Dynamic Peer Membership QA Software for Underserved Labs

适用于服务不足的实验室的动态同行成员质量保证软件

• 批准号: 6884191
• 负责人: JACQUELINE L COLEMAN
• 金额: $ 11.54万
• 依托单位: ATLANTIS LABORATORY SYSTEMS
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-02-01 至 2005-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6884191
• 关键词: computer program /software; computer system design /evaluation; data management; health science research; information dissemination

DESCRIPTION (provided by applicant): Clinical laboratory science is a $38 billion industry that is currently facing an unprecedented crisis of shortages in personnel and funding. Clinical laboratories must devote valuable resources to establish and maintain quality systems that produce accurate and precise testing results which meet regulatory requirements. Therefore, a commercial product that allows a clinical laboratory to save time and money performing these tasks will be profitable. This proposal describes the development of Neptune EQAL(TM), a virtual peer review program (statistical collaboration) designed to minimize resource requirements of the small laboratory. The major innovation of this approach to peer review will be the dynamic global membership achieved by the recognition of data transmitted that is unique to the individual laboratory. Specific Aims: The four aims to be met to prove feasibility of this concept are: 1) Develop a design requirements document that adheres to the FDA standards for software validation; 2) Develop a design plan (software blueprint) that meets the design requirements created in aim 1; 3) Create a program as defined in the design plan released in aim 2 to allow remote laboratories to post information to a centralized data repository for comparison of their quality control data with peer laboratories; 4) Alpha test the program by remote site transmission. Commercialization Potential: This potential availability of the product described in this proposal, targeted to more than 40,000 small-to-medium volume clinical laboratories in the US, has already created excitement in the clinical laboratory industry. For the first time, there will be dynamic enrollment in a virtual peer review group that is not tied to a single manufacturer of any type of product. Customers will be able to use this product for all of their instrumentation quality control, which is unique to the industry.

描述（由申请人提供）： 临床实验室科学是一个价值380亿美元的行业，目前正面临着前所未有的人员和资金短缺危机。临床实验室必须投入宝贵的资源来建立和维护质量体系，以产生符合法规要求的准确和精确的检测结果。因此，允许临床实验室节省执行这些任务的时间和金钱的商业产品将是有利可图的。该提案描述了海王星EQAL（TM）的发展，这是一个虚拟的同行评审计划（统计合作），旨在最大限度地减少小型实验室的资源需求。这种同行审查方法的主要创新将是通过承认传输的数据实现动态的全球成员资格，这些数据是各个实验室独有的。 具体目标：为证明这一概念的可行性，需要满足以下四个目标：1）制定符合FDA软件验证标准的设计需求文档; 2）制定设计计划（软件蓝图），符合目标1所订的设计要求;第三条按照aim 2中发布的设计计划中的定义创建一个程序，以允许远程实验室将信息发布到一个集中的数据存储库，与同行实验室的质量控制数据进行比较; 4）通过远程现场传输对程序进行阿尔法测试。 商业化潜力：本提案中描述的产品的潜在可用性，针对美国超过40，000个中小型临床实验室，已经在临床实验室行业引起了兴奋。这将是第一次在一个虚拟的同行评审小组中进行动态注册，该小组不与任何类型产品的单一制造商绑定。客户将能够使用该产品进行所有仪器的质量控制，这是行业所独有的。