Case Study: Molecular Diagnostics Lab achieves CLIA compliance in 28 days with Scispot

How a Molecular Diagnostics Lab Achieved CLIA Compliance in Just 28 Days with Scispot

Molecular Diagnostics Lab, a Midwest advanced clinical diagnostics team, faced an urgent CLIA certification deadline, limited staff resources, and complex compliance documentation needs. To meet strict CLIA and HIPAA requirements quickly, they engaged Scispot and deployed the Scispot Professional solution (alt-LIMS with integrated alt-QMS) to streamline sample tracking, document control, and quality-system setup.

Scispot implemented its integrated alt-QMS and traceable sample management within the alt-LIMS, providing electronic signatures, audit trails, and CLIA-ready workflows. The result: validation package assembly was shortened from an expected 12 weeks to 28 days (a 70% reduction in documentation preparation time), a 95% improvement in specimen tracking accuracy, and a 60% decrease in SOP management effort—rapidly enabling CLIA certification and reducing administrative burden.