Clin Lab. 2020 Apr 1;66(4). doi: 10.7754/Clin.Lab.2019.190718.
The aim was to produce quality results that clinical laboratories need to implement and maintain continuous quality improvement systems. In recent years, health organizations have increasingly prioritized the quality of laboratory services by implementing quality management systems (QMSs) and building quality improvement activities. Efforts to strengthen laboratory systems in the African region have received increased attention in recent years. Assessing the implementation levels of laboratory quality management system components is important to identify the gaps that need further improvements.
A cross-sectional study design was used between March and May 2017 in selected government hospitals of Ethiopia, and sample size was determined using a finite population formula, and a proportional sampling technique was employed; a sample size of 184 (62%) was calculated from 295 laboratory professionals.
All respondents were informed about the laboratory's experience in the quality management system implementation; of those, only 138 (79%) engaged in the implementation process. From the 18 selected laboratory quality management components, 5 were observed to have the list implementation status, which are: (1) Performance of internal quality control for all tests, (2) Development and communication of a quality manual for all tests, (3) Adequacy of storage space for the supplies, (4) Development of an action plan based on internal audit, and (5) monitoring of environmental conditions. Running quality controls for all types of tests became a headache in almost all laboratories. From 12 selected quality indicators studied in this research, the 5 indicators with either poor or very poor performance outcome were: control of documents 136 (77.7%), control of records 123 (70.3%), development of manuals and policies 122 (69.7%), development of process and procedures 120 (68.6%), and internal communication 114 (65.1%).
This research indicated the top 3 LQMS components with either poor or very poor implementation status: (1) Performance of internal quality controls for all tests, (2) Development and communication of quality manuals for all tests, (3) Adequacy of storage space for the supplies. Of the quality indicators studied, control of documents was perceived to have poor performance outcome by 136 (77.7%) of study participants.
本研究旨在制定临床实验室需要实施和维护持续质量改进系统的质量结果。近年来，卫生组织通过实施质量管理系统（QMS）和建立质量改进活动，越来越重视实验室服务的质量。近年来，加强非洲区域实验室系统的努力受到了更多关注。评估实验室质量管理系统组件的实施水平对于确定需要进一步改进的差距非常重要。
本研究采用横断面研究设计，于 2017 年 3 月至 5 月在埃塞俄比亚选定的政府医院进行，使用有限总体公式确定样本量，并采用比例抽样技术；从 295 名实验室专业人员中计算出 184 名（62%）的样本量。
所有受访者都被告知实验室在质量管理系统实施方面的经验；其中，只有 138 人（79%）参与了实施过程。在 18 个选定的实验室质量管理组成部分中，有 5 个被观察到具有清单实施状态，分别是：（1）对所有测试进行内部质量控制，（2）为所有测试制定和传达质量手册，（3）为用品提供充足的储存空间，（4）根据内部审计制定行动计划，（5）监测环境条件。运行所有类型测试的质量控制几乎成为所有实验室的头痛问题。在本研究中研究的 12 个选定质量指标中，有 5 个指标的表现结果较差或很差：文件控制 136（77.7%），记录控制 123（70.3%），手册和政策制定 122（69.7%），流程和程序开发 120（68.6%），内部沟通 114（65.1%）。
本研究表明，实施状态较差或很差的前 3 个 LQMS 组件是：（1）对所有测试进行内部质量控制，（2）为所有测试制定和传达质量手册，（3）为用品提供充足的储存空间。在所研究的质量指标中，有 136 名（77.7%）研究参与者认为文件控制的表现结果较差。
