Research Article: Developing a customised approach for strengthening tuberculosis laboratory quality management systems toward accreditation

Date Published: March 31, 2017

Publisher: AOSIS

Author(s): Heidi Albert, Andre Trollip, Donatelle Erni, Kekeletso Kao.


Quality-assured tuberculosis laboratory services are critical to achieve global and national goals for tuberculosis prevention and care. Implementation of a quality management system (QMS) in laboratories leads to improved quality of diagnostic tests and better patient care. The Strengthening Laboratory Management Toward Accreditation (SLMTA) programme has led to measurable improvements in the QMS of clinical laboratories. However, progress in tuberculosis laboratories has been slower, which may be attributed to the need for a structured tuberculosis-specific approach to implementing QMS. We describe the development and early implementation of the Strengthening Tuberculosis Laboratory Management Toward Accreditation (TB SLMTA) programme.

The TB SLMTA curriculum was developed by customizing the SLMTA curriculum to include specific tools, job aids and supplementary materials specific to the tuberculosis laboratory. The TB SLMTA Harmonized Checklist was developed from the World Health Organisation Regional Office for Africa Stepwise Laboratory Quality Improvement Process Towards Accreditation checklist, and incorporated tuberculosis-specific requirements from the Global Laboratory Initiative Stepwise Process Towards Tuberculosis Laboratory Accreditation online tool.

Four regional training-of-trainers workshops have been conducted since 2013. The TB SLMTA programme has been rolled out in 37 tuberculosis laboratories in 10 countries using the Workshop approach in 32 laboratories in five countries and the Facility-based approach in five tuberculosis laboratories in five countries.

Lessons learnt from early implementation of TB SLMTA suggest that a structured training and mentoring programme can build a foundation towards further quality improvement in tuberculosis laboratories. Structured mentoring, and institutionalisation of QMS into country programmes, is needed to support tuberculosis laboratories to achieve accreditation.

Partial Text

The World Health Organization’s (WHO) End TB Strategy calls for an end to the global tuberculosis epidemic. It aims to reduce deaths by 95% and new tuberculosis cases by 90% and to ensure that no family is burdened with catastrophic expenses due to tuberculosis by 2025.1 Despite the fall in global tuberculosis mortality by 47% since 1990, the disease still claimed more than 1.5 million lives in 2014.2 A cascade of events, including poor screening, failure to link screened patients to diagnostic services, and failure to link diagnosed patients to treatment, means that many people die from tuberculosis due to delayed diagnosis and treatment initiation.3

Since 2013, four regional TOTs have been conducted in Lesotho, Vietnam, South Africa and Moldova. Seventy trainees from 27 counties have been trained, and 59 are certified as trainers (including trainers under supervision), of which four participants are from WHO Supranational Reference Laboratories that provide tuberculosis laboratory technical support to countries. Twenty-six trainers are currently active in the TB SLMTA programme. Currently there are three Master Trainers. One Master Trainer, based in the African region, graduated after conducting a round of TB SLMTA, and we expect two more graduates in the coming year (one in the African region and one in South East Asia) for a total of six Master Trainers.

Tuberculosis laboratories are an essential element of tuberculosis prevention and care, providing testing for diagnosis, surveillance and treatment monitoring that can be accessible at all levels of the healthcare system. The TB SLMTA programme provides tuberculosis laboratories with customised support to accelerate the process of strengthening their QMS towards accreditation. There is an urgent need to expand the programme, as only 21 NTRLs (43%) on the African continent have received SLMTA training and only four NTRLs have reached accreditation. Although 44% of NTRLs report implementing a QMS, the extent of implementation is not known.25




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