J Lab Med Qual Assur 2015; 37(1): 12-22
Published online March 31, 2015
Copyright © Korean Association of External Quality Assessment Service.
Dae-Hyun Ko1, Tae-Dong Jeong1, Gum-Gyoung Gu1, Sail Chun1, and Jeong-Ho Kim2, as Therapeutic Drug Monitoring Subcommittee, The Korean Association of Quality Assurance for Clinical Laboratories
1Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine; 2Department of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
Correspondence to:Sail Chun
Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 138-736, Korea
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
As the Therapeutic Drug Monitoring Subcommittee (TDMS) of the Korean Association of Quality Assurance for Clinical Laboratories (KAQACL), we organised two trials as an external quality assessment of therapeutic drug monitoring (TDM) and testing for drugs of abuse (DOA) in 2014. In each trial, low and high level control materials for TDM testing, and positive and negative control materials for DOA testing, were requested from institutions. The number of participating laboratories was 107 for the first trial and 106 for the second. The average number of drug items provided was 5.7 per institution. The most commonly tested substances were, in descending order, valproic acid, digoxin, tacrolimus, phenytoin, and vancomycin. The mean inter-laboratory coefficients of variation for low- and highlevel TDM control materials were 8.5% and 7.2%, respectively. The most widely used TDM analysers were the Architect i System (Abbott Diagnostics, USA), followed by the Cobas Integra (Roche Diagnostics, Switzerland) and the Cobas c501 analyser (Roche Diagnostics). The number of participating laboratories for DOA testing was 23% higher that than in 2013. In 96.9% of cases, our analysis confirmed the suitability of the tests at participating DOA laboratories in both trials. In the external quality assessment of TDM by the TDMS of KAQACL in 2014, the overall performance of TDM testing was found to be similar to that observed in the previous years, and inter-laboratory precision was higher than that in 2013. Continuous quality improvement of TDM testing by participation in a proficiency-testing program is necessary. (J Lab Med Qual Assur 2015;37:12-22)
Keywords: Quality assurance, Laboratory proficiency testing, Drug monitoring
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