Management of postanalytical processes in the clinical laboratory according to ISO 15189:2012 Standard requirements: considerations on the review, reporting and release of results

The objective of this paper is to share some considerations about the management of postanalytical processes in relation to the review, reporting and release of test results in accordance with UNE-EN ISO 15189:2013 Standard requirements. The scope of this paper includes postanalytical activities and...

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Autores principales: López Yeste Mᵃ Liboria, Izquierdo Álvarez Silvia, Pons Mas Antonia R., Álvarez Domínguez Luisa, Marqués García Fernando, Rodríguez Mᵃ Patrocinio Chueca, Blanco Font Aurora, Bernabeu Andreu Francisco A., García Álvarez Ana, Contreras Sanfeliciano Teresa, Pascual Gómez Natalia, Sánchez Gancedo Lorena, Guiñón Muñoz Leonor
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ES
Publicado: De Gruyter 2021
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Acceso en línea:https://doaj.org/article/e840824ce312459190e7451717239294
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spelling oai:doaj.org-article:e840824ce312459190e74517172392942021-12-05T14:10:39ZManagement of postanalytical processes in the clinical laboratory according to ISO 15189:2012 Standard requirements: considerations on the review, reporting and release of results2628-491X10.1515/almed-2020-0110https://doaj.org/article/e840824ce312459190e74517172392942021-01-01T00:00:00Zhttps://doi.org/10.1515/almed-2020-0110https://doaj.org/toc/2628-491XThe objective of this paper is to share some considerations about the management of postanalytical processes in relation to the review, reporting and release of test results in accordance with UNE-EN ISO 15189:2013 Standard requirements. The scope of this paper includes postanalytical activities and the personnel involved (laboratory management and staff). We describe the criteria and information required to review and validate analytical results and ensure that clear reports are sent to requesters. These criteria also guarantee that results are transcribed in a reliable way and that all necessary information is provided for the correct interpretation of results. Likewise, the requirements for the correct release of laboratory results are described, with special emphasis on the release of alarming or critical results. In some European countries, clinical laboratories are required to hold partial or full ISO 15189 accreditation, which is a global trend. Therefore, understanding ISO 15189 requirements is imperative for a progressive and more effective implementation of the Standard.López Yeste Mᵃ LiboriaIzquierdo Álvarez SilviaPons Mas Antonia R.Álvarez Domínguez LuisaMarqués García FernandoRodríguez Mᵃ Patrocinio ChuecaBlanco Font AuroraBernabeu Andreu Francisco A.García Álvarez AnaContreras Sanfeliciano TeresaPascual Gómez NataliaSánchez Gancedo LorenaGuiñón Muñoz LeonorDe Gruyterarticleaccreditationclinical laboratoryiso 15189 standardpostanalytical processMedical technologyR855-855.5ENESAdvances in Laboratory Medicine, Vol 2, Iss 1, Pp 51-59 (2021)
institution DOAJ
collection DOAJ
language EN
ES
topic accreditation
clinical laboratory
iso 15189 standard
postanalytical process
Medical technology
R855-855.5
spellingShingle accreditation
clinical laboratory
iso 15189 standard
postanalytical process
Medical technology
R855-855.5
López Yeste Mᵃ Liboria
Izquierdo Álvarez Silvia
Pons Mas Antonia R.
Álvarez Domínguez Luisa
Marqués García Fernando
Rodríguez Mᵃ Patrocinio Chueca
Blanco Font Aurora
Bernabeu Andreu Francisco A.
García Álvarez Ana
Contreras Sanfeliciano Teresa
Pascual Gómez Natalia
Sánchez Gancedo Lorena
Guiñón Muñoz Leonor
Management of postanalytical processes in the clinical laboratory according to ISO 15189:2012 Standard requirements: considerations on the review, reporting and release of results
description The objective of this paper is to share some considerations about the management of postanalytical processes in relation to the review, reporting and release of test results in accordance with UNE-EN ISO 15189:2013 Standard requirements. The scope of this paper includes postanalytical activities and the personnel involved (laboratory management and staff). We describe the criteria and information required to review and validate analytical results and ensure that clear reports are sent to requesters. These criteria also guarantee that results are transcribed in a reliable way and that all necessary information is provided for the correct interpretation of results. Likewise, the requirements for the correct release of laboratory results are described, with special emphasis on the release of alarming or critical results. In some European countries, clinical laboratories are required to hold partial or full ISO 15189 accreditation, which is a global trend. Therefore, understanding ISO 15189 requirements is imperative for a progressive and more effective implementation of the Standard.
format article
author López Yeste Mᵃ Liboria
Izquierdo Álvarez Silvia
Pons Mas Antonia R.
Álvarez Domínguez Luisa
Marqués García Fernando
Rodríguez Mᵃ Patrocinio Chueca
Blanco Font Aurora
Bernabeu Andreu Francisco A.
García Álvarez Ana
Contreras Sanfeliciano Teresa
Pascual Gómez Natalia
Sánchez Gancedo Lorena
Guiñón Muñoz Leonor
author_facet López Yeste Mᵃ Liboria
Izquierdo Álvarez Silvia
Pons Mas Antonia R.
Álvarez Domínguez Luisa
Marqués García Fernando
Rodríguez Mᵃ Patrocinio Chueca
Blanco Font Aurora
Bernabeu Andreu Francisco A.
García Álvarez Ana
Contreras Sanfeliciano Teresa
Pascual Gómez Natalia
Sánchez Gancedo Lorena
Guiñón Muñoz Leonor
author_sort López Yeste Mᵃ Liboria
title Management of postanalytical processes in the clinical laboratory according to ISO 15189:2012 Standard requirements: considerations on the review, reporting and release of results
title_short Management of postanalytical processes in the clinical laboratory according to ISO 15189:2012 Standard requirements: considerations on the review, reporting and release of results
title_full Management of postanalytical processes in the clinical laboratory according to ISO 15189:2012 Standard requirements: considerations on the review, reporting and release of results
title_fullStr Management of postanalytical processes in the clinical laboratory according to ISO 15189:2012 Standard requirements: considerations on the review, reporting and release of results
title_full_unstemmed Management of postanalytical processes in the clinical laboratory according to ISO 15189:2012 Standard requirements: considerations on the review, reporting and release of results
title_sort management of postanalytical processes in the clinical laboratory according to iso 15189:2012 standard requirements: considerations on the review, reporting and release of results
publisher De Gruyter
publishDate 2021
url https://doaj.org/article/e840824ce312459190e7451717239294
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