医学实验室的管理评审(1)
摘要：目前检验医学的发展和检验技术的进步使得医学实验室的自动化程度日益提高。国内很多大型医院的实验室设施、设备配置已经接近西方发达国家水平，但是临床检验质量和技术能力与国外相比仍有较大差距。所以不仅要引进先进的实验设备，还要引进先进的管理理念。很多医学实验室正在或尝试用国际标准ISO15189建立、运行实验室质量管理体系，全国有六十多家实验室已经通过了医学实验室认可。众所周知，在运行和建立实验室管理体系的过程中，要进行内部审核和管理评审。但是很多实验室都只把管理评审当做实验室认可过程中的一个必要步骤，为了认可而做管理评审，而没有将管理评审作为一个对自己实验室进行全面总结和持续改进的有力手段，导致管理评审流于形式，和实验室的管理工作脱节，没有发挥它本身应有的作用。本文将通过对条款的解读，结合案例分析，对医学实验室如何进行切实有效的管理评审和应该注意的方面进行探讨。
关键词:医学实验室 管理评审
Medicine laboratory management appraisal
, 百拇医药
Li Junyan Chang Zhishui
Abstract:At present examines the medicine the development and the examination technology progress causes the medicine laboratory the automaticity to enhance day by day.The home were very many the large-scale hospital the laboratory facility, the equipment disposition already approaches the Western developed country level, but the clinical examination quality and technical ability and overseas compared still have the big disparity.Not only therefore must introduce the advanced test installation, but also must introduce the advanced management idea.The very many medicine laboratory or the attempt with the international standard ISO15189 establishment, the movement laboratory quality control system, the nation had more than 60 laboratories already to pass the medicine laboratory approval.It is well known, in moves and establishes the laboratory management system in the process, must carry on internal verification and the management appraisal.But very many laboratories all only will treat as the management appraisal in laboratory approval process an essential step, in order to approve makes the management appraisal, but will not have to manage the appraisal to take will carry on the powerful method to oneself laboratory which the comprehensive summary and will improve continually, will cause the management appraisal to become a mere formality, will come apart with the laboratory supervisory work, has not played the role which its itself will be supposed to have.Will this article through to the provision explanation, the union case analysis, how carry on the aspect to the medicine laboratory which the practical effective management appraisal and will be supposed to pay attention to carry on the discussion.
, 百拇医药
Keywords：Medicine laboratory Management appraisal
【中图分类号】R-0 【文献标识码】A 【文章编号】1008-1879(2010)12-0111-02
目前检验医学的发展和检验技术的进步使得医学实验室的自动化程度日益提高。国内很多大型医院的实验室设施、设备配置已经接近西方发达国家水平，但是临床检验质量和技术能力与国外相比仍有较大差距。所以不仅要引进先进的实验设备，还要引进先进的管理理念。
很多医学实验室正在或尝试用国际标准ISO15189建立、运行实验室质量管理体系，全国有六十多家实验室已经通过了医学实验室认可。众所周知，在运行和建立实验室管理体系的过程中，要进行内部审核和管理评审。但是很多实验室都只把管理评审当做实验室认可过程中的一个必要步骤，为了认可而做管理评审，而没有将管理评审作为一个对自己实验室进行全面总结和持续改进的有力手段，导致管理评审流于形式，和实验室的管理工作脱节，没有发挥它本身应有的作用。本文将通过对条款的解读，结合案例分析，对医学实验室如何进行切实有效的管理评审和应该注意的方面进行探讨。
, http://www.100md.com
第一部分：标准解读。
首先我们看看准则中对于管理评审的要求——管理要素4.15 管理评审。
4.15.1为确保为患者的医护提供持续适合及有效的支持，并进行必要的的变动和改进，实验室管理层应对实验室质量管理体系及其全部的医学服务进行评审，包括检验及咨询工作。评审结果应列入含目标、目的和措施的计划中。管理评审的典型周期为每12个月一次。
从定义中可以看出，管理评审的目的是为了使实验室的质量和能力能持续地符合临床需求。管理评审是由实验室管理层组织进行的。管理评审的内容要包括实验室质量管理体系和其全部的医学服务，这里面容易忽略的是只将质量管理体系的运行情况进行了评审，而忽略了很多技术能力方面的评审，对临床的沟通、检验结果的解释、咨询服务这部分内容更是常被忽略。
共3页, http://www.100md.com(李军燕 常志遂)
关键词:医学实验室 管理评审
Medicine laboratory management appraisal
, 百拇医药
Li Junyan Chang Zhishui
Abstract:At present examines the medicine the development and the examination technology progress causes the medicine laboratory the automaticity to enhance day by day.The home were very many the large-scale hospital the laboratory facility, the equipment disposition already approaches the Western developed country level, but the clinical examination quality and technical ability and overseas compared still have the big disparity.Not only therefore must introduce the advanced test installation, but also must introduce the advanced management idea.The very many medicine laboratory or the attempt with the international standard ISO15189 establishment, the movement laboratory quality control system, the nation had more than 60 laboratories already to pass the medicine laboratory approval.It is well known, in moves and establishes the laboratory management system in the process, must carry on internal verification and the management appraisal.But very many laboratories all only will treat as the management appraisal in laboratory approval process an essential step, in order to approve makes the management appraisal, but will not have to manage the appraisal to take will carry on the powerful method to oneself laboratory which the comprehensive summary and will improve continually, will cause the management appraisal to become a mere formality, will come apart with the laboratory supervisory work, has not played the role which its itself will be supposed to have.Will this article through to the provision explanation, the union case analysis, how carry on the aspect to the medicine laboratory which the practical effective management appraisal and will be supposed to pay attention to carry on the discussion.
, 百拇医药
Keywords：Medicine laboratory Management appraisal
【中图分类号】R-0 【文献标识码】A 【文章编号】1008-1879(2010)12-0111-02
目前检验医学的发展和检验技术的进步使得医学实验室的自动化程度日益提高。国内很多大型医院的实验室设施、设备配置已经接近西方发达国家水平，但是临床检验质量和技术能力与国外相比仍有较大差距。所以不仅要引进先进的实验设备，还要引进先进的管理理念。
很多医学实验室正在或尝试用国际标准ISO15189建立、运行实验室质量管理体系，全国有六十多家实验室已经通过了医学实验室认可。众所周知，在运行和建立实验室管理体系的过程中，要进行内部审核和管理评审。但是很多实验室都只把管理评审当做实验室认可过程中的一个必要步骤，为了认可而做管理评审，而没有将管理评审作为一个对自己实验室进行全面总结和持续改进的有力手段，导致管理评审流于形式，和实验室的管理工作脱节，没有发挥它本身应有的作用。本文将通过对条款的解读，结合案例分析，对医学实验室如何进行切实有效的管理评审和应该注意的方面进行探讨。
, http://www.100md.com
第一部分：标准解读。
首先我们看看准则中对于管理评审的要求——管理要素4.15 管理评审。
4.15.1为确保为患者的医护提供持续适合及有效的支持，并进行必要的的变动和改进，实验室管理层应对实验室质量管理体系及其全部的医学服务进行评审，包括检验及咨询工作。评审结果应列入含目标、目的和措施的计划中。管理评审的典型周期为每12个月一次。
从定义中可以看出，管理评审的目的是为了使实验室的质量和能力能持续地符合临床需求。管理评审是由实验室管理层组织进行的。管理评审的内容要包括实验室质量管理体系和其全部的医学服务，这里面容易忽略的是只将质量管理体系的运行情况进行了评审，而忽略了很多技术能力方面的评审，对临床的沟通、检验结果的解释、咨询服务这部分内容更是常被忽略。
共3页, http://www.100md.com(李军燕 常志遂)