Lessons from the Field

Mozambique’s journey toward accreditation of the National Tuberculosis Reference Laboratory

Sofia O. Viegas, Khalide Azam, Carla Madeira, Carmen Aguiar, Carolina Dolores, Ana P. Mandlaze, Patrina Chongo, Jessina Masamha, Daniela M. Cirillo, Ilesh V. Jani, Eduardo S. Gudo
African Journal of Laboratory Medicine | Vol 6, No 2 | a491 | DOI: https://doi.org/10.4102/ajlm.v6i2.491 | © 2017 Sofia O. Viegas, Khalide Azam, Carla Madeira, Carmen Aguiar, Carolina Dolores, Ana P. Mandlaze, Patrina Chongo, Jessina Masamha, Daniela M. Cirillo, Ilesh V. Jani, Eduardo S. Gudo | This work is licensed under CC Attribution 4.0
Submitted: 15 May 2016 | Published: 31 March 2017

About the author(s)

Sofia O. Viegas, Instituto Nacional de Saúde, Ministério da Saúde, Maputo, Mozambique
Khalide Azam, Instituto Nacional de Saúde, Ministério da Saúde, Maputo, Mozambique
Carla Madeira, Instituto Nacional de Saúde, Ministério da Saúde, Maputo, Mozambique
Carmen Aguiar, Instituto Nacional de Saúde, Ministério da Saúde, Maputo, Mozambique
Carolina Dolores, Instituto Nacional de Saúde, Ministério da Saúde, Maputo, Mozambique
Ana P. Mandlaze, Instituto Nacional de Saúde, Ministério da Saúde, Maputo, Mozambique
Patrina Chongo, Instituto Nacional de Saúde, Ministério da Saúde, Maputo, Mozambique
Jessina Masamha, Centers for Disease Control and Prevention, Maputo, Mozambique
Daniela M. Cirillo, IRCCS San Raffaele Scientific Institute, WHO Supranational TB Reference Laboratory, Tuberculosis & Mycobacteria Unit, Milan, Italy
Ilesh V. Jani, Instituto Nacional de Saúde, Ministério da Saúde, Maputo, Mozambique
Eduardo S. Gudo, Instituto Nacional de Saúde, Ministério da Saúde, Maputo, Mozambique


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Abstract

Background: Internationally-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.

Methods: The 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.

Results: Of 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 toachieve ISO 15189 accreditation.

Conclusions: From our experience, accreditation was made possible by institutional commitment, strong laboratory leadership, staff motivation, adequate infrastructure and a comprehensive action plan.


Keywords

ISO 15189 Accreditation; Tuberculosis; Laboratory; Mozambique

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