Abstract
Introduction: Given the relevance of quality-assured laboratory services for health system strengthening and improvement, this study had the objective of exploring the distribution of ISO 15189-accredited and non-accredited laboratories in Costa Rica, in order to identify possible gaps in the fulfillment of its commitment to provide ‘quality healthcare for all’. Methods: Our research was conducted with a descriptive scope and following a quantitative approach. Costa Rica’s Accreditation Body and College of Microbiologists databases were searched to collect data regarding clinical laboratory registration and ISO 15189 accreditation status. Laboratory availability indicators by geographical division were computed with this data. Results: Out of 480 clinical laboratories allowed to operate in Costa Rica as of January 2021, only 5 (about 1%) have been accredited in compliance with ISO 15189, all of which are private and located in the province of San José. Also, laboratory density (in terms of facilities per 100 km2 and per 100 000 population) is heterogeneous among provinces. Clinical laboratory services are more easily available in ‘central’ provinces of the country (e.g. San José and Heredia), where ratios for laboratory density are higher. On the contrary, coastal provinces such as Limón and Puntarenas exhibit low laboratory density ratios, reflecting geographical disparities in access to healthcare. Conclusions: Geographic disparities in the access to clinical laboratory services were observed. This should raise awareness among public health authorities and private healthcare providers regarding the country’s progress in attaining its ‘quality healthcare for all’ commitment.
References
Antúnez, J.A., & Murillo, T. (2014). Análisis del cumplimiento de la norma INTE/ISO 15189:2008 en la sucursal de San José de laboratorios LABIN y propuesta de trabajo para guiar la implementación de la norma como Sistema de Gestión de la Calidad [Master’s degree tesis from Central American Institute for Public Administration]. San José, Costa Rica: ICAP. Retrieved from https://bit.ly/2Ona1us
Caja Costarricense de Seguro Social. (2012). Manual de apoyo para la Implementación de la Gestión de Calidad en los Laboratorios Clínicos de la Caja Costarricense de Seguro Social: Estadios de exigencia con base en Norma INTE/ISO 15189 [PDF]. San José, Costa Rica: CCSS. Retrieved from https://www.binasss.sa.cr/laboratorioclinico.pdf
Carboni-Huerta, R., & Sáenz-Flor, K. (2019). Acreditación ISO 15189 en América Latina: Percepción en laboratorios de la región. Revista Mexicana de Patología Clínica y Medicina de Laboratorio, 66(3), 143-153.
Colegio de Microbiólogos y Químicos Clínicos de Costa Rica. (2020). Consulta de laboratorios [Official website]. San José, Costa Rica: CMQC. Retrieved from http://microbiologos.cr/frmbusquedaLab.php
Datema, T.A.M., Oskam, L. & Klatser, P.R. (2011). Review and comparison of quality standards, guidelines and regulations for laboratories. African Journal of Laboratory Medicine, 1(1). DOI: https://dx.doi.org/10.4102/ajlm.v1i1.3
Ente Costarricense de Acreditación. (2012). Laboratorio Clínico UCR LM-001 [Online document]. San José, Costa Rica: Author. Retrieved from https://bit.ly/2R1L7RX
Ente Costarricense de Acreditación. (2013). Servisalud Alcance de acreditación LM-003 [Online document]. San José, Costa Rica: Author. Retrieved from https://bit.ly/3cQSjci
Ente Costarricense de Acreditación. (2020). Entidades acreditadas: laboratorios clínicos [Official website]. San José, Costa Rica: Author. Retrieved from https://bit.ly/3hZmD5f
Giraldi, D.M., García, E., Kundu, I., & Famitangco, R.F. (2018). Disparities in Rural Health Care: A look at the field of Laboratory Medicine. Critical Values, 11(4), 40-45. DOI: https://doi.org/10.1093/crival/vay035
Hospital Clínica Bíblica. (2017). ASEMECO y su Programa de Acción Social [PDF]. San José, Costa Rica: Author. Retrieved from https://bit.ly/31L9rcV
Instituto Nacional de Estadística y Censos. (2011). Estadísticas demográficas 2011-2025. Proyecciones nacionales: Población total proyectada al 30 de junio por grupos de edades, según provincia y cantón [Official website]. San José, Costa Rica: Author. Retrieved from https://bit.ly/3q9x7SD
Instituto Nacional de Estadística y Censos. (2015). Área en kilómetros cuadrados, según provincia, cantón y distrito administrativo 2015 [Official website]. San José, Costa Rica: Author. Retrieved from https://bit.ly/3nuapTi
Instituto de Normas Técnicas de Costa Rica. (2014). INTE/ISO 15189:2014. Laboratorios clínicos requisitos para la calidad y la competencia. [Official website]. San José, Costa Rica: Author. Retrieved from https://bit.ly/39YmSuP
International Standardization Organization. (2012). ISO 15189:2012(en) Medical laboratories — Requirements for quality and competence [Official website]. Geneva, Switzerland: ISO. Retrieved from https://bit.ly/3cM948P
Morera, M. (2009). Inequidad en salud en Costa Rica: una realidad que no debemos ignorar. Revista Costarricense de Salud Pública,18(2), 64-65.
Organization for Economic Cooperation & Development. (2019). Health for Everyone?: Social Inequalities in Health and Health Systems [Online document]. Paris, France: OECD Publishing. Retrieved from https://bit.ly/3rvdMM9
Pan American Health Organization. (2004). Las desigualdades de salud en Costa Rica: una aproximación geográfico-poblacional [PDF]. San José, Costa Rica: Ministerio de Salud. Retrieved from https://www.bvs.sa.cr/php/situacion/desigualdades.pdf
Roa, L., Moeller, E., Fowler, Z., Vaz Ferreira, R., Mohar, S., Uribe-Leitz, T., ... & Macias, V. (2020). Assessment of diagnostics capacity in hospitals providing surgical care in two Latin American states. eClinicalMedicine, 29, 1-8. DOI: https://doi.org/10.1016/j.eclinm.2020.100620
Rosero-Bixby, L. (2004). Acceso y disponibilidad de servicios de salud en Costa Rica 2000. In Rosero-Bixby, L. (Ed.), Costa Rica a la luz del censo del 2000 (pp. 281-304). San José, Costa Rica: Centro Centroamericano de Población.
Thelen, M.H.M., & Huisman, W. (2018). Harmonization of accreditation to ISO15189. Clinical Chemistry and Laboratory Medicine, 56(10), 1637-1643. DOI: https://doi.org/10.1515/cclm-2017-0820
Tzankov, A., & Tornillo, L. (2017). Hands-on experience: Accreditation of Pathology Laboratories according to ISO 15189. Pathobiology, 84, 121-129. DOI: https://dx.doi.org/10.1159/000449254
United Nations. (2015). Sustainable Development. Goals: 3. Ensure healthy lives and promote well-being for all at all ages [Official website]. New York: UN Department of Economic and Social Affairs. Retrieved from https://sdgs.un.org/goals/goal3
Weinstein, J., Geller, A., Negussie, Y., & Baciu, A. (2017). Communities in action: pathways to health equity. Washington D.C., United States: National Academy of Sciences.
World Health Organization – Regional Office for Africa. (2008). The Maputo Declaration on Strengthening of Laboratory Systems [PDF]. Maputo, Mozambique: WHO Africa. Retrieved from https://bit.ly/3qw3bjS
World Health Organization, World Bank Group, Organization for Economic Cooperation and Development. (2018). Delivering quality health services: a global imperative for universal health coverage. Geneva: Switzerland.
Zima, T. (2017). Accreditation of Medical Laboratories – System, Process, Benefits for Labs. Journal of Medical Biochemistry, 36(3), 231-237. DOI: https://dx.doi.org/10.1515/jomb-2017-0025