Quality Performance of Blood Grouping Reagents in Last Fifteen Years: India

Quality control (QC) is a critical component of Laboratory Quality Management System for reliability of testing results.1Batch release by manufacturer of blood Grouping Reagents is mandatoryonly after products QC performance. The laboratory has evaluated a total number of 1320batches of different Blood Grouping Reagents types by haemagglutination technique. Out of 1320 batches, 275 were indigenous manufacturers and 1045 were imported. 242 of 275 indigenous batches were recommended and 33 were not recommend. 1003 of 1045 imported batches were recommended and 42 were not recommended. 94.3% of total 1320 batches were recommended and 5.7% were not recommended. The most serious risk is an acute haemolytic transfusion reaction caused by blood type-incompatible transfusion. Blood type-incompatible transfusion is one of the leading causes of transfusion-related deaths. The incidence of ABO-incompatible transfusion is estimated to be 1:38,000 to 1:100,000 units of RBCs in the United States, 1:16,500 to 1:100,000 units of RBCs in the United Kingdom, and around 1:100,000 units of RBCs in Canada.1Laboratory diagnostic services play a critical role in all health-related decisions both of an individual as well as of the population.