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
CATLAB, Barcelona, Spain.
Sociedad Española de Medicina de Laboratorio (SEQCML), Comisión de Acreditación de Laboratorios, Barcelona, Spain.
Adv Lab Med. 2021 Jan 11;2(1):51-70. doi: 10.1515/almed-2020-0110. eCollection 2021 Mar.
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.
本文的目的是分享一些关于分析后流程管理的考量，这些考量涉及根据UNE-EN ISO 15189:2013标准要求对检测结果进行审核、报告和发布。本文的范围包括分析后活动以及相关人员（实验室管理层和工作人员）。我们描述了审核和验证分析结果所需的标准和信息，以确保向请求者发送清晰的报告。这些标准还保证结果以可靠的方式转录，并提供所有必要信息以正确解释结果。同样，本文描述了正确发布实验室结果的要求，特别强调了发布警示或危急结果的要求。在一些欧洲国家，临床实验室需要获得部分或全部ISO 15189认可，这是一种全球趋势。因此，理解ISO 15189的要求对于逐步且更有效地实施该标准至关重要。
