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Improving the laboratory result release process in the light of ISO 15189:2012 standard.
Can Çubukçu H, Vanstapel F, Thelen M, Bernabeu-Andreu FA, van Schrojenstein Lantman M, Brugnoni D, Mesko Brguljan P, Milinkovic N, Linko S, Vaubourdolle M, O'Kelly R, Kroupis C, Lohmander M, Šprongl L, Panteghini M, Boursier G; European Federation of Clinical Chemistry, Laboratory Medicine EFLM Working Group Accreditation, ISO/CEN standards WG-A/ISO. Can Çubukçu H, et al. Among authors: brugnoni d. Clin Chim Acta. 2021 Nov;522:167-173. doi: 10.1016/j.cca.2021.08.013. Epub 2021 Aug 18. Clin Chim Acta. 2021. PMID: 34418364
Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO).
Thelen MH, Vanstapel FJ, Kroupis C, Vukasovic I, Boursier G, Barrett E, Bernabeu Andreu F, Brguljan PM, Brugnoni D, Lohmander M, Sprongl L, Vodnik T, Ghita I, Vaubourdolle M, Huisman W; Working Group Accreditation ISO/CEN standards (WG-A/ISO) of EFLM. Thelen MH, et al. Among authors: brugnoni d. Clin Chem Lab Med. 2015 Jul;53(8):1173-80. doi: 10.1515/cclm-2015-0257. Clin Chem Lab Med. 2015. PMID: 26055950 Free article.
Accreditation process in European countries - an EFLM survey.
Boursier G, Vukasovic I, Brguljan PM, Lohmander M, Ghita I, Bernabeu Andreu FA, Barrett E, Brugnoni D, Kroupis C, Sprongl L, Thelen MH, Vanstapel F, Vodnik T, Huisman W, Vaubourdolle M; Working Group Accreditation and ISO/CEN standards (WG-A/ISO) of the EFLM. Boursier G, et al. Among authors: brugnoni d. Clin Chem Lab Med. 2016 Apr;54(4):545-51. doi: 10.1515/cclm-2015-0780. Clin Chem Lab Med. 2016. PMID: 26744251 Free article. Review.
Documenting metrological traceability as intended by ISO 15189:2012: A consensus statement about the practice of the implementation and auditing of this norm element.
Thelen M, Vanstapel F, Brguljan PM, Gouget B, Boursier G, Barrett E, Kroupis C, Lohmander M, Šprongl L, Vodnik T, Bernabeu-Andreu F, Vukasović I, Sönmez Ç, Linko S, Brugnoni D, Vaubourdolle M, Huisman W, Panteghini M; European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO). Thelen M, et al. Among authors: brugnoni d. Clin Chem Lab Med. 2019 Mar 26;57(4):459-464. doi: 10.1515/cclm-2018-1212. Clin Chem Lab Med. 2019. PMID: 30511927 Free article.
Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demands for method verification and validation.
Roelofsen-de Beer R, Wielders J, Boursier G, Vodnik T, Vanstapel F, Huisman W, Vukasović I, Vaubourdolle M, Sönmez Ç, Linko S, Brugnoni D, Kroupis C, Lohmander M, Šprongl L, Bernabeu-Andreu F, Meško Brguljan P, Thelen M. Roelofsen-de Beer R, et al. Among authors: brugnoni d. Clin Chem Lab Med. 2020 Feb 25;58(3):361-367. doi: 10.1515/cclm-2019-1053. Clin Chem Lab Med. 2020. PMID: 31714885 Free article.
An approach for determining allowable between reagent lot variation.
van Schrojenstein Lantman M, Çubukçu HC, Boursier G, Panteghini M, Bernabeu-Andreu FA, Milinkovic N, Mesko Brguljan P, Linko S, Brugnoni D, O'Kelly R, Kroupis C, Lohmander M, Šprongl L, Vanstapel F, Thelen M; European Federation of Clinical Chemistry, Laboratory Medicine EFLM Working Group Accreditation, ISO/CEN standards WG-A/ISO. van Schrojenstein Lantman M, et al. Among authors: brugnoni d. Clin Chem Lab Med. 2022 Feb 16;60(5):681-688. doi: 10.1515/cclm-2022-0083. Print 2022 Apr 26. Clin Chem Lab Med. 2022. PMID: 35172415 Free article.
59 results