Introduction

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The persistent gap in TB case detection (only 63% of new smear-positive TB cases and only 53% of all new TB cases are detected globally) plus the increasing spread of drug-resistant TB amongst both new and previously treated cases underscores the need for access to reliable, sophisticated and rapid diagnostic methods, which requires intensive resource commitment. Quality assured laboratory services are an essential component of and critical resource for all National Tuberculosis Programs (NTP). Until recently, laboratory services have been considered amongst the weakest components of TB treatment and control efforts in high-burden and resource-limited countries. Major contributors to this dynamic include: lack of realization of the importance of laboratory services, limited funding, lack of qualified human resources, inadequate facilities (condition and design), inadequate access to materials, and insufficient technical assistance. The need to strengthen laboratory services and systems remains urgent and is essential to address the call of the World Health Assembly for universal access to TB laboratory diagnostic services.

In recent years, new initiatives and resources, such as those provided by the Global Fund to Fight Aids, Malaria, and Tuberculosis (GF), UNITAID, PEPFAR, USAID, and the WHO STOP-TB Partnership (STP) have resulted in an increased availability of funding and support for improved infrastructure, human resources development, and provision of technical assistance. In particular, the Global Laboratory Initiative (GLI), one of seven STP Working Groups, has accelerated and expanded access to quality assured laboratory services in response to the diagnostic challenges of TB. To reinforce the need for quality laboratory services, a systematic process is needed to ensure quality, reliability, proper utilization, and sustainability of laboratory services. Because National TB Reference Laboratories (NRLs) provide diagnostic services on behalf of patients as well as lead the national TB laboratory network, items such as requisition, patient preparation, patient identification, collection of samples, transport, storage, processing and examination of clinical samples, together with subsequent validation, interpretation, reporting and advice, quality assurance, safety and ethics must be addressed. A system for organizing and managing service quality at the National TB Reference Laboratory level must be established.

The International Organization for Standardization (ISO) international quality standard ISO 15189: Medical Laboratories – Particular requirements for quality and competence contains all the requirements for a quality management system (QMS) in medical laboratories and is the most widely used quality standard for accreditation of medical laboratories. The disadvantage of quality standards is that they provide no guidance on how to implement requirements; they merely provide an overview of all the requirements to a QMS.

Guidelines, such as the Clinical Laboratory Standards Institute (CLSI) GP26: Application of a quality management system model for laboratory services, provide more information on the structure and functioning of a QMS in a laboratory, leading to deeper insight in the general meaning and value of a QMS. However, guidelines still provide no day-to-day guidance in establishing a QMS. Therefore, GLI has developed a Stepwise Process towards TB Laboratory Accreditation to assist national level tuberculosis diagnostic laboratories implement a QMS that meets international standards. This guide translates the requirements of the ISO 15189 international standard into step-by-step activities, structures them in an interactive roadmap, and provides many user-modifiable support materials such as document templates, software, and information.

The GLI guide is published on this website. It is subdivided into different pages:

The Quality Management page provides general information on quality management; basic concepts and definitions.
The Directives page provides an explanation on how to use this guide.
Phase 1 to phase 4 lead to the actual ISO 15189 implementation guide.
The Checklist button leads to four checklists that can be used to check progress in implementing a QMS. Results can be used to point out possible gaps.
The Resources page leads to a page with references to resources that have been used in developing this tool and it also provides links to further reading materials.