Journal: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
| Full article 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 |
|---|---|
| Journal | Advances in Laboratory Medicine |
| Author(s) | Yeste, Mᵃ L.L.; Mas, Antonia R.P.; Muñoz, Leonor G.; Álvarez, Silvia I.; García, Fernando M.; Font, Aurora B.; Gómez, Natalia F.P.; Gancedo, Lorena S.; Álvarez, Ana G.; Andreu, Francisco A.B.; Rodríguez, Mᵃ P.C.; Domínguez, Luisa Á. |
| Author affiliation(s) | CATLAB, Hospital Universitari Son Espases, Hospital de la Santa Creu y Sant Pau, Hospital Universitario Miguel Servet, Germans Trias i Pujols Universitary Hospital, Hospital Universitari de Bellvitge, Hospital Universitario de la Princesa, Institute of Oncologic and Molecular Oncology, Hospital Clínico San Carlos, Hospital Universitario Puerta de Hierro, Laboratory Accreditation Board of the Spanish Society of Laboratory Medicine |
| Primary contact | Email: llopez at catlab dot cat |
| Year published | 2021 |
| Volume and issue | 2(3) |
| Page(s) | 373-380 |
| DOI | 10.1515/almed-2021-0044 |
| ISSN | 2628-491X |
| Distribution license | Creative Commons Attribution 4.0 International |
| Website | https://www.degruyter.com/document/doi/10.1515/almed-2021-0044/html |
| Download | https://www.degruyter.com/document/doi/10.1515/almed-2021-0044/pdf (PDF) |
 |
This article should be considered a work in progress and incomplete. Consider this article incomplete until this notice is removed. |
Abstract
ISO 15189:2012 Medical laboratories — Requirements for quality and competence establishes the requirements for clinical specimen management, ensuring the quality of processes and laboratory information management. ENAC (Entidad Nacional de Acreditación), the sole accreditation authority in Spain, established the requirements for the authorized use of the ISO 15189 accreditation label in reports issued by accredited laboratories. These recommendations are applicable to the lab's post-analytical 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 post-analytical 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 clinical laboratories being 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.
Keywords: accreditation, clinical laboratory, ISO 15189 standard, laboratory information system, post-analytical
Introduction
References
Notes
This presentation is faithful to the original, with only a few minor changes to presentation, spelling, and grammar. In some cases important information was missing from the references, and that information was added.
