Review of quality control program for clinical microbiology developed by the Tokyo Metropolitan Government

There are limitations or disadvantages in previous nation wide external quality control (QC) programs. Therefore, the Tokyo Metropolitan Government and the Tokyo Medical Association (TMA) initiated the first regional annual external QC program in 1982. The QC results in chemistry, hematology and immunology have shown rapid improvement. By contrast, some serious problems in microbiology have been revealed. METHODS AND RESULTS: The Tokyo Metropolitan external QC programs consist of so-called "open" and "blind" surveys. Simulated specimens were prepared for open and blind surveys and all laboratories were asked to examine the specimens using routine procedures. All participants were required to report not only their test results such as codes for computer analysis, but also to describe the process. Written answers included the following subjects, procedures, culture characteristics and others: number and type of selective media, incubation conditions, colonial morphology, microscopic and biochemical characteristics of the microorganisms, etc. The survey reports on the identification of some kinds of pathologic organism were inaccurate. Discrepancies between the number of media used for routine procedures and the number used in open survey were detected. CONCLUSIONS: Previous nationwide external QC programs using frozen-dried organisms have been valuable in promoting general improvement in clinical microbiology in Japan, but they have revealed only gross errors. Our 10-year experience has convinced us that additional important information is obtained when using simulated specimens for open and blind surveys. The turnaround time and other aspects of the reporting of results should be monitored. Due to possible legal ramifications of QC surveys, laboratories are now more afraid of making errors than before. The continuing education of laboratory personnel is essential.