基于危害分析与关键控制点原理的医疗质量改进在捐赠母乳消毒中的作用

The Role of Medical Quality Improvement Based on Hazard Analysis and Critical Control Point Principles in Donor Human Milk Pasteurization

摘要: 目的：探讨基于危害分析与关键控制点原理的医疗质量改进在捐赠母乳消毒中的作用。方法：围绕基于危害分析与关键控制点原理确定的关键控制点，对云南地区某捐赠母乳库采取了相应的医疗质量改进。分别将采取质量改进前的捐赠母乳作为对照组，质量改进之后的作为实验组，通过对比实验组与对照组的捐赠母乳合格率、同一母亲再次捐乳细菌情况、捐赠母乳巴氏消毒合格率、捐赠母乳不良事件发生率等安全指标之间的差异评估质量改进措施效果。结果：研究期间共处理了486批次捐赠母乳。捐赠母乳合格率分别为98.8% (242/245)、98.3% (237/241)，差异无统计学意义(P > 0.05)；采取质量改进前后，巴氏消毒合格率分别为97.9% (237/242)和100% (237/237)，差异无统计学意义(P > 0.05)；采取质量改进后，同一母亲再次捐赠的母乳细菌量较初次捐赠批次的减少明显，差异具有统计学意义(P < 0.05)；改进前不良事件发生率2.5% (6/237)，改进后发生率0% (0/237)，差异具有统计学意义(P < 0.05)。结论：在云南地区特定环境下，一项基于HACCP原理、包含捐赠者教育、操作流程优化和设备参数本土化调整的复合型质量改进干预，能有效降低再次捐赠母乳的细菌污染水平并减少操作相关不良事件的发生。未来建议开展前瞻性队列研究或多中心阶梯式实施研究，以提供更高级别的证据。

Abstract: Objective: To investigate the role of medical quality improvement based on the Hazard Analysis and Critical Control Point (HACCP) principles in donor human milk pasteurization. Methods: Corresponding medical quality improvement measures were implemented in a donor human milk bank in Yunnan province, focusing on the critical control points identified based on HACCP principles. Donor milk collected before the quality improvement was designated as the control group, and milk collected after the improvement was designated as the experimental group. The role of quality improvement in donor milk safety was evaluated by comparing the differences in safety indicators between the experimental and control groups, including the donor milk qualification rate, the bacterial load in subsequent donations from the same mother, the pasteurization qualification rate, and the incidence of adverse events related to donor milk. Results: During the study period, a total of 486 batches of donor milk were processed. The donor milk qualification rates were 98.8% (242/245) and 98.3% (237/241) for the pre- and post-improvement periods, respectively, showing no statistically significant difference (P > 0.05). The pasteurization qualification rates were 97.9% (237/242) before improvement and 100% (237/237) after improvement, also showing no statistically significant difference (P > 0.05). After the quality improvement, the bacterial load in subsequent donations from the same mother showed a significant decrease compared to the initial donation batches, and this difference was statistically significant (P < 0.05). The incidence of adverse events was 2.5% (6/237) before improvement and 0% (0/237) after improvement, a difference that was statistically significant (P < 0.05). Conclusion: In the specific environment of the Yunnan region, a comprehensive quality improvement intervention based on HACCP principles—incorporating donor education, operational process optimization, and tailoring equipment parameters to local conditions—effectively reduces bacterial contamination levels in re-donated human milk and decreases the occurrence of procedure-related adverse events. Future studies, such as prospective cohort studies or multicenter step-wedge implementation research, are recommended to provide higher-level evidence.