Abstractobjective Clinical laboratories in low-and middle-income countries (LMIC) need fundamental improvement because quality laboratory services are essential for the decision-making capacity of clinicians, health workers and public health authorities. To this end, a tiered accreditation scheme Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) was developed by WHO-AFRO, CDC and others for clinical laboratories in LMIC. One to five stars are accredited to laboratories based on the level of compliance with a checklist. Our aim was to evaluate the quality and applicability of this accreditation scheme compared with international quality standards.methods We performed a critical review of this scheme to formulate recommendations for implementation, harmonization and improvement. Two analyses were performed: one assessing its coverage of the ISO 15189:2007 standard and one to identify and evaluate priorities of the accreditation checklist.results Although the content of the checklist covers all aspects of total quality management, it strongly prioritizes resource management activities. We recommend identifying critical requirements for each tier of accreditation to assure a certain level of quality for each tier or instead using a pass ⁄ fail approach towards accreditation. In addition, the checklist should include more questions for assessing proper management, ethics and continuous improvement to meet ISO 15189.conclusion Launching accreditation schemes for laboratories in LMIC should be encouraged. After further optimization of SLIPTA, clinical laboratories may certainly benefit, leading to more correctly diagnosed patients and less waste of resources.

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.

BackgroundThe variety and number of laboratory quality standards, guidelines and regulations (hereafter: quality documents) makes it difficult to choose the most suitable one for establishing and maintaining a laboratory quality management system.ObjectivesThere is a need to compare the characteristics, suitability and applicability of quality documents in view of the increasing efforts to introduce quality management in laboratories, especially in clinical diagnostic laboratories in low income and middle income countries. This may provide valuable insights for policy makers developing national laboratory policies, and for laboratory managers and quality officers in choosing the most appropriate quality document for upgrading their laboratories.MethodWe reviewed the history of quality document development and then selected a subset based on their current use. We analysed these documents following a framework for comparison of quality documents that was adapted from the Clinical Laboratory Standards Institute guideline GP26 Quality management system model for clinical laboratory services.ResultsDifferences were identified between national and international, and non-clinical and clinical quality documents. The most salient findings were the absence of provisions on occurrence management and customer service in almost all non-clinical quality documents, a low number of safety requirements aimed at protecting laboratory personnel in international quality documents and no requirements regarding ethical behaviour in almost all quality documents.ConclusionEach laboratory needs to investigate whether national regulatory standards are present. These are preferred as they most closely suit the needs of laboratories in the country. A laboratory should always use both a standard and a guideline: a standard sums up the requirements to a quality management system, a guideline describes how quality management can be integrated in the laboratory processes.

BackgroundFunctional national laboratory networks and systems are indispensable to the achievement of global health security targets according to the International Health Regulations. The lack of indicators to measure the functionality of national laboratory network has limited the efficiency of past and current interventions to enhance laboratory capacity in resource-limited-settings.Scorecard for laboratory networksWe have developed a matrix for the assessment of national laboratory network functionality and progress thereof, with support from the African Society of Laboratory Medicine and the Association of Public Health Laboratories. The laboratory network (LABNET) scorecard was designed to: (1) Measure the status of nine overarching core capabilities of laboratory network required to achieve global health security targets, as recommended by the main normative standards; (2) Complement the World Health Organization joint external evaluation tool for the assessment of health system preparedness to International Health Regulations (2005) by providing detailed information on laboratory systems; and (3) Serve as a clear roadmap to guide the stepwise implementation of laboratory capability to prevent, detect and act upon infectious threats.ConclusionsThe application of the LABNET scorecard under the coordination of the African Society of Laboratory Medicine and the Association of Public Health Laboratories could contribute to the design, monitoring and evaluation of upcoming Global Health Security Agenda-supported laboratory capacity building programmes in sub Saharan-Africa and other resource-limited settings, and inform the development of national laboratory policies and strategic plans. Endorsement by the World Health Organization Regional Office for Africa is foreseen.

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