CLIA-证书介绍.pptx

CLIA 补充介绍报告人：日期：2010-9-9主要内容1 Different types of CLIA certificates2 the payment of the CLIA certificates3 PT1、 CLIA certifications1）Certificate of waived test(COW)performs only waived tests2）Certificate for PPMperforms specific microscopy proceduresWhen the lab applied for COC or COA，it can got a Certificate of Registration 3）Certificate of Registration 4）Certificate of Compliance (COC)nonwaived testing; compliant with all applicable CLIA requirements.5）Certificate of Accreditation (COA) nonwaived testing;accreditation organization approved by CMS.CMS-approved accreditation organizationsThere are six CMS-approved accreditation organizations : （1）AABB 美国血库协会 （2）American Osteopathic Association (AOA) 美国骨科协会 （3）American Society of Histocompatibility and Immunogenetics (ASHI)美国组织配型和免疫学会 （4） the Commission of Office Laboratory Accreditation（COLA） （5）College of American Pathologists (CAP)美国病理学家协会 （6） Joint Commission on Accreditation of Healthcare Organizations (JCAHO)美国医疗机构评审联合委员会Certificate of Accreditation (COA) If you are applying for a Certificate of Accreditation, you must provide evidence of accreditation for your laboratory by an approved accreditation organization for CLIA purposes or evidence of application for such accreditation within 11 months after receipt of your Certificate of Registration.第三方非盈利机构CAPCMS申请认证 认可发证COA现场调查认证证书COC提交CAP视察合格材料 发给申请证书视察合格认可证书认证证书临床实验室（中高度检测试验）2 the payment of the certificateCOW or a PPM certificate：pay a minimal certificate fee every two years. There are no registration or compliance fees.COC：pay a one time registration fee（covers the cost of the CLIA enrollment and a compliance fee）---pay a certificate fee----pay a certificate fee and a compliance fee every two years.COA：registration fee （only covers the cost of the CLIA enrollment）---a certificate fee and validation fee----a certificate fee and a validation fee every two years.3 PT programsWhat is PT?How to implement the PT programs What is PT?PT( proficiency testing):实