北京市第三方医学检验机构发展现状调查

Investigation and analysis of independent clinical laboratories in Beijing

目的全面了解北京市医学独立实验室（ICL）发展现状及存在的问题，探索适合此类新型医疗机构的监管模式。方法通过调查问卷，对北京市21所ICI。进行调查，了解其实验室规模、质量控制及服务等情况。结果北京市ICL已初具规模，100人以上的ICL占28．6％（6／21）。临床化学检验和分子生物学检验发展迅速，21所ICL仪器设备中，有全自动发光免疫分析仪者占26％，有核酸分析仪者占27％。北京市ICL的发展呈现标准化、专业化的态势。结论北京市ICL在标准化和质量控制等方面已取得一定成效，但在人员配置和规范化管理等方面仍存在问题，在监管和服务模式标准方面有待进一步完善和提高。

Objective To learn the development and problems of independent clinical laboratories in Beijing, and explore regulatory models fit for such medical institutions. Methods 21 independent clinical laboratories in Beijing were surveyed and analyzed with questionnaire to learn their lab size, quality control and services. Results Such labs were found with a considerable growth in scale, with 28. 6% of them having over 100 employees. Rapid development of the techniques of clinical chemistry and molecular biology. For example, of all the instruments and equipments of the 21 laboratories, and 26% were equipped with automated chemiluminescence immunoassay analyzers and 27% with nucleic acid spectrometers, This proves the standard and professional development of such laboratories in Beijing. Conclusion Such laboratories have made considerable progress in terms of standardization and quality control, but still are faced with such problems and defects as staffing and standardized management. Regulatory standards and service models should be further refined and improved.