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First donor haemovigilance system at a national level in China: Establishment and improvement
Junhong Yang1,2, Dinrong Fan3,4, Dongfu Xie2,5
1Chongqing Blood Center, Chongqing, China.
Insights
China established a national blood donor safety monitoring system to track adverse reactions (ARs) from blood donation. The new system improved data quality and reporting for donor haemovigilance (DHV).
Area of Science:
- Public Health
- Transfusion Medicine
- Health Informatics
Background:
- Prior to 2019, no systematic national-level data existed on adverse reactions (ARs) to blood donation in China.
- Establishing a robust reporting system is crucial for monitoring and improving blood donor safety.
Purpose of the Study:
- To establish an effective reporting system for collecting data on ARs to blood donation nationwide in China.
- To evaluate the status of donor haemovigilance (DHV) and analyze the prevalence and data quality of ARs.
Main Methods:
- An online donor haemovigilance (DHV) system was developed and implemented in July 2019.
- Definitions of ARs aligned with International Society of Blood Transfusion (ISBT) standards.
- Data from participating blood collection facilities from 2019 to 2021 were analyzed for prevalence and quality.
Main Results:
- A standardized online reporting system for ARs to blood donation was successfully established.
- From July 2019 to December 2021, the incidence of ARs was 3.8‰ for whole blood and 2.2‰ for apheresis platelets.
- Data completeness significantly improved from 41.7% in 2019 to 74.4% in 2020, with sustained quality in 2021.
Conclusions:
- The development of a blood donor safety monitoring system led to the successful establishment of the DHV system in China.
- The DHV system demonstrated improvements, including an increased number of reporting sites and enhanced data quality.
Background And Objectives:
No systematic study has measured the incidence of adverse reactions (ARs) to blood donation at the national level in China before 2019. The objective of this study was to establish an effective reporting system to collect information on ARs to blood donation in China.
Materials And Methods:
The status of donor haemovigilance (DHV) in blood collection facilities in China was evaluated, and an online DHV system was established to collect data on ARs to blood donation in July 2019. The definitions of ARs were based on the International Society of Blood Transfusion (ISBT) standards. The prevalence and data quality of ARs from 2019 to 2021 were analysed.
Results:
A standard online reporting system has been established for ARs to blood donation. In total, 61, 62 and 81 participating sites were included in this pilot study in 2019, 2020 and 2021, respectively. From July 2019 to December 2021, 21,502 cases of whole-blood-related ARs and 1114 cases of apheresis platelet-related ARs were reported, with an incidence of 3.8‰ and 2.2‰, respectively. Data completeness for key reporting elements improved from 41.7% (15/36) in 2019 to 74.4% (29/39) in 2020. Data quality analysis for the year 2021 yielded similar results as for 2020.
Conclusion:
The construction and continuous improvement of the blood donor safety monitoring system prompted the establishment of the DHV system. Improvements have been made to the DHV system in China, with a significant increase in sentinels and higher data quality.
