医学检验实验室在区域新型冠状病毒核酸检测中的质量监管

doi:10.16150/j.1671-2870.2022.02.014

摘要/Abstract

摘要：

目的：保证本市区域新型冠状病毒（新冠）核酸检测医学检验实验室的检测质量。方法：自2022年3月~5月,通过月度检查、蹲点督查、应急督查、盲样调查、留样再测等方法,加强对本市新冠病毒核酸检测的质量监管。结果：区域新冠核酸检测医学检验实验室在人员资质、业务培训、室内质量控制、结果判断、复检流程、报告上传、清洁消毒和医疗废物（医废）处理等方面存在不合格情况。开展新冠核酸检测实验室从3月18日疫情初期的29个,逐渐扩展到5月16日的98个,但不合格实验室数未明显增多。本市医学检验实验室盲样调查合格率为96.6%~100.0%,实验室留样再测结果与留样检测机构结果一致率为98.3%~100.0%。结论：本市区域新冠病毒核酸检测质量可控,没有发现系统性质量问题。多种措施并举的质量监管模式值得在区域新冠核酸检测质量监管中推广应用。

关键词: 新型冠状病毒核酸, 质量监管, 检测

Abstract:

Objective: To explore the quality and safety of testing in the city′s regional medical laboratories for COVID-19 nucleic acid detection. Methods: To strengthen the quality control of the city′s medical laboratories for COVID-19 nucleic acid detection through monthly inspections, squatting inspections, emergency inspections, blind sample surveys, sample retention, and retesting. Results: Regional medical laboratories for COVID-19 nucleic acid detection were non-compliant in terms of personnel qualifications, business training, internal quality control, result judgement, retesting processes, report uploading, cleaning and disinfection, and medical waste disposal. The number of laboratories conducting COVID-19 nucleic acid testing gradually expanded from 29 at the beginning of the outbreak on March 18 to 98 on May 16, but the number of non-compliant laboratories did not increase significantly. The pass rate of the blind sample survey of the city′s medical testing laboratories ranged from 96.6% to 100.0%, and the concurrence rate between the results of the laboratory′s retained samples for retesting and the results of the retained testing facilities ranged from 98.3% to 100.0%. Conclusions: The quality of regional COVID-19 nucleic acid detection in the city is generally controllable, with no systematic quality problems. The quality control model with multiple measures is worthy of application in the quality control of regional COVID-19 nucleic acid detection.

Key words: COVID-19 nucleic acid detection, Quality control, Detection

中图分类号:

R181.8

娄娇, 蒋玲丽, 王寅, 周靖, 胡晓波, 王青. 医学检验实验室在区域新型冠状病毒核酸检测中的质量监管[J]. 诊断学理论与实践, 2022, 21(02): 174-177.

LOU Jiao, JIANG Lingli, WANG Yin, ZHOU Jing, HU Xiaobo, WANG Qing, et al . Exploration of quality control methods for regional COVID-19 nucleic acid detection laboratories[J]. Journal of Diagnostics Concepts & Practice, 2022, 21(02): 174-177.

图/表 3

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日期	实验室数（个）	不合格实验室数（个）	不合格实验室比例（%）
3月18日	29	2	6.8
4月20日	70	14	20.0
5月16日	98	7	7.1

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