期刊文献+
任意字段
题名或关键词
题名
关键词
文摘
作者
第一作者
机构
刊名
分类号
参考文献
作者简介
基金资助
栏目信息

美国临床实验室的质量控制要求 被引量：8

原文传递
导出
摘要 严格执行监管和认可的质控要求是临床实验室保证检测结果可靠性和时效性的重要途径。1988年美国颁布临床实验室改进修正法案（Clinical Laboratory Improvement Amendments，CLIA）中的质控要求适用于所有临床实验室，其中根据其复杂性将试验分为豁免和非豁免试验两类。美国临床实验室按照试验分类，依据不同的质控要求采用不同的质控方法，不断提高美国临床实验室的管理水平，也为将来其他地区建立标准的质控监管和认证要求提供帮助和建议。
作者 张诗诗 王薇 赵海建 王治国
机构地区 北京医院卫生部I临床检验中心(北京市临床检验工程技术研究中心)
出处 《中华检验医学杂志》 CAS CSCD 北大核心 2016年第8期654-656,共3页 Chinese Journal of Laboratory Medicine
基金 北京市自然科学基金资助项目（7143182） 北京医院课题资助（BJ-2015-025）
关键词 临床实验室 质量控制要求 美国 LABORATORY 检测结果 质控 时效性 可靠性
分类号 R446 [医药卫生—诊断学]
  • 相关文献

参考文献15

  • 1Medicare, Medicaid and CLIA programs : regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA)--HCFA. Final rule with comment period[J]. Fed Regist, 1992,57(40) :7002-7186.
  • 2Tests granted waived status under CLIA [ EB/OL]. [2015-12- 10 ]. http ://www. cms. gov/Regulations-and-Guidance/ Legislation/CLIA/Downloads/waivetbl. pdf.
  • 3Medicare, Medicaid, and CLIA programs : laboratory requirements relating to quality systems and certain personnel qualifications [ EB/OL] ( 2003 ). [ 2015-12-10 ]. http ://wwwn. cdc. gov/clia/ regs/toc, aspx.
  • 4Ehrmeyer SS. Satisfying regulatory and accreditation requirements for quality control [ J]. Clin Lab Med, 2013, 33 ( 1 ) : 27-40.
  • 5State Operations Manual Appendix C - Survey Procedures and ~nterpreti'~e Guidelines for Laboratories and Laboratory Se~ices (Subpart K, Partl ) [ EB/OL]. [ 2015-12-10 ]. http://www. gov/Regulations-and-Guidance/Legislation/CLIA/ Interpretive_ Guidelines for Laboratories. html.
  • 6Equivalent Quality Control ( EQC ) Procedures Brochure #4 [ EB/ OL]. [ 2015-12-10 I. http://www, eros. gov/Regulationsand- Guidance/Legislation/CLIA/Downloads/6066bk. pdf.
  • 7CLSI EP23-A. Laboratory quality control based on risk management[ S ]. Wayne ( PA ) : Clinical Laboratory Standards Institute; 2011.
  • 8CLSI+ Laboratory quality control based on risk management; workbook [ S ]. Wayne ( PA ) : Clinical Laboratory Standards Institute ; 2011.
  • 9CLSI. Laboratory quality control based on risk management; worksheet [ S ]. Wayne ( PA ) : Clinical Laboratory Standards Institute ; 2011.
  • 10Implementing the Individualized Quality Control Plan (IQCP) for Clinical Laboratory Improvement Amendments (CLIA) [ EB/OLI ~ [ 2015-12-10 ]. http://www, ems+ gov/Medicare/Provider- Enrollment -and-Certification/SurveyCertifieationGenlnfo/ Downloads/SCLetterl 2_20-. pdf.

二级参考文献10

  • 1CLSI. Laboratory Quality Control Based on Risk Management,Approved Guideline[S].PA,USA:Clinical and Laboratory Standards Institute,2011.
  • 2CLSI. Risk Management Techniques to Identify and Control Laboratory Error Sources,Approved Guideline-Second Edition[S].PA,USA:Clinical and Laboratory Standards Institute,2009.
  • 3Joint Commission Resources. Failure Mode and Effects Analysis in Health Care:Proactive Risk Reduction[M].Chicago,IL:Joint Commission Resources,2010.19-23.
  • 4ISO. Medical devices-Application of risk management to medical devices[S].Switzerland:International Organization for Standardization,2007.
  • 5ISO. Risk management-Principles and guidelines[S].Switzerland:International Organization for Standardization,2009.
  • 6CLSI. Quality Management System:A Model for Laboratory Services,Approved Guideline-Fourth Edition[S].PA,USA:Clinical and Laboratory Standards Institute,2011.
  • 7王治国.临床检验质量控制技术[M]北京:人民卫生出版社,200838-54.
  • 8ISO. Medical laboratories-Particular requirements for quality and competence[S].Switzerland:International Organization for Standardization,2007.
  • 9陈文祥.医院管理学从书-临床实验室管理分册[M]北京:人民卫生出版社,20111-10.
  • 10ISO. Medical laboratories-Reduction of error through risk management and continual improvement[S].Switzerland:International Organization for Standardization,2008.

共引文献8

同被引文献65

引证文献8

二级引证文献65

中华检验医学杂志
2016年 第8期

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部