Master Every patient deserves the GOLD STANDARD ... Anatomic Pathology Checklist CAP Accreditation Program College of American Pathologists 325 Waukegan Road Northfield, IL 60093-2750 www.cap.org 04.21.2014 2 of 71 Anatomic Pathology Checklist 04.21.2014 Disclaimer and Copyright Notice On-site inspections are performed with the edition of the Checklists mailed to a facility at the completion of the application or reapplication process, not necessarily those currently posted on the Web site. The checklists undergo regular revision and a new edition may be published after the inspection materials are sent. For questions about the use of the Checklists or Checklist interpretation, email [email protected] or call 800-323-4040 or 847-832-7000 (international customers, use country code 001). The Checklists used for inspection by the College of American Pathologists' Accreditation Programs have been created by the CAP and are copyrighted works of the CAP. The CAP has authorized copying and use of the checklists by CAP inspectors in conducting laboratory inspections for the Commission on Laboratory Accreditation and by laboratories that are preparing for such inspections. Except as permitted by section 107 of the Copyright Act, 17 U.S.C. sec. 107, any other use of the Checklists constitutes infringement of the CAP's copyrights in the Checklists.The CAP will take appropriate legal action to protect these copyrights. All Checklists are ©2014. College of American Pathologists. All rights reserved. 3 of 71 Anatomic Pathology Checklist 04.21.2014 Anatomic Pathology Checklist TABLE OF CONTENTS SUMMARY OF CHANGES.....................................................................................................................5 INTRODUCTION....................................................................................................................................7 GENERAL ANATOMIC PATHOLOGY...................................................................................................7 SAFETY................................................................................................................................................................................7 SURGICAL PATHOLOGY......................................................................................................................8 QUALITY MANAGEMENT....................................................................................................................................................8 QUALITY CONTROL..........................................................................................................................................................12 SURGICAL SPECIMEN EXAMINATION......................................................................................................................12 INTRA-OPERATIVE CONSULTATION (RAPID DIAGNOSIS)......................................................................................16 FINE NEEDLE ASPIRATE (FNA) SPECIMENS...........................................................................................................18 SURGICAL PATHOLOGY REPORTS..........................................................................................................................20 HISTOLOGY LABORATORY...............................................................................................................25 GENERAL QUALITY CONTROL.........................................................................................................26 SPECIAL STAINS (HISTOCHEMISTRY).............................................................................................27 IMMUNOLOGIC AND MOLECULAR METHODS................................................................................28 IMMUNOFLUORESCENCE MICROSCOPY......................................................................................................................28 IMMUNOHISTOCHEMISTRY.............................................................................................................................................29 FLUORESCENCE AND NON-FLUORESCENCE IN SITU HYBRIDIZATION (FISH, ISH)................................................34 PREDICTIVE MARKERS...................................................................................................................................................35 DIGITAL IMAGE ANALYSIS................................................................................................................................................41 Validation and Calibration.............................................................................................................................................41 Quality Control.............................................................................................................................................................42 Specimen Analysis.......................................................................................................................................................44 DNA Staining................................................................................................................................................................45 Reports.........................................................................................................................................................................46 Personnel.....................................................................................................................................................................46 INSTRUMENTS AND EQUIPMENT...................................................................................................................................47 PHYSICAL FACILITIES........................................................................................................................50 STORAGE AND SUPPLY...................................................................................................................................................50 HISTOLOGY LABORATORY SAFETY................................................................................................50 CIRCULATING TUMOR CELL ANALYSIS (CTC)................................................................................53 VALIDATION AND CALIBRATION......................................................................................................................................53 QUALITY CONTROL (CTC)...............................................................................................................................................54 SPECIMEN ANALYSIS.......................................................................................................................................................56 REPORTS (CTC)................................................................................................................................................................57 PERSONNEL (CTC)...........................................................................................................................................................57 AUTOPSY PATHOLOGY......................................................................................................................58 QUALITY MANAGEMENT..................................................................................................................................................58 AUTOPSY CONSENT PROCEDURES..............................................................................................................................60 AUTOPSY ROOM...............................................................................................................................................................61 AUTOPSY PERFORMANCE AND DOCUMENTATION.....................................................................................................62 AUTOPSY SAFETY............................................................................................................................................................65 ELECTRON MICROSCOPY.................................................................................................................68 4 of 71 Anatomic Pathology Checklist 04.21.2014 QUALITY CONTROL..........................................................................................................................................................68 ELECTRON MICROSCOPY SAMPLE PREPARATION...............................................................................................68 INSTRUMENTS AND EQUIPMENT............................................................................................................................69 REPORTS....................................................................................................................................................................70 RECORDS, FILES AND PHOTOGRAPHS..................................................................................................................70 LABORATORY SAFETY.....................................................................................................................................................71 5 of 71 Anatomic Pathology Checklist 04.21.2014 ON-LINE CHECKLIST AVAILABILITY Participants of the CAP accreditation programs may download the checklists from the CAP Web site (www.cap.org) by logging into e-LAB Solutions. They are available in different checklist types and formatting options, including: ● Master — contains ALL of the requirements and instructions available