临床POCT检测项目质量管理体系的建立与实践

Establishment and Practice of Quality Management System for Clinical POCT Testing Project

目的通过临床即时检测(POCT)检测项目质量管理体系建立与实践,保证其结果的准确性与及时性。方法成立临床POCT管理小组,制定覆盖临床POCT检测全过程的质量管理办法,包括项目的申请与审批、制定操作标准和质量管理规范,检测人员的资质确定与授权并定期考核评价,对全院各POCT仪实行准入制与档案化管理以及定期综合评价等方式。结果质量管理体系运行首月取消了开展不合适的2台POCT仪器及相应的检测项目,随后及时淘汰了5台性能不合格的POCT仪器,并在运行一年后将全院POCT仪器的室内质控、室间质评开展率和合格率及比对试验合格率均提升至100%。结论通过建立并实施临床POCT检测项目质量管理体系,有效地保证了检测结果的准确性与及时性,保障了检测质量和医疗安全。

Objective Through the clinical testing project of POCT quality management system establishment and practice,to ensure the accuracy and timeliness of their results.Methods Established a clinical POCT management team to formulate quality management measures covering the whole process of clinical POCT testing,including application and approval of projects,formulation of operational standards and quality management norms,qualification determination and authorization of testing personnel and regular assessment and evaluation,implementation of access system,archival management and periodic comprehensive evaluation of all POCT instruments in the hospital.Results In the first month of the operation of the quality management system,two inappropriate POCT instruments and corresponding testing items were cancelled,and then five unqualified POCT instruments were eliminated in time.After one year of operation,the indoor quality control,the rate of carrying out the external quality assessment and the rate of passing the comparative test were all raised to 100%.Conclusion By establishing and implementing the quality management system of clinical POCT testing project,the accuracy,timeliness of testing results,the testing quality and medical safety can be effectively guaranteed.