DEVELOPMENT OF THE LEAP PROTOCOL: A High-Performance Operational Model for Immunization Networks through Quality Governance and Auditing

This technical report describes the development and application of the LEAP Protocol, an operational governance and auditing protocol for immunization networks, tested through on-site technical audits in 11 immunization clinics within the Federal District, Brazil, in 2024. The study, utilizing a descriptive design, assessed the compliance of critical processes, including infrastructure, cold chain integrity, waste management, information systems, secure communication during dose administration, and the existence of Standard Operating Procedures (SOPs). Based on the observed non-conformities, corrective action matrices (5W2H) were generated for each unit, establishing evidence trails and execution timeframes. During follow-up monitoring, administrative production indicators recorded in the official dashboard showed a 62% increase in the annual volume of doses in 2025 compared to 2024 in the audited units, parallel to the stabilization of routines and the reinforcement of operational controls. This is a descriptive study documenting a low-cost, highly replicable operational intervention model designed to elevate audit readiness, reduce risks of immunobiological potency loss, and strengthen the operational integrity of immunization programs. The LEAP Protocol is compatible with international priorities regarding compliance and programmatic oversight, with applicability to resource-constrained operational contexts and units situated in areas of higher vulnerability and limited infrastructure.