ISO 15189:2012: What changes for African laboratories?

Bouchet, Nicolas

doi:10.4102/ajlm.v4i1.325

Cited by 5 publications

(6 citation statements)

References 8 publications

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“…Accreditation is a long journey that may take months or even years to obtain as it requires a well-documented quality manual, which is the cornerstone of a QMS. 33 The quality manual is submitted to an accreditation body like SANAS for a document review process, an assessor will be appointed to review the quality manual to confirm if all ISO requirements have been incorporated in the manual, after which the accreditation process can begin in the laboratory.…”

Section: Implementation Of Technical 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growth; to examine the state of accreditation in South Africa with regard to how many are accredited, suspended or withdrawn; and to highlight the advantages of being an accredited laboratory.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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Section: Implementation Of Technical 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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“…Most hospitals in Sub-Saharan Africa are small (185). This not only puts a strain on the CBL staff but also means that staff that are competent in ABS and IPC are rarely present (81).…”

Section: Other Challenges For Clinical Bacteriology Laboratories At Tmentioning

confidence: 99%

Diagnostic Bacteriology in District Hospitals in Sub-Saharan Africa: At the Forefront of the Containment of Antimicrobial Resistance

et al. 2019

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This review provides an update on the factors fuelling antimicrobial resistance and shows the impact of these factors in low-resource settings. We detail the challenges and barriers to integrating clinical bacteriology in hospitals in low-resource settings, as well as the opportunities provided by the recent capacity building efforts of national laboratory networks focused on vertical single-disease programmes. The programmes for HIV, tuberculosis and malaria have considerably improved laboratory medicine in Sub-Saharan Africa, paving the way for clinical bacteriology. Furthermore, special attention is paid to topics that are less familiar to the general medical community, such as the crucial role of regulatory frameworks for diagnostics and the educational profile required for a productive laboratory workforce in low-resource settings. Traditionally, clinical bacteriology laboratories have been a part of higher levels of care, and, as a result, they were poorly linked to clinical practices and thus underused. By establishing and consolidating clinical bacteriology laboratories at the hospital referral level in low-resource settings, routine patient care data can be collected for surveillance, antibiotic stewardship and infection prevention and control. Together, these activities form a synergistic tripartite effort at the frontline of the emergence and spread of multi-drug resistant bacteria. If challenges related to staff, funding, scale, and the specific nature of clinical bacteriology are prioritized, a major leap forward in the containment of antimicrobial resistance can be achieved. The mobilization of resources coordinated by national laboratory plans and interventions tailored by a good understanding of the hospital microcosm will be crucial to success, and further contributions will be made by market interventions and business models for diagnostic laboratories. The future clinical bacteriology laboratory in a low-resource setting will not be an “entry-level version” of its counterparts in high-resource settings, but a purpose-built, well-conceived, cost-effective and efficient diagnostic facility at the forefront of antimicrobial resistance containment.

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“…Similarly, the International Standardization Organization (ISO) 15189 accreditation is recognised as the gold standard for measuring laboratory quality globally. 3 One pathway to attaining this accreditation is by implementing a quality management system (QMS). In addition to a QMS training programme, the World Health Organization developed a checklist entitled Stepwise Laboratory Quality Improvement Process Towards Accreditation to measure quality improvement within laboratories and provide continued recognition and motivation of staff to continue and sustain improvements.…”

Section: Introductionmentioning

confidence: 99%

Critical success factors for Vietnamese laboratories striving to implement quality management systems

Robinson

Johnson

Yao

et al. 2020

African Journal of Laboratory Medicine

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Accurate laboratory reporting is crucial to patient diagnosis and treatment. This study identified critical success factors (CSF) for implementing a laboratory quality management system (QMS). This descriptive research used qualitative and quantitative methods to collect and analyze data from laboratory managers and staff employed in Vietnamese hospital laboratories implementing a QMS. The top five CSFs identified were: (1) staff QMS knowledge, (2) manager leadership, (3) staff commitment, (4) mentorship, and (5) hospital administration support. Identifying CSFs is critical to successful planning and implementation of QMS.

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ISO 15189:2012: What changes for African laboratories?

Abstract: No abstract available.

Cited by 5 publications

References 8 publications

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

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

Diagnostic Bacteriology in District Hospitals in Sub-Saharan Africa: At the Forefront of the Containment of Antimicrobial Resistance

Critical success factors for Vietnamese laboratories striving to implement quality management systems

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