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埃塞俄比亚亚的斯亚贝巴部分私营和政府卫生机构的医学实验室认证状况及相关因素。

Medical laboratory accreditation status and associated factors in selected private and government health facilities of Addis Ababa, Ethiopia.

机构信息

Ethiopian National Accreditation Office (ENAO), Addis Ababa, Ethiopia.

Addis Ababa University, College of Health Sciences, Department of Clinical Laboratory Sciences, Addis Ababa, Ethiopia.

出版信息

Pan Afr Med J. 2023 Jun 21;45:96. doi: 10.11604/pamj.2023.45.96.29164. eCollection 2023.

Abstract

INTRODUCTION

quality medical laboratory service(s) is a key to patient safety with a great emphasis on medical diagnoses and treatment. ISO 15189 laboratory accreditation is an effective way to demonstrate competency. Despite the benefits, there are considerable exigent efforts towards achieving its target, mainly in sub-Saharan Africa. Hence, determining those factors that hinder laboratory quality services and the process of accreditation is important to address and resolve. Thus, this study aimed to assess medical laboratory accreditation process and in selected private and government health facility laboratories in Addis Ababa, Ethiopia.

METHODS

institutional-based cross-sectional study design was conducted in Addis Ababa from July 1 to August 30, 2018. Data was entered into EPI-data version 3.1 and analyzed by SPSS version 23. Data from focus group discussions were categorized and discussed thematically. Additionally, logistic regression analyses were computed to examine the relationship between the explanatory and response variable.

RESULTS

a total of 411 professionals participated in this study, of which 117(28.8%) participants were female, 280 (68.2%) participants with a bachelor´s degree, and 352 (85.6%) participants had information about accreditation. The current laboratory accreditation status in Addis Ababa is 3.6%. The primary identified factors were gaps related to method verification/validation, equipment calibration, and continual program quality improvement.

CONCLUSION

strengthening laboratory management standards towards accreditation (SLMTA) will significantly improve the accreditation process. However, there are internal and external factors may hinder the current accreditation process. Therefore, all responsible agencies/services should give more attention to solving those identified major barriers to achieving accreditation.

摘要

简介

高质量的医学实验室服务是患者安全的关键,尤其对医疗诊断和治疗有重要影响。ISO15189 实验室认证是展示能力的有效途径。尽管有诸多益处,但在撒哈拉以南非洲地区,要实现这一目标仍需要付出巨大的努力。因此,确定阻碍实验室质量服务和认证过程的因素对于解决问题至关重要。因此,本研究旨在评估埃塞俄比亚亚的斯亚贝巴的私立和政府卫生机构实验室的医学实验室认证流程。

方法

本研究于 2018 年 7 月 1 日至 8 月 30 日在亚的斯亚贝巴采用基于机构的横断面研究设计进行。数据输入 EPI-data 版本 3.1 并使用 SPSS 版本 23 进行分析。对焦点小组讨论的数据进行分类,并进行主题讨论。此外,还进行了逻辑回归分析,以检验解释变量和响应变量之间的关系。

结果

共有 411 名专业人员参与了本研究,其中 117 名(28.8%)参与者为女性,280 名(68.2%)参与者拥有学士学位,352 名(85.6%)参与者了解认证情况。亚的斯亚贝巴目前的实验室认证状态为 3.6%。主要确定的因素是与方法验证/确认、设备校准和持续的项目质量改进相关的差距。

结论

加强实验室管理标准以实现认证(SLMTA)将显著改善认证流程。然而,内部和外部因素可能会阻碍当前的认证进程。因此,所有相关机构/服务部门应更加关注解决那些已确定的实现认证的主要障碍。

相似文献

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ISO 15189:2012: What changes for African laboratories?ISO 15189:2012:非洲实验室有哪些变化?
Afr J Lab Med. 2015 Jul 31;4(1):325. doi: 10.4102/ajlm.v4i1.325. eCollection 2015.

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