Construction Of Quality Control System For The Whole Process Of Totally Implantable Venous Access Port Based On HACCP System

ObjectiveBased on the hazard analysis and critical control point system,a set of comprehensive and scientific whole process quality control system of totally implantable venous access port was constructed,which can provide reference for the safety management and quality control of intravenous infusion port and guarantee for the safety of patients in the port.MethodsWe searched the Chinese and English literatures related to the operation flow,safety management and quality control of the totally implantable venous access port,and used the content analysis method to extract the operation method of the whole process of the infusion port.Based on the theory of hazard analysis and critical control point,a multidisciplinary quality and safety management team was established,the processing flow chart is made and verified,the potential hazard of each operation step was analyzed,and the critical control point of this study was determined according to the critical control point judgment tree.Combined with the subject index formed by the content analysis,the quality control system of the process before the infusion port was preliminarily constructed.The Delphi method was used to inquire the first draft of the whole process quality control system of the infusion port for two rounds of expert correspondence.According to the expert feedback,the members of this research group discussed,sorted out and summarizied the contents of the system,and finally established the whole process quality control system of the totally implantable venous access port.Results1.Through systematic search and screening of literatures related to this study,a total of 52 articles were included.After analyzing the contents of the literature,22 main operation links were extracted,including the use index of the totally implantable venous access port,the preparation before catheterization,the operation in the catheterization,the operation after the catheterization and the maintenance of the implantable intravenous infusion port.2.According to the 12 steps and 7 basic principles of hazard analysis and critical point control theoretical model,a total of 13 critical control points were established,namely,usage index of implantable intravenous infusion port,body surface measurement,establishment of aseptic area,pre-flushing and pruning catheter,withdrawal of guide wire,feeding catheter,establishment of capsule bag,suture,disinfection,fixation,auxiliary equipment to determine catheter position,flushing and sealing catheter,disinfection and replacement of auxiliary materials.Catheter removal,health education,management of complications.By the way of group discussion,the inquiry table of the whole process quality control system of totally implantable venous access port is further established,which includes five parts:critical limits of each critical control point,monitoring requirements,corrective measures,verification procedures,that is,file records.3.Two rounds of expert letters were conducted on the importance and feasibility of each index in the first draft letter.The recovery rates of the two rounds of questionnaires were 82.6%and 94.7%respectively,the percentage of experts who put forward opinions was 52.6%and 11.1%respectively,and the degree of expert authority was 0.892 and 0.884 respectively,all≥ 0.70.the importance and maneuverability Kendall’s W of the inquiry index were 0.222 and 0.214 respectively,and all P<0.001,indicating that the expert evaluation opinions of this study tend to be consistent and the coordination is high.The results have good credibility.Finally,there are 13 critical control points,each with 5 parts,including 132 items.Conclusions1.We formed the corresponding whole process operation steps through the operation process and safety management of the fully implantable intravenous infusion port,which mainly included six parts,such as use index,pre-port preparation,port placement,post-port placement and its maintenance.It involved 22 links,such as indications,contraindications,patients,materials,environmental preparation and the establishment of aseptic area,which provides the basis for the construction of this research system.2.In this study,we based on the analysis of the whole process of fully implantable intravenous infusion por and the HACCP system,through hazard analysis of the whole process,13 key control steps were selected,included use index of fully implantable intravenous infusion port;body surface measurement;establishment of aseptic area;pre-flushing and pruning catheter;withdrawal of guide wire and feeding into catheter;establishment of bag;suture,disinfection and fixation.Auxiliary equipment to determine the location of the catheter;flushing and sealing of the catheter;disinfection and replacement of excipients;catheter removal;health education and complication management3.The whole process quality control system of the fully implanted intravenous infusion port based on HACCP system,a quality control system with good enthusiasm,expert authority coefficient,and high coordination coefficient of item importance and feasibility has been formed after two rounds of expert,which can provide reference and guidance for the safety management of intravenous infusion port to a certain extent.