医学检验实验室设备管理内审结果分析与改进

目的通过内部审核,剖析医学检验实验室设备管理存在的问题,通过针对性措施的有效实施,推进设备管理的持续改进。方法回顾性分析2016—2018年上海市东方医院南院医学检验科3次内部审核中发现的72项不符合项,实验室设备不符合项15项占比20.83%。针对占比前4位的问题:校准报告内容不完善、新安装设备档案不齐全、设备校准延时、设备故障维修问题,制定对应的措施并培训实施,实现设备管理的规范化。通过检验科月质量督查的实施,及时检查及推进岗位工作人员对设备管理制度的有效执行。结果2019年医学检验实验室内部审核不符合项共27项,设备相关不符合项2项,占比7.41%,比2016—2018年下降。结论实验室内部审核可以有效发现设备管理中存在的问题,针对性地制定设备管理的方法及保证方法执行的控制策略,可有效推进医学检验实验室设备管理的持续改进。

Methods and Strategies for Continuous Improvement of Equipment Management in Medical Laboratory

Objective There are many kinds of instruments and equipment in medical laboratory. Analyzing the problems existing in the management of medical laboratory equipment, through the internal audit of the laboratory.To promote the continuous improvement of medical laboratory equipment management through the effective implementation of targeted measures. Methods A retrospective analysis of 72 nonconformities found in three internal audits of the Medical Laboratory of a top three hospital in Shanghai from 2016 to 2018. The total number of laboratory equipment nonconformities was 15, accounting for 20.83%. The first four non-conforming items are in order: the contents of the calibration report are not perfect, the equipment calibration time delay, the newly installed equipment file is not complete, and the equipment fails to maintain. In view of the above problems, the contents of the calibration report can be effectively improved by developing the content catalogue of the calibration report of the testing equipment. Manage the equipment calibration time through the laboratory information system to eliminate the calibration blank period.The establishment of catalogue of new instrument installation and arrangement contents can promote the timely and effective establishment of instrument and equipment archives and realize the standardized management of equipment archives. Formulate "operation flow chart of instrument and equipment maintenance" and train all staff to ensure the standardization of instrument maintenance operation.Through the implementation of the department"s monthly quality supervision, timely check and promote the effective implementation of the equipment management system by the post staff. Results In 2019, there were 27 non-conformance items in the internal audit of medical laboratory, and 2 non-conformance items related to equipment. The proportion of equipment-related non-conformities was 7.41%, significantly lower than in previous years. Conclusions The internal audit of the laboratory can effectively discover the problems existing in the equipment management.d Targeted formulation of equipment management methods and control strategies to ensure the implementation of the methods can effectively promote the continuous improvement of equipment management in medical laboratory.