Survey-Defined and Interview-Elicited Challenges That Faced Ethiopian Government Hospital Laboratories as They Applied ISO 15189 Accreditation Standards in Resource-Constrained Settings in 2017.

Objectives: The World Health Organization African Regional Office recommends ISO 15189 standards to improve performance quality in sub-Saharan African laboratories. We specify challenges Ethiopian laboratorians encountered applying ISO 15189 standards.

Methods: From a structured survey at 12 Ethiopian government hospitals, 175 laboratory staff replied; all were aware of the ISO standards and 138 had been involved in the ISO 15189 inspection process. In addition, 11 laboratory heads, 10 quality officers, and three medical directors were interviewed in depth.

Results: Half or more respondents identified six challenges obstructing accreditation to a "large" or "very large" degree: (1) low management support, (2) inadequate training, (3) insufficient infrastructure, (4) excessive documentation, (5) little mentorship, and (6) increased accreditation-related workload. Interviewees added (7) poor equipment, (8) unavailable/poor-quality reagents, and (9) high staff turnover.

Conclusions: The survey and interviews specified nine major challenges for Ethiopian government hospital laboratories that seriously obstruct meeting ISO 15189 demands.