PATIENT SAFETY MONITORING IN INTERNATIONAL LABORATORIES (SMILE)

国家过敏和传染病研究所(NIAID)、国家卫生研究院(NIH)、卫生与公众服务部(DHHS)支持与微生物学和免疫学基本知识有关的研究，从而开发疫苗、治疗学和医学诊断学，以预防、治疗和诊断传染病和免疫介导性疾病。NIAID艾滋病部门需要一种全面和统一的方法来评估最初和正在进行的实验室的能力以及在美国境外执行NIAID资助的临床试验方案的准备情况。NIAID将确保参与其临床试验的受试者的安全性和最佳管理，以及获得对研究结果的有意义解释至关重要的可靠的基于实验室的数据作为最优先事项。同样重要的是那些进行实验室检测的人的安全。美国的临床实验室被要求满足临床实验室改进修正案(CLIA)的性能标准，并参与各种外部能力测试计划。尽管存在非美国的认证组织和水平测试计划提供商，但这些组织和提供商在对临床实验室的要求和监督水平方面存在很大差异。国际实验室患者安全监测(SMILE)合同的目的是提供一种全面和统一的方法来评估最初和正在进行的实验室的能力以及执行NIAID资助的临床试验方案的准备情况，方法是：(1)监测实验室遵守良好临床实验室规范(GCLP)的情况，(2)通过评估编码样本小组获得的结果来监测实验室可靠地执行方案规定的测试的能力，(3)为实验室提供各种协助、指导和培训，以解决和防止GCLP和/或熟练测试中的缺陷再次发生，以及(4)维护包括实验室性能数据和指导文件的计算机化数据管理系统和文档库。

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of AIDS has a requirement for a comprehensive and uniform approach to evaluate initial and on-going laboratory capability and readiness to carry out NIAID-funded clinical trial protocols outside the U.S. NIAID places the highest priority on ensuring the safety and optimal management of subjects who participate in its clinical trials and on obtaining reliable laboratory-based data critical for the meaningful interpretation of study findings. Equally important is the safety of those who perform the laboratory testing. Clinical laboratories in the U.S. are required to meet Clinical Laboratory Improvement Amendments (CLIA) performance standards and participate in a variety of external proficiency testing programs. Though non-U.S. accreditation organizations and providers of proficiency testing programs exist, these vary significantly in their requirements and level of oversight of clinical laboratories. The purpose of the Patient Safety Monitoring in International Laboratories (SMILE) contract is to provide a comprehensive and uniform approach to evaluate initial and on-going laboratory capability and readiness to carry out NIAID-funded clinical trial protocols by (1) monitoring laboratories compliance with Good Clinical Laboratory Practices (GCLP), (2) monitoring the ability of laboratories to reliably perform protocol-specified tests by evaluating results obtained with panels of coded samples, (3) providing Labs with various means of assistance, guidance and training to address and prevent recurrence of deficiencies in GCLP and/or proficiency testing, and (4) maintaining a computerized data management system and document library that include lab performance data and guidance documents.