关键词: 血液安全监测, 采供血不良事件, 血液安全, 不符合项

Abstract: Objective To analyze the haemovigilance of adverse events in blood establishments conducted by the Working Party on Haemovigilance of the Chinese Society of Blood Transfusion, and to investigate improvement of data application and surveillance of adverse events in blood establishments. Methods A retrospective analysis of the data of adverse events in blood establishments reported by sentinels from 2020~2021 was conducted. Results During last two years, the percentages of adverse events reported by sentinels were 38.71% (24/62) and 25.61% (21/82). Analysis of data completeness showed that only 50% (6/12) of the reported data elements were compliant. In total, 440 and 295 cases were reported each year, and the data belonged to the adverse events analysis accounted for 27.50% (121/440) and 50.85% (150/295), respectively. Reported adverse events mainly occurred during donor counselling and blood collection, with 3 and 4 cases of donors suspected with health risk showing no abnormalities in follow-up, and 28.93% (35/121) and 30.67% (46/150) of the reported cases were controlled due to affected blood quality. Conclusion Haemovigilance provides a basis for the continuous improvement of the quality management system in blood establishment. In order to promote haemovigilance, the definition and standards, identification and management, and data integrity of adverse events in blood establishment requires further training and continuous improvement.

Key words: Haemovigilance, Adverse events in blood establishment, Blood safety, Non-conformity