FMRP-LEAN: HIPAA-Compliant AI LIMS Cuts Clinical Assay Latency

Clinical biomarker workflows in translational research are often plagued by spreadsheet-driven tracking, manual quality control (QC) reconciliation, and loosely integrated systems—leading to poor state visibility, delayed reporting, and increased operational risk. These issues are especially acute in multi-day assays like Luminex-based quantification of Fragile X Messenger Ribonucleoprotein (FMRP), where HIPAA-compliant data governance, deterministic workflow progression, and coordinated team communication are essential. The FMRP-LEAN system directly addresses these challenges.

FMRP-LEAN formalizes biospecimen lifecycle management through a finite-state workflow model with explicit transition guards and dwell-time observability. Its architecture includes a self-hosted Supabase/PostgreSQL stack deployed within hospital-controlled infrastructure, hybrid edge-internal isolation with encrypted tunneling and loopback-only services, and bi-directional REDCap synchronization. A unified MRN-UUIDv7 identifier framework with QR-based tracking ensures traceable clinical-research linkage under PHI residency constraints. The system also incorporates automated statistical QC pre-screening and a governance-constrained AI operations module that works solely on aggregate projections, with deterministic fallback guarantees. Deployment results demonstrate improved workflow observability, reduced QC latency, and enhanced cross-role transparency between lab technicians, research coordinators, and patient-facing teams. This architecture offers a reproducible model for secure, state-explicit, and AI-augmented clinical research workflows in regulated healthcare environments.