关键词: 中心供应室, 医院, 质量管理体系, 结构-过程-结果, 调查, 医院感染控制, 护理

Abstract:

Objective To investigate the current status of quality management system construction in central sterile supply departments（CSSDs） of hospitals across China，to analyze differences between hospitals of different levels，and to provide references for promoting standardized CSSD construction. Methods A national cross-sectional survey was conducted from May 12 to 30，2025，using convenience sampling. A validated，self-developed questionnaire was administered to 2，456 hospitals across 31 provinces in China. The questionnaire，based on the “Structure-Process-Outcome” Model，encompasses 3 dimensions：Structure（institutional development，satisfaction with human resource allocation），Process（information management system），and Outcome（establishment of quality monitoring indicators，continuous quality improvement），consisting of 31 items in total. The descriptive statistical analysis was conducted to assess the current status of hospital management practices and compare variations across hospitals stratified by administrative grade. Results A total of 2，456 questionnaires were distributed，yielding 2，377 valid responses，resulting in an effective response rate of 96.78%. In structural dimensions：over 95.00% of CSSDs have established formal regulations covering core operational domains（including job responsibilities，emergency response plans，standard operating procedures，workflow protocols，disinfection and isolation practices，equipment and facility management，and adverse event reporting systems）. Regarding satisfaction with human resource allocation，18.13% of CSSD managers reported being fully satisfied，noting that staffing levels were adequate to complete tasks to a high standard，while 54.77% reported being generally satisfied，noting that although workloads were sometimes heavy，they were manageable. Notably，satisfaction with personnel allocation was significantly higher in tertiary hospitals than in secondary hospitals（P<0.001）. In the process dimensions：only 28.23% of CSSDs have achieved information-based monitoring of quality-sensitive indicators；23.52% of CSSDs possess information systems with built-in quality control functionalities；merely 21.37% of the CSSD information systems support quantitative analysis of personnel workload. In the outcome dimensions：the setting rate for the instrument cleaning quality pass rate indicator was 95.37%. The setting rates for other indicators—listed in descending order—were as follows：sterilization quality pass rate（89.27%），packaging quality pass rate （89.19%），sterilization wet-pack rate（77.41%）. The sterile item timely supply rate had the lowest proportion of hospitals conducting monitoring，at only 25.54%. Finally，regarding continuous quality improvement activities，9.42% of CSSDs reported no engagement in structured continuous quality improvement activities. Conclusion The structural framework of the domestic CSSD quality management system has largely taken shape，but process management remains weak，and there is still room for improvement in areas such as the depth of digital traceability and mechanisms for continuous quality improvement.

Key words: Central Supply Department, Hospital, Quality Management System, Structure-Process-Outcome, Survey, Hospital Infection Control, Nursing Care