J Lab Med Qual Assur.  2010 Jun;32(1):115-130.

Annual Report on External Quality Assessment in Therapeutic Drug Monitoring and Drug of Abuse in Korea (2009)

• Kim JH
• Kim BK
• Lee W
• Lee SY
• Chun S
• Kwon GC
• Yoon Y
• Shin DH
• Song KE
• Song SM
• Suh SP
• Kim JQ

Abstract

We performed two trials of external quality assessment for Therapeutic Drug Monitoring (TDM) subcommittee of Korean Association of Quality Assurance for Clinical Laboratory (KAQACL) in 2009. The number of participating laboratories were 110, which is similar with that of previous 3 years. Average response rates were 97.8% in both trials, similar to those of previous years. Two kinds of control materials were requested to be tested in each trial so that each institution could find the possible systematic errors. The average drug item responded was 6.2 per institution, which was decreased slightly from 6.5 in recent 5 years. The most common test items were valproic acid, digoxin, carbamazepine, phenytoin, and theophylline which were peformed in more than 63.8% of participating laboratories, followed by phenobarbital, cyclosporine, tacrolimus, vancomycin, lithium, methotrexate, amikacin, gentamicin, acetaminophen, tobramycin, salicylate, free phenytoin, amitryptyline, ethosuximide, and primidone. The widely used TDM analyzers were Abbott AxSym (26.9%), followed by Abbott TDx/TDxFLx (24.8%), Roche Cobas Integra (15.1%), Siemens Diagnostics Viva-E (5.5%), Roche cobas c501 (5.1%), Siemens Diagnostics Dimension (3.4%), and many other analyzers. The inter-laboratory coefficients of variations showed similar tendency comparing with those of the previous years. The number of participating laboratories for drug of abuse (DOA) tests were 19, which was slightly increased compared to that of the previous year. Average DOA items were 3.8~4.2. We found the good performance of participating laboratories for DOA. In conclusion, the TDM and DOA external quality assessment of 2009 showed similar performance comparing with that of the recent 3 years.

Keyword

Quality assurance; External quality assessment; Therapeutic drug monitoring

MeSH Terms

Acetaminophen
Amikacin
Carbamazepine
Cyclosporine
Digoxin
Drug Monitoring
Ethosuximide
Gentamicins
Korea
Lithium
Methotrexate
Phenobarbital
Phenytoin
Primidone
Tacrolimus
Theophylline
Tobramycin
Valproic Acid
Vancomycin
Acetaminophen
Amikacin
Carbamazepine
Cyclosporine
Digoxin
Ethosuximide
Gentamicins
Lithium
Methotrexate
Phenobarbital
Phenytoin
Primidone
Tacrolimus
Theophylline
Tobramycin
Valproic Acid
Vancomycin