A-062 Development of Quality Control Indicators in the Pre-analytical Phase and a Survey on the Current Status of Clinical Laboratories in Korea

Abstract

Abstract Background Pre-analytical errors, which account for 50%–75% of all laboratory errors, include various processes handled by various occupations such as prescription, data input, sample collection, sample transport, and sample reception, making it difficult to present standardized quality indicators. Internationally, efforts are being made to present pre-analytical quality indicators and standardize/harmonize them, but in Korea, the status of pre-analytical errors in laboratories has not been identified. Therefore, this study attempted to contribute to improving the quality of domestic clinical laboratories by presenting pre-analytical quality indicators that can be easily applied and effectively managed in domestic clinical laboratories. Methods Domestic and foreign programs for pre-analytical quality indicators were investigated, and a pre-analytical quality indicator survey was conducted for domestic clinical laboratories. The survey results were analyzed to identify the current status and problems of quality management in the pre-analytical stage of the domestic clinical laboratories, and the appropriateness of the pre-analytical quality indicators in the application of the domestic clinical laboratories was reviewed. Results We prepared 22 pre-analytical quality indicators by referring to the “Quality indicators of the Pre-analytical phase” presented by the International Federation of Clinical Chemistry Working Group (2017) and “Development of an external quality control program in the pre-analytical stage for reliable laboratory implementation” presented by the Korean Association of External Quality Assessment (2021). A survey was conducted on 90 institutions nationwide, including tertiary hospitals, secondary hospitals, and professional consignment laboratories. As a result of the survey, 42 institutions (47%) responded, of which 64% were tertiary hospitals, 22% were secondary hospitals, and 14% were professional consignment laboratories. Among the quality indicators, the rate of complete blood counts accompanied by blood clots (93%) and the insufficient sample volume rate (90%) showed the highest response rate. On the other hand, the sample recollection rate (17% in the out of laboratory, 21% in the laboratory), the ratio of samples carried at nonconforming temperatures (24%), and the ratio of delayed samples (24%) showed the lowest response rate, respectively. The median value of the clinical laboratory error rate for all quality indicators of pre-analytical phase was generally very good with a sigma value of 5 or higher. Conclusion In this study, 22 pre-analytical quality indicators applicable to domestic clinical laboratories were prepared. Using this, the status of quality management in the pre-analytical phase of the domestic clinical laboratory was identified, and the appropriateness of quality indicators was reviewed. This is an important cornerstone for the standardization of quality management in the pre-analytical phase, and it is expected that it will greatly contribute to improving the quality of clinical laboratories in Korea by establishing a pre-analytical quality management system in the future.