Risk Management and Quality According to ISO 22367 Standard in the Clinical Laboratory of the Basic Hospital of Jipijapa
DOI:
https://doi.org/10.70577/asce.v5i1.658Keywords:
Standardization; Evaluation; Indicators; International Standards; SafetyAbstract
Risk management in the clinical laboratory is a systematic process that ensures patient safety and the quality of results through the identification and control of risks across the phases of the analytical process. Quality is based on the precision, accuracy, and reliability of results. Within this framework, the ISO 22367 standard provides guidelines for risk management in medical laboratories, promoting a risk-based approach and a culture of patient safety. The main objective of this study was to analyze risk and quality management according to ISO 22367 in the clinical laboratory of Jipijapa Basic Hospital. The methodology used was descriptive, cross-sectional, and prospective, applying criteria based on ISO 22367 in the laboratory of this institution, without the use of biological samples. The results obtained from the applied instruments showed an overall compliance of 93.7%, with similar performance in risk management (90%) and quality management (97.4%). Regarding the areas evaluated for quality, the clinical laboratory achieved 100% compliance, while the hospitalization and emergency areas reported 97.4%. In addition, the lack of preventive signage and continuous staff training on risk-related topics was identified. In conclusion, the risk and quality management protocols in the clinical laboratory of Jipijapa Basic Hospital demonstrate compliance and organization, aligned with international standards and recommended best practices.
Downloads
References
Abdalla, A., Alneil, H., & Eltayeb, H. (2024). Risk management strategies in medical laboratory practice. International Journal of Medical Laboratory Research, 9(2), 18-32. https://doi.org/http://doi.org/10.35503/IJMLR.2024.9203 DOI: https://doi.org/10.35503/IJMLR.2024.9203
Azua, M., Basurto, A., & López, N. (2024). Bioseguridad en el laboratorio de práctica, medidas importantes para el trabajo seguro en el laboratorio clínico. Revista Multidisciplinaria de Investigación Científica, 8(1), 4216-4232. https://doi.org/https://doi.org/10.56048/MQR20225.8.1.2024.4216-4232 DOI: https://doi.org/10.56048/MQR20225.8.1.2024.4216-4232
Doria, A., Lopez, L., Bonilla, M., & Parra, G. (2020). Metodología para la implementación de la gestión de riesgo en un sistema de gestión de calidad. SIGNOS-Investigación en Sistemas de gestión, 12(1), 123-135. Retrieved Agosto 19, 2025, from https://www.redalyc.org/journal/5604/560465477007/html/ DOI: https://doi.org/10.15332/24631140.5424
Galárraga, E., Moreira, A., & Chasi, J. (2024). Assessment of the management requirements of the services provided by the private clinical laboratories of Ambato Canton. Salud, Ciencia y Tecnología, 4(746), 1-7. https://doi.org/10.56294/saludcyt2024746 DOI: https://doi.org/10.56294/saludcyt2024746
Karadağ, C. (2023). Risks and opportunities provided by ISO 15189:2022 standard for continuous improvement of medical laboratory practices. Turkish Journal of Biochemistry, 48(1), 49. https://doi.org/10.1515/tjb-2023-frontmatter48s3 DOI: https://doi.org/10.1515/tjb-2023-frontmatter48s3
Linko, S., Boursier, G., Bernabéu, F., Dzneladze, N., Vanstapel, F., Brguljan, P., Tosheska, K., Mehay, H., Panteghini, M., Brugnoni, D., Milinkovic, N., Lohmander, M., Šprongl, L., & Can, H. (2025). EN ISO 15189 revision: EFLM Committee Accreditation and ISO/CEN standards (C: A/ISO) analysis and general remarks on the changes. Clinical Chemistry and Laboratory Medicine, 63(6), 1084-1098. https://doi.org/10.1515/cclm-2024-1451 DOI: https://doi.org/10.1515/cclm-2024-1451
Morales, C., Uzeta, M., Ramírez, M., & Giraldo, R. (2024). Ten years of an external quality program control in clinical microbiology: a statistical analysis of the results. Accreditation and Quality Assurance, 29, 115–127. https://doi.org/https://doi.org/10.1007/s00769-023-01566-7 DOI: https://doi.org/10.1007/s00769-023-01566-7
Palomino, Á., Saldaña, G., & Rodriguez, A. (2024). Quality of care and patient safety in the clinical laboratory process. Espirales Revista multidisciplinaria de investigación científica, 8(50), 1-14. https://doi.org/https://doi.org/10.31876/er.v8i50.866 DOI: https://doi.org/10.31876/er.v8i50.866
Paz, V. (2022). Enfoque de gestión de riesgos en los laboratorios clínicos. (Tesis Posgrado). Quito: Universidad Central del Ecuador. Recuperado el 29 de Mayo de 2025, de http://www.dspace.uce.edu.ec/handle/25000/27517
Peltier, L., Van, S., Peeters, B., Raimbourg, J., & Pacheco, J. (2025). Patient risk management in laboratory medicine: an internacional survey to assess the severity of harm associated with erroneous reported. Clinical chemistry and laboratory medicine, 63(8), 1-7. https://doi.org/https://doi.org/10.1515/cclm-2024-1477 DOI: https://doi.org/10.1515/cclm-2024-1477
Pilco, C., Aleaga, M., Alarcón, P., & Urquizo, S. (2023). Impacto de la seguridad del paciente en la calidad de los servicios de laboratorio clínico. Revista científica arbitrada multidisciplinaria PENTACIENCIAS, 5(5), 1-21. https://doi.org/https://doi.org/10.59169/pentaciencias.v5i5.699 DOI: https://doi.org/10.59169/pentaciencias.v5i5.699
Pincay, R., Lino, A., Valero, N., & Cedillo, J. (2021). Diagnóstico de estándares de calidad internacionales en laboratorios de docencia de una universidad ecuatoriana. Enfermería Investiga, 6(5), 4–9. https://doi.org/https://doi.org/10.31243/ei.uta.v6i5.1449.2021 DOI: https://doi.org/10.31243/ei.uta.v6i5.1449.2021
Quintana, S., Varela, B., Aguirre, L., Andrade, T., Espinoza, E., Laitano, G., Luna, L., Peruzzetto, C., Piana, A., & Sierra, R. (2024). La gestión de la calidad y la acreditación ISO en los laboratorios clínicos de Latinoamérica. Acta bioquímica clínica latinoamericana, 58(3), 257-268. Retrieved Mayo 27, 2025, from https://www.scielo.org.ar/pdf/abcl/v58n3/1851-6114-ABCL-58-03-07.pdf
Romero, A., Gómez, J., Fagundo, J., Cruz, Ó., Ortega, M., Romero, M., & Romero, A. (2022). Compliance with the clinical laboratory quality protocol in public primary healthcare centres. Medicine, 101(30), 1-7. https://doi.org/10.1097/MD.0000000000029095 DOI: https://doi.org/10.1097/MD.0000000000029095
Viteri, J. (2023). ISO 22367:2020 ¿Cómo gestionar los riesgos en los laboratorios clínicos?. (Tesis Posgrado). Quito: Pontificia Universidad Católica del Ecuador. Recuperado el 27 de Mayo de 2025, de https://repositorio.puce.edu.ec/server/api/core/bitstreams/adb1d2a4-702f-4d01-9aa1-200cb2c6f032/content
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2026 Taissha Nayeli Franco Garcia, Melissa Anahi Delgado Fores, William Antonio Lino Villacreses
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
Eres libre de:
- Compartir : copiar y redistribuir el material en cualquier medio o formato
- Adaptar : remezclar, transformar y desarrollar el material
- El licenciante no puede revocar estas libertades siempre y cuando usted cumpla con los términos de la licencia.
En los siguientes términos:
- Atribución : Debe otorgar el crédito correspondiente , proporcionar un enlace a la licencia e indicar si se realizaron cambios . Puede hacerlo de cualquier manera razonable, pero no de ninguna manera que sugiera que el licenciante lo respalda a usted o a su uso.
- No comercial : no puede utilizar el material con fines comerciales .
- CompartirIgual — Si remezcla, transforma o construye sobre el material, debe distribuir sus contribuciones bajo la misma licencia que el original.
- Sin restricciones adicionales : no puede aplicar términos legales ni medidas tecnológicas que restrinjan legalmente a otros hacer algo que la licencia permite.
