CAP MOL Sep07 实验室认证程序 分子病理学检查表.pdf

Revised: 09/27/2007 COMMISSION ON LABORATORY ACCREDITATION Laboratory Accreditation Program MOLECULAR PATHOLOGY CHECKLIST Disclaimer and Copyright Notice The College of American Pathologists (CAP) Checklists are posted on the CAPs Web site for information only. If you are enrolled in the CAPs Laboratory Accreditation Program and are preparing for an inspection, you must use the Checklists that were mailed in your application or reapplication packet, not those posted on the Web site. The Checklists undergo regular revision and Checklists may be revised after you receive your packet. If a Checklist has been updated since receiving your packet, you will be inspected based upon the Checklists that were mailed. If you have any questions about the use of Checklists in the inspection process, please e-mail the CAP (accred@), or call (800) 323-4040, ext. 6065. All Checklists are ©2007. College of American Pathologists. All rights reserved. College of American Pathologists Revised: 09/27/2007 MOLECULAR PATHOLOGY OUTLINE SUMMARY OF CHANGES 3 INSPECTION TECHNIQUES – KEY POINTS5 APPLICABILITY 7 PROFICIENCY TESTING 8 QUALITY MANAGEMENT AND QUALITY CONTROL13 GENERAL ISSUES 13 PROCEDURE MANUAL17 ASSAY VALIDATION 21 REQUISITIONS26 SPECIMEN HANDLING 27 SPECIMEN PROCESSING 29 QUANTITATIVE ASSAYS; CALIBRATION AND STANDARDS31 REAGENTS 37 CONTROLS 39 ANALYSIS 44 Extraction44 Amplification45 Restriction Endonuc