Abstract Background Clinical laboratories constantly face challenges where adopting technologies to optimize critical processes is essential. Automated electronic signatures, integrated with a Laboratory Information System (LIS), have proven to be an effective solution to streamline result release, reduce validation times, and improve traceability. This approach, supported by dynamic data analysis using Business Intelligence (BI), enables data-driven decisions, ensuring operational efficiency and regulatory compliance while enhancing diagnostic security. Methods The study was conducted in a clinical laboratory in Argentina that utilizes an LIS as part of its technological infrastructure. A module for automated validation and electronic signatures was configured. Biochemists developed customized rules using: • The calculation of the % Delta Check, based on the internally designed Reference Change Value (RCV). • Analytical variability (CVa), obtained through statistical analysis of internal quality control. • Key parameters such as the Index of Individuality (0.6) and the Sigma Coefficient (3), ensuring the quality of the analyte to be automated. Additionally, the laboratory incorporated a BI system that analyzes and visualizes data in real time, providing clear metrics to evaluate the performance of the automated module and make adjustments when necessary. Configured Boolean Rules:If the result is within the normal range, it is automatically released.If critical values are exceeded or the % Delta Check limit is surpassed, results are withheld for manual review. Results Automation generated notable improvements: Diagnostic Area % Automatically Released Tests (ART) % Manually Released Tests (MRT) Hematology - ART 40.1%, MRT 43.9%. Hemostasis - ART 59.4%, MRT 39.8%. Clinical Chemistry - ART 64.9%, MRT 31.2%. Immunoanalysis - ART 61.4%, MRT 27.0%. The data obtained by the laboratory corroborate Randell et al. (2018), where structured actions enabled a percentage of 40% to 60% of tests to be released through automatic verification. Key Findings 65% reduction in manual interventions in certain areas. • Complete traceability aligned with international quality standards. Optimization of validation times from 09:27 hours in the first 8 months of 2024 (prior to the improvement action with automation implementation) to 05:38 hours from September to December 2024, following routine implementation—a reduction of approximately 67% in average time. Use of BI to identify improvement areas and measure the real impact of automation, reducing action time due to real-time data availability. Conclusion The combination of automation and Business Intelligence represents a significant advancement in quality management in clinical laboratories. These tools not only increase operational efficiency but also enable proactive, data-driven control, strengthening trust and security in diagnostics. This innovative model can be adapted to different scales and specific needs, establishing a replicable standard in the international clinical setting.
R. J. Peña (Wed,) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: