Methodology and Subspecialty Consolidation in the Clinical Laboratory

Abstract

The design of instruments as automated workstations for the clinical laboratory has evolved steadily over the last two decades. The grouping of assays into clinical chemistry disciplines has been largely influenced by the instrumentation available, e.g., multicomponent chemistry analyzers and specialty analyzers, including analyte-specific analyzers, blood gas analyzers, nephelometers, instruments dedicated to therapeutic drug monitoring (TDM), and instruments dedicated to protein or other immunoassays. This evolution has been a synergy of needs and technologies. The advent of managed care has led to stringent efforts to decrease the unit costs of laboratory testing and to increase productivity. Increases in efficiency in the clinical laboratory can be achieved by modifying the overall process flow and by using more-efficient technologies. These changes are assumed to decrease labor requirements and, therefore, to decrease the major component of the direct cost of testing. The use of multiple instrument types, however, even for such altruistic reasons as optimizing analytical performance, can create a process and scheduling problem in attempts to reduce unit costs (1)(2). Each instrument utilized in a clinical chemistry laboratory (or in a multidiscipline automated core laboratory) incurs support costs: for calibration, regulation compliance, utilities, maintenance (including service contracts), computer interfacing, and inventory control, among others. These costs will exist if the front and back ends of the specimen-processing functions are completely automated. Therefore, even if all specimen manipulations are automated, reducing the number of instrument workstations can still reduce costs. The report by Scholer et al. in this issue of Clinical Chemistry describes an immunoturbidimetric method for digoxin that requires no pretreatment (3). The assay is adaptable to general chemistry analyzers, and its performance at several different centers with a variety of instrumentation is well documented here (3). Considering the analytical requirements for an acceptable assay for serum digoxin, the performance …