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97 results

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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: kroupis c. 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.
Human papilloma virus (HPV) molecular diagnostics.
Kroupis C, Vourlidis N. Kroupis C, et al. Clin Chem Lab Med. 2011 Nov;49(11):1783-99. doi: 10.1515/CCLM.2011.685. Epub 2011 Aug 30. Clin Chem Lab Med. 2011. PMID: 21875401 Review.
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: kroupis c. 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: kroupis c. 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.
Recommendation for the review of biological reference intervals in medical laboratories.
Henny J, Vassault A, Boursier G, Vukasovic I, Mesko Brguljan P, Lohmander M, Ghita I, Andreu FA, Kroupis C, Sprongl L, Thelen MH, Vanstapel FJ, Vodnik T, Huisman W, Vaubourdolle M; Working Group Accreditation and ISO/CEN standards (WG-A/ISO) of the EFLM. Henny J, et al. Among authors: kroupis c. Clin Chem Lab Med. 2016 Dec 1;54(12):1893-1900. doi: 10.1515/cclm-2016-0793. Clin Chem Lab Med. 2016. PMID: 27748267 Free article. Review.
Corrigendum to: Recommendation for the review of biological reference intervals in medical laboratories.
Henny J, Vassault A, Boursier G, Vukasovic I, Brguljan PM, Lohmander M, Ghita I, Andreu FA, Kroupis C, Sprongl L, Thelen MH, Vanstapel FJ, Vodnik T, Huisman W, Vaubourdolle M. Henny J, et al. Among authors: kroupis c. Clin Chem Lab Med. 2017 Mar 1;55(3):470. doi: 10.1515/cclm-2016-0793_C. Clin Chem Lab Med. 2017. PMID: 28161692 Free article. No abstract available.
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: kroupis c. 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.
A proposed Common Training Framework for Specialists in Laboratory Medicine under EU Directive 2013/55/EC (The Recognition of Professional Qualifications).
Wieringa G, Queraltó J, Homšak E, Jassam N, Cavalier E, Svinarov D, Krleža JL, Christou S, Pikner R, Larsen TR, Tomberg K, Linko-Parvinen A, Sapin V, Baum H, Kroupis C, Bagoly Z, Costelloe S, Sciacovelli L, Stasulans J, Vitkus D, Meunier D, Solnica B, Reguengo H, Mambet C, Kovac G, Krhin B, Ohlson M, Buhagiar G, Simundic AM. Wieringa G, et al. Among authors: kroupis c. Clin Chem Lab Med. 2020 Nov 30;59(3):505-512. doi: 10.1515/cclm-2020-1504. Print 2021 Feb 23. Clin Chem Lab Med. 2020. PMID: 33554548 Free article.
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: kroupis c. 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
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: kroupis c. 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.
97 results