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制定一种定制化方法,以加强结核病实验室质量管理体系以实现认证。

Developing a customised approach for strengthening tuberculosis laboratory quality management systems toward accreditation.

作者信息

Albert Heidi, Trollip Andre, Erni Donatelle, Kao Kekeletso

机构信息

Foundation for Innovative New Diagnostics (FIND), Cape Town, South Africa.

Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.

出版信息

Afr J Lab Med. 2017 Mar 31;6(2):576. doi: 10.4102/ajlm.v6i2.576. eCollection 2017.

Abstract

BACKGROUND

Quality-assured tuberculosis laboratory services are critical to achieve global and national goals for tuberculosis prevention and care. Implementation of a quality management system (QMS) in laboratories leads to improved quality of diagnostic tests and better patient care. The Strengthening Laboratory Management Toward Accreditation (SLMTA) programme has led to measurable improvements in the QMS of clinical laboratories. However, progress in tuberculosis laboratories has been slower, which may be attributed to the need for a structured tuberculosis-specific approach to implementing QMS. We describe the development and early implementation of the Strengthening Tuberculosis Laboratory Management Toward Accreditation (TB SLMTA) programme.

DEVELOPMENT

The TB SLMTA curriculum was developed by customizing the SLMTA curriculum to include specific tools, job aids and supplementary materials specific to the tuberculosis laboratory. The TB SLMTA Harmonized Checklist was developed from the World Health Organisation Regional Office for Africa Stepwise Laboratory Quality Improvement Process Towards Accreditation checklist, and incorporated tuberculosis-specific requirements from the Global Laboratory Initiative Stepwise Process Towards Tuberculosis Laboratory Accreditation online tool.

IMPLEMENTATION

Four regional training-of-trainers workshops have been conducted since 2013. The TB SLMTA programme has been rolled out in 37 tuberculosis laboratories in 10 countries using the Workshop approach in 32 laboratories in five countries and the Facility-based approach in five tuberculosis laboratories in five countries.

CONCLUSION

Lessons learnt from early implementation of TB SLMTA suggest that a structured training and mentoring programme can build a foundation towards further quality improvement in tuberculosis laboratories. Structured mentoring, and institutionalisation of QMS into country programmes, is needed to support tuberculosis laboratories to achieve accreditation.

摘要

背景

质量有保证的结核病实验室服务对于实现全球和国家结核病预防与护理目标至关重要。实验室实施质量管理体系(QMS)可提高诊断检测质量并改善患者护理。加强实验室管理以实现认证(SLMTA)计划已使临床实验室的质量管理体系有了可衡量的改进。然而,结核病实验室的进展较慢,这可能归因于需要一种针对结核病的结构化方法来实施质量管理体系。我们描述了加强结核病实验室管理以实现认证(TB SLMTA)计划的开发和早期实施情况。

开发

TB SLMTA课程是通过对SLMTA课程进行定制而开发的,包括针对结核病实验室的特定工具、工作辅助材料和补充材料。TB SLMTA统一检查表是根据世界卫生组织非洲区域办事处迈向认证的实验室质量逐步改进过程检查表制定的,并纳入了全球实验室倡议迈向结核病实验室认证在线工具中针对结核病的要求。

实施

自2013年以来已举办了四次区域培训员讲习班。TB SLMTA计划已在10个国家的37个结核病实验室中推行,其中32个实验室采用讲习班方法在5个国家实施,5个结核病实验室采用基于机构的方法在5个国家实施。

结论

TB SLMTA早期实施的经验教训表明,结构化的培训和指导计划可为结核病实验室进一步提高质量奠定基础。需要结构化的指导以及将质量管理体系纳入国家计划,以支持结核病实验室获得认证。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fcd4/5523923/4a628c1c9a47/AJLM-6-2-576-g001.jpg

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