关键词: 自动质控, 自动复测, 在线冰箱, 样本周转时间, 检测效率, 精益管理

Abstract:

Objective Based on the practical application of a post-analytical on-line refrigerator module integrated with a total laboratory automation（TLA）system in a clinical laboratory，to evaluate the effects of automatic quality control and automatic retest functions on improving specimen testing efficiency and shortening turn-around time（TAT）. Methods The data from 1 week in July and 1 week in August 2023 were extracted from the laboratory information system（LIS）of the Pudong Campus，Huashan Hospital，Fudan University. For 25 biochemical analytes，precision，first-batch specimen loading time，and TAT compliance rates across different blood collection time periods were compared between automatic quality control and conventional manual quality control. A 7-day on-board stability verification protocol for analytes stored in the on-line refrigerator was established，and the efficiency of manual retest and TLA-based automatic retest was compared. Results Among the 25 biochemical analytes，the cumulative coefficient of variation（CV） with automatic quality control were lower than those with conventional manual quality control in 88%（22/25） of low-level quality control materials and 92%（23/25）of high-level quality control materials （P<0.05）. Except for total bilirubin and direct bilirubin，the remaining 23 analytes met the allowable imprecision criteria for 7-day on-board storage in the on-line refrigerator. Automatic quality control enabled pre-run operation with zero manual intervention；the first-batch specimen loading time occurred 43 min earlier on average than with manual quality control，and the mean pre-loading waiting time of specimens was reduced from 112 min to 67 min（P<0.05）. TAT compliance rates improved significantly across all blood collection time periods. The time required for automatic retest（23 min）was markedly shorter than that for manual retest（52 min），representing a 56% improvement in retest efficiency. In the automatic quality control and automatic retest mode，the mean overall daily TAT was 114 min，37% shorter than that in the manual QC mode（178 min）. Conclusions The on-line refrigerator integrated with the TLA system supports automatic quality control and automatic retest functions. Its testing quality is comparable to or even superior to the manual mode，and it provides favorable lean management benefits by shortening TAT，improving overall laboratory efficiency，and reducing labor requirements.

Key words: Automatic quality control, Automatic retest, On-line refrigerator, Turn-around time, Testing efficiency, Lean management