Lin Yanchun, Spies Nicholas C, Zohner Kimberly, McCoy Diane, Zaydman Mark A, Farnsworth Christopher W
Department of Pathology and Immunology, Washington University in St. Louis, St. Louis, MO, USA.
Barnes-Jewish Hospital, St. Louis, MO, USA.
Clin Chem Lab Med. 2025 May 5. doi: 10.1515/cclm-2025-0190.
Clinical laboratory errors pose a threat to patient safety and previous studies have demonstrated that pre-analytical error is the most common error type. Our study aimed to determine the types and frequency of errors occurring in clinical laboratory testing in contemporary practice.
Errors occurring in a core laboratory between 01/2022 and 05/2023 were recorded retrospectively. Errors were quantified using multiple data-streams including real-time manual technologist intervention, incidence reports filed by hospital staff/physicians, and retrospective assessment using automated reports from the lab information system (LIS). Errors were adjudicated and binned into pre-analytical, analytical, and post-analytical phases. Total test volumes were assessed in the LIS and electronic medical record.
There were 37,680,242 billable results reported from approximately 11,000,000 specimens during the study period. In total, 87,317 errors occurred impacting 0.23 % (2,300 ppm) of billable results and approximately 0.79 % (7,900 ppm) of specimens. Among these errors, 85,894 (98.4 %, 984,000 ppm) were in the pre-analytical, 451 (0.5 %, 5,000 ppm) were in the analytical, and 972 (1.1 %, 11,000 ppm) occurred in the post-analytical phase. Hemolysis impacting specimen integrity (60,748/87,317, 69.6 %, 696,000 ppm) was the most common error. When excluding hemolysis, there were 26,569 errors documented (0.06 %, 600 ppm of billable results), among which 94.6 %, 1.7 % (17,000 ppm) and 3.7 % (37,000 ppm) were in the pre-analytical, analytical and post-analytical phase respectively.
Observed error rates were consistent with previous studies with pre-analytical errors comprising most errors. High prevalence of pre-analytical errors implies a need for enhanced tools for error detection and mitigation in the pre-analytical phase of testing.
临床实验室错误对患者安全构成威胁，以往研究表明分析前错误是最常见的错误类型。我们的研究旨在确定当代临床实验室检测中出现的错误类型和频率。
回顾性记录2022年1月至2023年5月期间核心实验室发生的错误。使用多种数据流对错误进行量化，包括实时人工技术人员干预、医院工作人员/医生提交的事件报告以及使用实验室信息系统（LIS）的自动报告进行回顾性评估。对错误进行判定并分类到分析前、分析中和分析后阶段。在LIS和电子病历中评估总检测量。
在研究期间，从大约1100万个标本中报告了37680242个可计费结果。总共发生了87317起错误，影响了0.23%（2300 ppm）的可计费结果和约0.79%（7900 ppm）的标本。在这些错误中，85894起（98.4%，984000 ppm）发生在分析前阶段，451起（0.5%，5000 ppm）发生在分析阶段，972起（1.1%，11000 ppm）发生在分析后阶段。影响标本完整性的溶血（60748/87317，69.6%，696000 ppm）是最常见的错误。排除溶血后，记录了26569起错误（0.06%，可计费结果的600 ppm），其中94.6%、1.7%（17000 ppm）和3.7%（37000 ppm）分别发生在分析前、分析中和分析后阶段。
观察到的错误率与以往研究一致，分析前错误占大多数。分析前错误的高发生率意味着需要在检测的分析前阶段加强错误检测和缓解工具。
