泰国血液学实验室红细胞沉降率外部质量评估计划的制定与实施

S. Duangmano, Panida Kulawong, Puwadon Lawapakull, Panida Pongpunyayuen, Saowanit Chairatanapiwong
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引用次数: 0

摘要

背景:红细胞沉降率(ESR)仍是监测感染、炎症性疾病和某些类型癌症病程最广泛使用的筛查试验。泰国目前还没有针对红细胞沉降率的能力验证(PT)计划。研究目的本研究旨在制定并启动能力验证计划,通过评估和分析血沉实验室检测结果来提高检测质量。材料和方法:根据 ISO/IEC17043:2010 的要求,AMS CMU EQA 部门制定了 ESR 的 PT 计划。该单位制作并向参与者发送 ESR 对照材料,供其进行实验室分析;测试结果返回给该单位。检测计划每年分两个周期进行,每个周期检测两个样品。每个实验室的绩效采用稳健的 Z 评分和绩效评分进行评估。结果:根据 ISO 13528: 2015 标准,ESR 对照材料的均匀性和稳定性令人满意。有 144 家实验室加入了 PT 计划。在这些实验室中,96 家(92.3%)交回了数据:其中 40 家(42.7%)使用改良韦斯特格伦方法,29 家(29.2%)、14 家(15.7%)和 13 家(12.4%)分别使用 Microsed、Mixrate 和其他方法。82/96(85.4.%)和 8/96(8.3%)的结果令人满意或有问题。6/96 (6.3%)的测试结果为不合格。其中 82 个实验室(约 85%)达到了优秀水平。在分析所收到的数据时发现的两类主要错误是:(i) 标本处理和 (ii) 分析方法识别错误。结论:我们的研究结果表明,参与血沉检测试验计划的优势在于实验室可以监测和调查实验室错误的来源。因此,血沉检测的 PT 计划应成为实验室质量保证体系的一个组成部分。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and implementation of the external quality assessment program for erythrocyte sedimentation rate in hematology laboratories in Thailand
Background: The erythrocyte sedimentation rate (ESR) remains the most widely used screening test for monitoring the course of infections, inflammatory diseases, and some types of cancer. Proficiency Testing (PT) programs are unavailable in Thailand for ESR. Objective: This study aimed to develop and initiate the PT program to improve testing quality through evaluation and analysis of the laboratory test results for ESR. Materials and methods: The PT program for ESR was established at the AMS CMU EQA Unit by the ISO/IEC17043:2010 requirements. The unit produced and sent the ESR control materials to participants for laboratory analysis; the test results were returned to the unit. The PT program was carried out in two cycles per year, with two samples in each cycle. The performance of each laboratory was assessed using robust Z score and performance score. Results: ESR control materials presented with satisfactory homogeneity and stability according to ISO 13528: 2015. One hundred and four laboratories were enrolled in the PT program. Of these laboratories, 96 (92.3%) returned their data: 40 (42.7%) used the modified Westergren method, 29 (29.2%), 14 (15.7%), and 13 (12.4%) used Microsed, Mixrate, and other methods, respectively. Satisfactory and questionable performance was obtained in 82/96 (85.4.%) and 8/96 (8.3%), respectively. Unsatisfactory performance was noted at 6/96 (6.3%). The level of excellent performance was achieved by 82 (approx. 85%) of these laboratories. Two main types of errors found from analyzing the received data were (i) specimen processing and (ii) incorrect identification of the analytical method. Conclusion: Our results indicate that the advantage of participation in the PT program for ESR is that the laboratories can monitor and investigate the source of laboratory errors. Therefore, the PT program for ESR testing should become an integral part of the quality assurance system in the laboratory.
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