摘要
目的 了解北京市三级医院临床实验室基本情况及存在的普遍问题 ,为进一步规范临床实验室管理和提高临床检验质量提供依据。方法 根据“北京市临床实验室管理办法”规定 ,拟定了“人员资格”、“仪器、试剂”、“室内质控”、“室间质评”等 8方面 30多项内容 ,由专家组进行现场调查 ,逐一记录每个调查项目存在的问题 ,以满意、缺陷或不满意给出评价 ,并反馈给被检查单位。结果 检验科存在的主要问题有SOP文件不规范、IQC记录、失控记录不完整等 7项 ,在所调查 30多项中 ,存在的不足主要是在缺陷级别上。其他临床实验室存在的问题含上述 7项 ,尚包括“设备校准”及“室间质评”方面的 6项 ,有缺陷级别问题外 ,还有许多问题为不满意级别。结论 在对临床实验室管理的基本要求方面 ,实验室间有所差异 ,今后检验科应在质量意识的强化及质量体系完善方面下功夫 ,其他临床实验室还需从加强基本培训及基本质量保证措施的建立方面做起。调查分析提出了从实际出发 ,进行“分类分级”培训和指导等合理设想。
Objective To improve the quality of clinical laboratory, understand the basic performance and problems in clinical laboratories of Category III hospitals in Beijing and provide the basis for improvement of the exiting clinical laboratory regulation. Method According to Beijing Clinical Laboratory Regulation, we designed the survey checklist focusing on eight areas including thirty subjects such as personnel qualification, instrument & reagent, in-house quality control, proficiency testing, etc. A group of experts conducted on-site inspections of 237 departments of medicine and satellite clinical testing labs in 49 hospitals. The reports, grading the labs from satisfactory, deficiency and unsatisfactory, were sent back to the inspected labs. Results For Departments of Laboratory Medicine, among 30 subjects inspected, most of problems are in the category of deficiency while seven major problems are found including non standardized document, incomplete documentation for IQC and out-of-range QC result, etc.For those satellite clinical testing labs, there are six major problems including calibration of equipment and proficiency testing in addition to those seven problems associated with department of laboratory medicine and many of the problems are in the category of unsatisfactory. Conclusion There should be different requirements for improvement of quality for department of laboratory medicine from that for clinical testing labs based on our survey results. Department of laboratory medicine should focus on improving quality control system and building the mind set for continued quality improvement while satellite clinical testing labs need to provide fundamental training in quality assurance to their staff. The authors propose to train lab staff and direct these laboratories according to their needs and the categories they belong to.
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2004年第2期120-123,共4页
Chinese Journal of Laboratory Medicine
