The Integration of Decision Analysis Techniques in High-Throughput Clinical Analyzers

From the early 1990s, the introduction of high-throughput clinical analyzers has significantly changed the workflow of In-Vitro-Diagnostics (IVD) tests. These high-tech instruments have helped and keep helping clinical laboratories both to increase quality diagnostic responses and to get more for every dollar they spend. Nevertheless, IVD industrial research has been up to now largely hardware-driven with the introduction in the market of many sophisticated technologies. The software component, models and decision support systems in particular, has lagged behind. To reach the full potential of diagnostic automation, it must be addressed the challenge of making the most intelligent use of the hardware that is deployed. Focusing on time efficiency, the authors have devised an operations research-based method for a class of high-throughput clinical analyzers. To demonstrate the validity of the research, the proposed method has been coded and integrated into the Laboratory Information System of the Laboratorio di Analisi Cliniche Dr. P. Pignatelli, one of the most important clinical laboratories in Southern Italy. Siemens Immulite ®; 2000 has been the reference case. The enhanced operating planning procedure provides a monetary benefit of 52,000 USD/year per instruments and a trade-off between clinical benefits and operating costs equivalent to the one provided by the current hardware-driven research at Siemens. Despite the proposed approach has the potential to determine guidelines for enhancing a wide range of current high-throughput clinical analyzers, we have to register a failure in trying to convince technology providers to invest in embedding such new models in their hardware. Some possible causes for such failure are highlighted, trying to find possible improvements for future developments.