Experience of the first survey of the pilot project of Asian Quality Assurance Survey program.

The Asian Network for Clinical Laboratory Standardization (ANCLS) decided to start her First Inter-laboratory Quality Assurance survey at the business meeting during the Second Asian Colloquium on October 21-22, 2000 in Kobe, Japan. The first survey materials of Asian Quality Assurance Survey (AQuAS) were distributed in July 2001 to 21 hospitals in the field of chemistry and 22 hospitals in the field of hematology among total 24 participating laboratories from seven Asian countries: Indonesia, Japan, Korea, Malaysia, Philippines, Singapore and Thailand. The survey methods in chemistry and in hematology were somewhat different. In chemistry the survey material was considered as unknown but handled similarly to the sample from the patient. Nineteen routine tests were performed only once. The hematology samples were considered as unknown but handled similarly to control or calibration material. Five parameters were tested five times repetitively and their average for each parameter was calculated. All the results were supposed to be sent back to the office within two weeks. Although it took more than two weeks, the return rate was 100%. The analysis was performed in several ways such as all the results together, by instruments and by methods. Mean, standard deviation (SD), standard deviation index (SDI), coefficient of variation (CV) and variance index score (VIS) were to be calculated in chemistry, and in hematology the same parameter were to be calculated except CV and VIS. In the first survey, the CV in chemistry was not calculated and the analysis by instrument or by methodology was also not attempted since there were not enough participating hospitals to do such analysis. In hematology the analysis was done by instrument only. The survey process was carried out successfully though there were some difficulties in communication tools, transportation methods and handling of specimens due to different weather conditions, and returning the report in the correct unit and to the correct place. The submitted data were acceptable for analysis. There were some differences in the units of measurement in different countries or laboratories. It was necessary to convert some of the units. Some laboratories apparently do not perform certain tests such as calcium, potasium and gamma-glutamyltransferase (gamma-GT). The gamma-GT is the most frequently not performed test. With the experience of this first survey, all the members involved in the survey have been trained well to do future surveys.

External quality assurance in diagnostic immunology: a twenty-year experience in Korea.

External Quality Assurance (EQA) Program in diagnostic immunology was founded in 1982 in Korea, starting from proficiency testing for HBsAg and serological tests for syphilis. Proficiency testing for antisteptolysin O (ASO) and Widal tests was started in 1983, rheumatoid factor (RF), C-reactive protein (CRP) and anti-HBs tests in 1986, anti-HIV in 1992, and anti-HCV in 1993, now assessing total nine immunological tests. EQA surverys are performed twice annually and about 400 laboratories have been participating now. Over 75% of participating laboratories have used immunoassays including enzyme immunoassay for HBsAg, anti-HBs, anti-HCV and anti-HIV, and less than 20% of laboratories used hemagglutination tests. Overall error rate for HBsAg was less than 5%, those for anti-HBs and anti-HCV about 3% and anti-HIV less than 0.5%. Only negative samples are now used for anti-HIV proficiency testing and two levels (negative and weakly positive or positive) of samples should be included in proficiency testing to assure the results. Thirty-five to forty-five percentages of participating laboratories have used nephelometry or turbidimetric immunoassay for CRP, RF and ASO. When comparing two kinds of nephelometry reagents most popularly used in Korea, quantitative results for CRP and RF by one kind were statistically different from the other. The reason for these discrepancies was not clear yet, however, standardization should be required. In the future, EQA in diagnostic immunology in Korea not only includes laboratory performance evaluation, but also evaluation of method performance and reagent evaluation.

Clinical pathologist in Korea--training program and its roles in laboratories.

A rapid development of practice of laboratory medicine in Korea owes its success to the clinical pathologists (CP), who have played a role of a pathfinder for laboratories. The Korean CP postgraduate education (residency) program is unique in that it is exclusively for laboratory medicine. The training program for clinical pathologists includes diagnostic hematology, diagnostic immunology, clinical microbiology, clinical chemistry, blood bank, diagnostic genetics, informatics and laboratory management. The program has produced a strong group of about 600 laboratory physicians, officially clinical pathologists since 1963. Most of Korean clinical pathologists work as laboratory directors, directors of university hospital laboratories or teaching faculty members in medical schools. The roles of clinical pathologists are laboratory management, interpretation of laboratory test results, clinical consulting services to clinicians and patients, ordering secondary tests after reviews of requested test results and utilization management. The clinical pathologists have developed clinical laboratories to be a main contributor for improved medical practice. During the last 40 years under the turbulent healthcare system, clinical pathologists have significantly contributed to safeguard the laboratory interests. The education program and the role of clinical pathologists are described.