From July 20 to July 22, 2024, the expert group of China National Accreditation Service for Conformity Assessment (CNAS) conducted a comprehensive on-site review of the storage activities of the Biobank of Zhongnan Hospital of Wuhan University (hereinafter referred to as the Biobank). The expert group was led by Lu Xing 'an, director of the Chinese Academy of Inspection and Quarantine, and included Zhang Xiaoyan, director of the Shanghai National Engineering Research Center for Biochips, Guo Dan, director of the Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences, and Xu Midie, director of the Affiliated Cancer Hospital of Fudan University. Wang Xinghuan, President of Zhongnan Hospital of Wuhan University, Xu Hua, Executive Vice Minister of Wuhan University Health Science Center, Hou Zuoyong, Deputy Secretary of the Party Committee and Discipline Inspection Committee of Zhongnan Hospital of Wuhan University, Zou Xiaofeng, deputy director of Discipline and Platform Construction Office, Ma Haoli, deputy secretary of the Party Branch of the Discipline Platform Biobank, Qian Kaiyu, deputy director of the Biobank, attended the on-site review meeting.
On July 20, Director Lu Xing 'an, the review team leader, organized the first on-site review meeting to introduce the review process, methods and principles. On behalf of Zhongnan Hospital of Wuhan University, President Wang Xinghuan warmly welcomed the arrival of the expert group and pointed out that our hospital attaches great importance to the development of the biobank. Since the construction of the biobank in 2017, it has been paying attention to the construction of the quality management system and storage capacity. It is hoped that the expert group can put forward more valuable suggestions in this review activity, further improve the quality of the biobank and capacity building.
In the 3-day review process, according to CNAS accreditation standards, the expert group through the quality system document review, field inspection, field experiment, personnel ability assessment, user forum, employee forum and other forms, the sample database from reception, transfer, registration, inspection, preparation, storage, management, destruction and distribution of the whole process. All elements of human, machine, material, law and environment were carefully reviewed, the operation of the quality management system and technical capabilities were verified, and valuable opinions and suggestions were put forward.
After a comprehensive review and assessment, the expert group fully affirmed the quality management system operation and storage capacity of the biobank. On July 22, the expert group held the final meeting, gave feedback on the problems found in the review process, issued 16 non-conforming items, and put forward guidance on the rectification of non-conforming items. Finally, the expert group announced that the Biobank of Zhongnan Hospital of Wuhan University completed the CNAS-CL10:2020 (ISO 20387:2018) accreditation on-site review. The Biobank will make positive rectification according to the review team's comments, continue to improve the quality management system, improve the quality and capacity building of the biobank, and provide high-quality biological samples and related data for clinical and translational research.