HACCP Enteral NutritionPreparation Quality Safety And Control
南京医科大学附属儿童医院青苗人才基金（ETYYQM2014028）
目的：为保证肠内营养制剂配制的安全性及有效性，因地制宜，在我院肠内营养配制室建立HACCP管理体系。方法：依据HACCP原理对肠内营养制剂配制过程及环境进行危害分析（HA），确定关键控制点（CCP）及监管措施并记录存档。结果：经危害分析后确定6个关键控制点，分别为手卫生、配制用具洗刷消毒、巴氏杀菌、称重配制、冷藏和发放接收。对每一个CCP给出关键限值并加以监管。其中，配制用具采用远红外消毒法，温度达125 ℃，维持时间≥15 min，消毒后清洁柜保存时间不超过24 h。巴氏消毒温度为62.5 ℃，维持30 min，消毒后0~4 ℃冰箱冷藏保存，保存时间不超过24 h。发放与接收环节采用二维码溯源系统。采用医院消毒卫生标准（GB 15982-2012）进行效果验证，HACCP计划施行前微生物监测结果合格率为84.52%，施行后合格率为95.24%，施行前后合格率差异有统计学意义（X2=4.19，P＜0.05）。结论：HACCP计划的实施，规范了我院肠内营养配制的工作流程，保证了肠内营养液配制、运送和储存过程的安全性。
Objective：In order to ensure the safety and effectiveness of the preparation of enteral nutrition preparations，the HACCP management system was established in the enteral nutrition preparation room of our hospital in accordance with local conditions. Methods：According to the principle of HACCP，the hazard analysis（HA）was carried out for preparation process and environment of EN in the hospital，while the critical control points（CCP）and regulatory measures were determined and recorded. Results：Six critical control points were identified after hazard analysis，which were hand hygiene，washing and disinfection of preparation appliance，pasteurization，weighing preparation，refrigeration and reception. Each CCP was given a critical limit and supervised. The preparation utensils were disinfected by far-infrared，the disinfection temperature reached 125 ℃，and the maintenance time was ≥15 min. After disinfection，the storage time of the clean cabinet didn’t exceed 24 h. The pasteurization temperature was 62.5 ℃，maintained for 30 minutes. EN preparations stored in the refrigerator at 0~4 ℃ after sterilization，and the storage time was not more than 24 h. The QR code traceability system was adopted in the issuance and reception links. The effect was verified by the hygienic standard for distinction in hospitals（GB 15982-2012），the qualified rate of microbiological monitoring results before and after the implementation of HACCP were respectively 84.52% and 95.24%，and the difference was statistically significant（X2=4.19，P < 0.05）. Conclusion：The implementation of HACCP program has standardized the work flow of enteral nutrition preparation in our hospital，and ensured the safety of the preparation，transportation and storage of enteral nutrient solution.