혈액관리업무 심사평가자 교육프로그램 개발

Abstract

Background: Standardized management and surveillance at a national level is essential to maintain blood product safety. Officials of the Korean Division of Human Blood Safety Surveillance, Korea Centers for Disease Control and Prevention, and Korean laboratory transfusion medicine specialists, currently participate as inspectors in the Korean National Blood Inspection Program for Blood Establishments. However, lack of definitive guidelines and absence of standardized inspector training programs compromise the goal of objective and consistent safety management results. In this study, we propose establishment of written inspection guidelines and a clearly documented accreditation training program. Methods: Inspector training programs in the US and EU were reviewed online and the results of the Korean National Blood Inspection in our country performed during last 4 years were analyzed. Results: We suggested inspection guidelines for every question of inspection checklists. Also, for the questions similar to those of Laboratory Accreditation Program of the Korean Society for Laboratory Medicine (KSLM),guidelines were proposed as ‘Results of Laboratory Accreditation Program of the KSLM could be concerned if inspected laboratory obtained 2 year accreditation lately’. We suggest an 18hr-basic training program composed of lectures, e-learning and a visit to a blood center, as well as 12hr-continuing courses, should be established. Conclusion: To establish the Blood Inspection Program in a more systematic manner, thorough management and training of inspectors are essential. We expect the guidelines and training program for inspectors, suggested in our study, will be the cornerstone for creating a more professional quality management system and further ensure the safety of the national blood management system.