Kumasaka K
Department of Clinical Pathology, Nihon University School of Medicine, Tokyo.
Rinsho Byori. 1993 May;41(5):578-82.
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.
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.
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.
以往全国性的外部质量控制（QC）项目存在局限性或缺点。因此，东京都政府和东京医师协会（TMA）于1982年启动了首个地区年度外部QC项目。化学、血液学和免疫学方面的QC结果显示有快速改善。相比之下，微生物学方面则暴露出一些严重问题。
东京都外部QC项目包括所谓的“公开”和“盲法”调查。为公开和盲法调查准备模拟标本，并要求所有实验室使用常规程序检测标本。所有参与者不仅要报告其检测结果，如用于计算机分析的代码，还要描述检测过程。书面回答包括以下主题、程序、培养特征等：选择性培养基的数量和类型、培养条件、菌落形态、微生物的显微镜和生化特征等。关于某些病原菌鉴定的调查报告不准确。检测到常规程序使用的培养基数量与公开调查中使用的培养基数量之间存在差异。
以往使用冻干生物体的全国性外部QC项目在促进日本临床微生物学的总体改善方面具有重要价值，但它们仅揭示了明显错误。我们10年的经验使我们相信，在公开和盲法调查中使用模拟标本时能获得更多重要信息。应监测周转时间和结果报告的其他方面。由于QC调查可能产生法律后果，实验室现在比以前更害怕出错。实验室人员的继续教育至关重要。
