Agajie Bogale, Ajanaw Baye, Kidist Shitu, Mulu G, Rahel Yehualla, Elenie Abera and Sisay Adane
Background: Quality management system in Ethiopia implemented more than one decade and training was provided in different seasons. Meanwhile, there is no encouraging implementation in the system even in the center of excellence national reference laboratory. Objective: This study is aimed to assess progress towards accreditation, the case of Ethiopian Public Health Institute national Human Immunodeficiency Virus (HIV) molecular reference laboratory. Methods: Retrospective record review was applied from January 2016 to December 2017. After being finalized all the documents based on required standard, baseline audit and bi-annual intensive internal audit conducted, and action items developed regularly. Advanced molecular technique is used for testing of HIV viral load and early infant diagnosis. Findings were described thematically. Results: During the base line assessment using the ISO15189 checklist, the main challenges identified were inadequate human resource, turnaround time out of range, lack of Inventory system, lack of awareness, poor sample management, and lack of address for referring sites, lack of appropriate safety measures, calibration &traceability. To address those aforementioned bottlenecks, additional staff members were recruited, training provided, the required safety measures fulfilled. For those occurrences identified, detailed root cause analysis was performed and notified for all staff members and respective management. As of August 16, 2017 the laboratory was accredited. Conclusion: Accreditation was successful with all challenges in the national HIV molecular reference laboratory. All staff and management commitment is crucial to resolve challenges and oversee changes on accreditation. Continual follow-up and maintenance of accreditation in the laboratory is recommended.