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What is this?

This is the GLI tool. A tool in the form of a website that provides a stepwise plan to guide tuberculosis (TB) laboratories towards ISO 15189 accreditation. It was developed by the Royal Tropical Institute in cooperation with partners from the Centers for Disease Control and Prevention (CDC), The International Union Against TB and Lung Diseases and the KNCV Tuberculosis Foundation for the Global Laboratory Initiative. The structure and contents of the tool are the result of two consensus meeting held at WHO headquarters in 2011 (click here for more information on the development and optimization of the GLI tool). The development of the GLI tool was partly funded by the TB CARE I project of USAID.

Why was this tool developed?

Until recently, laboratory services were amongst the weakest components of TB treatment and control efforts in high-burden, resource-limited countries. Strengthening laboratory services and systems is essential for universal access to TB laboratory diagnostic services. A first step is to strengthen national TB laboratories by implementing a quality management system. One of the best methods of laboratory strengthening is to implement a quality management system complying with the requirements of the international quality standard for medical laboratories, ISO 15189:2011. This will enable them to better support the rest of the national TB laboratory network. Read more.

Who can use this tool?

This tool can be used by tuberculosis laboratories worldwide.

NOTE: Since the start of 2014 the World Health Organization has launched a similar tool for any type of medical laboratory that wants to achieve ISO 15189 compliance: the WHO Laboratory Quality Stepwise Implementation tool (LQSI tool). The structure of this tool is based on the GLI tool. Hence, laboratories that do not specifically focus on tuberculosis diagnostic testing are recommended to refer to the LQSI tool.

How does this tool work?

This tool is a stepwise plan for implementing a quality management system. Each step of this plan is called an activity that consists of:

• One sentence stating what should be done
• A description with an explanation of why the activity should be completed, what should exactly be done, how it should it be completed (in chronological order) and who can best complete the activity
• Links to additional support materials such as further background reading, document templates and other tools

To implement the quality management system in a logical way the activities are divided over four phases of implementation, with each phase having a specific focus. The tool is constructed such that, even when a laboratory does not reach full implementation of the quality management system, it has already improved its quality service provision from phase 1, and as such has benefited already.

• Phase 1: Ensuring that the primary process of the laboratory operates correctly and safely
• Phase 2: Controlling and assuring quality and creating traceability
• Phase 3: Ensuring proper management, leadership and organization
• Phase 4: Create continuous improvement and prepare for accreditation

Click to read more about the phases of this tool

To view the activities in each phase you can choose between two frameworks:

1. Roadmaps, showing all the activities in an ideal sequence for day-to-day implementation
2. Quality System Essential framework, showing the activities sorted per quality system essential (as formulated by the Clinical and Laboratory Standards Institute)

To assess correct completion of the activities this tool also provides an option to create checklists based on the extent of implementing the quality management system.

In the User Instructions section a you'll find an extensive explanation on how to use the tool.