Abstract

BackgroundInternationally-accredited laboratories are recognised for their superior test reliability, operational performance, quality management and competence. In a bid to meet international quality standards, the Mozambique National Institute of Health enrolled the National Tuberculosis Reference Laboratory (NTRL) in a continuous quality improvement process towards ISO 15189 accreditation. Here, we describe the road map taken by the NTRL to achieve international accreditation.MethodsThe NTRL adopted the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme as a strategy to implement a quality management system. After SLMTA, the Mozambique National Institute of Health committed to accelerate the NTRL’s process toward accreditation. An action plan was designed to streamline the process. Quality indicators were defined to benchmark progress. Staff were trained to improve performance. Mentorship from an experienced assessor was provided. Fulfilment of accreditation standards was assessed by the Portuguese Accreditation Board.ResultsOf the eight laboratories participating in SLMTA, the NTRL was the best-performing laboratory, achieving a 53.6% improvement over the SLMTA baseline conducted in February 2011 to the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) assessment in June 2013. During the accreditation assessment in September 2014, 25 minor nonconformities were identified and addressed. In March 2015, the NTRL received Portuguese Accreditation Board recognition of technical competency for fluorescence smear microscopy, and solid and liquid culture. The NTRL is the first laboratory in Mozambique to achieve ISO 15189 accreditation.ConclusionsFrom our experience, accreditation was made possible by institutional commitment, strong laboratory leadership, staff motivation, adequate infrastructure and a comprehensive action plan.

Highlights

  • Implementation of quality management systems (QMS) ensures that laboratory services meet international standards and that results are accurate, reliable and timely, representing a vital role in diagnosis, monitoring of disease treatment, training, surveillance and disease prevention.[1]

  • We describe the National Tuberculosis Reference Laboratory (NTRL)’s road map, challenges and successes during the journey taken from February 2011 to March 2015 to attain international accreditation

  • Six quality improvement projects were conducted in the NTRL during the Strengthening Laboratory Management Toward Accreditation (SLMTA) training (Table 1)

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Summary

Introduction

Implementation of quality management systems (QMS) ensures that laboratory services meet international standards and that results are accurate, reliable and timely, representing a vital role in diagnosis, monitoring of disease treatment, training, surveillance and disease prevention.[1] in resource-limited settings, laboratories are poorly funded and suffer from chronic underinvestment, resulting in inadequate infrastructure, lack of equipment maintenance and calibration services, irregular training for laboratory workers and lack of QMS.[2,3] To improve the quality of laboratory services in Africa, the World Health Organization’s Regional Office for Africa and its international partners established a framework that allows for incremental implementation of QMS This process, called the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) recognises laboratories’ efforts at each level toward full implementation of the ISO 15189 Standard requirements using a zero- to five-star grading system.[4] In 2011, the Mozambique Ministry of Health adopted this approach and implemented the first round of Strengthening Laboratory Management Toward Accreditation (SLMTA), an innovative training and mentorship programme for continuous quality improvement, with the aim of improving patient care.[5,6] The National Tuberculosis Reference Laboratory (NTRL) was one of the eight participating laboratories enrolled in SLMTA. We describe the road map taken by the NTRL to achieve international accreditation

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