Nonconformities in clinical laboratories in Macapá, Amapá, Brazil, based on the RDC no. 302/2005/Anvisa

ABSTRACT Introduction: Clinical analysis laboratories are health care facilities that provide resources for outpatient and/or emergency diagnoses; they are regulated in Brazil by the Resolution of the Collegiate Board of Directors (RDC) no. 302, of October 13, 2005, of the Brazilian National Agency of Sanitary Surveillance (Anvisa). Objective: The aim of this study was to perform a normative evaluation in clinical analysis laboratories, based on RDC no. 302, of October 13, 2005. Material and method: This is a cross-sectional and descriptive study. Twelve clinical laboratories participated in the study. The data were obtained through a structured questionnaire and answered by the technical leaders of the participating laboratories, in the municipality of Macapá, Amapá, Brazil. Results: The average nonconformity found among the participants was 9.64%, which allowed an overall evaluation among them as satisfactory, in relation to the minimum requirements demanded by the standardization recommended by Anvisa. When the participants were analyzed individually, there was a variation from 4.82% to 21.69% of the nonconformities index. Other studies agree with the results, however there is disagreement in a research carried out in Porto Alegre, Rio Grande do Sul, Brazil, possibly due to the fact that the laboratories present in this study do not have a quality management system in their processes. Conclusion: Laboratories 2, 3, 4, 6, 9, 11, and 12 were rated as satisfactory. Laboratories 1, 5, 7, 8 and 10 were rated as partially satisfactory. No laboratories were rated as unsatisfactory.

ABSTRACT
引言：临床检验实验室是为门诊及急诊诊断提供支撑的医疗保健机构，在巴西受巴西国家卫生监督局（Anvisa）2005年10月13日第302号理事会决议（RDC no. 302）监管。
研究目的：本研究旨在依据巴西国家卫生监督局2005年10月13日第302号理事会决议，对临床检验实验室开展规范性评估。
材料与方法：本研究为横断面描述性研究，共纳入12家临床实验室。相关数据通过结构化问卷收集，由巴西阿马帕州马卡帕市各参与实验室的技术负责人填写完成。
研究结果：参与本次研究的实验室平均不合格率为9.64%，对照巴西国家卫生监督局推荐的标准化规范所规定的最低要求，整体评估结果为合格。对各实验室单独分析后发现，其不合格率区间为4.82%至21.69%。部分现有研究与本次结果一致，但巴西南里奥格兰德州阿雷格里港开展的一项研究结果存在分歧，推测原因为本次研究涉及的实验室未在其运营流程中建立质量管理体系。
研究结论：实验室2、3、4、6、9、11及12被评定为合格；实验室1、5、7、8及10被评定为基本合格；无实验室被评定为不合格。