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 Complexo Oncológico de Referência do Estado de Goiás (CORA) is the first hospital specialized in the diagnosis and treatment of pediatric oncology in the state of Goiás. Due to the anticipated high demand for transfusions, the implementation of a Transfusion Agency (TA) became necessary to provide rapid and safe care to patients. The validation of the Cold Chain Network (CCN) encompasses three processes: Installation Qualification (IQ), Performance Qualification (PQ), and Operational Qualification (OQ). The adoption of this process, combined with continuous monitoring and Quality Control (QC), ensures the integrity of hemocomponents and reinforces transfusion safety. This involves maintaining the proper temperature throughout the entire process, from collection to transfusion, as well as validating equipment and procedures to prevent losses and guarantee the quality of the final product. To characterize and demonstrate the quality control of the cold chain network (CCN) of the Transfusion Agency (TA) at CORA. The TA's cold chain network consists of six refrigerators (R1 to R6) and one freezer (F1). The validation followed three stages: Installation Qualification (IQ), Thermal Performance Qualification (TPQ), and Operational Qualification (OQ), conducted by clinical engineering according to manufacturers’ manuals. Expired hemocomponents were used to simulate real usage in the equipment. Technical reports were generated at the end of the process. Quality control (QC) is performed through manual temperature records every four hours, daily, including records of incidents and alarm tests. These data are evaluated monthly based on legal parameters: refrigerators (+2 to +6°C), freezer (-20°C), and environment (+20 to +24°C). At CORA's TA, the focus is on the proper storage and distribution of Hemocomponents (HC), made possible through a partnership with the Hemocenter of Goiás (HEMOGO), which provided HC for both clinical use and thermal validation of the equipment. Clinical engineering played a key role in conducting the Thermal Performance Qualification (TPQ), ensuring equipment validation and issuance of reports. Thermal boxes for internal and external transport were also validated. Quality control is rigorous, with continuous monitoring of temperatures of the CCN, environment, and thermal boxes, all within legal limits during the evaluation period.The implementation of the TA at CORA, combined with the partnership with the Hemocentro de Goiás, was crucial to ensure the adequate supply of hemocomponents and enable realistic thermal validation of the cold chain network. It is well understood that validation and quality control of the cold chain are necessary steps to ensure the integrity and safety of hemocomponents, especially in a pediatric oncology setting.