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加强越南结核病实验室的质量以获得认证。

Strengthening Quality of Tuberculosis Laboratories Toward Accreditation in Viet Nam.

机构信息

Foundation for Innovative New Diagnostics (FIND), National Lung Hospital, Hanoi, Viet Nam.

FIND, Campus Biotech, Geneva, Switzerland.

出版信息

Am J Clin Pathol. 2019 Nov 4;152(6):808-817. doi: 10.1093/ajcp/aqz104.

Abstract

OBJECTIVES

Early diagnosis of tuberculosis (TB) and multidrug-resistant TB (MDR-TB) is a priority for Viet Nam's National TB Control Programme. In many laboratories, quality systems are weak; few have attained accreditation. We implemented a structured training and mentoring program for TB laboratories and measured impact on quality.

METHODS

Six TB culture laboratories implemented the Strengthening TB Laboratory Management Towards Accreditation (TB SLMTA) program, consisting of three training workshops and on-site mentoring between workshops to support improvement projects. Periodic audits, using standardized checklists, monitored laboratories' progress toward accreditation readiness.

RESULTS

At baseline, all six laboratories achieved a zero-star level. At exit, five laboratories attained three stars and another one star. Overall checklist scores increased by 44.2% on average, from 29.8% to 74.0%; improvements occurred across all quality system essentials.

CONCLUSIONS

The program led to improved quality systems. Sites should be monitored to ensure sustainability of improvements and country capacity expanded for national scaleup.

摘要

目的

结核病(TB)和耐多药结核病(MDR-TB)的早期诊断是越南国家结核病控制规划的重点。在许多实验室中,质量体系薄弱;获得认证的实验室很少。我们为结核病实验室实施了一项结构化的培训和指导计划,并衡量了其对质量的影响。

方法

六个结核培养实验室实施了“加强结核实验室管理以获得认证(TB SLMTA)”计划,该计划包括三次培训研讨会和研讨会之间的现场指导,以支持改进项目。定期使用标准化检查表进行审核,以监测实验室获得认证的准备情况。

结果

在基线时,所有六个实验室均达到零星级。在结束时,五个实验室达到了三星级,另一个实验室达到了一星。总体检查表评分平均提高了 44.2%,从 29.8%提高到 74.0%;所有质量体系要素均有所改善。

结论

该计划导致了质量体系的改进。应监测这些地点,以确保改进的可持续性,并扩大国家能力以实现全国范围的推广。

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