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.
