From Establishment to ISO15189:2012 Accreditation: The Case of Hararghe Health Research Laboratory, Harar, Ethiopia

Accreditation of laboratories offering diagnostic services improves the operation of clinical as well as research performance.

This case report describes the journey of Hararghe Health Research Laboratory from it's inception to the International Organization for Standardization 15189:2012 accreditation by the Ethiopian Accreditation Service.

An external consultant conducted a baseline audit in November 2019 following the World Health Organization African Region's Stepwise Laboratory Quality Improvement Process Towards Accreditation guideline. The follow-up internal audit was conducted in January 2021. Then, an on-site laboratory assessment was conducted by experts from Ethiopian Accreditation Service towards the end of 2022.

The Hararghe Health Research laboratory received multiple remarks during audit by external consultant and drew up a corrective action plan. Some of the actions were revision of quality policy manual, managerial and technical documents, participation in the United Kingdom National External Quality Assessment Scheme and implementation of the International Organization for Standardization 15189:2012 accreditation checklist. The internal audit revealed a total of 26 gaps in the microbiology and 16 in the molecular biology sections and these were filled by the end of April 2022.The laboratory was cited for nine minor non-conformities during an assessment by experts from the Ethiopian Accreditation Service. The laboratory developed a corrective action plan, cleared non-conformities by end of February 2023 and received the accreditation certificate on 3rd May 2023. The laboratory's accreditation achievement in less than five years is a significant milestone and serves as a model for other institutions to achieve it in a similar time frame.