Coefficient of variation selected as a quality specification for external evaluation systems in resource-limited environments
Keywords:
CONTROL DE CALIDAD; INDICADORES DE CALIDAD DE LA ATENCIÓN DE SALUD; LABORATORIOS CLÍNICOS. , QUALITY CONTROL; QUALITY INDICATORS, HEALTH CARE; LABORATORIES, CLINICAL., CONTROLE DE QUALIDADE; INDICADORES DE QUALIDADE EM ASSISTÊNCIA À SAÚDE; LABORATÓRIOS CLÍNICOS.Abstract
Introduction: Quality specifications for External Assessment Programs have proven useful in clinical laboratory management processes.
Objectives: To obtain the Selected Coefficient of Variation for 13 analytes as a quality specification for an External Quality Assessment system for clinical chemistry in resource-limited environments.
Methods: An analytical, prospective, cross-sectional study was conducted in clinical laboratory services during the years 2023 and 2024. Using data from the External Evaluation Program, the Selected Coefficients of Variation were calculated through the aggregate variance and the weighted mean using an alternative and a commercial controller. They were compared using the Forkman Test, with a 95% confidence interval. The lowest integer value was assumed. The performance of each participating laboratory was evaluated using the Average Variation Index and the Global Variation Index during the year 2024.
Results: No significant differences were found with the use of control materials. In all cases, the p value obtained was greater than 0.05. The coefficients ranged from 9 to 19. 6.6% of the laboratories received an excellent rating, and the same percentage received an acceptable rating. 86.7% showed good performance. No laboratory received a poor rating.
Conclusions: Obtaining the Selected Coefficients of Variation allows the program to evaluate the performance of clinical laboratories and analytical methods based on the limited resource conditions in which they operate.
Downloads
References
1. Espinosa Hernández PN. Diseño del Sistema de Gestión de la Calidad de Acuerdo con la Norma ISO 15189 en el Laboratorio Clínico Labomed Cía. Ltda. “Paúl Nicolás”. [Tesis]. Universidad Técnica del Norte. Quito, Ecuador; 2022 [citado 17/08/2025]. Disponible en: http://repositorio.utn.edu.ec/handle/123456789/11970
2. Bauzá FR, Salas Á. Manual básico de garantía de la calidad en los Laboratorios Clínicos. Universidad Católica de Cuenca. Ecuador[Internet]; 2025[citado 17/08/2025]. Disponible en: https://ebooks.ucacue.edu.ec/library/publication/manual-basico-de-garantia-de-la-calidad-en-los-laboratorios-clinicos
3. Cruz Rodríguez CL. Implementación del sistema de evaluación externa de la calidad de los laboratorios clínicos del segundo y tercer nivel de atención [Tesis doctoral]. Universidad de Ciencias Médicas de La Habana, Cuba [Internet]; 2010[citado 27/08/2025]. Disponible en: https://tesis.sld.cu/index.php?P=FullRecord&ID=576
4. González Fajardo I, Linares Guerra EM, León Sánchez MA, Trujillo Valdés YC, Figueroa Cabrera EM. Sistema de evaluación externa de la calidad para laboratorios clínicos en entornos de recursos limitados. Universidad y Sociedad [Internet]. 2022[citado 27/8/2025]; 14(4): 206-1. Disponible en: https://rus.ucf.edu.cu/index.php/rus/article/view/3037
5. Litardo Macías YF, Solórzano Navia DL, Chávez Palacios, DG, Lino Villacreses W A. Lineamientos y estándares de calidad según normativas ISO 15189 para la acreditación de los laboratorios clínicos: Una actualización. Dom Cien [Internet]. 2021 [citado 28/8/2025]; 7(3): 656-668. Disponible en: https://doi.org/10.23857/dc.v7i3.2018
6. González Fajardo I, Linares Guerra EM, León Sánchez MA, Santana Porbén S. Validación del Laboratorio Clínico como Unidad Rectora para un Sistema de Control Externo de la Calidad. Rev. Ciencias Médicas [Internet]. 2020 [citado: 18/08/25]; 24(5) e4518. Disponible en: http://revcmpinar.sld.cu/index.php/publicaciones/article/view/4518
7. International Standard. Statistical methods for use in proficiency testing by interlaboratory comparisons (ISO 13528:2015(E) 2 ed. Switzerland: ISO[Internet]; 2015 [citado 17/08/2025]. Disponible en: https://www-iso-org.translate.goog/standard/56125.html?_x_tr_sl=en&_x_tr_tl=es&_x_tr_hl=es&_x_tr_pto=tc
8. Hoartvath RA, Bell KJL,Ceriotti F,Jones GRD,Loh TP, Lord S et col. Outcome-based analytical performance specification, status and future trends. Clin Chem Lab med [Internet]. 2024 [citado: 18/08/25]; 62(8): 1474-1482. Disponible en: https://doi.org/10.1515/cclm-2024-0125
9. Plebani M. Control interno de la calidad y garantía externa de la calidad: un gran pasado abre el camino a un brillante futuro. Adv Lab Med [Internet]. 2022 [citado: 18/08/25]; 3(3): 218–220. Disponible en: https://doi.org/10.1515/almed-2022-0080
10. Ricós C, Fernández-Calle P, Perich P y Sandberg S. Control externo de la calidad en medicina del laboratorio. Avances y futuro. Adv Lab Med [Internet]. 2022 [citado 17/08/2025]; 3(3): 218–220. Disponible en: https://doi.org/10.1515/almed-2022-0058
11. C, Perich C, Bullich S, Montserrat Ventura BP, Panadés M, Fernández-Calle P. Cumplimiento de las especificaciones en un programa de garantía externa de la calidad. ¿Han tenido impacto los nuevos estimados de variación biológica de la European Federation of Laboratory Medicine (EFLM) en la calidad de los resultados del laboratorio? Adv Lab Med [Internet]. 2023 [citado 17/08/2025]; 4(4): 387–395. Disponible en: https://doi.org/10.1515/almed-2023-0057
12. Migliarino GA. Esquemas de evaluación externa de la calidad en América Latina. Rev eJIFCC [Internet]. 2015 [citado 17/08/2025]; 26(4): 238-50. Disponible en: https://cms.ifcc.org/media/334087/eJIFCC2015Vol26No4pp238-250.pdf
13. Sociedad Española de Medicina de Laboratorio (SEQC). Recomendación para el uso de las especificaciones de la calidad analítica. Bioanálisis[Internet] [citado 17/08/2025]; 2020. Disponible en: https://www.revistabioanalisis.com/images/flippingbook/Rev67n/NOTA%201.pdf
14. Westgard JO. Especificaciones de la base de datos de variaciones biológicas deseables [Internet]; 2025 [citado 12/08/2025]. Disponible en: https://www.westgard.com/biodatabase1.htm
15. Riqas.net. UK: Randox[Internet]; 2025 [ citado 19/08/2025]. Disponible en: https://www.randox.com/riqas-external-quality-assessment/
16. Morancho JM, Batista J, Salas A, Prada E, Redín ME, Bauzá FR. Especificaciones de la calidad. ¿Quo vadis? Rev. Med Lab[Internet]. 2021[citado 17/08/2025]; 2(2):47-9. Disponible en: https://doi.org/10.20960/revmedlab.00094
Additional Files
Published
How to Cite
Issue
Section
License
Copyright (c) 2025 Ivette González Fajardo, Elisa Maritza Linares Guerra , María Amparo León Sánchez , Enrique Jorge Valdés Peña Valdés Peña, Clara Teresa Ordaz Zambrana, Yulainee Madera Hernández Madera Hernández

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
Authors who have publications with this journal agree to the following terms: Authors will retain their copyrights and grant the journal the right of first publication of their work, which will be publication of their work, which will be simultaneously subject to the Creative Commons Attribution License (CC-BY-NC 4.0) that allows third parties to share the work as long as its author and first publication in this journal are indicated.
Authors may adopt other non-exclusive license agreements for distribution of the published version of the work (e.g.: deposit it in an institutional telematic archive or publish it in a volume). Likewise, and according to the recommendations of the Medical Sciences Editorial (ECIMED), authors must declare in each article their contribution according to the CRediT taxonomy (contributor roles). This taxonomy includes 14 roles, which can be used to represent the tasks typically performed by contributors in scientific academic production. It should be consulted in monograph) whenever initial publication in this journal is indicated. Authors are allowed and encouraged to disseminate their work through the Internet (e.g., in institutional telematic archives or on their web page) before and during the submission process, which may produce interesting exchanges and increase citations of the published work. (See The effect of open access). https://casrai.org/credit/
