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COVID-19 对实体瘤分子诊断检测质量检查的影响。印度 EQAS 提供商的监测。

Impact of COVID-19 on quality checks of solid tumor molecular diagnostic testing-A surveillance by EQAS provider in India.

机构信息

Department of Pathology, Molecular Pathology Laboratory, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.

出版信息

PLoS One. 2022 Sep 22;17(9):e0274089. doi: 10.1371/journal.pone.0274089. eCollection 2022.

Abstract

BACKGROUND

Molecular tests in solid tumours for targeted therapies call for the need to ensure precision testing. To accomplish this participation in the External Quality Assessment Program (EQAS) is required. This evaluates the consistency of diagnostic testing procedures and offers guidance for improving quality. Outbreak of COVID-19 pandemic led to worldwide lockdown and disruption of healthcare services including participation in EQAS.The present study describes the extended scope of EQAS offered byMPQAP (Molecular Pathology Quality Assurance Program), the first proficiency test provider for solid tumor diagnostics in India. The study surveys the preparedness of molecular testing laboratories in routine diagnostics and participation for quality assessment scheme.

METHODS

A documented guideline for measures and precautions to be carried by testing laboratories in performing routine diagnostic tests during the lockdown period were charted and distributed to all MPQAP participant centres. A survey was conducted for MPQAP participants to check whether laboratories were involved in COVID-19 testing and to evaluate the impact of lockdown on the operations of diagnostics procedures. From the acquired response of the survey, 2 cycles out of initially proposed 11 cycles were executed with transformed approach using digital tools and image interpretation modules.

FINDINGS

Out of 25 solid tumour testing laboratories registered as participants, 15 consented to participate in survey. The summary of survey conveyed the impact of COVID-19onroutine operations of diagnostics tests such as shortcomings in inventory and human resource management. Thirteen participants showed active willingness and consented to participate in EQAS test scheme.

INTERPRETATIONS

The survey findings and assessment of EQAS cycles endorsed the quality testing procedures carried by participating laboratories throughout the lockdown. It highlighted the utility of EQAS participation during pandemic along with emphasis on safety measures for continual improvement in quality of diagnostic services.

摘要

背景

针对靶向治疗的实体瘤分子检测需要确保精准检测。为此,需要参与外部质量评估计划(EQAS)。这可以评估诊断测试程序的一致性,并为提高质量提供指导。COVID-19 大流行导致全球封锁,包括参与 EQAS 在内的医疗保健服务中断。本研究描述了印度首个实体瘤诊断用分子病理学质量保证计划(MPQAP)提供的更广泛的 EQAS 范围。该研究调查了常规诊断中分子检测实验室的准备情况和参与质量评估计划的情况。

方法

制定了一份文件指南,规定了在封锁期间进行常规诊断测试的检测实验室应采取的措施和预防措施,并分发给所有 MPQAP 参与者中心。对 MPQAP 参与者进行了一项调查,以检查实验室是否参与了 COVID-19 检测,并评估封锁对诊断程序操作的影响。根据调查的回复,最初提出的 11 个周期中的 2 个周期使用数字工具和图像解释模块进行了转换方法执行。

发现

在注册为参与者的 25 个实体瘤检测实验室中,有 15 个同意参与调查。调查总结传达了 COVID-19 对诊断测试常规操作的影响,例如库存和人力资源管理方面的不足。13 名参与者表示积极愿意并同意参与 EQAS 测试计划。

解释

调查结果和 EQAS 周期评估证实了参与实验室在整个封锁期间进行的质量测试程序。它强调了在大流行期间参与 EQAS 的实用性,并强调了安全措施,以持续提高诊断服务质量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65b2/9498956/c564505fb170/pone.0274089.g001.jpg

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