Browsing by Author "Ayele Zewdu"

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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 ; Nigatu Alemayehu
    Background: Accreditation is a procedure by which a third party gives witness for aconformity assessment body conveying formal demonstration of its competence to carry out specific tasks. Itis very important for the maintenance of quality; and most accredited laboratories have to beutilizing their quality performance throughout accreditation cycle as long as they are in theservice. In this regard, there is limited documented evidence in Ethiopia. Thus, this study aimedto assess the ISO 15189 laboratory accreditation utilization rate and to identify hindering factorsamong accredited laboratories in Ethiopia, 2021. Methods: A cross sectional study design was employed in 46 government and private accreditedhealth 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 20software. P-value <0.05 was considered as statistically significant. Qualitative data werecategorized 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 utilizedaccreditation. Personnel incompetence (0.4, CI [0.003-0.560]) with p-value 0.041, noappointment of quality manager (0.13, CI [0.3-0.595]) with p-value 0.008, and inadequateregulatory follow up (0.014, CI [0.00-0.47]) with p-value 0.017 were found to be majorhindering factors for accreditation and had significant association with accreditation utilization.Non-commitment and low attention from top management, inadequate training, inconsistentmentorship and work load were also among the identified factors. Conclusion: In Ethiopia, even though efforts are there to implement medical laboratoryaccreditation, we learnt that there is an irregular substantial utilization rate, mainly due to lack ofspecial dealing among the accredited and non-accredited laboratory by regulatory body. Hence,we strongly recommend the need for better engagement, commitment and advocacy with allstakeholders to harmonize and lead accreditation utilization service for the stupendous qualityperformance that can benefit the community at most.