Application Of Fmea To The Infectious Disease Reporting And Management System In Hospitals In Shangchen District, Hangzhou

Background and Aim:Reporting system is the cornerstone of infectious diseases prevention and control in China. Effective reporting system for infectious diseases is the foundation of an early forecast and alerting and risk assessment for infectious disease outbreaks. It is also an important part of hospital management. It has been one of the important indicators for evaluation for hospital ranking and National Health City. China formally launched a national online report system of notifiable infectious diseases on January1,2004. The system is a real-time nationwide reporting system and is accessible by all kinds of hospitals and centers for disease control and prevention (CDC). Hospitals play very important role in the system. The infectious disease report system in hospitals involves many departments, including"gateway"physicians in clinic, ancillary departments, disease management department, etc and multiple steps, such as patient register, disease diagnosis, report card to fill, and online-reporting. If any problem occurs in any component of the system, it will affect the system operation. Nevertheless, an effective tool to qualitatively analyze the risk of the infectious disease reporting system at hospital level is still absent. Failure Mode and Effects Analysis (FMFA) is a forward logic technique for failure analysis. With successfully identifying failure modes, ideally it can effectively lower the probability by eliminating the causes. The concept of this technique is taking steps "Before-the event" rather than "After-the fact". In recent years, the method has been successfully applied to medical risk management, health care management, and prevention against nosocomial infection. It has not been used in risk reduction for hospital infectious disease reporting system yet. In this study, we applied FMEA to analyze the infectious disease reporting system in hospitals, in an attempt to find a specific FMEA worksheet suitable for infectious disease control and management in various kinds of hospitals, and consequently improve the reporting system.Methods:FMEA was used to design a specific FMEA worksheet for evaluating the infectious disease reporting system in hospitals in Shangchen District, Hangzhou and to identify the key components of the system. A questionnaire was developed accordingly for field survey. The current situation of infectious disease reporting system from18hospitals with different rankings was investigated via a questionnaire survey.Results:1. The expert group consisted of16staffs from CDC at different levels and hospitals who are responsible for infectious disease reporting. They established a specific FMEA worksheet and determined17crucial parts of the hospital infectious disease reporting system. From the FMEA worksheet, the highest value of RPN was182.00, and the lowest value was27.00. According to the value of RPN, the first five parts of hospital infectious disease reporting system were as the following: administrators’attention, expertise of clinicians and related staff and their awareness of reporting, performance evaluation system, construction of hospital online reporting system, and hospital policy of reporting abnormal findings from ancillary departments.2. The field survey from18hospitals found top5failure modes of the reporting system were low capacity of clinical laboratory diagnosis of infectious diseases (38.33%), not enough attentions from administrative panel(42.29%), insufficient construction of online reporting system (49.00%), inadequate specimen examination from outside independent clinical laboratories (55.80%), and lack of internal investigation policy (58.80%).3. The risk level for the system was divided into4categories according to the25th,50th, and75th percentile of the scores:high risk, relatively high risk, medium risk, and low risk. Out of the18hospitals investigated,4were at high risk,5were at relatively high risk,5were at medium risk, and4were at low risk. Non-parametric test was used to analyze the risk among hospitals with different rankings and found that an approximately significant probability for Kruskal-Wallis H value was0.001, which means the null hypothesis was rejected (α=0.05). The result indicated that the risk level varies among hospitals with different rankings.Conclusions:This is the first attempt to use FMEA in assessing risks for the hospital infectious disease reporting system. Based on the field survey from18hospitals, the following conclusions were made:1. The FMEA tool is effective in evaluating the risk of hospital infectious disease reporting system and should be widely applied to the study of medical risks.2. According to the specific FMEA worksheet,17key parts in the reporting system were determined. RPN values determined from the worksheet can be used to identify the most important components with high risk of failure. Appropriate counter-measures can be developed accordingly to realize priority control.3. The risk level of the system in provincial and municipal hospitals were generally lower than that in private hospitals and district hospitals. Private hospitals had the highest risk level (a significant difference was found among the3types of hospitals). This indicates that CDC should closely monitor the reporting system operation in private hospitals and district hospitals.4. At present, the medical institutions of infectious disease reporting and management work is carried out in the government under the framework of passive monitoring, a monitoring scheme can be implemented for several years, but the risk of infectious disease reporting and management of medical institutions are changing in a process of change, while FMEA is a dynamic active risk management method, it can be adjusted according to the change of each report links, make up the shortage of current infectious disease reporting and management.5. The risk management of hospital infectious disease reporting system is a complex, multi-factor involved process. Many factors will affect it and hinder the qualitative analysis of failures. Interference of governmental action when an onset of new infectious disease or a high incidence of certain major infectious disease occurs, patients’ intention to conceal their actual situation or inappropriate use of FMEA may also lead to a failure of risk control. Therefore, the use of FMEA in identifying failure modes of the infectious disease reporting system is limited. As long as FMEA activity is a dynamic process, we need further work to determine correct failure modes for the hospital infectious disease reporting system.