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pISSN 2384-2458 eISSN 2288-7261
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Annual Report


J Lab Med Qual Assur 2016; 38(1): 11-21

Published online March 31, 2016

https://doi.org/10.15263/jlmqa.2016.38.1.11

Copyright © Korean Association of External Quality Assessment Service.

Annual Report on the External Quality Assessment of Therapeutic Drug Monitoring and Testing for Drugs of Abuse in Korea (2015)

Dae-Hyun Ko1, Gum-Gyoung Gu1, Eun-Jung Cho1, Eun Suk Shin1, Sail Chun1, and Jeong-Ho Kim2, as Therapeutic Drug Monitoring Subcommittee, Korean Association of External Quality Assessment Service

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 05505, Korea
Tel: +82-2-3010-4513
Fax: +82-2-478-0884
E-mail:sailchun@amc.seoul.kr

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.


Abstract

As an annual function of the Therapeutic Drug Monitoring Subcommittee of Korean Association of External Quality Assessment Service (K-EQAS), we organised two trials for an external quality assessment of therapeutic drug monitoring (TDM) and testing for drugs of abuse (DOA) in 2015. For the TDM assessment, we sent low- and high-level control materials from various clinical institutions, and for the DOA testing, we sent positive and negative control materials. The number of participating laboratories was 105 for the TDM trial and 106 for the DOA test. The average number of drug items provided was 5.6 per institution. The most commonly tested substances, in descending order, were: valproic acid, digoxin, vancomycin, tacrolimus, and carbamazepine. The mean inter-laboratory coefficients of variation for low- and high-level TDM control materials were 7.3% and 7.4%, 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 the DOA analysis was 16% higher that than of our 2014 study. In 98.6% of cases, our analysis confirmed the reliabilityviability of the tests at participating DOA laboratories in both trials. In the external quality assessment of TDM by the TDM subcommittee of K-EQAS in 2015, the overall performance of TDM testing was found to be similar to that reported in previous years, and inter-laboratory precision was higher than that of 2014. Continuous improvement in the quality of TDM testing through participation in a proficiency-testing program will remain necessary in the future.
(J Lab Med Qual Assur 2016;38:11-21)

Keywords: Quality assurance, Laboratory proficiency testing, Drug monitoring

References

  1. Kim JQ, Jung YS, Kwon OH, Kwon HJ, Kim YK, Kim JW, et al. Annual report on external quality assessment in therapeutic drug monitoring in Korea (1995). J Clin Pathol Qual Control 2009;18:119-25.
  2. Kim JH, Kim BK, Lee SY, Chun S, Kwon GC, et al. Annual report on quality assessment in therapeutic drug monitoring and drug of abuse in Korea (2007). J Lab Med Qual Assur 2008;30:133-49.
  3. Jeong TD, Gu GG, Chun S, Kim JH; Therapeutic Drug Monitoring Subcommittee, The Korean Association of Quality Assurance for Clinical Laboratory. Annual report on the external quality assessment of therapeutic drug monitoring and testing for drugs of abuse in Korea (2013). J Lab Med Qual Assur 2014;36:12-22.
    CrossRef
  4. Ko DH, Jeong TD, Gu GG, Chun S, Kim JH; Therapeutic Drug Monitoring Subcommittee, The Korean Association of Quality Assurance for Clinical Laboratories. Annual report on the external quality assessment scheme for therapeutic drug monitoring and testing for drugs of abuse in Korea (2014). J Lab Med Qual Assur 2015;37:1222.

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