Abstract

BackgroundThis study analyzes the regulation of and developments in blood donation in China from 1996 to 2019, and demonstrates the government’s efforts to improve blood safety.ResultsSince the implementation of the Blood Donation Law in 1998, the number of blood donors in China increased by 275% from 1998 to 2018 (from 4 million to 15 million). The principle of no-fault liability was proposed and has been applied since 2010 to the tort liability related to blood transfusion malpractice. In 2015, mutual blood donation accounted for 4.2% of the national collection. However, in some provinces of China, the percentage of mutual blood donation increased from 9.3 to 35.6% in 2016. The National Health Commission canceled mutual blood donation in March of 2018. Since 2015, nucleic acid amplification testing has become a routine test item for screening blood.ConclusionsThe Chinese government institutionalized the voluntary non-remunerated donation principle, enacted regulations for the management of blood transfusion, and adopted advanced blood testing technology to sustain blood supply and ensure blood safety. Despite increased blood donation, blood shortages persist. The quality and safety of blood collection can be further improved through the cancellation of mutual blood donation and incentive measures for voluntary non-remunerated donation of blood, which needs facilitation by governmental legislation.

Highlights

  • This study analyzes the regulation of and developments in blood donation in China from 1996 to 2019, and demonstrates the government’s efforts to improve blood safety

  • According to the World Health Organization (WHO)’s 2016 Global Status Report on Blood Safety and Availability, apart from increased voluntary nonremunerated blood donation (VNRBD), the number of blood donations, and volume of blood collection, blood safety has been improved by the blood nucleic acid test (NAT) technology adopted by China; and the clinical, rational use of blood has likewise significantly improved in China [12]

  • Regulations, and notices were collected from official Chinese government websites, and the data on blood donation were obtained from official reports of the National Health Commission (NHC) from 1998 to 2019, the WHO’s Global Database on Blood Safety from 1998 to 2011, and the 2016 Global Status Report on Blood Safety and Availability

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Summary

Introduction

This study analyzes the regulation of and developments in blood donation in China from 1996 to 2019, and demonstrates the government’s efforts to improve blood safety. The number of blood donations and the volume of blood collection in China have been on the rise for 20 consecutive years [10]. According to the WHO’s 2016 Global Status Report on Blood Safety and Availability, apart from increased VNRBD, the number of blood donations, and volume of blood collection, blood safety has been improved by the blood nucleic acid test (NAT) technology adopted by China; and the clinical, rational use of blood has likewise significantly improved in China [12]. Despite more than 20 years of continuous improvement, there are still many shortcomings in blood safety in China, such as the increasing need for blood and blood products, the risk of transfusion-transmitted infections that lead to chronic blood shortages, unsafe blood products, and unsound clinical transfusion practices [13,14,15,16,17,18]

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