Cheng Xiuli, Yu Haimiao, Zhang Le, Zhang Biao, Wang Qin
Department of Clinical Laboratory, Tianjin Key Laboratory of Cerebral Vessels and Neural Degeneration, Tianjin Huanhu Hospital, Tianjin, China.
Huanhu Hospital Affiliated to Tianjin Medical University, Tianjin, China.
PLoS One. 2025 Jun 3;20(6):e0324840. doi: 10.1371/journal.pone.0324840. eCollection 2025.
Up to 60% of errors occur in the pre-analytical stage of laboratory testing, potentially impairing clinical decision-making. This study aimed to assess pre-analytical errors using Six Sigma metrics and identify underlying causes for quality improvement.
A retrospective analysis of pre-analytical sample errors was conducted over three years in a clinical laboratory. Errors were categorized, and Sigma values were calculated to assess quality. Trends over time were also analyzed.
Of 2,068,074 samples, 2,214 (0.107%) were rejected. The top errors were clotted blood specimens (67.34%), insufficient volumes (8.22%), and cancelled test requests (6.28%), with Sigma values of 4.42, 5.25, and 5.32, respectively. The outpatient department performed best (Sigma = 5.47), while other wards required improvement.
Efforts are needed to reduce specimen rejection, particularly clotted samples, to enhance laboratory quality.
高达60%的误差发生在实验室检测的分析前阶段，这可能会影响临床决策。本研究旨在使用六西格玛指标评估分析前误差，并确定质量改进的潜在原因。
在一家临床实验室对分析前样本误差进行了为期三年的回顾性分析。对误差进行分类，并计算西格玛值以评估质量。还分析了随时间的趋势。
在2,068,074个样本中，有2,214个（0.107%）被拒收。最主要的误差是凝血标本（67.34%）、样本量不足（8.22%）和取消的检测申请（6.28%），其西格玛值分别为4.42、5.25和5.32。门诊部表现最佳（西格玛值=5.47），而其他病房则需要改进。
需要努力减少样本拒收，尤其是凝血样本，以提高实验室质量。
