| Sumario: | Patients worldwide suffer from high-frequency adverse events (AEs). However, the reported rate of severe AEs is significantly below the actual incidence. In particular, patient harm caused by clinical laboratory AEs is generally hidden, indirect, and delayed, and patient safety-oriented quality management models have not been well established. Promoting the recognition of errors, risk control, and safety culture by developing and learning from an AE database could improve patient safety and medical quality. Therefore, this study aimed to develop a patient safety-oriented quality management model by analyzing the risk priority of adverse events (RPAEs) in an AE database and achieve standardization, risk control, and continuous improvement using procedural safety checklists. This study, launched in January 2008, retrospectively examined a multisource AE database of the emergency laboratory at Taizhou Enze Medical Center between 2008 and 2023. This study graded and classified 1,012 AEs from internal and external staff, hospital leaders, patient complaints, and auditors according to severity and content based on the standards of the National Health Commission of the People's Republic of China and the International Organization for Standardization standards for medical laboratories (ISO 22367). The subscore of a specific class of an AE category was obtained by calculating the severity score and frequency score, and the risk score of a specific AE category was calculated by summing subscores of all classes. AE categories in the top 80% of the total risk scores were considered RPAEs, the focus for improvement and quality checks. Among the AEs, 98.62% were reported between 2014 and 2023; 68.67% involved patients and 21.84% caused patient harm. High-risk processes included information inconsistency at sample packet encapsulation and sample receipt, and failure of the pneumatic logistics transmission system (PLTS) in the preanalytical phase; reagent and consumable errors and incorrect results in the analytical phase; delayed reporting of critical values in the postanalytical phase; and delayed turnaround time, incorrect information system settings, and equipment malfunctions in the whole analytical process. Continuous improvements were implemented using quality management tools, such as information systems, Lean management, and process optimization. Key improvements included information consistency checks on sending and receiving samples; monitoring specimen transportation using a PLTS; standardized verification and confirmation of settings or modifications in the information system; early warning regarding equipment malfunction; and visual management of reagents, consumables, and equipment. Using this information, the authors designed a process safety checklist for on-site and immediate assessments and standardization of staff behaviors in key processes to improve patient safety. The authors developed a quality model referred to as the "RPAEs, the root causes, countermeasures, implementation, and safety checklist" model. Moreover, this study presents future directions for quality management in medical laboratories, for China or other countries, such as constructing an indicator system to evaluate the effect of AEs on patient safety. Research at Taizhou Enze Medical Center in China focused on the risk priority of adverse events during all phases of emergency laboratory analysis, and it implemented continuous systematic improvements and quality checks to establish a patient safety-oriented quality management model.
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