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 07.29.2013 2 of 72 Anatomic Pathology Checklist 07.29.2013 Disclaimer and Copyright Notice If you are enrolled in the CAP's 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 ([email protected]), or call (800) 323-4040, ext. 6065. The checklists used in connection with the inspection of laboratories by the Laboratory Accreditation Program of the College of American Pathologists have been created by the College and are copyrighted works of the College.The College has authorized copying and use of the checklists by College inspectors in conducting laboratory inspections for the CLA 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 College’s copyrights in the checklists.The College will take appropriate legal action to protect these copyrights. All Checklists are ©2013. College of American Pathologists. All rights reserved. 3 of 72 Anatomic Pathology Checklist 07.29.2013 Anatomic Pathology Checklist TABLE OF CONTENTS SUMMARY OF CHANGES.....................................................................................................................5 UNDERSTANDING THE CAP ACCREDITATION CHECKLIST COMPONENTS..................................8 HOW TO INSPECT USING R.O.A.D INSPECTION TECHNIQUES.......................................................9 INTRODUCTION..................................................................................................................................10 DEFINITION OF TERMS......................................................................................................................10 GENERAL ANATOMIC PATHOLOGY.................................................................................................12 INTERLABORATORY COMPARISONS.............................................................................................................................12 SAFETY..............................................................................................................................................................................13 SURGICAL PATHOLOGY....................................................................................................................14 QUALITY MANAGEMENT..................................................................................................................................................14 QUALITY CONTROL..........................................................................................................................................................17 SURGICAL SPECIMEN EXAMINATION......................................................................................................................17 INTRA-OPERATIVE CONSULTATION (RAPID DIAGNOSIS)......................................................................................21 FINE NEEDLE ASPIRATE (FNA) SPECIMENS...........................................................................................................24 SURGICAL PATHOLOGY REPORTS..........................................................................................................................25 HISTOLOGY LABORATORY...............................................................................................................30 GENERAL QUALITY CONTROL.........................................................................................................31 SPECIAL STAINS (HISTOCHEMISTRY).............................................................................................32 IMMUNOLOGIC AND MOLECULAR METHODS................................................................................33 IMMUNOFLUORESCENCE MICROSCOPY......................................................................................................................33 IMMUNOHISTOCHEMISTRY.............................................................................................................................................34 FLUORESCENCE AND NON-FLUORESCENCE IN SITU HYBRIDIZATION (FISH, ISH)................................................38 PREDICTIVE MARKERS...................................................................................................................................................40 DIGITAL IMAGE ANALYSIS................................................................................................................................................45 Validation and Calibration.............................................................................................................................................45 Quality Control.............................................................................................................................................................46 Specimen Analysis.......................................................................................................................................................48 DNA Staining................................................................................................................................................................49 Reports.........................................................................................................................................................................50 Personnel.....................................................................................................................................................................50 INSTRUMENTS AND EQUIPMENT...................................................................................................................................51 Instruments and Equipment Maintenance....................................................................................................................51 Pipettes and Thermometers.........................................................................................................................................52 Tissue Processor.........................................................................................................................................................53 Flotation Baths.............................................................................................................................................................54 Microtomes...................................................................................................................................................................54 Cryostat........................................................................................................................................................................55 PHYSICAL FACILITIES........................................................................................................................55 STORAGE AND SUPPLY...................................................................................................................................................55 HISTOLOGY LABORATORY SAFETY................................................................................................55 AUTOPSY PATHOLOGY......................................................................................................................58 QUALITY MANAGEMENT..................................................................................................................................................58 AUTOPSY CONSENT PROCEDURES..............................................................................................................................60 4 of 72 Anatomic Pathology Checklist 07.29.2013 AUTOPSY ROOM...............................................................................................................................................................61 AUTOPSY PERFORMANCE AND DOCUMENTATION.....................................................................................................62 AUTOPSY SAFETY............................................................................................................................................................66 ELECTRON MICROSCOPY.................................................................................................................68 QUALITY CONTROL..........................................................................................................................................................68 ELECTRON MICROSCOPY SAMPLE PREPARATION...............................................................................................69 INSTRUMENTS AND EQUIPMENT............................................................................................................................70 REPORTS....................................................................................................................................................................70 RECORDS, FILES AND PHOTOGRAPHS..................................................................................................................71 LABORATORY SAFETY.....................................................................................................................................................71 5 of 72 Anatomic Pathology Checklist 07.29.2013 SUMMARY OF CHECKLIST EDITION CHANGES Anatomic Pathology Checklist 07/29/2013 Edition The following lists of requirements provide information on what has changed in this edition of the checklist, or in the previous edition.This information is provided in three categories: 1. New — requirements that have been added 2. Revised — requirements listed in this section fall into two categories: ● A major change to a requirement or a note that would necessitate a change in procedure for the laboratory ● A change to the Phase 3. Deleted/Moved/Merged — requirements listed in this section fall into three categories: ● Deleted — requirements that have been removed ● Moved — requirements that have been relocated from this checklist into another checklist, or have been moved within this checklist and given a new checklist requirement number (resequenced) ● Merged — requirements that have been combined with a similar requirement in the checklist If this checklist was created for an on-site inspection or self-evaluation, it has been customized based on the laboratory's activity menu.The listing below is comprehensive; therefore, some of the requirements included may not appear in the customized checklist. Such requirements are not applicable to the testing performed by the laboratory. Note: For the detail of the changes, refer to the "Changes Only" document which may be found on the CAP website through e-LAB Solutions (Laboratory Accreditation Program Master and Custom Checklists).To access this document select "Changes Only" from the Checklist Type drop-down menu. The "Changes Only" document contains the text of new and deleted checklist requirements, major and minor requirement revisions, and changes to explanatory text.These changes are presented, in order, as they appear in the checklist. Major requirement revisions will display a "Revised" flag. Minor revisions will not display a "Revised" flag and are defined as those editorial changes that are not likely to affect your laboratory operations, but are worded to better convey the intent of the requirement. Changes appear in redline/strikeout format that compares the previous checklist edition to this edition. Requirements that have been moved or merged will appear at the end of that file. NEW Checklist Requirements Requirement Effective Date ANP.11650 07/29/2013 ANP.11716 07/31/2012 ANP.12170 07/31/2012 ANP.12173 07/29/2013 ANP.21360 07/29/2013 ANP.21460 07/29/2013 ANP.22985 07/31/2012 ANP.23045 07/29/2013 ANP.23130 07/29/2013 ANP.33025 07/29/2013 REVISED Checklist Requirements Requirement Effective Date ANP.08216 07/29/2013 ANP.10150 07/29/2013 ANP.10260 07/29/2013 6 of 72 Anatomic Pathology Checklist 07.29.2013 ANP.11605 07/29/2013 ANP.11640 07/29/2013 ANP.11670 07/31/2012 ANP.11713 07/29/2013 ANP.11734 07/31/2012 ANP.11756 07/29/2013 ANP.11800 07/31/2012 ANP.11900 07/31/2012 ANP.12092 07/29/2013 ANP.12094 07/29/2013 ANP.12385 07/31/2012 ANP.12500 07/31/2012 ANP.21382 07/31/2012 ANP.21450 07/29/2013 ANP.22570 07/29/2013 ANP.22615 07/31/2012 ANP.22964 07/31/2012 ANP.22970 07/29/2013 ANP.22976 07/29/2013 ANP.22978 07/29/2013 ANP.22999 07/29/2013 ANP.23002 09/25/2012 ANP.23003 07/31/2012 ANP.23018 07/31/2012 ANP.23037 07/31/2012 ANP.23038 07/31/2012 ANP.23048 07/31/2012 ANP.23095 07/29/2013 ANP.23100 07/29/2013 ANP.23120 07/29/2013 ANP.23150 07/29/2013 ANP.24300 07/29/2013 ANP.32450 07/29/2013 ANP.33100 07/31/2012 ANP.33120 07/29/2013 ANP.33200 07/31/2012 ANP.55100 07/29/2013 DELETED/MOVED/MERGED Checklist Requirements Requirement Effective Date ANP.10000 07/30/2012 ANP.11450 07/30/2012 ANP.12450 07/30/2012 ANP.21366 07/30/2012 ANP.21390 07/30/2012 ANP.23006 07/30/2012 ANP.23014 07/28/2013 ANP.23075 07/30/2012 ANP.30050 07/28/2013 ANP.32150 07/30/2012 ANP.32600 07/30/2012 ANP.32650 07/30/2012 ANP.33250 07/30/2012 ANP.51100 07/30/2012 ANP.54100 07/30/2012 ANP.55050 07/30/2012 7 of 72 Anatomic Pathology Checklist 07.29.2013 ANP.55150 07/30/2012 ANP.57050 07/30/2012 8 of 72 Anatomic Pathology Checklist 07.29.2013 UNDERSTANDING THE CAP ACCREDITATION CHECKLIST COMPONENTS To provide laboratories with a better means to engage in and meet their accreditation requirements, the CAP has enhanced the checklist content and updated its design. New components containing additional information for both the laboratory and inspectors include Subject Headers, Declarative Statements and Evidence of Compliance. See below for a definition of each new feature as an example of how they appear in the checklists. USING EVIDENCE OF COMPLIANCE (EOC) This component, which appears with several checklist requirements, is intended to: 1 Assist a laboratory in preparing for an inspection and managing ongoing compliance 2 Drive consistent understanding of requirements between the laboratory and the inspector 3 Provide specific examples of acceptable documentation (policies, procedures, records, reports, charts, etc.) Evidence of Compliance suggests ways to document compliance with checklist requirements. Other types of documentation may be acceptable.Whenever a policy/procedure/process is referenced within a requirement, it is only repeated in the Evidence of Compliance if such statement adds clarity. All policies/procedures/processes covered in the CAP checklists must be documented. A separate policy is not needed for each item listed in EOC as it may be referenced in an overarching policy. 9 of 72 Anatomic Pathology Checklist 07.29.2013 HOW TO INSPECT USING R.O.A.D INSPECTION TECHNIQUES (READ, OBSERVE, ASK, DISCOVER) CAP has streamlined the inspection approach used during onsite inspections and is now offering guidance to inspectors by providing assessment techniques to facilitate a more efficient, consistent, and effective inspection process. Specific inspector instructions are listed at the beginning of a grouping of related requirements. Rather than reviewing each individual requirement, CAP inspectors are encouraged to focus on the Inspector Instructions for a grouping of related requirements. Once an area of concern has been identified through "Read," "Observe," "Ask," "Discover," or a combination thereof, inspectors are encouraged to "drill down" to more specific requirements, when necessary and review more details outlined in the Evidence of Compliance statements. If a requirement is non-compliant, circle the requirement number to later list on the Inspector Summation Report. Inspectors may also make notes in the margins of the checklist document. Inspector Instructions and Icons used to evaluate a laboratory's performance now appear in several areas throughout the Inspector Checklists. Please note that all four R.O.A.D elements are not always applicable for each grouping, or sections of related requirements. Inspector Instructions: READ/review a sampling of laboratory documents. Information obtained from this review will be useful as you observe processes and engage in dialogue with the laboratory staff. (Example of the complimentary inspector instructions for Quality Management/Quality Control General Issues section appearing across checklists): ● Sampling of QM/QC policies and procedures ● Incident/error log and corrective action OBSERVE laboratory practices by looking at what the laboratory personnel are actually doing and note if practice deviates from the documented policies/procedures. (Example) ● Observe the settings/QC range limits established in the laboratory LIS/HIS to ensure that the laboratory's stated ranges are accurately reflected ASK open-ended, probing questions that start with phrases such as "tell me about..." or "what would you do if..." This approach can be a means to corroborate inspection findings that were examined by other techniques, such as Read & Observe. Ask follow-up questions for clarification. Include a variety of staff levels in your communication process. (Example) ● As a staff member, what is your involvement with quality management? ● How do you detect and correct laboratory errors? DISCOVER is a technique that can be used to "drill down" or further evaluate areas of concern uncovered by the inspector. "Follow the specimen" and "teach me" are two examples of Discovery. Utilizing this technique will allow for the discovery of pre-analytic, analytic, and post-analytic processes while reviewing multiple requirements simultaneously. (Example) ● Select several occurrences in which QC is out of range and follow documentation to determine if the steps taken follow the laboratory policy for corrective action 10 of 72 Anatomic Pathology Checklist 07.29.2013 INTRODUCTION An inspection of a laboratory section, or department will include the discipline-specific checklist(s), the Laboratory General Checklist, and the All Common Checklist (COM). In response to the ongoing request to reduce the redundancy within the Accreditation Checklists, the CAP accreditation program is introducing the All Common Checklist. The purpose of the All Common Checklist is to group together those requirements that were redundant in Laboratory General and the discipline-specific checklists.Therefore, the CAP centralized all requirements regarding: proficiency testing, procedure manuals, test method validation, and critical results into one checklist, the COM checklist. Laboratories that do not file slides on-site (for example, some "read-only" laboratories) must retain a sample of slides on-site for review by the inspector on all days when the laboratory is subject to its regular on-site inspection. The sample must, at a minimum, include all slides accessioned over a continuous 2-week period within the previous 2 years. DEFINITION OF TERMS Annual - Every 12 calendar months Biennial - Every 24 calendar months Calibrator, historical - The set of archived results of a single-point calibrator that demonstrates stability of the assay over time Check - Examination to determine the accuracy, quality or presence of any attribute of a test system Confirmation - Establishment of the correctness of a value or process Correlation - Establishment of agreement between two or more measured values Credentialing - The process of obtaining, verifying, and assessing the qualifications of a practitioner to provide care in a health care organization Digital image analysis - The computer-assisted detection or quantification of specific features in an image following enhancement and processing of that image, including immunohistochemistry, DNA analysis, morphometric analysis, and in situ hybridization Equipment - Single apparatus or set of devices or apparatuses needed to perform a specific task Examination - In the context of checklist requirements, examination refers to the process of inspection of tissues and samples prior to analysis. An examination is not an analytical test. FDA - In the context of checklist requirements, FDA should be taken to mean the national, state, or provincial authority having jurisdiction over in vitro diagnostic test systems. Function Check - Operational check performed to confirm that instruments and equipment (electrical, mechanical systems) are working according to manufacturer's specifications on a daily basis or before use. Examples may include base line calibration, balancing/zero adjustment, component operational checks (electronics, lamps, tubing), operational readiness (thermometer calibration, reagent delivery), and electronic function and peak performance.