Vol. 24 • Issue 1 • Page 21
Laboratories were the first non-research users of computer systems. Laboratory information systems (LIS) had their origins in the mid-1960s; since then, their functionality and processing power has increased manifold. In the early days, only chemistry and hematology were supported. Microbiology, anatomic pathology and blood bank followed soon after.
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), 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. The EMR or HIS 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.
LIS scope of functionality will become more specialized and inward (laboratory) focused. Functional emphasis will be on new diagnostic technologies, including molecular diagnostics and cytogenetics. Operational focus will be on optimizing laboratory operations by serving as highly specialized work area managers (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. Some laboratories will perform significant research and customized test protocol activities and may still require a full featured, independent LIS.
LIS vs. LIMS
Two different segments of LISs are in the market today. One is the traditional LIS, which is patient focused, and the other is the Laboratory Information Management System (LIMS), which has been traditionally project focused. However, several of the LIMS vendors have added a patient orientation to their products and some LIS vendors have added the ability to manage clinical trials to their products, so the distinction between the two is starting to blur. We envision that most robust LIS products will have both foci.
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, not just to the laboratory. Further, co-existence with enterprise-wide systems (EWS) 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 application modules of EWS 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. Each of these products will need robust knowledge-based process control and expert rule engines to manage disease pattern evaluations, test cancellations and cascades and clinical decision support. 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, biobanking and quality management.
The Protecting Access to Medicare Act of 2014 (PAMA) will have a significant impact on the clinical laboratory. Labs may be facing potential revenue reductions of as much as 75 percent. In addition, labs must collect and report on the volume of tests and prices paid by every payor. The role of the LIS, coupled with robust business intelligence tools, may be the determining factor in how a laboratory will be able to influence physician ordering patterns, improve turnaround times and productivity within the lab. Having the data available to monitor and manage entire process of laboratory testing will be a major differentiator. As the healthcare system in the U.S. transitions from volume- to value-based payments, from patient to population management, and continuing increases in government regulations, having an LIS system that can provide timely access to critical laboratory data will be crucial.
As well, more integration with the laboratory and other departments in the healthcare institution will be required as the Clinical Decision Support (CDS) rules mandated by Meaningful Use phase 3, which requires incorporation of data from laboratory results, medications, patient demographics and problem lists to generate real-time best practice care suggestions to clinicians.
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. And 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 patient’s 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.
Hal Weiner is president of Weiner Consulting Services, LLC located in Eugene, Oregon. (www.weinerconsulting.com). Dennis Winsten is president of Dennis Winsten & Associates, Inc. (DWA) a healthcare systems consulting firm specializing in laboratory information systems with headquarters in Tucson, Arizona (www.dwinsten.com, firstname.lastname@example.org). An ADVANCE editorial advisory board member, he has more than 35 years’ computer experience, including over 30 years in healthcare systems.