Evaluation of nonconformities related to sanitary regulations applied to clinical laboratories in public hospital in the city of Rio de Janeiro-RJ from November 2016 to November 2017

ABSTRACT The study presents the main nonconformities related to the sanitary regulations found in clinical laboratory analysis (CLA) attached to a public hospital in the city of Rio de Janeiro (RJ) from November 2016 to November 2017. The evaluation of the nonconformities related to sanitary conditions is fundamental to ensure the goals in improving quality control, increasing the reliability of the results generated and reducing health risks. Through the evaluation of 20 federal and municipal public health laboratories, it was possible to analyze the main sanitary nonconformities in the different laboratories phases (pre-analytical, analytical and post-analytical), evaluating, through Fisher's exact test, the frequency and trend distribution of reported nonconformities. One hundred percent (100%) of the clinical analysis laboratories presented at least, one nonconformity. Among those with the highest frequencies of nonconformity related to sanitary conditions are those related to the lack of standard operating procedures (SOPs), presenting 45.5% in clinical analysis laboratories of federal hospitals and 66.7% in clinical analysis laboratories of municipal hospitals. Moreover flaws in the cleaning, disinfection and sterilization processes, in equipments and in the presence of the technical manager (TM) throughout the working hours. Sanitary surveillance actions seek to provide health services to the population that comply with established quality standards, even though the identification of nonconformities subsidizes the adoption of corrective actions by the health establishment.摘要 本研究针对2016年11月至2017年11月期间，里约热内卢市（RJ）某公立医院附属临床实验室分析（Clinical Laboratory Analysis, CLA）工作中发现的、与卫生法规相关的主要不合格项展开分析。对卫生相关不合格项的评估，是达成提升质量控制水平、增强检测结果可靠性、降低健康风险等目标的核心前提。本研究对20家联邦及市级公立卫生实验室开展评估，分析不同实验室阶段（分析前、分析中、分析后）的主要卫生不合格项，并通过费希尔精确检验（Fisher's exact test）对报告的不合格项的发生频率与趋势分布进行统计分析。所有受访临床分析实验室均存在至少1项不合格项。在各类卫生相关不合格项中，发生频率最高的为缺乏标准作业程序（Standard Operating Procedures, SOPs）：联邦医院临床分析实验室的该项不合格率达45.5%，市级医院临床分析实验室则达66.7%。此外还存在设备清洁、消毒与灭菌流程缺陷，以及技术主管（Technical Manager, TM）未能全程在岗等问题。卫生监督工作旨在为民众提供符合既定质量标准的卫生服务，而不合格项的识别则可为卫生机构采取整改措施提供依据。