Developing a customised approach for strengthening tuberculosis laboratory quality management systems toward...

Area of Science:

• Clinical diagnostics
• Laboratory quality management systems
• Tuberculosis control

Background:

• Quality-assured tuberculosis laboratory services are essential for global and national tuberculosis prevention and care goals.
• Implementing a quality management system (QMS) improves diagnostic test quality and patient care.
• While the Strengthening Laboratory Management Toward Accreditation (SLMTA) program improved QMS in clinical labs, tuberculosis labs have progressed slower, necessitating a tailored approach.

Purpose of the Study:

• To describe the development of the Strengthening Tuberculosis Laboratory Management Toward Accreditation (TB SLMTA) program.
• To report on the early implementation of the TB SLMTA program in tuberculosis laboratories.

Main Methods:

• The TB SLMTA curriculum was adapted from the existing SLMTA curriculum, incorporating tuberculosis-specific tools, job aids, and supplementary materials.
• A TB SLMTA Harmonized Checklist was created, integrating requirements from the WHO Regional Office for Africa's Stepwise Laboratory Quality Improvement Process Towards Accreditation checklist and the Global Laboratory Initiative's Stepwise Process Towards Tuberculosis Laboratory Accreditation online tool.
• The program was implemented through regional training-of-trainers workshops and a facility-based approach across 37 laboratories in 10 countries.

Main Results:

• Four regional training-of-trainers workshops have been conducted since 2013.
• The TB SLMTA program has been rolled out in 37 tuberculosis laboratories across 10 countries.
• Implementation utilized both a workshop approach (32 labs in 5 countries) and a facility-based approach (5 labs in 5 countries).

Conclusions:

• Early implementation indicates that a structured training and mentoring program can establish a foundation for enhanced quality improvement in tuberculosis laboratories.
• Continued structured mentoring and the institutionalization of QMS into national programs are crucial for tuberculosis laboratories to achieve accreditation.
• The TB SLMTA program offers a structured, tuberculosis-specific pathway to improve laboratory quality management and advance towards accreditation.