MOLECULAR PATHOLOGY - 检验医学信息网.docVIP

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 ?2004. College of American Pathologists. All rights reserved. MOLECULAR PATHOLOGY OUTLINE SUMMARY OF CHANGES 3 APPLICABILITY 5 PROFICIENCY TESTING 6 QUALITY CONTROL AND QUALITY MANAGEMENT 8 SUPERVISION 8 PROCEDURE MANUAL 15 ASSAY VALIDATION 19 TEST SYSTEMS 23 Paternity and Forensic Identity Testing 23 In Situ Hybridization 27 REQUISITIONS 29 SPECIMEN HANDLING 31 SPECIMEN PROCESSING 35 RESULTS REPORTING 40 Molecular Inherited Disease Testing 43 Parentage Testing 45 In Situ Hybridization 46 RECORDS 46 REAGENTS 49 CONTROLS 52 INSTRUMENTS AND EQUIPMENT 53 Instrument Maintenance 53 Spectrophotometers 56 Signal Detection Instruments 57 Film Processing/Photographic Equipment 58 Electrophoresis Equipment and Power Supplies 59 pH Meters 60 Centrifuges 60 Balances and Weights 61 Volumetric Glassware and Pipettes 63 Thermometers and Temperature-Dependent Equipment 65 PERSONNEL 67 PHYSICAL FACILITIES 69 LABORATORY SAFETY 74 RADIATION SAFETY 75 SUMMARY OF CHANGES MOLECULAR PATHOLOGY Checklist 12/29/2004 Edition The following questions have been added, revised, or deleted in this edition of the checklist, or in the two edit