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      External quality assurance for HIV point-of-care testing in Africa: A collaborative country-partner approach to strengthen diagnostic services

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      African Journal of Laboratory Medicine
      AOSIS

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          Abstract

          It is important to consider the role of diagnostics and the critical need for quality diagnostics services in resource-limited settings. Accurate diagnostic tests play a key role in patient management and the prevention and control of most infectious diseases. As countries plan for implementation of HIV early infant diagnosis and viral load point-of-care testing, the London School of Hygiene & Tropical Medicine has worked with countries and partners with an interest in external quality assurance to support quality point-of-care testing on the continent. Through a series of collaborative consultations and workshops, the London School of Hygiene & Tropical Medicine has gathered lessons learned, tools, and resources and developed quality assurance models that will support point-of-care testing. The London School of Hygiene & Tropical Medicine is committed to the continued advancement of laboratory diagnostics in Africa and quality laboratory services and point-of-care testing.

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          Most cited references14

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          Laboratory medicine in Africa: a barrier to effective health care.

          Providing health care in sub-Saharan Africa is a complex problem. Recent reports call for more resources to assist in the prevention and treatment of infectious diseases that affect this population, but policy makers, clinicians, and the public frequently fail to understand that diagnosis is essential to the prevention and treatment of disease. Access to reliable diagnostic testing is severely limited in this region, and misdiagnosis commonly occurs. Understandably, allocation of resources to diagnostic laboratory testing has not been a priority for resource-limited health care systems, but unreliable and inaccurate laboratory diagnostic testing leads to unnecessary expenditures in a region already plagued by resource shortages, promotes the perception that laboratory testing is unhelpful, and compromises patient care. We explore the barriers to implementing consistent testing within this region and illustrate the need for a more comprehensive approach to the diagnosis of infectious diseases, with an emphasis on making laboratory testing a higher priority.
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            The World Health Organization African region laboratory accreditation process: improving the quality of laboratory systems in the African region.

            Few developing countries have established laboratory quality standards that are affordable and easy to implement and monitor. To address this challenge, the World Health Organization Regional Office for Africa (WHO AFRO) established a stepwise approach, using a 0- to 5-star scale, to the recognition of evolving fulfillment of the ISO 15189 standard rather than pass-fail grading. Laboratories that fail to achieve an assessment score of at least 55% will not be awarded a star ranking. Laboratories that achieve 95% or more will receive a 5-star rating. This stepwise approach acknowledges to laboratories where they stand, supports them with a series of evaluations to use to demonstrate improvement, and recognizes and rewards their progress. WHO AFRO's accreditation process is not intended to replace established ISO 15189 accreditation schemes, but rather to provide an interim pathway to the realization of international laboratory standards. Laboratories that demonstrate outstanding performance in the WHO-AFRO process will be strongly encouraged to enroll in an established ISO 15189 accreditation scheme. We believe that the WHO-AFRO approach for laboratory accreditation is affordable, sustainable, effective, and scalable.
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              Evidence from 617 laboratories in 47 countries for SLMTA-driven improvement in quality management systems

              Background The Strengthening Laboratory Management Toward Accreditation (SLMTA) programme is a large-scale effort to improve the quality of laboratories in resource-limited countries. Objectives This study sought to evaluate the first four years (2010–2013) of SLMTA implementation. Methods Country-level data were submitted by SLMTA programme leads and compiled globally. Performance was measured before (baseline) and after (exit) SLMTA implementation using an audit checklist which results in a percentage score and a rating of zero to five stars. Some laboratories continued to monitor performance in post-exit surveillance audits. We evaluated score improvements using two-tailed t-tests for equal variances and estimated the number of tests performed by SLMTA laboratories based on star level. Results SLMTA was implemented in 617 laboratories in 47 countries in Africa, the Caribbean, Latin America and Southeast Asia. At the baseline audit, the laboratories scored an average of 39% on the checklist and 84% of them were rated below one star. As of December 2013, 302 laboratories had completed the SLMTA programme; mean checklist scores increased from 39% at baseline to 64% at exit (p < 0.001) over an average 16-month programme duration. Ninety-two laboratories conducted a surveillance audit at a median of 11 months after their exit audit; 62% further increased their performance. Six SLMTA laboratories have achieved accreditation status. In total, the 617 SLMTA laboratories conduct an estimated 111 million tests annually. Only 16% of these tests were conducted by laboratories with at least one star at baseline, which increased to 68% of tests after SLMTA training. Thus, approximately 23 million tests are conducted annually by laboratories previously at zero stars that now have one to five stars; this number is projected to increase to 58 million when currently-enrolled laboratories complete the programme. Conclusion SLMTA has transformed the laboratory landscape in resource-limited countries worldwide and has the potential to make a substantial and sustainable impact on the quality of laboratory testing and patient care.
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                Author and article information

                Journal
                Afr J Lab Med
                Afr J Lab Med
                AJLM
                African Journal of Laboratory Medicine
                AOSIS
                2225-2002
                2225-2010
                17 October 2016
                2016
                : 5
                : 2
                : 556
                Affiliations
                [1 ]London School of Hygiene and Tropical Medicine, London, United Kingdom
                Author notes
                Corresponding author: Rosanna Peeling, rosanna.peeling@ 123456lshtm.ac.uk
                Author information
                http://orcid.org/0000-0002-9850-3479
                http://orcid.org/0000-0001-7404-8873
                Article
                AJLM-5-556
                10.4102/ajlm.v5i2.556
                5433831
                4cb795c5-186b-4dad-af83-1e08b43e0d44
                © 2016. The Authors

                Licensee: AOSIS. This work is licensed under the Creative Commons Attribution License.

                History
                : 31 August 2016
                : 31 August 2016
                Categories
                Lessons from the Field

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