Harmonizing quality improvement of TB laboratories with generic accreditation initiatives

Background: Lesotho has the second highest incidence of TB, and second highest prevalence of HIV among TB cases in the world. The Ministry of Health, together with partners, has introduced a SLMTA-based approved to improving quality of laboratory services in the country, and has completed 3 rounds of the program with encouraging improvements in participating laboratories, but did not include the National TB Reference Laboratory (NTRL). New WHO-approved TB diagnostics have been introduced at NTRL, and are being established in a newly refurbished regional TB laboratory, requiring strengthening of TB lab quality management. The Global Laboratory Initiative has developed a stepwise approach to accreditation for TB laboratories. Instead of the 0 -5 stars rating for the level of implementation of Quality Management System, the GLI uses phases 1 – 4 that are not scored. Methods: We have adapted the GLI TB-specific checklist to include and to align with all components of the SLIPTA checklist, and to improve format for ease of use during assessment visits. All questions were scored, comments section added, a 0 – 5 stars rating included and 53 additional questions required by ISO 15189 clauses not originally covered. Questions were organized by the 12 Quality System Essentials and an audit report template developed. Results: We present the modified TB laboratory-specific assessment tool, and report on piloting it in Mafeteng Regional TB Laboratory, and development of a structured mentoring approach based on the tool, including TB-specific quality improvement projects. Conclusions: Harmonisation of the GLI checklist with the SLIPTA checklist will enable integration of TB laboratory quality improvements with generic laboratory improvement programmes which are being scaled up in many countries, whilst providing specialised guidance in support of TB laboratories. Strengthening of the TB laboratory quality management system is critical to ensure new diagnostics have the maximum patient impact.