Ứng dụng Six Sigma trong đánh giá và cải tiến hiệu năng xét nghiệm sinh hóa tại Bệnh viện Thống Nhất

The accuracy and reliability of laboratory test results are paramount for effective patient diagnosis, treatment, and monitoring. Traditional quality control (QC) methods, such as Levey-Jennings charts, often fall short in comprehensively assessing the analytical performance of laboratory assays. In this context, the Six Sigma methodology emerges as a robust framework to objectively evaluate and improve the quality of laboratory services. This study aims to apply the Six Sigma approach to assess the performance of various biochemistry assays on AU5800 and cobas c503 analyzers at Thong Nhat Hospital, identify underperforming tests, and implement targeted quality improvement interventions. The findings underscore the critical role of advanced quality metrics in enhancing diagnostic reliability and patient care.

Clinical laboratory professionals, quality managers, medical technologists, and healthcare administrators interested in laboratory quality improvement and Six Sigma methodology.

This cross-sectional study comprehensively evaluated the analytical performance of 10 common biochemistry assays on two automated systems, AU5800 (Beckman Coulter) and cobas c503 (Roche Diagnostics), at Thong Nhat Hospital using Six Sigma metrics. Data collected from January to March 2024, including internal and external quality control results, were used to calculate individual Sigma values for each assay. The methodology involved assessing performance across multiple quality levels and implementing corrective actions for tests with suboptimal efficiency. Key findings revealed significant differences in performance between the two analyzers and among various assays. On the AU5800, 50% of the tested assays (urea, creatinine, cholesterol, HDL-Cho, total bilirubin) demonstrated "unacceptable" analytical performance (Sigma < 3), while only 30% (triglycerides, GGT, uric acid) achieved "excellent" performance (Sigma > 6). In contrast, the cobas c503 exhibited superior overall performance, with 90% of assays classified as "acceptable" to "excellent," and only creatinine showing "unacceptable" performance. Specifically, the creatinine (Jaffe method) was identified as "not good" on both systems. Following targeted improvement, where the creatinine method on cobas c503 was switched to an enzymatic assay, its performance transitioned from "not good" to "excellent." Similarly, enhanced management of chemical handling for creatinine (Jaffe) on AU5800 improved its performance from "not good" to "good." This study highlights the practical utility of Six Sigma in systematically identifying and addressing analytical performance gaps, leading to enhanced quality control and improved diagnostic accuracy in clinical laboratory settings.