Abstract
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 therequirements 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.
Highlights
Clinical laboratories increasingly devote more efforts to improve their methodological and communication skillsThis work is licensed under the Creative Commons Attribution 4.0López Yeste et al.: Sample and information management in the laboratory according to ISO-15189 to help physicians in the interpretation of test results
Added to UNE-EN ISO 15189:2013 requirements for the revision, reporting and release of clinical test results, described elsewhere [1], this Standard establishes other requirements for postanalytical processes. These requirements address sample storage, retention and disposal, the inclusion of postanalytical processes in laboratory quality assurance and continuous improvement, laboratory information management, and the need for a contingency plan that ensures the communication of test results in any scenario [2, 3]
Considering that the use of the ENAC label in laboratory reports is the way laboratories demonstrate that they comply with accreditation requirements, it is important to pay attention on the ENAC document CEA-ENAC-01 “Requirements for the use of the ENAC label and reference of certification”, which establishes the requirements for label use, which must be known to all accredited laboratories
Summary
Management of post-analytical processes in the clinical laboratory according to ISO 15189:2012. Laboratory Accreditation Board of the Spanish Society of Laboratory Medicine (SEQCML)
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