Cornell Veterinary Biobank, College of Veterinary Medicine, Cornell University, Ithaca, New York, USA.
Department of Population Medicine and Diagnostic Sciences, Animal Health Diagnostic Center, College of Veterinary Medicine, Cornell University, Ithaca, New York, USA.
Biopreserv Biobank. 2021 Jun;19(3):163-170. doi: 10.1089/bio.2020.0068. Epub 2020 Nov 4.
Biobanks play an integral role in research and precision medicine by acquiring, processing, storing, and distributing high-quality, clinically annotated biological material. Compliance with biobanking standards and the implementation of quality management systems (QMS) can improve the quality of the biological material and associated data (BMaD). By undergoing third-party assessments, biobanks can demonstrate compliance to these standards and instill confidence in their users. In the 8 months following the publication of the International Organization for Standardization (ISO) 20387:2018 General Requirements for Biobanking standard, the Cornell Veterinary Biobank (CVB) became compliant with the standard requirements, including developing and implementing a QMS. This was achieved through the documentation of all biobanking processes, demonstration of personnel competence, the stringent control of documents and records, and ongoing evaluation of processes and the QMS. Procedures describing the control of documents and records were implemented first to provide a foundation on which to build the QMS, followed by procedures for documenting the identification of risks and opportunities, improvements, and corrective actions following nonconforming outputs. Internal audit and management review programs were developed to verify QMS performance and to monitor quality objectives. Procedures for the governance and management of the biobank were developed, including the following: organizational structure; confidentiality and impartiality policies; facility and equipment maintenance, calibration, and monitoring; personnel training and competency; and evaluation of external providers. All processes on scope were described, along with the validation and verification of methods, to ensure the fitness-for-purpose of the BMaD and the reproducibility of biobanking processes. Training sessions were held during implementation of the QMS to ensure all personnel would conform to the procedures. In April 2019, the CVB underwent third-party assessment by the American Association of Laboratory Accreditation (A2LA) and became the first biobank in the world to receive accreditation to ISO 20387:2018.
生物库通过获取、处理、存储和分发高质量、具有临床注释的生物材料，在研究和精准医学中发挥着重要作用。遵守生物库标准和实施质量管理体系（QMS）可以提高生物材料和相关数据（BMaD）的质量。通过进行第三方评估，生物库可以证明其符合这些标准，并使用户对其产生信心。在国际标准化组织（ISO）20387：2018 生物库一般要求标准发布后的 8 个月内，康奈尔兽医生物库（CVB）符合标准要求，包括开发和实施 QMS。这是通过记录所有生物库流程、证明人员能力、严格控制文件和记录以及持续评估流程和 QMS 来实现的。首先实施了描述文件和记录控制的程序，为建立 QMS 提供了基础，然后实施了记录识别风险和机遇、改进以及对不符合输出采取纠正措施的程序。制定了内部审核和管理评审程序，以验证 QMS 绩效并监测质量目标。制定了生物库的治理和管理程序，包括以下内容：组织结构；保密性和公正性政策；设施和设备维护、校准和监测；人员培训和能力；以及外部供应商的评估。描述了所有范围内的流程，以及方法的验证和确认，以确保 BMaD 的适用性和生物库流程的可重复性。在实施 QMS 期间举行了培训课程，以确保所有人员都符合程序。2019 年 4 月，CVB 接受了美国实验室认可协会（A2LA）的第三方评估，并成为世界上第一个获得 ISO 20387：2018 认证的生物库。
