A Quantifiable 3D Closed-Loop Framework for Controlled Substance Safety in a HIMSS Electronic Medical Record Adoption Model (EMRAM) Stage 7 Hospital: Pre-Post Quality Improvement Study.

BACKGROUND: Controlled substances require strict life cycle management, but manual workflows can lead to documentation errors, traceability gaps, and delays in empty-ampoule recovery. OBJECTIVE: This study aimed to construct a quantifiable 3D closed-loop framework integrating technology, process redesign, and organizational accountability and to examine whether implementation was temporally associated with changes in controlled substance process indicators. METHODS: A single-center pre-post quality improvement study was conducted in a Healthcare Information and Management Systems Society (HIMSS) Electronic Medical Record Adoption Model (EMRAM) stage 7 hospital. The preintervention period was September 2024 to November 2024, and the postintervention period was December 2024 to February 2025. The intervention combined unique drug identifiers, personal digital assistant (PDA)-based bedside verification, smart medication cabinets, predispensing prescription review rules, batch-number traceability, daily reconciliation, tiered alerts, staff training, and anomaly-handling standard operating procedures (SOPs). Outcomes were prescription dispensing record compliance, batch-number management noncompliance, failure to complete empty-ampoule recovery and electronic documentation within 24 hours, and implementation fidelity. Proportions were reported with Wilson 95% CIs. Between-period absolute differences and 95% CIs were calculated using the Wald normal approximation for independent proportions. Comparisons used the chi-square test or Fisher exact test, as appropriate. RESULTS: The analysis included 3264 prescription dispensing records before implementation and 3311 prescription dispensing records after implementation. Prescription dispensing record compliance increased from 94.82% (3095/3264) to 98.7% (3268/3311). Batch-number management noncompliance decreased from 2.4% (24/1000) to 0.6% (6/1000). The rate of failure to complete empty-ampoule recovery and electronic documentation within 24 hours decreased from 5.61% (68/1213) to 0.78% (10/1274). Implementation fidelity indicators generated from operational logs were high across system stability, scanning execution, and anomaly closure. CONCLUSIONS: Implementation of the 3D closed-loop framework was temporally associated with improvements in controlled substance process indicators in a digitally mature hospital. The implementation parameters may serve as a reference for local feasibility testing in other wards or institutions, but transferability remains to be evaluated. Multicenter studies are still needed to confirm sustainability and transferability.