Contexts for developing of national essential diagnostics lists. Lessons from a mixed-methods study of existing documents, stakeholders and decision making on tier-specific essential in-vitro diagnostics in African countries.

Autor:	Koster W; Amsterdam Institute for Global Health and Development, University of Amsterdam, Amsterdam, the Netherlands., Mutegi EM; African Society for Laboratory Medicine, Addis Ababa, Ethiopia., Ocen F; African Society for Laboratory Medicine, Addis Ababa, Ethiopia., Odhiambo CO; African Society for Laboratory Medicine, Addis Ababa, Ethiopia., Waweru MM; African Society for Laboratory Medicine, Addis Ababa, Ethiopia., Ndione AG; Department of Sociology, Faculty of Arts and Humanities, Cheikh Anta Diop University, Dakar, Senegal., Yerra SLP; Department of Epidemiology, School of Public Health, University of Washington, Seattle, Washington State, United States of America., Grunwald JL; School of Public Health, Health Systems and Population Health, University of Washington, Seattle, Washington State, United States of America., Mack D; School of Public Health, Health Systems and Population Health, University of Washington, Seattle, Washington State, United States of America., Kao K; FIND, Geneva, Switzerland., Perrone LA; Department of Global Health, University of Washington, Seattle, Washington State, United States of America.; Department of Laboratory Medicine, University of Washington, Seattle, Washington State, United States of America.; Department of Pathology and Laboratory Medicine, Faculty of Medicine, University of British Columbia, Vancouver, Canada., Ondoa P; Amsterdam Institute for Global Health and Development, University of Amsterdam, Amsterdam, the Netherlands.; African Society for Laboratory Medicine, Addis Ababa, Ethiopia.
Jazyk:	angličtina
Zdroj:	PLOS global public health [PLOS Glob Public Health] 2023 May 18; Vol. 3 (5), pp. e0001893. Date of Electronic Publication: 2023 May 18 (Print Publication: 2023).
DOI:	10.1371/journal.pgph.0001893
Abstrakt:	Since 2019, the WHO recommends the development and implementation of National Essential Diagnostics List (NEDL) to facilitate availability of In-Vitro Diagnostics (IVDs) across the various tiers of the healthcare pyramid, facilities with or without a laboratory on-site. To be effective, the development of NEDL should take into consideration the challenges and opportunities associated with current modalities for organization of tier specific testing services in-country. We conducted a mixed-methods analysis set out to explore available national policies, guidelines and decision-making processes that affect accessibility of diagnostics in African countries; 307 documents from 48 African countries were reviewed and 28 in-depth (group) interviews with 43 key-informants in seven countries were conducted between June and July 2022. Of the 48 countries, Nigeria was the only one with formal NEDL. Twenty-five countries had national test menus (63% outdated, from 2015 or earlier) all specifying tests by laboratory tier (5 including the "community tier"), with additional details on equipment (20), consumables (12), and personnel requirements (11). The most popular criteria to select essential IVDs in the quantitative analysis relate to specificities of the tests, whereas in the qualitative study most mentioned were health care and laboratory contextual factors. Quality assurance and waste management for tests at "community tier" were highlighted as concerns by all the respondents. Additional barriers to implementation included the low decision-making power of Laboratory Directorates within the Ministry of Health, as well as the chronic budgetary gaps for clinical laboratory services and policy and strategic plan development outside of vertical programmes. Four countries out of seven would rather revise their test menus by updating them and add ''community tier", than developing a separate NEDL, the former being considered more operational. This study provides a unique set of practical recommendations to the process of development and effective implementation on NEDL in Africa. Competing Interests: The authors have declared that no competing interests exist. (Copyright: © 2023 Koster et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Databáze:	MEDLINE
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