, co-existence with EWSs will require transparent interoperability with regard to data definitions and format, display and reporting of results, coordinated expert rules, common sign-on and security among others. The LIS EWS application modules have been making strides to achieve parity with best-of-breed systems while stressing the lower costs of licensing and the benefits of enterprise-wide integration across multiple clinical departments.
Failure to prove substantial benefits and return-on-investment (ROI) by “best-of-breed” LIS companies will require restructuring to create low cost, specialized WAMs that can be justified by improvements in lab operations and productivity. In addition, pressure from established LIMS vendors, who already have much of the WAM capabilities as part of their lower cost offering, will place pressure on “best of breed” companies to adapt. Each of these products will need robust knowledge-based process control and expert rule engines to manage disease pattern evaluations, test cancelations and cascades, and clinical decision support, but many of these functions are being currently built into EWS systems combined with EWS vendor or third-party business analytic tools. This will also open the opportunity for vendors of niche products to fill needs that are not met by either the EWS or best of breed vendors. Such niche products may include fleet management, document control and compliance management, cost accounting, bio-banking and quality management.
