Application progress on construction of quality management system for blood group genotyping

In transfusion medicine, DNA-based genotyping is rapidly being employed as an alternative to serological antibody-based methods for blood group determination in donor-recipient matching, becoming a crucial method for precise blood typing. Currently, there is a lack of unified quality management norms, including quality control and quality assurance programs, as well as standard operating procedures (SOPs) related to blood genotyping technology. The blood genotyping quality management system (QMS) serves as the core framework to ensure the accuracy of genotyping results and the safety of clinical samples, covering key dimensions such as technical standards, personnel competency, equipment management, data security, and sample compliance. Blood genotyping quality management provides a systematic strategy and direction for quality control, while quality control implements the objectives of quality management through specific technical measures. The combination of both forms a closed-loop management system of "prevention-control-improvement", covering the entire process: pre-testing, under testing, and post-testing phases. By integrating relevant regulations and work practices, this paper conducts an initial application focusing on the QMS framework and standards, quality control of key processes, personnel and facility requirements, data security and sample safety compliance, as well as continuous improvement and future development.