Why was this tool developed?

Although laboratories are essential for a clinician to make an evidence-based diagnostic decision, they have long been a neglected component of the health care systems in low- and middle-income countries. This has led to weak laboratory systems which in turn led to decrease in the confidence of clinicians in laboratory results.

Several international meetings recognized that limited laboratory capacity represents a major barrier to implementation and sustainability of prevention, treatment and care programs for HIV, malaria and tuberculosis. For example: The Maputo Declaration recognizes that the burden of priority diseases HIV, malaria and tuberculosis is high and is still increasing. It recognizes that there is a need to expand and further develop quality-assured laboratory services as part of a greater framework of health systems strengthening within resource-limited settings.

Implementing a quality management system is generally accepted as the best way to improve a laboratory. A quality management system is based on a set of requirements that are described in a document called a standard. For clinical laboratories this is ISO 15189: Medical Laboratories – Particular Requirements for Quality and Competence. The problem with standards is that they only state what a laboratory should have in place, they don’t explain how this should be done. This is a difficulty faced by almost all laboratories implementing a quality management system, especially by laboratories in resource-limited settings that have to come a long way to achieve compliance with a standard.

With this in mind, several useful tools and laboratory trainings have been developed that assist in implementing a quality management system. Examples are the WHO/CDC/CLSI Laboratory Quality Management Training and the TB-CAP Laboratory toolbox (which contains templates for many quality management documents). But there is no tool that helps the laboratory in a stepwise manner to completely implement standard requirements leading to a properly functioning quality management system. To prevent that each laboratory has to reinvent the wheel the GLI Stepwise Process towards TB Laboratory Accreditation was developed.

The GLI tool helps laboratories to implement a quality management system in a stepwise manner. A strong point is that with each step the GLI tool links to templates of documents and training materials developed by others where convenient. This way the GLI tool also forms a portal to many other useful laboratory resources