Markin R S, Whalen S A
University of Nebraska Medical Center, Department of Pathology and Microbiology, 983135 Nebraska Medical Center, Omaha, NE 68198-3135, USA.
Clin Chem. 2000 May;46(5):764-71.
Laboratory automation is in its infancy, following a path parallel to the development of laboratory information systems in the late 1970s and early 1980s. Changes on the horizon in healthcare and clinical laboratory service that 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 technology drivers include outcomes optimization and phenotypically targeted drugs. Constant cost pressures in the clinical laboratory have forced diagnostic manufacturers into less than optimal profitability states. Laboratory automation can be a tool for the improvement of laboratory services and may decrease costs. The key to improvement of laboratory services is implementation of the correct automation technology. The design of this technology should be driven by required functionality. Automation design issues should be centered on the understanding of the laboratory and its relationship to healthcare 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 implementation are rapidly expanding areas. It is clear that hardware and software are functionally interdependent and that the interface between the laboratory automation system and the laboratory information system is a key component. 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 been collected to determine payback is suboptimal. The trend in automation has moved from total laboratory automation to a modular approach, from a hardware-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 marketing tool. Multiple vendors are present in the marketplace, many of whom are in vitro diagnostics manufacturers providing an automation solution coupled 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.
实验室自动化尚处于起步阶段，其发展历程与20世纪70年代末和80年代初实验室信息系统的发展轨迹并行。影响实验室结果交付的医疗保健和临床实验室服务领域即将出现的变化包括北美人口老龄化、《平衡预算法案》（1997年）的实施以及疾病管理公司的创立。主要的技术驱动因素包括结果优化和表型靶向药物。临床实验室持续的成本压力迫使诊断制造商处于盈利状况欠佳的状态。实验室自动化可以成为改善实验室服务的工具，并可能降低成本。改善实验室服务的关键在于实施正确的自动化技术。该技术的设计应以所需功能为导向。自动化设计问题应围绕对实验室的理解以及它与医疗保健交付以及临床实验室业务和运营流程的关系展开。自动化设计理念已从基于硬件的方法演变为基于软件的方法。支持重复检测、反射检测和运输管理的过程控制软件，以及实验室自动化实施的整体计算机集成制造方法是迅速发展的领域。很明显，硬件和软件在功能上相互依存，并且实验室自动化系统与实验室信息系统之间的接口是关键组件。然而，供应商提出的自动化解决方案的成本效益难以评估，因为自动化装置的数量很少，而且为确定投资回报而收集运营数据的精度也不尽人意。自动化的趋势已从全实验室自动化转向模块化方法，从硬件驱动系统转向过程控制，从独一无二的新奇事物转向标准化产品，从体外诊断新奇事物转向营销工具。市场上有多家供应商，其中许多是体外诊断制造商，他们提供与仪器配套的自动化解决方案，而其他一些则是专注于自动化的公司。自动化技术不断进步，认可度持续攀升，投资回报和成本论证方法也在不断发展。
