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Lean and Agile Point-of-Care Diagnostic Services Quality Systems Management for Low- and Middle-Income Countries

Jaya, Ziningi BTech; Mashamba-Thompson, Tivani Phosa PhD, MMEDSci, BScHon, PGDip

Point of Care: The Journal of Near-Patient Testing & Technology: December 2016 - Volume 15 - Issue 4 - p 152–157
doi: 10.1097/POC.0000000000000111
Original Articles

The main goal of clinical activities such as point-of-care (POC) diagnostic services is to provide the highest quality service, given the resources that are available. Contextualizing the implementation of POC diagnostics is one of the key elements in ensuring the effectiveness and sustainability of these services. Moreover, the regulation of POC diagnostic testing using appropriate quality management systems is imperative to control and support all testing processes in order to ensure the reliability of results for users. The World Health Organization stipulates a set of criteria for POC diagnostics in rural and resource-limited settings. These are known as quality-ASSURED criteria—affordability, sensitivity, specificity, user-friendly, rapid and robust, equipment-free and deliverable to those who need it. In this review, we discuss quality indicators for diagnostic tests in relation to the defined quality-ASSURED criteria for POC diagnostics in resource-limited settings. We recommend a lean and agile quality management system to ensure the sustainability of POC diagnostic services in low- and middle-income countries.

From the Discipline of Public Health Medicine, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.

Reprints: Tivani Phosa Mashamba-Thompson, PhD, MMEDSci, BScHon, PGDip, Discipline of Public Health Medicine, School of Nursing and Public Health, University of KwaZulu-Natal, 2nd Floor, George Campbell Building, Science Drive, Howard College Campus, Durban 4001, South Africa. E-mail:

Z.J. and T.P.M.-T. conceptualized the study. Z.J. produced the first draft of the manuscript. T.P.M.-T. critically reviewed the draft and contributed to the final version. Both authors reviewed and approved the final manuscript.

The authors declare no conflict of interest.

Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved