Laboratory Information Systems
A laboratory information system, or LIS, is a software program that provides all the basic functionality needed for a clinical laboratory, whether that laboratory is hospital-based or a standalone commercial laboratory facility. Various components of the LIS will handle patient check-in, order entry, results entry, physician and patient demographics, specimen processing, and have some level of reporting ability.
Legacy laboratory information systems are typically homegrown, that is, they were developed within the organization 20 or 30 years ago, or were purchased ”off the shelf.” Homegrown systems and legacy systems often have problems with connectivity, scalability and flexibility, especially as technology changes within the laboratory and healthcare industry. Off-the-shelf products often force laboratories to modify their workflow to adapt to the LIS, rather than the other way around. Also, numerous LIS vendors have gone out of business or shifted their focus to other areas in the last two decades. Often legacy LISes utilize multiple databases, which create a great deal of difficulty with database interfaces and data synchronization.
Newer LISes are increasingly able to offer what laboratories need: modular-based systems with customizable functionality, scalability and a high level of adaptable connectivity for both institutional electronic medical records (EMRs) and physician access. Laboratories also require a LIS to to interface with the laboratory’s instrumentation, which allows patient results to be directly entered into the database and then into the EMR; Web-based order entry/result inquiry; and workload balancing. The LIS often has non-clinical functionality such as workflow monitoring and billing services.
In addition, these systems need to be customizable, be able to effectively and easily interface with both the institution’s electronic health record, the laboratory’s automated equipment, and provide Web-based access for physicians.
The environment for health information technology, specifically LISes, requires adherence to a number of national and international standards including CLIA, CCHIT, ANSI, HL7, HITSP, and LOINC.
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CURRENT ISSUE
Volume XXXI, No. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
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