2016-2021年微生物实验室标本可接受性相关检验前质量指标结果分析

Analysis of quality indicators results pre-analytical stage related to the sample acceptability of microbial laboratory from 2016 to 2021

目的通过回顾分析2016-2021年微生物实验室标本可接受性相关检验前质量指标的室间质评结果,了解微生物实验室标本可接受性,为建立初步质量规范提供参考。方法国家卫生健康委临床检验中心联合31个省(自治区、直辖市)和新疆生产建设兵团临床检验中心同步开展质量指标室间质量评价计划,并通过已开发的室间质量评价系统在线回报结果,收集2016—2021年实验室的基本信息和相关质量指标数据,对全国总体、连续回报实验室(分级和分省)进行统计分析,并采用西格玛度量评价实验室质量水平。结果全国实验室13项质量指标所有年份的M均为0(2018年第一次微生物标本污染率除外);其中10项质量指标(标本采集量错误率、标本丢失率、标本标识错误率、标本检验前储存不适当率、标本运输途中损坏率、标本运输温度不适当率、标本运输时间过长率、标本采集时机不正确率、实验室人员导致的标本重新采集率、非实验室人员导致的标本重新采集率)所有年份的四分位数均为0,均达到6σ水平。连续回报实验室3项质量指标三级医院各年M(Q3)结果显示,标本容器错误率最低,其次是标本类型错误率,微生物标本污染率最高,对应的M(Q3)结果最高值分别为0.047%(0.191%),0.059%(0.252%),0.251%(0.6%);按照省份分别对标本类型错误率和标本容器错误率2016年第1次和2021年第1次三级医院M进行排列,标本类型错误率中辽宁、河北、江西、天津、北京、贵州、甘肃、青海和宁夏2021年第1次三级医院较2016年第1次明显降低,标本容器错误率中辽宁、四川、浙江、湖北、山西、天津、重庆、贵州、宁夏和湖南2021年第1次三级医院较2016年第1次明显降低。结论全国临床微生物实验室标本可接受性结果整体尚可,实验室应探索并建立适合自身的质量指标体系,加强重点质量指标的长期监测,提升服务质量。

Objective By reviewing and analyzing the results of external quality assessment of pre-test quality indicators related to the acceptability of microbiology laboratory sample from 2016-2021,we aimed to understand the acceptability of microbiology laboratory sample and therefore to provide a reference for establishing preliminary quality specifications.Methods The National Center for Clinical Laboratories organized 31 provinces(including autonomous regions and municipalities directly under the Central Government)and the Xinjiang production and Construction Corps centers to launch a synchronous Quality Indicators(QIs)-External Quality Assessment(EQA)program and the collected data were reported via an online EQA system.The essential information of the clinical laboratories and the data of quality indicators from 2016 to 2021 were collected and the data from overall,continuous return laboratories were analyzed.Sigma values were calculated to assess the quality level of laboratory.Results The median of the 13 quality indicators of national laboratories for all years was 0(except for the first microbiological contaminated sample rate in 2018).Ten of the quality indicators(incorrect fill level rate,sample loss rate,misidentified sample rate,unsuitable sample for storage rate before analysis,sample damaged rate during transportation,sample transported at inappropriate temperature rate,sample with excessive transportation time rate,inappropriate time in sample collection rate,sample recollection rate for error due to laboratory staff,sample recollection rate for error not due to laboratory staff)had quartiles of 0 for all years,reaching six sigma level.The results of the median(upper quartile)of each year of the three quality indicators of continuous return laboratories for tertiary hospitals show that the incorrect sample container rate was the lowest,followed by the incorrect sample type rate,and the microbiological contaminated sample rate was the highest.The highest values of corresponding median(upper quartile)results were 0.047%(0.191%),0.059%(0.252%),0.251%(0.6%)respectively.The median incorrect sample type rate and median incorrect sample container rate in 2016/1 and 2021/1 tertiary hospitals were ranked by province respectively.The median for the incorrect sample type rate of Liaoning,Hebei,Jiangxi,Tianjin,Beijing,Guizhou,Gansu,Qinghai and Ningxia tertiary hospitals in 2021/1 was significantly lower than the respective values in 2016/1,and the median for incorrect sample container rate of Liaoning,Sichuan,Zhejiang,Hubei,Shanxi,Tianjin,Chongqing,Guizhou,Ningxia and Hunan tertiary hospitals in 2021/1 was significantly lower than those respective values in 2016/1.Conclusions The results of the sample acceptability of microbial laboratory are generally acceptable.The laboratories should explore and establish their own quality indicators system,strengthen the long-term monitoring of key quality indicators and improve their service quality.