Lean Six Sigma in Clinical Laboratories: A Systematic Review and Future Perspectives in the Era of Digital Health
Keywords:
Lean Six Sigma, Clinical laboratory, Quality improvement, Patient safety, Salud digitalAbstract
Lean Six Sigma (LSS) has emerged as a key methodology for continuous quality improvement in clinical laboratories, integrating waste reduction and variability control to enhance diagnostic accuracy and operational efficiency. This study aimed to systematically analyze the application of Lean Six Sigma in clinical laboratory settings and to explore its role within the context of digital health transformation. A systematic review was conducted following PRISMA guidelines, including studies published between 2018 and 2025 from PubMed, Scopus, and Web of Science. Results indicate that LSS implementation significantly improves turnaround time, reduces pre-analytical and analytical errors, and enhances sigma performance levels, often exceeding 3 sigma in multiple analytes. Additionally, the integration of LSS with digital technologies, such as laboratory information systems and artificial intelligence, represents a promising frontier for laboratory medicine. Despite its benefits, challenges remain, including resistance to change, implementation costs, and the need for organizational culture transformation. It is concluded that Lean Six Sigma, when combined with digital health strategies, constitutes a robust framework for advancing quality, patient safety, and sustainability in clinical laboratories.
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