Challenges with the pursuit of ISO 15189 accreditation in a public health laboratory in Ghana.

Abstract

Background: Accreditation is important for all medical laboratories, particularly public health laboratories in developing countries. Several laboratories in Ghana implemented the requirements of the International Organization for Standardization (ISO) 15189 but were unable to proceed to accreditation. This article describes the challenges faced by the Pathology Division Laboratory of the 37 Military Hospital, Accra, Ghana, during the acquisition of ISO 15189 accreditation and suggests solutions for a better approach.

Intervention: Following ISO 15189 accreditation in 2017, an online survey was conducted between 01 and 30 March 2020 among the laboratory staff. Respondents were required to grade, on a scale of 0 (least) to 5 (most), the extent to which 16 key challenges influenced the process of obtaining accreditation. Key informant interviews were also held with laboratory personnel who were directly involved in the establishment of the quality management system in the laboratory and the accreditation acquisition process.

Lessons learnt: Documentation, laboratory safety measures, laboratory management support, and reagent unavailability were estimated as the challenges that most affected the acquisition of laboratory accreditation. Challenges such as poor communication, staff apathy and workload had the least effect on the accreditation process. There was no difference in challenges identified between persons who worked in the laboratory before or after accreditation (p = 0.11).

Recommendations: To surmount the anticipated challenges, there is the need for national strategic direction for laboratory accreditation, hospital and laboratory management support for the accreditation acquisition and maintenance processes, and sufficient technical assistance in the form of training and mentorship.