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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| Format: | Article |
| Language: | English |
| Published: |
De Gruyter
2021-01-01
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| Series: | Advances in Laboratory Medicine |
| Subjects: | |
| Online Access: | https://doi.org/10.1515/almed-2020-0110 |
| _version_ | 1797795075687710720 |
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| 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 |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-13T03:12:23Z |
| format | Article |
| id | doaj.art-e840824ce312459190e7451717239294 |
| institution | Directory Open Access Journal |
| issn | 2628-491X |
| language | English |
| last_indexed | 2024-03-13T03:12:23Z |
| publishDate | 2021-01-01 |
| publisher | De Gruyter |
| record_format | Article |
| series | Advances in Laboratory Medicine |
| spelling | doaj.art-e840824ce312459190e74517172392942023-06-26T10:46:03ZengDe GruyterAdvances in Laboratory Medicine2628-491X2021-01-0121515910.1515/almed-2020-0110Management of postanalytical processes in the clinical laboratory according to ISO 15189:2012 Standard requirements: considerations on the review, reporting and release of resultsLópez Yeste Mᵃ Liboria0Izquierdo Álvarez Silvia1Pons Mas Antonia R.2Álvarez Domínguez Luisa3Marqués García Fernando4Rodríguez Mᵃ Patrocinio Chueca5Blanco Font Aurora6Bernabeu Andreu Francisco A.7García Álvarez Ana8Contreras Sanfeliciano Teresa9Pascual Gómez Natalia10Sánchez Gancedo Lorena11Guiñón Muñoz Leonor12CATLAB, Barcelona, SpainSociedad Española de Medicina de Laboratorio (SEQCML), Comisión de Acreditación de Laboratorios, Barcelona, SpainSociedad Española de Medicina de Laboratorio (SEQCML), Comisión de Acreditación de Laboratorios, Barcelona, SpainSociedad Española de Medicina de Laboratorio (SEQCML), Comisión de Acreditación de Laboratorios, Barcelona, SpainSociedad Española de Medicina de Laboratorio (SEQCML), Comisión de Acreditación de Laboratorios, Barcelona, SpainSociedad Española de Medicina de Laboratorio (SEQCML), Comisión de Acreditación de Laboratorios, Barcelona, SpainSociedad Española de Medicina de Laboratorio (SEQCML), Comisión de Acreditación de Laboratorios, Barcelona, SpainSociedad Española de Medicina de Laboratorio (SEQCML), Comisión de Acreditación de Laboratorios, Barcelona, SpainSociedad Española de Medicina de Laboratorio (SEQCML), Comisión de Acreditación de Laboratorios, Barcelona, SpainSociedad Española de Medicina de Laboratorio (SEQCML), Comisión de Acreditación de Laboratorios, Barcelona, SpainSociedad Española de Medicina de Laboratorio (SEQCML), Comisión de Acreditación de Laboratorios, Barcelona, SpainSociedad Española de Medicina de Laboratorio (SEQCML), Comisión de Acreditación de Laboratorios, Barcelona, SpainSociedad Española de Medicina de Laboratorio (SEQCML), Comisión de Acreditación de Laboratorios, Barcelona, SpainThe 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.https://doi.org/10.1515/almed-2020-0110accreditationclinical laboratoryiso 15189 standardpostanalytical process |
| spellingShingle | 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 Advances in Laboratory Medicine accreditation clinical laboratory iso 15189 standard postanalytical process |
| 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_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_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_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 |
| topic | accreditation clinical laboratory iso 15189 standard postanalytical process |
| url | https://doi.org/10.1515/almed-2020-0110 |
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