广东省性病实验室规范化建设与质量管理体系研究

目的　探讨性病实验室规范化管理和质量管理体系。方法　根据各实验室的任务、人员和设备等条件,采用三级和中心实验室模式开展全省性病实验室规范化建设。通过室内质控和室间质评方式建立性病实验室质控体系。结果　确定规范化性病实验室的三级管理体制与各级任务。2 0 0 3年9月～2 0 0 4年9月,举办性病实验室诊断技术培训班8期,培训学员4 70人。5 9间完成规范化建设并申请达标的性病实验室中,38间性病实验室通过考评,包括三级性病实验室5间,二级1 9间和一级1 4间。研究建立了性病实验室室内质控和室间质评的质量管理体系。首批1 9间通过考评的实验室的室间质评结果均符合要求,3间得分>90分,评为优秀;1 2间得75～90分,评为良好;4间得6 0～75分,评为合格。结论　规范化性病实验室和质量管理体系的建立,确保性病实验室科学管理和发展,对于性病艾滋病的防治有重要的意义。

Study of standardized STDs laboratories and quality control systems in Guangdong Province

Objective To study and construct the normalized STDs laboratory and quality control system. Methods Based on missions, technicians and facilities, the STDs laboratories were established in three levels and the center laboratories were assigned in province, city and country, respectively. IQC and EQC were applied to the administrative system for the qualified laboratories.Results We established a three-level administrative system and standardized the hardware and software requirements and the laboratory mission for different level laboratory. From Sept 2003 to Sept 2004, 8 training courses with the total of 470 trainees were held. Out of 58 laboratories which set up and applied for qualification, 38 qualified as the mormalized STDs laboratory, including 5 third-level, 19 second-level and 14 first-level laboratories. The system of quality control was established based on IQC and EQC. The EQC activity was conducted among the first 19 qualified laboratories. All laboratories graded well, 3 with above 90 scores excellent, 12 with scores between 75 and 90 nicer and 4 with 60-75 eligible.Conclusion Establishing the normalized STDs laboratory and the QC system is of great importance in scientifically developing and administrating STDs laboratory, and in controlling and preventing STDs.