Medical Laboratory Sciences

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Browsing Medical Laboratory Sciences by Subject "Accreditation, accreditations utilization, accreditation standards, Ethiopia."

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    ISO 15189 Laboratory Accreditation Utilization Rate and Challenges among Accredited Laboratories in Ethiopia, 2021
    (Addis Abeba University, 2021-06) Ayele, Zewdu; Sisay, Abay (MSc, PhD Cand., Assistant Professor); Nigatu, Alemayehu(BSc, MSc, MPH)
    Background: Accreditation is a procedure by which a third party gives witness for a conformity assessment body conveying formal demonstration of its competence to carry out specific tasks. It is very important for the maintenance of quality; and most accredited laboratories have to be utilizing their quality performance throughout accreditation cycle as long as they are in the service. In this regard, there is limited documented evidence in Ethiopia. Thus, this study aimed to assess the ISO 15189 laboratory accreditation utilization rate and to identify hindering factors among accredited laboratories in Ethiopia, 2021. Methods: A cross sectional study design was employed in 46 government and private accredited health facility laboratories from January 2021 to June 2021 in Ethiopia by comprising quantitative and qualitative data types. Data was entered and analyzed using SPSS version 20 software. P-value <0.05 was considered as statistically significant. Qualitative data were categorized and described thematically. Result: There were 276 respondents from 46 accredited conformity assessment bodies (CABs) were participated in this study. Among the current accredited laboratories, 82.6 % were utilized accreditation. Personnel incompetence (0.4, CI [0.003-0.560]) with p-value 0.041, no appointment of quality manager (0.13, CI [0.3-0.595]) with p-value 0.008, and inadequate regulatory follow up (0.014, CI [0.00-0.47]) with p-value 0.017 were found to be major hindering factors for accreditation and had significant association with accreditation utilization. Non-commitment and low attention from top management, inadequate training, inconsistent mentorship and work load were also among the identified factors. Conclusion: In Ethiopia, even though efforts are there to implement medical laboratory accreditation, we learnt that there is an irregular substantial utilization rate, mainly due to lack of special dealing among the accredited and non-accredited laboratory by regulatory body. Hence, we strongly recommend the need for better engagement, commitment and advocacy with all stakeholders to harmonize and lead accreditation utilization service for the stupendous quality performance that can benefit the community at most.