FMRP-LEAN: A HIPAA-Compliant AI-Augmented LIMS Architecture for End-to-End Clinical Assay Workflow Optimization

תקציר מקורי באנגליתarXiv:2607.20382v1 Announce Type: cross Abstract: Clinical biomarker workflows in translational research settings often rely on spreadsheet-driven tracking, manual quality control (QC) reconciliation, and loosely integrated systems, resulting in limited state visibility, delayed reporting, and increased operational risk. These challenges are particularly pronounced in multi-day assays such as Luminex-based quantification of Fragile X Messenger Ribonucleoprotein (FMRP), where HIPAA-compliant data governance, deterministic workflow progression, and coordinated communication across laboratory and clinical teams are required. This paper presents FMRP-LEAN, a HIPAA-compliant, AI-augmented Laboratory Information Management System (LIMS) architecture that formalizes biospecimen lifecycle manageme