Construction Of Quality Control And Safety Management System For Human Milk Bank Based On HACCP

ObjectivesConstruct a relatively complete set of targeted and practical hospital human milk bank quality control and safety management system.Provide reference for the operation quality and safety management of human milk bank.MethodRetrieves the relevant literature about the operation and management of the human milk bank,analyzes the research content of the included literature by content analysis method,and extracts the specific links of the quality management of the human milk bank.According to the Hazard Analysis and Critical Control Points(HACCP)theory,a quality management team was set up to create a process flow chart,list potential hazards and analyze them,identify critical control points,and combine the evidence obtained by systematically searching the literature.Based on the results of content analysis,determine the quality control and safety management system of human milk bank.Using Delphi to conduct two rounds of consultations with medical administrators,nursing managers,human milk bank nurses,experienced nursing managers and hospital infection specialists,combined with expert opinions The content was revised to finalize the quality control and safety management system of the hospital's human milk bank.Results1.A total of 19 articles were included,and the content analysis finally extracted the'buildings and facilities,the recruitment and screening of donors,collection human milk at home,the operation process of human milk bank,the distribution of donated human milk,the transportation of donated human milk,quality management and donation of human milk.37 items including 8 aspects including nutrition.2.Based on the 12 steps and 7 principles of HACCP,four critical control points were established,including donor screening,bacterial testing for the first donation,human milk collection at home,and pasteurization(including cooling)for breastfeeding.A group discussion on four critical control points was carried out,and a quality control and safety management system for human milk bank including critical limits,monitoring system,corrective actions,verification procedures and record-keeping and documentation process was initially constructed.3.Through two rounds of expert correspondence,expert opinions tend to be consistent.The response rates of the two rounds of expert correspondence were 81.8%and 94.4%respectively,and the proportion of experts who submitted opinions was 44.4%and 11.8%respectively.The authoritative coefficients of the experts were 0.886 and 0.880 respectively.The second round of the letter was important and operable.The coordination coefficients of sex are 0.202 and 0.226,respectively.The final system includes 4 critical control points,5 parts each,and 72 items in total.Conclusions1.There are many foreign literatures related to the operation and management of human milk bank,and most of them are evidence-based guidelines or expert consensus,which has strong guidance.Although the existing domestic literature can be used to guide clinical practice,it still lacks a systematic,practical and suitable quality and safety management system suitable for China's national conditions.2.In this study,the HACCP theory was used to screen out the critical control points,and the evidence obtained from the literature and the results of the content analysis were used to establish a targeted quality control and safety management system for the human milk bank.The enthusiasm and authority of the two rounds of experts are high,and the importance of each item and the coordination coefficient of operability are good.It can provide reference and basis for the quality and safety management of human milk bank in mainland China.