Anatomic Pathology Checklist
MasterEvery patientdeserves theGOLD STANDARD .Anatomic PathologyChecklistCAP Accreditation ProgramCollege of American Pathologists325 Waukegan RoadNorthfield, IL 60093-2750www.cap.org07.11.2011
3 of 76Anatomic Pathology Checklist07.11.2011Disclaimer and Copyright NoticeIf you are enrolled in the CAP's Laboratory Accreditation Program and are preparing for an inspection, you mustuse the Checklists that were mailed in your application or reapplication packet, not those posted on the Website. 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 Checkliststhat were mailed. If you have any questions about the use of Checklists in the inspection process, please e-mailthe CAP (accred@cap.org), or call (800) 323-4040, ext. 6065.The checklists used in connection with the inspection of laboratories by the Laboratory Accreditation Program ofthe College of American Pathologists have been created by the College and are copyrighted works of theCollege. The College has authorized copying and use of the checklists by College inspectors in conductinglaboratory inspections for the CLA and by laboratories that are preparing for such inspections. Except aspermitted by section 107 of the Copyright Act, 17 U.S.C. sec. 107, any other use of the checklists constitutesinfringement of the College’s copyrights in the checklists. The College will take appropriate legal action toprotect these copyrights.All Checklists are 2011. College of American Pathologists. All rights reserved.
4 of 76Anatomic Pathology Checklist07.11.2011Anatomic PathologyChecklistTABLE OF CONTENTSSUMMARY OF CHANGES. 6UNDERSTANDING THE 2010 CAP ACCREDITATION CHECKLIST COMPONENTS . 9HOW TO INSPECT USING R.O.A.D INSPECTION TECHNIQUES. 10INTRODUCTION . 11GENERAL ANATOMIC PATHOLOGY . 11INTERLABORATORY COMPARISONS . 11PROCEDURE MANUAL . 12SAFETY . 13SURGICAL PATHOLOGY . 14QUALITY MANAGEMENT . 15QUALITY CONTROL . 18SURGICAL SPECIMEN EXAMINATION . 18INTRAOPERATIVE CONSULTATION (RAPID DIAGNOSIS) . 22FINE NEEDLE ASPIRATE (FNA) SPECIMENS . 25SURGICAL PATHOLOGY REPORTS . 26HISTOLOGY LABORATORY . 31GENERAL QUALITY CONTROL. 32SPECIAL STAINS (HISTOCHEMISTRY) . 34IMMUNOLOGIC AND MOLECULAR METHODS . 34IMMUNOFLUORESCENCE MICROSCOPY . 34IMMUNOHISTOCHEMISTRY . 35FLUORESCENCE AND NON-FLUORESCENCE IN SITU HYBRIDIZATION (FISH, ISH) . 40PREDICTIVE MARKERS . 42DIGITAL IMAGE ANALYSIS . 47Validation and Calibration . 47Quality Control . 49Specimen Analysis . 51DNA Staining . 51Reports . 52Personnel . 53INSTRUMENTS AND EQUIPMENT . 54Equipment Maintenance . 54Pipettes and Thermometers . 55Tissue Processor . 56Flotation Baths . 56Microtomes . 56PHYSICAL FACILITIES . 57STORAGE AND SUPPLY . 57HISTOLOGY LABORATORY SAFETY . 57AUTOPSY PATHOLOGY . 60QUALITY MANAGEMENT . 61DEATH PROCEDURES. 62
5 of 76Anatomic Pathology Checklist07.11.2011AUTOPSY ROOM . 63AUTOPSY PERFORMANCE AND DOCUMENTATION . 65AUTOPSY SAFETY . 69ELECTRON MICROSCOPY. 71QUALITY CONTROL . 71SPECIMEN COLLECTION . 71ELECTRON MICROSCOPY SAMPLE PREPARATION . 72INSTRUMENTS AND EQUIPMENT . 73REPORTS . 73RECORDS, FILES AND PHOTOGRAPHS . 74LABORATORY SAFETY. 75
6 of 76Anatomic Pathology Checklist07.11.2011SUMMARY OF CHECKLIST EDITION CHANGESAnatomic Pathology Checklist07/11/2011 EditionThe following requirements have been added, revised, or deleted in this edition of the checklist, or in the twoeditions immediately previous to this one.If this checklist was created for a reapplication, on-site inspection or self-evaluation it has been customizedbased on the laboratory's activity menu. The listing below is comprehensive; therefore some of the requirementsincluded may not appear in the customized checklist. Such requirements are not applicable to the testingperformed by the laboratory.Note: For revised checklist requirements, a comparison of the previous and current text may be found on theCAP website. Click on Laboratory Accreditation, Checklists, and then click the column marked Changes for theparticular checklist of interest.NEW Checklist ANP.23004Effective D Checklist 969ANP.22970ANP.22973ANP.22997ANP.22998Effective 201007/11/201107/11/201107/11/201107/11/2011
7 of 76Anatomic Pathology 201107/11/201107/11/201107/11/2011DELETED Checklist P.21400Effective 201106/16/201007.11.2011
8 of 76Anatomic Pathology 01107/10/201107/10/201107/10/201107.11.2011
9 of 76Anatomic Pathology Checklist07.11.2011UNDERSTANDING THE CAP ACCREDITATIONCHECKLIST COMPONENTSTo provide laboratories with a better means to engage in and meet their accreditation requirements, the CAPhas enhanced the checklist content and updated its design. New components containing additional informationfor both the laboratory and inspectors include Subject Headers, Declarative Statements and Evidence ofCompliance. 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:123Assist a laboratory in preparing for an inspection and managing ongoing complianceDrive consistent understanding of requirements between the laboratory and the inspectorProvide specific examples of acceptable documentation (policies, procedures, records, reports,charts, etc.)In addition to the Evidence of Compliance listed in the checklist, other types of documentation may beacceptable. Whenever a policy/procedure/process is referenced within a requirement, it is only repeated in theEvidence of Compliance if such statement adds clarity. All policies/procedures/processes covered in the CAPchecklists must be documented. A separate policy is not needed for each item listed in EOC as it may bereferenced in an overarching policy.
10 of 76Anatomic Pathology Checklist07.11.2011HOW 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 toinspectors by providing assessment techniques to facilitate a more efficient, consistent, and effective inspectionprocess. 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 InspectorInstructions 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 morespecific requirements, when necessary and review more details outlined in the Evidence of Compliancestatements. If a requirement is non-compliant, circle the requirement number to later list on the InspectorSummation 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 areasthroughout the Inspector Checklists. Please note that all four R.O.A.D elements are not always applicable foreach grouping, or sections of related requirements.Inspector Instructions:READ/review a sampling of laboratory documents. Information obtained from this review will beuseful as you observe processes and engage in dialogue with the laboratory staff.(Example of the complimentary inspector instructions for Quality Management/Quality ControlGeneral Issues section appearing across checklists): Sampling of QM/QC policies and procedures Incident/error log and corrective actionOBSERVE laboratory practices by looking at what the laboratory personnel are actually doing andnote if practice deviates from the documented policies/procedures.(Example) Observe the settings/QC range limits established in the laboratory LIS/HIS to ensure that thelaboratory's stated ranges are accurately reflectedASK open-ended, probing questions that start with phrases such as "tell me about." or "whatwould you do if." This approach can be a means to corroborate inspection findings that wereexamined 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 concernuncovered by the inspector. "Follow the specimen" and "teach me" are two examples ofDiscovery. Utilizing this technique will allow for the discovery of pre-analytic, analytic, and postanalytic processes while reviewing multiple requirements simultaneously.(Example) Select several occurrences in which QC is out of range and follow documentation todetermine if the steps taken follow the laboratory policy for corrective action
11 of 76Anatomic Pathology Checklist07.11.2011INTRODUCTIONAn inspection of a laboratory section, or department will include the discipline-specific checklist(s), theLaboratory General Checklist, and the All Common Checklist (COM).In response to the ongoing request to reduce the redundancy within the Accreditation Checklists, the CAPaccreditation program is introducing the All Common Checklist.The purpose of the All Common Checklist is to group together those requirements that were redundant inLaboratory General and the discipline-specific checklists. Therefore, the CAP centralized all requirementsregarding: proficiency testing, procedure manuals, test method validation, and critical results into on checklist,the COM checklist.Laboratories that do not file slides on-site (for example, some "read-only" laboratories) must retain a sample ofslides on-site for review by the inspector on all days when the laboratory is subject to its regular on-siteinspection. The sample must, at a minimum, include all slides accessioned over a continuous 2-week periodwithin the previous 2 years.GENERAL ANATOMIC PATHOLOGYDo NOT use this Checklist if the laboratory does NOT perform any on-site preparation or examination ofanatomic pathology specimens, but refers all submitted material to an outside laboratory, or if the laboratory'sinvolvement in anatomic pathology is limited to filing of reports and/or slidesThis Checklist covers several areas of anatomic pathology services, and is divided into the following sections:Surgical Pathology, Histology Laboratory, Autopsy Pathology, and Electron Microscopy. Cytopathology (bothgynecologic and non-gynecologic) is covered in a separate Checklist. The sequence for inspection of theanatomic pathology service is at the discretion of the inspection team. The sequence herein is consistent withthat used for all other sections of the laboratory, but is not restrictive.INTERLABORATORY COMPARISONSInspector Instructions: Sampling of records of peer educational program participation How does your laboratory participate in peer educational performance comparisons?
12 of 76Anatomic Pathology ChecklistANP.02000Education Participation07.11.2011Phase IAs applicable, the laboratory participates in a peer educational program in anatomicpathology (e.g. CAP Educational Anatomic Pathology Programs).NOTE: The laboratory should consider participation in programs appropriate to its scope ofservice. Such programs provide valuable educational opportunities for peer performancecomparisons in both technical and diagnostic arenas. While none of these completely emulatesthe precise clinical setting involving anatomic pathology preparations and rendering of anatomicor clinical diagnoses, they can be a useful benchmark of peer-based performance in a nationaldatabase.Evidence of Compliance: Records such as CAP order form, purchase order AND Completed/submitted results indicating that the laboratory is participating in a CAPeducational AP program OR records of enrollment/participation in another AP peereducational program OR records for participation in a laboratory-developed program bycirculating case material with other laboratories or within the laboratory's own practice withdocumentation of peer reviewPROCEDURE MANUALThe procedure manual should be used by personnel at the workbench and must include the following elements,when applicable to the test procedure:1. Principle and clinical significance2. Requirements for patient preparation; specimen collection, labeling, storage, preservation,transportation, processing, and referral; and criteria for specimen acceptability and rejection3. Microscopic examination, including the detection of inadequately prepared slides4. Step-by-step performance of the procedure, including test calculations and interpretation of results.5. Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used intesting.6. Calibration and calibration verification procedures.7. The analytic measurement range for test results for the test system, if applicable*8. Control procedures.9. Corrective action to take when calibration or control results fail to meet the laboratory's criteria foracceptability10. Limitations in the test methodology, including interfering substances11. Reference intervals (normal values)12. Imminently life-threatening (critical) test results13. Pertinent literature references14. The laboratory's system for entering results in the patient record and reporting patient resultsincluding, when appropriate, the protocol for reporting imminently life-threatening (critical) results15. Description of the course of action to take if a test system becomes inoperable(*The analytic measurement range may not apply to qualitative or semi-quantitative tests.)The manual should address relevant pre-analytic and post-analytic considerations, as well as the analyticactivities of the laboratory. The specific style and format of procedure manuals are at the discretion of thelaboratory director.Inspector Instructions: Slide/block handling policy
13 of 76Anatomic Pathology Checklist ANP.0732807.11.2011Autopsy policy, if applicableSlide/Block HandlingPhase IIThere is a policy defining the handling of original slides/blocks for consultation and legalproceedings.NOTE: This must include appropriate handling and documentation of the use, circulation,referral, transfer, and receipt of original slides and blocks. The laboratory must have a record ofthe location of original slides and blocks that have been referred for consultation or legalproceedings.ANP.07650Autopsy RoomPhase IAs applicable, there is a policy for performance of autopsies off-site.NOTE: If feasible, the autopsy room should be located within the institution. Requirements in theAutopsy Pathology section that relate to the physical facility, dissection and handling of organsand tissues apply only to those cases that are performed at the site under CAP accreditation.The pathologist should encourage off-site locations where autopsies are performed (e.g. Funeralhomes) to provide facilities that meet the standards expected for accredited autopsy rooms.REFERENCES1) Hanzlick RL, et al. Autopsy facility design. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2nd ed. Northfield, IL:College of American Pathologists: 2003; chap 14SAFETYInspector Instructions: Sampling of formaldehyde/xylene vapor monitoring records Space, storage, cleanliness, ventilation, outlets, sinks, lighting are all sufficient Is the work area sufficient for you to perform your duties safely and accurately?
14 of 76Anatomic Pathology ChecklistANP.0821607.11.2011Formaldehyde/Xylene SafetyPhase IIFormaldehyde and xylene vapor concentrations are maintained below the followingmaxima, expressed as parts per million, in all areas of the Anatomic PathologyDepartment where formaldehyde or xylene are used.NOTE: Formaldehyde and xylene vapor concentrations must be monitored in all areas wherethese reagents are used: e.g. surgical pathology gross dissection room, histology laboratory,autopsy room, etc. Initial monitoring involves identifying all employees who may be exposed ator above the action level or at or above the STEL and accurately determining the exposure ofeach employee identified. After the initial formaldehyde monitoring procedure, further periodicformaldehyde monitoring is mandated if results of the initial monitoring equal or exceed 0.5 ppm(8 hr time-weighted exposure, the “action level”) or 2.0 ppm (STEL). Initial monitoring must berepeated any time there is a change in production, equipment, process, personnel, or controlmeasures which may result in new or additional exposure to formaldehyde for any employeeinvolved in the activity. The laboratory may discontinue periodic formaldehyde monitoring ifresults from 2 consecutive sampling periods taken at least 7 days apart show that employeeexposure is below the action level and the short-term exposure limit, and 1) no change hasoccurred in production, equipment, process or personnel or control measures that may result innew or additional exposure to formaldehyde, and 2) there have been no reports of conditions thatmay be associated with formaldehyde exposure.If any personnel report signs or symptoms of respiratory or dermal conditions associated withformaldehyde exposure, the laboratory must promptly monitor the affected person's exposure.Xylene must be monitored initially, but there is no requirement for periodic monitoring of xylene.FormaldehydeXylene8 hr Time-Weighted Exposure Action Level ( 8Limithr Time-WeightedExposure)0.750.510015 min Short-TermAverage ExposureLimit (STEL)2.0150Evidence of Compliance: Written procedure for formalin/xylene safety including action limits, criteria for discontinuationof monitoring and criteria for resumption of monitoring AND Record of initial formalin/xylene monitoring and repeat monitoring of formalin when indicatedAND Records of corrective action when exposure limits are exceededREFERENCES1) Montanaro A. Formaldehyde in the workplace and in the home. Exploring its clinical toxicology. Lab Med. 1996;27:752-7572) Goris JA. Minimizing the toxic effects of formaldehyde. Lab Med. 1997;29:39-423) Wenk PA. Disposal of histology stains. Lab Med. 1998;29:337-3384) Occupational Safety and Health Administration. 29CFR1910.1048 and 1450, revised July 1, 1998ANP.09104Adequate SpacePhase IISufficient space is available so that there is no compromise of the quality of work,(including quality control activities) or safety of personnel.NOTE: This checklist item applies to all areas of anatomic pathology.REFERENCES1) NCCLS. A Quality Management System Model for Health Care; Approved Guideline—Second Edition. NCCLS document HS1-A2(ISBN 1-56238-554-2). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.2) NCCLS. Application of a Quality Management System Model for Laboratory Services; Approved Guideline—Third Edition. NCCLSdocument GP26-A3 (ISBN 1-56238-553-4). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA,2004
15 of 76Anatomic Pathology Checklist07.11.2011SURGICAL PATHOLOGYQUALITY MANAGEMENTMany technical and procedural quality control items are covered elsewhere in this Checklist. They are integralcomponents of comprehensive quality management and should be included within the defined program. Thissection determines if there is an active program of surveillance of the quality of surgical pathology activities,particularly the diagnostic reports. How this is accomplished depends upon the number of departmental staff,as well as the volume and type of diagnostic material. Such a program must include appropriate combinationsof activities such as the use of intra- and extra-departmental consultations, circulation of diagnostic material(random or by case type), periodic review of completed surgical pathology reports, and participation in selfassessment and performance improvement programs.Inspector Instructions: ANP.10000Sampling of QM policies and proceduresQM program, including pre-analytic, analytic and post-analytic monitor records and correctiveaction when indicators do not meet thresholdIncident/error log and corrective actionSampling of the following records: previous/current material review, intra-departmentalconsultations, extra-departmental consultationsHow do you evaluate data on the incident/error log? How do you determine appropriatecorrective action?As a staff member, what is your involvement with quality management?Does your laboratory exclude any specimen types from routine submission to the pathologydepartment?What is your laboratory's course of action when a significant disparity exists between the initialintra-operative consultation and final pathology diagnosis?Follow an incident identified on the incident/error log and follow actions including notificationand resolutionSelect several problems identified by the QM plan and follow tracking and corrective action.Determine if the methods used led to discovery and effective correction of the problem.Documented QM PlanPhase IIThe quality management program is defined and documented for surgical pathology.NOTE: The type of program may vary depending upon factors such as number of staff andworkload.REFERENCES1) Kempson RL. The time is now. Checklists for surgical pathology reports. Arch Pathol Lab Med. 1992;116:1107-11082) Zarbo RJ. Interinstitutional assessment of colorectal carcinoma surgical pathology report adequacy. A College of AmericanPathologists Q-Probes study of practice p
6 of 76 Anatomic Pathology Checklist 07.11.2011 SUMMARY OF CHECKLIST EDITION CHANGES Anatomic Pathology Checklist 07/11/2011 Edition The following requirements have been added, revised, or deleted in this edition of the checklist, or in the two
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