Abstract:

Objective To investigate the applicability of 3 quality management methods，exponentially weighted moving average（EWMA） of patient data，interlocalization of internal quality control（IQC） and automatic audit，in clinical laboratories of primary medical institutions. Methods The IQC data of 6 items including glucose，total cholesterol，triglyceride，total protein，albumin and urea were collected from 3 primary community health service centers under the supervision of Xi'an Area Medical Laboratory Center from June to November 2021. EWMA was used to analyze，and the application effect of EWMA was evaluated. Based on the standard deviation coefficient（SDI），coefficient of variation ratio（CVR） and other quality evaluation indexes，the consistency of results between clinical laboratories was compared. Automatic audit rules for 24 biochemical determination items were established，the coincidence rate and pass rate of manual audit and automatic audit were compared，and the differences in key indexes such as clinical laboratory sample turn-around time（TAT） before and after using automatic audit rules were compared as well. Results The trend of traditional IQC was consistent with the trend of EWMA quality control，EWMA can be offset earlier than traditional IQC identification and inspection system，but the uneven age distribution caused the false out-of-control alarm of EWMA. Among the 3 primary community health service centers，1 item（urea） SDI exceeded the allowable range and had serious negative deviation，which was consistent with the deviation trend of the results of external quality assessment（EQA） in the same period. The coincidence rate of automatic audit and manual audit during verification period was 100%，and the total pass rate of automatic audit during formal use was 95.33%. The median and 90th percentile of TAT were shortened by 24 and 136 min，respectively. Conclusions EWMA of patient data，interlocalization of IQC and automatic audit perform well in the quality management of primary medical institutions. They can sensitively identify the changes of clinical laboratory determination system，assist in out-of-control analysis，ensure the accuracy of clinical laboratory results and effectively shorten TAT.

Key words: Primary medical institute, Clinical laboratory, Patient datum, Exponentially weighted moving average, Real-time quality control, Interlocalization of quality control, Automatic audit