Sự thay đổi một số chỉ số quản lý và chất lượng xét nghiệm trước và sau triển khai quản lý chất lượng theo tiêu chuẩn ISO 15189:2022 tại Phòng Xét nghiệm, Bệnh viện Bỏng Quốc gia Lê Hữu Trác

Abstract

Objective: To evaluate changes in selected laboratory management and quality indicators following the implementation of the laboratory quality management system according to ISO 15189:2022.
Materials and Methods: A pre-post interventional study without a control group was conducted using retrospective data from quality management records and laboratory operational data at the Laboratory of Le Huu Trac National Burn Hospital. The study period was from July 2024 to June 2026, with the pre-implementation phase from July 2024 to June 2025 and the post-implementation phase from July 2025 to June 2026. The indicators included: Quality management system; pre-analytical, analytical, and post-analytical phases; equipment management; reagents and consumables; and customer satisfaction levels.
Results: After implementing ISO 15189:2022, the proportion of standard operating procedure (SOPs) undergoing periodic review increased from 86.49% to 100%, the proportion of internal audits conducted as scheduled increased from 50% to 100%, and risk management implementation increased from 80% to 100%. The sample rejection rate decreased from 3% to 0.1%. The rate of acceptable internal quality control results increased from 90.48% to 99.05% and the rate of satisfactory external quality control results increased from 95.07% to 100%. The proportion of test results reported within the agreed turnaround time increased from 93% to 100%. The rate of equipment maintenance performed on schedule increased from 71% to 100%. The proportion of reagents inspected prior to use increased from 93% to 100%. Satisfaction among clinical departments increased from 92% to 98%, while patient satisfaction increased from 96% to 100%.
Conclusion: Following the implementation of ISO 15189:2022, several laboratory management and quality indicators improved particularly in document review, internal audits, risk management, pre-analytical phase control, turnaround time, equipment maintenance, and pre-use chemical testing. However, the uncontrolled before-and-after design does not allow the observed changes to be attributed solely to ISO 15189:2022 implementation. Further monitoring of these indicators is necessary to assess the sustainability of the results.