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

Viegas, Sofía; Azam, Khalide; Madeira, Carla; Aguiar, Carmen; Dolores, Carolina; Mandlaze, Ana P.; Chongo, Patrina; Masamha, Jessina; Cirillo, Daniela María; Jani, Ilesh; Gudo, Eduardo Samo

doi:10.4102/ajlm.v6i2.491

Cited by 6 publications

(21 citation statements)

References 10 publications

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“…11,12,20,24,25,27,29,30,31,32,33,34,35 Also, SLIPTA can be well combined with other guidance methods for laboratory accreditation as is evident from many studies on SLMTA implementation. 20 , 22 , 27 , 29 , 30 , 33 , 34 , 35 , 36 …”

Section: Discussionmentioning

confidence: 99%

Review of the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) version 2:2015

Datema¹,

Oskam²,

Broerse

et al. 2020

African Journal of Laboratory Medicine

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Background: In 2011 the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) was launched, aimed at strengthening the quality and competence of African clinical, public health and reference laboratories. We reviewed the first version of the SLIPTA checklist in 2011. The continued development and publication of a new version of the International Organization for Standardization (ISO) 15189 standard demands a renewed review.Objective: This study aimed to determine the suitability of SLIPTA in guiding laboratories towards ISO 15189:2012 compliance and accreditation and provide recommendations for further SLIPTA improvement.Methods: The study was conducted between September 2018 and April 2019. Coverage of ISO 15189:2012 by SLIPTA checklist version 2:2015 was determined and the point distribution of the scoring system over the different sections of the SLIPTA checklist was re-investigated. These findings were compared with the review of the first version of the SLIPTA checklist (based on ISO 15189:2007) and with findings published on SLIPTA implementation and roll-out.Results: The coverage of ISO 15189 by the SLIPTA checklist has increased, even though ISO 15189:012 is more extensive than ISO 15189:2007. The point distribution is still skewed towards sections related to quality planning rather than quality control and improvement. Although to date 314 laboratories have been assessed, barriers for laboratories to participate in SLIPTA are high. Sustainability of SLIPTA results is insufficiently studied.Conclusion: SLIPTA checklist version 2:2015 has improved compared to earlier versions. We recommend increasing accessibility for laboratories to participate and increasing guidance for ISO-based quality management system implementation.

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Section: Discussionmentioning

confidence: 99%

Review of the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) version 2:2015

Datema¹,

Oskam²,

Broerse

et al. 2020

African Journal of Laboratory Medicine

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“…When the laboratory fulfils international requirements, this gives assurance that results are correct, trustworthy and within the appropriate time frame. 25 This is cost-effective as it reduces laboratory errors and reruns. To have an effective QMS, the laboratory directors (management) must be technically and clinically competent in their defined specialities, and also have relevant common managerial, statistical computer knowledge and skills.…”

Section: Implementation Of Management Requirementsmentioning

confidence: 99%

“…27 A properly implemented QMS is cost-effective and significantly reduces laboratory errors. 28 The accreditation process requires four processes to implement a QMS. Management will show its commitment to development and implementation through a strategic plan, controlling the system through documented policies, procedures and implementing all ISO management clauses.…”

Section: Implementation Of Management Requirementsmentioning

confidence: 99%

An overview of medical diagnostic laboratories in South Africa that meet the international standard of accreditation: ISO 15189

Khadambi-Morokane

Bhowan

Ayuk

2021

The Journal of Medical Laboratory Science and Technology of Sou

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Accreditation is an official recognition that a facility or laboratory is competent to perform specific tasks and has a documented manual on a Quality Management System (QMS) in place. According to the Accreditation Act 19 of 2006, South African National Accreditation Systems (SANAS) is the only internationally recognised accreditation body in South Africa. The International Organization for Standardization (ISO) standard specifically for medical laboratory accreditation is ISO 15189:2012. This review is designed to bring awareness of accredited and unaccredited medical diagnostic laboratories in SA; to look at the number of accredited, unaccredited laboratories and the rate of accreditation growth; to examine the state of accreditation in South Africa with regard to how many are accredited, suspended or withdrawn; and to highlight the advantages of being an accredited laboratory. It also examines the nonconformances commonly raised during assessment and an overview of accreditation around the world. Upon accreditation, the laboratory is given the right to use the SANAS symbol on patient request forms or results as a confirmation of competency. This has motivated more and more laboratories to be accredited. Diagnostic laboratories contribute much toward the final decisions taken by clinicians to diagnose the patients or treatment; this may be from an accredited or non-accredited laboratory. Since patient care is inextricably linked to pathology testing, every laboratory should engage a premium QMS and be evaluated by an accreditation body to ensure that patients receive a trustworthy report. Accreditation is a voluntary process in South Africa but mandatory in some Western countries. Although some laboratories might lose accreditation along the way, the ratio compared to those accredited is still very small. The fact that a majority remain accredited is a good indication of a well-implemented QMS. The challenges faced by the medical technologist-owned laboratories remain, as they are still not accredited.

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“…5,6,7 Effective laboratory quality management requires that laboratory supervisors have not only the technical knowledge of quality management systems (QMS) and national and international standards for medical laboratory quality such as the International Organization for Standardization (ISO)15189 but also the strong leadership and managerial skills to lead their staff and drive accreditation efforts. 8,9,10,11,12 The Strengthening Laboratory Management Toward Accreditation (SLMTA) programme was launched in 2009, 13,14 and provides iterative quality management training to hundreds of laboratory personnel. SLMTA programme addresses common workforce knowledge gaps in resource-constrained settings via a multi-workshop implementation model.…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Improving laboratory quality and capacity through leadership and management training: Lessons from Zambia 2016–2018

Gopolang

Zulu-Mwamba

Nsama

et al. 2021

African Journal of Laboratory Medicine

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Background: Competent leadership and management are imperative for delivering quality laboratory services; however, few laboratory managers receive job-specific training in organisational management and leadership.Objective: To develop and evaluate participants' competencies in organisational leadership and management as measured through learner and laboratory quality improvement assessments.Methods: This professional development programme employed a mentored, blended learning approach, utilising in-person didactic and online training, with the practical application of a capstone project in the laboratories. Programme impact was evaluated through a series of pre-and post-laboartory assessments using the Stepwise Laboratory Improvement Process Towards Accreditation checklist, as well as learner-competency assessments through online quizzes and discussions.Results: From 2016 to 2018, 31 managers and quality officers from 16 individual laboratories graduated from the programme having completed capstone projects addressing areas in the entire laboratory testing process. Laboratories increased their compliance with the International Organization for Standardization 15189 standard and all but two laboratories significantly increased their accreditation scores. Two laboratories gained three stars, two laboratories gained two stars, and five laboratories gained one star. Five laboratories subsequently achieved International Organization for Standardization 15189 accreditation in 2019. Conclusion:This programme taught leadership theory to laboratory managers and allowed them to implement leadership and management practices in the laboratory setting. Programmes such as this complement existing laboratory quality management training programmes such as Strengthening Laboratory Management Toward Accreditation.

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

Cited by 6 publications

References 10 publications

Review of the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) version 2:2015

Review of the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) version 2:2015

An overview of medical diagnostic laboratories in South Africa that meet the international standard of accreditation: ISO 15189

Improving laboratory quality and capacity through leadership and management training: Lessons from Zambia 2016–2018

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