Dynamic Peer Membership QA Software for Underserved Labs

描述(由申请人提供)： 临床检验科学是一个价值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，一种使临床实验室能够节省时间和金钱执行这些任务的商业产品将是有利可图的。本提案描述了海王星EQAL(TM)的开发，这是一个旨在将小型实验室的资源需求降至最低的虚拟同行审查计划(统计协作)。这种同行审查方法的主要创新将是通过承认所传输的数据是个别实验室所独有的，从而实现动态的全球成员资格。 具体目标：要证明这一概念的可行性，需要达到的四个目标是：1)制定符合FDA软件验证标准的设计要求文件；2)制定符合Aim 1中规定的设计要求的设计计划(软件蓝图)；3)创建Aim 2中发布的设计计划中定义的计划，以允许远程实验室将信息发布到中央数据存储库，以便将其质量控制数据与同行实验室进行比较；4)通过远程现场传输对计划进行Alpha测试。 商业化潜力：该提案中描述的产品的这种潜在可用性，目标是美国40,000多个中小型临床实验室，已经在临床实验室行业引起了兴奋。第一次，将有一个虚拟同行评审组的动态登记，不受任何类型产品的单一制造商的约束。客户将能够使用该产品进行所有仪表的质量控制，这是行业独一无二的。

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.