Abstract: Objective: To analyze the overall quality management on COVID-19 nucleic acid specimen collection based on the Donabedian structure-process-result theory. Methods: To identify associated factors related to the quality control of upper respiratory tract nucleic acid collection, to formulate the implementational strategies on sample collection according to Donabedian structure-process-result theory, and to apply these strategies to 1274 cases of suspected COVID-19 individuals and related groups in our hospital from January 23, 2020 to February 17, 2020. Results: The overall positive rate was 2.59% among all screened individuals, with the false negative rate being 0.24%. The rate of the qualified samples remained at 99.68%. Medical staff reported with 100.00% in mastering the operational skills during sample collection, and the rates of correct sampling in terms of location and method were 99.92% and 99.84%, respectively. The qualified rate on bacteriological detection in air and surfaces was 100.00%, and no infected case was reported among medical staff. Conclusion: The collection and implementation strategy of nucleic acid sampling via upper respiratory tract based on Donabedian structure-process-result theory can improve the qualified rate of collected samples, prevent cross infection, therefore provide references for establishment of a scientific and rigorous nucleic acid detection quality management system.

Key words: COVID-19; upper respiratory tract specimens; Donabedian structure-process-result theory; quality control