VALIDATION AND QUALITY CONTROL OF THE COLD CHAIN FOR HEMOTHERAPEUTIC PRODUCTS DURING THE IMPLEMENTATION OF THE TRANSFUSION AGENCY IN A COMPLEXO ONCOLÓGICO DE REFERÊNCIA DO ESTADO DE GOIÁS

The initial stages of the transfusion process is the handling flow of hemocomponents, from their arrival to proper storage, so that the transfusion procedure can subsequently proceed. As this is a critical step, it requires dedication and strict technical standards. Ensuring quality and compliance with current regulations involves the acquisition of necessary supplies, the development and application of protocols, and the validation of processes. The Transfusion Agency (TA) of Complexo Oncológico de Referência do Estado de Goiás (CORA) underwent an implementation process that required the full execution of the transport protocol in accordance with current legislation. To describe the implementation process of the hemocomponent transport validation protocol in a TA linked to the CORA, a pediatric oncology hospital in Brazil. A regulatory review was conducted, followed by the acquisition of specific supplies, the purchase and adaptation of a dedicated vehicle for external transport of hemocomponents, definition of internal workflows, and the planning and execution of thermal box validation procedures. In compliance with all regulatory requirements, the vehicle designated for hemocomponent transport was properly labeled, adapted with waterproof material in the trunk, and equipped with safety straps to secure thermal boxes. The vehicle was inspected by the Sanitary Surveillance authority, and a certificate of compliance was issued.Every validation protocol and Standard Operating Procedure (SOP) was developed and approved. The staff directly involved in the process (drivers) underwent specific training and qualification at the Hemocenter de Goiás – Hemogo. The thermal boxes used were subjected to thermal validation to ensure proper temperature maintenance during transport.Each stage and adopted measure aimed to ensure quality, safety, and traceability throughout the process, minimizing risks and promoting excellence in transfusion care. The implementation of the transport validation protocol at CORA’s TA demonstrated the feasibility of structuring technically demanding processes even in newly established institutions. This effort reinforced transfusion safety, ensured traceability, and fully complied with regulatory standards. The multidisciplinary engagement and clear execution of each technical phase were essential to the project's success. The support of the State Hemocenter Coordinator Prof. Nion Albernaz and the Secretaria de Saúde do Estado de Goiás (SES-GO) were indispensable to the achievement of this initiative.