Conceptual frame work on challenges for ISO 15189 accreditation, Jimma Zone, Oromia Regional State, Ethiopia

Abstract

Background: Inadequate quality of medical laboratory services is one of the challenging factors in health care delivery particularly in sub-Saharan Africa. Similarly, in Ethiopia getting consistent laboratory services and quality test results remains a critical challenge. Though laboratory accreditation is important to improve the quality of laboratory service, in Ethiopia, from 2012 up to 2020, only 53 medical laboratories were accredited by Ethiopian Accreditation Service in 74 scopes. Hence, it is important to identify the challenges that hinder public hospital laboratories from ISO 15189 accreditation. Objective: To assess challenges of medical laboratories for ISO 15189 accreditation in selected public hospitals of Jimma Zone, Oromia Regional State, Ethiopia, 2022. Method: The study was conducted at five Public Hospitals found in Jimma Zone, those were selected based on their enrolment in SLIPTA/ISO accreditation program. A cross-sectional study design was employed using quantitative and qualitative data collection approaches. The data was collected from October 20, 2021, to January 10, 2022,using a structured questionnaire and in- depth interviews. The data were entered and cleaned using EPI-Data version 4.6 and exported to statistical package software for social sciences (SPSS version 25.0) for further processing and analysis and it was presented using simple descriptive statistics like percentages and frequency. Result: From the five public hospital laboratories selected, 102 laboratory professionals and 19 key informants participated in this study. Of 102, respondents 75% of them had awareness about SLIPTA/ISO accreditation, of which 60% of them were involved in SLIPTA/ISO implementation. Only around, 39% of the respondents have training related to LQMS. High routine workload by 70%, irregular mentorship by 67%, and low staff participation by 55% of participants was perceived as major challenges encounter during SLIPTA/ISO implementation. Conclusion: Though their current initiation intended to have an accredited laboratory was appreciated, achieving accreditation was still challenging for almost all of the laboratories under this study because of insufficient training, high routine workload, irregular mentorship, inadequate awareness about SLIPTA/ISO accreditation, and low staff participation among of the identified factors. Based on these facts this study stresses the necessity of awareness, allocating adequate human resources, training, active participation, staff motivation, regular mentorship, and support of all responsible bodies to achieve and sustain the laboratory accreditation system.