A well-established and functional quality management system is an integral part of any diagnostic laboratory. It assures the reliability and standards of the laboratory function. A pandemic situation such as that caused by the influenza H1N1 2009 virus or the recent severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) increases the demands on the public health system, and the need to build, upgrade and expand the number of diagnostic laboratories. The Coronavirus disease-19 (COVID-19) pandemic caused by the SARS-CoV-2 unleashed a public health emergency of an unprecedented scale. The need has been highlighted for the accreditation of tests relating to COVID-19 by the National Accreditation Board for Testing and Calibration Laboratories (NABL) or any agencies approved by the World Health Organization (WHO) or Indian Council of Medical Research. The implementation of quality system in diagnostic laboratories would ensure accurate, reliable and efficient test results at par with the international standards. The functional aspects of a laboratory such as a well-defined organogram, standard operating procedures, good laboratory practices, quality controls, human resources, equipment management, reagents, inventory of records, proper communication need to be addressed to assure quality. Biosafety considerations should include the guidelines laid out by the WHO, the Institutional Biosafety Committee and the Department of Biotechnology, Government of India for carrying out diagnostic work in the laboratory. Currently, there are 1922 laboratories, operational for COVID-19 diagnosis in India. Considering the urgency of testing, the NABL has expedited the process of accreditation and issued accreditation to 818 laboratories. The adherence to the practicable aspects of quality described in this article would help in establishing quality in COVID-19 testing laboratories.


中文翻译：

---

2019年冠状病毒病诊断实验室质量管理的步骤、实施和重要性



完善且实用的质量管理体系是任何诊断实验室不可或缺的一部分。它确保了实验室功能的可靠性和标准。 2009 年 H1N1 流感病毒或最近出现的严重急性呼吸系统综合症冠状病毒-2 (SARS-CoV-2) 等大流行病增加了对公共卫生系统的需求，需要建设、升级和扩大数量诊断实验室。由 SARS-CoV-2 引起的冠状病毒病 19 (COVID-19) 大流行引发了规模空前的公共卫生紧急事件。国家测试和校准实验室认证委员会 (NABL) 或世界卫生组织 (WHO) 或印度医学研究委员会批准的任何机构强调需要对与 COVID-19 相关的测试进行认证。诊断实验室质量体系的实施将确保检测结果准确、可靠、高效，符合国际标准。实验室的功能方面，如明确的组织图、标准操作程序、良好的实验室实践、质量控制、人力资源、设备管理、试剂、记录清单、适当的沟通，需要得到解决，以确保质量。生物安全考虑因素应包括世界卫生组织、机构生物安全委员会和印度政府生物技术部为在实验室进行诊断工作制定的准则。目前，印度有 1922 个实验室可用于 COVID-19 诊断。考虑到检测的紧迫性，NABL加快了认可进程，向818家实验室颁发了认可证书。 遵守本文中描述的质量的实际方面将有助于在 COVID-19 检测实验室中建立质量。