Total Value of Ownership and Overall Equipment Effectiveness analysis to evaluate the impact of automation on time and costs of therapeutic drug monitoring

Fabio Settanni; Federico Ponzetto; Agnese Veronesi; Antonello Nonnato; Francesco Martinelli; Francesca Rumbolo; Maurizio Fimognari; Giovanna Martinasso; Giulio Mengozzi

doi:10.1016/j.aca.2021.338455

Total Value of Ownership and Overall Equipment Effectiveness analysis to evaluate the impact of automation on time and costs of therapeutic drug monitoring

Anal Chim Acta. 2021 May 22:1160:338455. doi: 10.1016/j.aca.2021.338455. Epub 2021 Mar 27.

Authors

Fabio Settanni¹, Federico Ponzetto², Agnese Veronesi¹, Antonello Nonnato¹, Francesco Martinelli¹, Francesca Rumbolo³, Maurizio Fimognari¹, Giovanna Martinasso¹, Giulio Mengozzi¹

Affiliations

¹ Clinical Biochemistry Laboratory, City of Health and Science University Hospital, Turin, Italy.
² Endocrinology, Diabetes and Metabolism, Department of Medical Sciences, City of Health and Science University Hospital, University of Turin, Turin, Italy. Electronic address: federico.ponzetto@unito.it.
³ Endocrinology, Diabetes and Metabolism, Department of Medical Sciences, City of Health and Science University Hospital, University of Turin, Turin, Italy.

PMID: 33894968
DOI: 10.1016/j.aca.2021.338455

Abstract

Total Value of Ownership (TVO) and Overall Equipment Effectiveness (OEE) analysis are novel tools capable of monitoring and analyzing industrial processes by assessing the efficiency of the entire instrumental equipment and calculating instrument capacity utilization. Such integrated analysis, measuring quality indicators of the testing process, could also provide new perspectives and methodologies for the workflow organization of clinical laboratories. In this study, TVO and OEE were employed for the evaluation of two different configurations of a therapeutic drug monitoring sector, comparing the results obtained for immunosuppressant (ISD) and anti-epileptic drugs (AED) analysis as well as checking their quantitative performance in terms of limit of quantification, accuracy and precision. TVO analysis was performed for ISDs, including the Total Direct Labor Time, Total Cycle Time and Turnaround Time as well as cost of testing. Instruments' performance and workload were assessed using OEE indicator, studying Availability, Performance and Quality factors. Total Cycle Time for a batch was 3.55 h, decreasing of 1.5 h in the new setting where personnel are engaged for 0.98 h, 25% of total testing time. The calculated cost per sample was 6.60 euro. Availability values were significantly higher for automated sample-handling system and ISDs analysis by LC-MS. Higher Performance values were obtained for LC-MS system for AED and other TDM. Quality values were >0.94 for all instruments. TVO and OEE proved to be applicable to clinical laboratory environment, quantifying benefits and costs of newly developed semi-automated therapeutic drug monitoring sector. This novel approach based on an integrated analysis may help activity planning and quality improvement and could be used in the future for benchmarking progress as a product/process comparison tool in other laboratory fields.

Keywords: Automation; LC-MS; Overall equipment effectiveness; Therapeutic drug monitoring; Total value of ownership.

MeSH terms

Automation
Chromatography, Liquid
Drug Monitoring*
Immunosuppressive Agents
Ownership*

Substances

Immunosuppressive Agents