Tanpaiboon P, Salazar D, Pan M, Xu L, Sharma R
Quest Diagnostics Nichols Institute, San Juan Capistrano, CA 92675, USA.
Mol Genet Metab Rep. 2025 Aug 21;44:101247. doi: 10.1016/j.ymgmr.2025.101247. eCollection 2025 Sep.
Quality control (QC) in clinical laboratory is critical to ensuring quality and accuracy of patient results. However, QC monitoring is complicated in the multi-analyte, multi-instrument assays common to biochemical genetics laboratories. Comprehensive off-the-shelf QC management systems optimized for such highly complex assays and platforms are relatively scarce. A manual QC review process can impact laboratory productivity and increase risk of errors. Here we describe a novel software application that integrates, processes, and displays QC statistical parameters from multiple instruments in near real-time results by automated processor.
A customizable, cloud-based software application was developed to centralize the information, automate an extra review step in the QC review process and increase clinical utility. We monitored time spent on each step of QC review and QC range assignments before and one year after implementing the program and documented quality improvements.
This QC program has modules for different assay platforms. The program's functions include automated collection and assay data analysis, Levey-Jennings charts with integrated data from multiple instruments, graphical data visualization, instrument data centralization, assay monitoring, and a QC audit trail. The program also generates email notifications for QC lot expiration, QC review reminder, and critical results alert enabling prompt communication to providers. After the first year, this program provided 81 %-time reduction of hands-on time.
This program improves assay quality and provides considerable time savings. One benefit of this software is the ease of updating program capabilities and customizing them to meet specific and changing needs, especially for high-complexity testing.
临床实验室的质量控制（QC）对于确保患者检测结果的质量和准确性至关重要。然而，在生化遗传学实验室常见的多分析物、多仪器检测中，质量控制监测很复杂。针对这种高度复杂的检测和平台进行优化的综合现成质量控制管理系统相对较少。手动质量控制审查过程会影响实验室效率并增加出错风险。在此，我们描述一种新型软件应用程序，它通过自动化处理器近乎实时地整合、处理并显示来自多台仪器的质量控制统计参数。
开发了一种可定制的基于云的软件应用程序，以集中信息、自动化质量控制审查过程中的额外审查步骤并提高临床实用性。我们监测了实施该程序之前和之后一年在质量控制审查和质量控制范围分配的每个步骤上花费的时间，并记录了质量改进情况。
该质量控制程序有针对不同检测平台的模块。该程序的功能包括自动收集和检测数据分析、带有来自多台仪器综合数据的Levey-Jennings图表、图形数据可视化、仪器数据集中化、检测监测以及质量控制审计追踪。该程序还会针对质量控制批次到期、质量控制审查提醒和关键结果警报生成电子邮件通知，以便及时与提供者沟通。在第一年之后，该程序使实际操作时间减少了81%。
该程序提高了检测质量并节省了大量时间。此软件的一个优点是易于更新程序功能并根据特定和不断变化的需求进行定制，特别是对于高复杂性检测。
