Management of post-analytical processes in the clinical laboratory according to ISO 15189:2012. Considerations about the management of clinical samples, ensuring quality of post-analytical processes, and laboratory information management

ISO 15189:2012 establishes the requirements for clinical sample management, ensuring quality of process and laboratory information management. The accreditation authority, ENAC in Spain, established the requirements for the authorized use of the label in reports issued by accredited laboratories. Th...

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Autores principales:	López Yeste Mᵃ Libòria, Pons Mas Antonia R., Guiñón Muñoz Leonor, Izquierdo Álvarez Silvia, García Fernando Marqués, Blanco Font Aurora, Pascual Gómez Natalia F., Sánchez Gancedo Lorena, García Álvarez Ana, Bernabeu Andreu Francisco A., Chueca Rodríguez Mᵃ Patrocinio, Álvarez Domínguez Luisa
Formato:	article
Lenguaje:	EN ES
Publicado:	De Gruyter 2021
Materias:	accreditation clinical laboratory iso 15189 standard laboratory information system post-analytical Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/062ad58d3f7a4a1fb7709ebad2bbadde
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spelling	oai:doaj.org-article:062ad58d3f7a4a1fb7709ebad2bbadde2021-12-05T14:10:40ZManagement of post-analytical processes in the clinical laboratory according to ISO 15189:2012. Considerations about the management of clinical samples, ensuring quality of post-analytical processes, and laboratory information management2628-491X10.1515/almed-2021-0044https://doaj.org/article/062ad58d3f7a4a1fb7709ebad2bbadde2021-05-01T00:00:00Zhttps://doi.org/10.1515/almed-2021-0044https://doaj.org/toc/2628-491XISO 15189:2012 establishes the requirements for clinical sample management, ensuring quality of process and laboratory information management. The accreditation authority, ENAC in Spain, established the requirements for the authorized use of the label in reports issued by accredited laboratories. These recommendations are applicable to the postanalytical processes and the professionals involved. The Standard requires laboratories to define and document the duration and conditions of sample retention. Laboratories are also required to design an internal quality control scheme to verify whether postanalytical activities attain the expected standards. Information management requirements are also established and laboratories are required to design a contingency plan to ensure the communication of laboratory results. Instructions are finally provided about the correct use of the accreditation label in laboratory reports. A range of nations and scientific societies support that clinical laboratories should be required to obtain accreditation. With ISO 15189 being the most specific standard for demonstrating technical performance, a clear understanding of its requirements is essential for proper implementation.López Yeste Mᵃ LibòriaPons Mas Antonia R.Guiñón Muñoz LeonorIzquierdo Álvarez SilviaGarcía Fernando MarquésBlanco Font AuroraPascual Gómez Natalia F.Sánchez Gancedo LorenaGarcía Álvarez AnaBernabeu Andreu Francisco A.Chueca Rodríguez Mᵃ PatrocinioÁlvarez Domínguez LuisaDe Gruyterarticleaccreditationclinical laboratoryiso 15189 standardlaboratory information systempost-analyticalMedical technologyR855-855.5ENESAdvances in Laboratory Medicine, Vol 2, Iss 3, Pp 373-380 (2021)
institution	DOAJ
collection	DOAJ
language	EN ES
topic	accreditation clinical laboratory iso 15189 standard laboratory information system post-analytical Medical technology R855-855.5
spellingShingle	accreditation clinical laboratory iso 15189 standard laboratory information system post-analytical Medical technology R855-855.5 López Yeste Mᵃ Libòria Pons Mas Antonia R. Guiñón Muñoz Leonor Izquierdo Álvarez Silvia García Fernando Marqués Blanco Font Aurora Pascual Gómez Natalia F. Sánchez Gancedo Lorena García Álvarez Ana Bernabeu Andreu Francisco A. Chueca Rodríguez Mᵃ Patrocinio Álvarez Domínguez Luisa Management of post-analytical processes in the clinical laboratory according to ISO 15189:2012. Considerations about the management of clinical samples, ensuring quality of post-analytical processes, and laboratory information management
description	ISO 15189:2012 establishes the requirements for clinical sample management, ensuring quality of process and laboratory information management. The accreditation authority, ENAC in Spain, established the requirements for the authorized use of the label in reports issued by accredited laboratories. These recommendations are applicable to the postanalytical processes and the professionals involved. The Standard requires laboratories to define and document the duration and conditions of sample retention. Laboratories are also required to design an internal quality control scheme to verify whether postanalytical activities attain the expected standards. Information management requirements are also established and laboratories are required to design a contingency plan to ensure the communication of laboratory results. Instructions are finally provided about the correct use of the accreditation label in laboratory reports. A range of nations and scientific societies support that clinical laboratories should be required to obtain accreditation. With ISO 15189 being the most specific standard for demonstrating technical performance, a clear understanding of its requirements is essential for proper implementation.
format	article
author	López Yeste Mᵃ Libòria Pons Mas Antonia R. Guiñón Muñoz Leonor Izquierdo Álvarez Silvia García Fernando Marqués Blanco Font Aurora Pascual Gómez Natalia F. Sánchez Gancedo Lorena García Álvarez Ana Bernabeu Andreu Francisco A. Chueca Rodríguez Mᵃ Patrocinio Álvarez Domínguez Luisa
author_facet	López Yeste Mᵃ Libòria Pons Mas Antonia R. Guiñón Muñoz Leonor Izquierdo Álvarez Silvia García Fernando Marqués Blanco Font Aurora Pascual Gómez Natalia F. Sánchez Gancedo Lorena García Álvarez Ana Bernabeu Andreu Francisco A. Chueca Rodríguez Mᵃ Patrocinio Álvarez Domínguez Luisa
author_sort	López Yeste Mᵃ Libòria
title	Management of post-analytical processes in the clinical laboratory according to ISO 15189:2012. Considerations about the management of clinical samples, ensuring quality of post-analytical processes, and laboratory information management
title_short	Management of post-analytical processes in the clinical laboratory according to ISO 15189:2012. Considerations about the management of clinical samples, ensuring quality of post-analytical processes, and laboratory information management
title_full	Management of post-analytical processes in the clinical laboratory according to ISO 15189:2012. Considerations about the management of clinical samples, ensuring quality of post-analytical processes, and laboratory information management
title_fullStr	Management of post-analytical processes in the clinical laboratory according to ISO 15189:2012. Considerations about the management of clinical samples, ensuring quality of post-analytical processes, and laboratory information management
title_full_unstemmed	Management of post-analytical processes in the clinical laboratory according to ISO 15189:2012. Considerations about the management of clinical samples, ensuring quality of post-analytical processes, and laboratory information management
title_sort	management of post-analytical processes in the clinical laboratory according to iso 15189:2012. considerations about the management of clinical samples, ensuring quality of post-analytical processes, and laboratory information management
publisher	De Gruyter
publishDate	2021
url	https://doaj.org/article/062ad58d3f7a4a1fb7709ebad2bbadde
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Management of post-analytical processes in the clinical laboratory according to ISO 15189:2012. Considerations about the management of clinical samples, ensuring quality of post-analytical processes, and laboratory information management

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