Twenty-years of experiences in external quality assurance in Korea.

The Korean External Quality Assurance Scheme (KEQAS) was set up by a voluntary organization, the Korean Society of Quality Control in Clinical Pathology (KSQC) in 1976. The KSQC was reorganized as the Korean Association of Quality Assurance for Clinical Laboratories (KAQACL) in 1991. The KAQACL is a government authorized organization. With the growing popularity of the KEQAS, its coverage has expanded to include ten disciplines, and the number of participants has grown to 470 clinical laboratories by the end of 1998. The ten programs are: clinical chemistry, clinical microbiology, diagnostic hematology, diagnostic immunology. blood bank, urinalysis, immunoassay, TDM (therapeutic drug monitoring), inborn errors of metabolism and diagnostic genetics. KAQACL membership accreditation is based on the QAP return rate, of which the minimum criterion for acceptability is 50%. Membership in KAQACL is highly regarded by the Inspection and Accreditation Program of the Korean Hospital Association and is an essential requirement for outreach services of commercial laboratories. While monitoring the quality of laboratory performances during the last two decades, the KEQAS has provided information on reliability of laboratory performances regarding methods, manufacturers and laboratory groups. The inter-laboratory coefficient variations (CVs) and the variance index score (VIS) have gradually decreased over the years, particularly during the 1990s. The participants who achieved good performances (less than 100 VIS) in clinical chemistry tests have gradually increased in number up to 83.2% of all participants.

Country reports from Japan: external quality assessment scheme in Japan.

Several external quality assessment schemes (EQAS) have been conducted in Japan. Results obtained from nation-scale EQAS reveal the current quality of laboratory testing in each laboratory. The largest nation-scale EQAS in Japan is that conducted by the Japan Medical Association. The numbers of participants and of items evaluated have increased in EQAS by JMA over its history of 32 years. Improvement in inter-laboratory differences has been observed for most items in EQAS in recent decades. In 1998, about 2,500 laboratories from throughout the country participated in this surveillance, and 47 items were evaluated. The coefficient of variations for the group of all participants was less than 5% for about one third of all test items. On the other hand, very high variations over 20% were observed for 6 items. Also, inter-method differences exist for many items, which may be or may not be related to matrix effects. Retrospective evaluation of all EQAS data suggests that there is still room for improvement in inter-laboratory differences.