Abstract: OBJECTIVE To establish the risk management system of nosocomial infection in pharmacy intravenous admixture service(PIVAS) so as to optimize the management strategy and effectively reduce the risk of nosocomial infection. METHODS The risk of nosocomial infection in PIVAS were identified and evaluated through the failure mode and effect analysis(FMEA) to find the key risks that needed to be controlled. The failure causes of potential failure mode was analyzed, corresponding improvement measures and improvement cycle were formulated, and the control effect was evaluated. RESULTS The risk management system for nosocomial infection in PIVAS included 32 risk points in five aspects:unreasonable building layout, unqualified management of personnel, ineffective operation of instruments and equipment, nonstandard operation process, unqualified cleaning and disinfection effect monitoring. There were 7 key risks that needed to be controlled. The risk priority number decreased significantly and the risk effectively was controled after the targeted interventions were taken. CONCLUSION The risk identify and assessment based on FMEA and the establishment of nosocomial infection risk management system in PIVAS may facilitate the timely discovery of potential risk of nosocomial infection and reduce the probability of adverse events related to nosocomial infection in PIVAS.