QC Constellation: a cutting-edge solution for risk and patient-based quality control in clinical laboratories.

IF 3.8 2区医学 Q1 MEDICAL LABORATORY TECHNOLOGY Clinical chemistry and laboratory medicine Pub Date : 2024-05-31 DOI:10.1515/cclm-2024-0156

Hikmet Can Çubukçu

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引用次数: 0

Abstract

Objectives: Clinical laboratories face limitations in implementing advanced quality control (QC) methods with existing systems. This study aimed to develop a web-based application to addresses this gap, and improve QC practices.

Methods: QC Constellation, a web application built using Python 3.11, integrates various statistical QC modules. These include Levey-Jennings charts with Westgard rules, sigma-metric calculations, exponentially weighted moving average (EWMA) and cumulative sum (CUSUM) charts, and method decision charts. Additionally, it offers a risk-based QC section and a patient-based QC module aligning with modern QC practices. The codes and the web application links for QC Constellation were shared at https://github.com/hikmetc/QC_Constellation, and http://qcconstellation.com, respectively.

Results: Using synthetic data, QC Constellation demonstrated effective implementation of Levey-Jennings charts with user-friendly features like checkboxes for Westgard rules and customizable moving averages graphs. Sigma-metric calculations for hypothetical performance values of serum total cholesterol were successfully performed using allowable total error and maximum allowable measurement uncertainty goals, and displayed on method decision charts. The utility of the risk-based QC module was exemplified by assessing QC plans for serum total cholesterol, showcasing the application's capability in calculating risk-based QC parameters including maximum unreliable final patient results, risk management index, and maximum run size and offering risk-based QC recommendations. Similarly, the patient-based QC and optimization modules were demonstrated using simulated sodium results.

Conclusions: In conclusion, QC Constellation emerges as a pivotal tool for laboratory professionals, streamlining the management of quality control and analytical performance monitoring, while enhancing patient safety through optimized QC processes.

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QC Constellation：临床实验室基于风险和患者的质量控制尖端解决方案。

目的：临床实验室在利用现有系统实施先进的质量控制（QC）方法时面临诸多限制。本研究旨在开发一款基于网络的应用程序，以弥补这一不足，并改进质量控制实践：QC Constellation 是一款使用 Python 3.11 开发的网络应用程序，集成了各种统计质量控制模块。这些模块包括带有 Westgard 规则的 Levey-Jennings 图表、西格玛度量计算、指数加权移动平均（EWMA）和累积和（CUSUM）图表以及方法决策图表。此外，它还提供了一个基于风险的质量控制部分和一个基于病人的质量控制模块，与现代质量控制实践保持一致。QC Constellation 的代码和网络应用程序链接分别在 https://github.com/hikmetc/QC_Constellation 和 http://qcconstellation.com 上共享：通过使用合成数据，QC Constellation 展示了 Levey-Jennings 图表的有效实施，该图表具有用户友好的功能，如 Westgard 规则复选框和可定制的移动平均线图表。使用允许总误差和最大允许测量不确定性目标，成功地对血清总胆固醇的假设性能值进行了西格玛计量计算，并显示在方法决策图上。通过评估血清总胆固醇的质量控制计划，展示了基于风险的质量控制模块的实用性，该应用软件能够计算基于风险的质量控制参数，包括最大不可靠最终患者结果、风险管理指数和最大运行规模，并提供基于风险的质量控制建议。同样，还利用模拟钠结果展示了基于病人的质量控制和优化模块：总之，QC Constellation 是实验室专业人员的重要工具，它简化了质量控制和分析性能监测的管理，同时通过优化质量控制流程提高了患者安全。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical chemistry and laboratory medicine 医学-医学实验技术

CiteScore

11.30

自引率

16.20%

发文量

306

审稿时长

3 months

期刊介绍： Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!