Date Published: March 31, 2017
Author(s): 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.
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.
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.
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 to achieve ISO 15189 accreditation.
From our experience, accreditation was made possible by institutional commitment, strong laboratory leadership, staff motivation, adequate infrastructure and a comprehensive action plan.
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 However, 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.
Internationally-accredited laboratories are recognised for their superior test reliability, operational performance, quality management and competence.11 In pursuit of this recognition, the NTRL began its journey by first renovating the laboratory as a foundation for establishing QMS. The good infrastructure contributed to the high scores achieved for Facilities and Safety, an area that pulls down the scores of many laboratories in resource-limited settings.2,12 Moving to a newly-renovated facility was also motivating for all NTRL staff.
Implementing a QMS is a continuous process that needs to be improved constantly in order to maintain accreditation. The benefits of implementing a QMS outweigh the challenges encountered and impact client and staff satisfaction, better service delivery and overall healthcare improvement. Many factors contributed to achieving international accreditation in Mozambique, including availability of financial resources, well-trained and motivated staff to implement the QMS and robust action plans. Most importantly, the commitment at all levels, especially from high-level leadership and stakeholders turned the dream of accreditation into a reality.