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Implementation of quality management systems and progress towards accreditation of National Tuberculosis Reference Laboratories in Africa

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      Laboratory services are essential at all stages of the tuberculosis care cascade, from diagnosis and drug resistance testing to monitoring response to treatment. Enabling access to quality services is a challenge in low-resource settings. Implementation of a strong quality management system (QMS) and laboratory accreditation are key to improving patient care.


      The study objective was to determine the status of QMS implementation and progress towards accreditation of National Tuberculosis Reference Laboratories (NTRLs) in the African Region.


      An online questionnaire was administered to NTRL managers in 47 World Health Organization Regional Office for Africa member states in the region, between February and April 2015, regarding the knowledge of QMS tools and progress toward implementation to inform strategies for tuberculosis diagnostic services strengthening in the region.


      A total of 21 laboratories (43.0%) had received SLMTA/TB-SLMTA training, of which 10 had also used the Global Laboratory Initiative accreditation tool. However, only 36.7% of NTRLs had received a laboratory audit, a first step in quality improvement. Most NTRLs participated in acid-fast bacilli microscopy external quality assurance (95.8%), although external quality assurance for other techniques was lower (60.4% for first-line drug susceptibility testing, 25.0% for second-line drug susceptibility testing, and 22.9% for molecular testing). Barriers to accreditation included lack of training and accreditation programmes. Only 28.6% of NTRLs had developed strategic plans and budgets which included accreditation.


      Good foundations are in place on the continent from which to scale up accreditation efforts. Laboratory audits should be conducted as a first step in developing quality improvement action plans. Political commitment and strong leadership are needed to drive accreditation efforts; advocacy will require clear evidence of patient impact and cost-benefit.

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      Most cited references 17

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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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        Improving quality management systems of laboratories in developing countries: an innovative training approach to accelerate laboratory accreditation.

        The Strengthening Laboratory Management Toward Accreditation (SLMTA) program was developed to promote immediate, measurable improvement in laboratories of developing countries. The laboratory management framework, a tool that prescribes managerial job tasks, forms the basis of the hands-on, activity-based curriculum. SLMTA is implemented through multiple workshops with intervening site visits to support improvement projects. To evaluate the effectiveness of SLMTA, the laboratory accreditation checklist was developed and subsequently adopted by the World Health Organization Regional Office for Africa (WHO AFRO). The SLMTA program and the implementation model were validated through a pilot in Uganda. SLMTA yielded observable, measurable results in the laboratories and improved patient flow and turnaround time in a laboratory simulation. The laboratory staff members were empowered to improve their own laboratories by using existing resources, communicate with clinicians and hospital administrators, and advocate for system strengthening. The SLMTA program supports laboratories by improving management and building preparedness for accreditation.
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          Global tuberculosis report 2016

           K Floyd,  HM Dias,  D. Falzon (2015)

            Author and article information

            [1 ]FIND, Cape Town, Western Cape, South Africa
            [2 ]World Health Organisation, African Region Country Office, Brazzaville, Congo
            [3 ]FIND, Campus Biotech, Geneva, Switzerland
            [4 ]African Society for Laboratory Medicine, Addis Ababa, Ethiopia
            [5 ]World Health Organisation, African Region Country Office, Harare, Zimbabwe
            Author notes
            Corresponding author: Heidi Albert, heidi.albert@
            Afr J Lab Med
            Afr J Lab Med
            African Journal of Laboratory Medicine
            31 March 2017
            : 6
            : 2
            5523922 AJLM-6-490 10.4102/ajlm.v6i2.490
            © 2017. The Authors

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

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