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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。
Objective To explore the standardized management and quality management system for STDs. Methods According to the conditions of each laboratory’s tasks, personnel, and equipment, the use of three levels and the central laboratory model to carry out standardized construction of the province’s STD laboratory. The quality control system for STDs was established through indoor quality control and inter-certificate evaluation. Results The three-level management system and tasks of the standardized STD laboratory were determined. From September 2003 to September 2004, there were 8 training sessions for STD laboratory diagnostic techniques and 470 trainees. Among the 59 STD laboratories that completed standardized construction and applied for compliance, 38 STD laboratories passed the assessment, including three STD laboratories, two Class I9 and one Class I4. The establishment of a quality management system for STD laboratory quality control and room quality assessment was established. The first batch of 19 interlaboratory quality assessments that passed the assessment met the requirements. 3 scores were scored >90 points and rated as excellent; 1 2 scored 75 to 90 points, and rated as good; 4 scored 60%. 75 points, rated as qualified. Conclusion The establishment of standardized STD laboratory and quality management system to ensure the scientific management and development of STD laboratories is of great significance for the prevention and treatment of STDs and AIDS.