Analysis of quality indicators results pre-analytical stage related to the sample acceptability of microbial laboratory from 2016 to 2021 / 中华检验医学杂志

ABSTRACT

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.