Under the Southern Africa Tuberculosis and Health Systems Support (SATBHSS) project, a total of 11 laboratories from Lesotho, Malawi, Mozambique and Zambia have undergone a successful assessment using the World Health Organization Regional Office for Africa (WHO/AFRO) Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA). This exercise took place from 14th May – 01st June 2018 and is a follow up from the baseline assessment conducted in 2017.
The results and findings from the assessment indicate that on average, the performance of the 11 laboratories was below 50% in management reviews, corrective actions and root cause analysis. The aim of the project is to ensure that each laboratory undergoes a comprehensive quality improvement process with a target of achieving at least 2 Stars by the end of the project. During this assessment, one (1) achieved five stars, one (1) four stars, two (2) three stars, three (3) attained two stars, three (3) attained one star and one (1) received zero stars. A total of 13 laboratories were earmarked for assessment and audit under the SATBHSS project but during this exercise only 11 were audited because two laboratories were undergoing renovations from Lesotho and Zambia.
In each project country, the audit team provided feedback to the Ministry of Health (MoH) during the Centralized De-brief meeting. The meetings were attended by the Permanent Secretary, National TB Program Managers, MoH Laboratory Services Directorates, managers and staff of audited laboratories and MoH implementing partners. Overall feedback on performance of the audited laboratories including results (scores and star levels), areas where laboratories performed well, areas of improvement and recommendations are provided during this meeting. The auditors also used these meetings as platform for advocacy for laboratory system strengthening.
The SLIPTA checklist evaluates laboratory performance based on the 12 Quality Systems Essentials (QSEs) that cover requirements for the pre-analytic, analytic and post analytic phases of the testing services. In order to build capacity of the countries to be able to conduct quality in-country audits, the SATBHSS project trained 26 laboratories from the four project countries in March 2017 in collaboration with African Society for Laboratory Medicine (ASLM). In the 2018 audits, 15 (58%) of the trained auditors underwent competency evaluation and were recommended to ASLM for certification as ASLM SLIPTA auditors. These auditors will also be able to conduct regional audits under the WHO/AFRO SLIPTA program, contributing to regional efforts to strengthen laboratory systems.
After the assessments, two main recommendations came out. Firstly, that there was need to set up a target to attain ISO 15189:2012 International accreditation within 12–24 months for laboratories with three (3) and above with tangible milestones in-between. This recommendation was given based on an assessment of existence of the basic requirements for accreditation that included commitment from management and staff, participation in External Quality Assessments, availability of testing platforms for the TB Testing services expected and existence of required policies and procedures. And secondly, based on the results and findings of the SLIPTA audit the Ministries of Health (MoH) and their partners should jointly develop a plan of action to address the gaps identified during the audits. The plan of action should be accompanied by an effective monitoring and evaluation component for easy follow up to track progress.