医学检验能力验证提供者认可评审不符合项分析  

Nonconformities during the assessment of proficiency testing provider accreditation in laboratory medicine

作　　者：贾汝静[1] 赵炳南[1] 张传宝[2] 王华梁 黄维纲 曹实[1] 

机构地区：[1]中国合格评定国家认可委员会,北京100062 [2]卫生部临床检验中心,北京100730 [3]上海市临床检验中心,上海200126

出　　处：《检验医学》2016年第5期423-425,共3页Laboratory Medicine

摘　　要：目的通过对我国医学检验能力验证提供者(PTP)认可评审中发现的不符合项进行汇总分析,探讨国内医学检验PTP的质量管理体系现状。方法收集所有获准认可的医学检验PTP在现场评审中发现的不符合项,根据不符合项对应的认可准则(CNAS CL-03)条款号进行汇总分类,计算报告不符合项条款出现的频率。结果在对4家医学检验PTP的11次现场评审中,共计报告了68个不符合项,对应15个条款。其中技术要求和管理要求分别占76.0%和24.0%。技术要求中最常见的不符合条款分别为4.2(人员)、4.4(能力验证的设计)、4.6(计划的运作)和4.7(数据分析与结果评价);管理要求中最常见的不符合条款为5.1(组织)。结论当前认可的所有医学检验PTP在有些条款中都出现了不符合项,在现场评审中出现问题最多的条款分别为4.2、4.4、4.6和4.7。这些是当前医学检验PTP质量体系建立、发展和管理中需要关注的主要方向。Objective To study the status of PTP system in laboratory medicine,through collecting and analyzing the nonconformities during the assessment of profi ciency testing provider（PTP）accreditation in laboratory medicine. Methods The nonconformities during the assessment of PTP accreditation in laboratory medicine were collected and categorized according to the criteria of PTP accreditation（CNAS CL-03）. The occurrence frequency of nonconformities was calculated and compared. Results There were 68 nonconformities in 11 on-site assessments against the criteria of PTP accreditation,involving 15 clauses of CNAS CL-03. Among them,76.0% was against technical requirements,and 24.0% was against management requirements. For technical requirements,nonconformities were most frequently reported against Clause 4.2（personnel）,4.4（profi ciency testing scheme）,4.6（proficiency testing operation scheme） and 4.7（datum analysis and result evaluation）.For management requirements,nonconformities were most frequently reported against Clause 5.1（organization）. Conclusions The most frequently found nonconformities are Clause 4.2,4.4,4.6 and 4.7,which are the main directions needed to be focused to establish, develop and improve the quality management system of PTP in laboratory medicine.

关 键 词：能力验证提供者 认可 医学检验 

分 类 号：R192[医药卫生—卫生事业管理]