Laboratory automation: Trajectory, technology, and tactics

Laboratory automation is in its infancy, following a path parallel to the d evelopment of laboratory information systems in the late 1970s and early 19 80s. Changes on the horizon in healthcare and clinical laboratory service t hat affect the delivery of laboratory results include the increasing age of the population in North America, the implementation of the Balanced Budget Act (1997), and the creation of disease management companies. Major techno logy drivers include outcomes optimization and phenotypically targeted drug s. Constant cost pressures in the clinical laboratory have forced diagnosti c manufacturers into less than optimal profitability states. Laboratory aut omation can be a tool for the improvement of laboratory services and may de crease costs. The key to improvement of laboratory services is implementati on of the correct automation technology. The design of this technology shou ld be driven by required functionality. Automation design issues should be centered on the understanding of the laboratory and its relationship to hea lthcare delivery and the business and operational processes in the clinical laboratory. Automation design philosophy has evolved from a hardware-based approach to a software-based approach. Process control software to support repeat testing, reflex testing, and transportation management, and overall computer-integrated manufacturing approaches to laboratory automation impl ementation are rapidly expanding areas. It is clear that hardware and softw are are functionally interdependent and that the interface between the labo ratory automation system and the laboratory information system is a key com ponent. The cost-effectiveness of automation solutions suggested by vendors , however, has been difficult to evaluate because the number of automation installations are few and the precision with which operational data have be en collected to determine payback is suboptimal. The trend in automation ha s moved from total laboratory automation to a modular approach, from a hard ware-driven system to process control, from a one-of-a-kind novelty toward a standardized product, and from an in vitro diagnostics novelty to a marke ting tool. Multiple vendors are present in the marketplace, many of whom ar e in vitro diagnostics manufacturers providing an automation solution coupl ed with their instruments, whereas others are focused automation companies. Automation technology continues to advance, acceptance continues to climb, and payback and cost justification methods are developing. (C) 2000 Americ an Association for Clinical Chemistry.