A Model for Design and Implementation of a Laboratory Information-Management System Specific for Molecular Pathology Laboratory Operations

Abstract

The Molecular Pathology Section Q8 , Cleveland Clinic (Cleveland, OH Q9), has undergone enhancement of its testing portfolio and processes. An electronic Q10 -and paper-based data-management system was replaced with a commercially available laboratory information-management system (LIMS) software application, a separate bioinformatics platform, customized test-interpretation applications, a dedicated sampleaccessioning service, and a results-releasing software application. The customized LIMS solution manages complex workflows, large-scale data packets, and process automation. A customized approach was required because, in a survey of commercially available off-the-shelf Q11 software products, none met the diverse and complex needs of this molecular diagnostics service. The project utilized the expertise of clinical laboratorians, pathologists, genetics counselors, bioinformaticians, and systems analysts in partnering with software-engineering consultants to design and implement a solution. Concurrently, Agile software-building best practices were formulated, which may be emulated for scalable and costeffective laboratory-authored software.