Establishment of the Korean haemovigilance system

Abstract

BackgroundThe first regulation on haemovigilance in South Korea was first established in 1999 by the Blood Management Act. The purpose of this act was mainly focused on management of transfusion‐transmitted infections.AimsA more general form of haemovigilance system was needed for surveillance on the transfusion chain.Materials & MethodsA research funded by the government was initiated in 2007 for development of a haemovigilance system. Review on haemovigilance systems of other countries and development of draft report forms were proceeded on the first year. Pilot operation of the system with 46 voluntary participating institutions was conducted during 2008‐2009 including development of an online reporting system via the website.ResultsThe system was formally launched in a nationwide scale in 2010, financially supported continuously by the government but independently operated by the Korean Society of Blood Transfusion. The program is a centralized, stand‐alone, voluntary reporting, non‐punitive, anonymized, comprehensive system. The number of reporting hospitals and reports submitted has grown every year, with a significant increase after several administrative changes regarding financial incentives and institutional accreditation programs which requested the participation of haemovigilance. Workshops are held for participants every year, and the annual reports can be accessed on the website. Among 215 participating hospitals, 169 reported 3,375 adverse events during the fiscal year 2016.ConclusionWe have successfully operated the program for ten years, including a two‐year pilot study. We hope to further enhance the system qualitatively regarding case validation and standardization of case reporting.