COMMISSION ON LABORATORY ACCREDITATION. Laboratory Accreditation Program ANATOMIC PATHOLOGY CHECKLIST QUESTIONS RELATED TO REPORTING OF RESULTS ONLY

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1 Revised: 04/28/2005 COMMISSION ON LABORATORY ACCREDITATION Laboratory Accreditation Program ANATOMIC PATHOLOGY CHECKLIST QUESTIONS RELATED TO REPORTING OF RESULTS ONLY Disclaimer and Copyright Notice The College of American Pathologists (CAP) Checklists are posted on the CAP's Web site for information only. 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 the CAP (accred@cap.org), or call (800) , ext All Checklists are College of American Pathologists. All rights reserved.

2 ANATOMIC PATHOLOGY OUTLINE SURGICAL PATHOLOGY...3 QUALITY MANAGEMENT...3 QUALITY CONTROL...5 SURGICAL SPECIMEN EXAMINATION...5 INTRAOPERATIVE CONSULTATION (RAPID DIAGNOSIS OR FROZEN SECTION)...6 SURGICAL PATHOLOGY REPORTS...7 HISTOLOGY LABORATORY...15 IMMUNOHISTOCHEMISTRY...15 FLUORESCENCE AND NON-FLUORESCENCE IN SITU HYBRIDIZATION (FISH, ISH)...16 AUTOPSY PATHOLOGY...17 QUALITY MANAGEMENT...17 AUTOPSY PERFORMANCE AND DOCUMENTATION...19 ELECTRON MICROSCOPY...24 QUALITY CONTROL...24 REPORTS...24 ANATOMIC PATHOLOGY Reporting-related questions only Page 2 of 2

3 ############################################################################ SURGICAL PATHOLOGY ############################################################################ **************************************************************************** QUALITY MANAGEMENT **************************************************************************** Many technical and procedural quality control items are covered elsewhere in this Checklist. They are integral components of comprehensive quality management and should be included within the defined program. This section 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 combinations of 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 self-assessment and performance improvement programs. ANP Phase II YES NO When significant disparities exist between initial intraoperative consultation (e.g., frozen section, cytology, gross evaluation) and final pathology diagnosis, are these reconciled and documented either in the surgical pathology report or in the departmental quality management file? REFERENCES: 1) Gephardt GN, Zarbo RJ. Interinstitutional comparison of frozen section consultations. A College of American Pathologists Q-Probes study of cases in 461 institutions. Arch Pathol Lab Med. 1996;120: ; 2) Nakhleh RE, Zarbo RJ. Amended reports in surgical pathology and implications for diagnostic error detection and avoidance. A College of American Pathologists Q-Probes study of accessioned cases in 359 laboratories. Arch Pathol Lab Med. 1998;122: ; 3) Firlik KS, et al. Use of cytological preparations for the intraoperative diagnosis of stereotactically obtained brain biopsies: a 19-year experience and survey of neuropathologists. J Neurosurg. 1999;91: ANATOMIC PATHOLOGY Reporting-related questions only Page 3 of 3

4 ANP Phase II YES NO Does the laboratory have a policy for inclusion of INTRA-departmental consultations in the patient's final report? NOTE: Intradepartmental consultations may be included in the patient s final report, or filed separately. The pathologist in charge of the surgical pathology case must decide whether the results of intra-departmental consultations provide relevant information for inclusion in some manner in the patient's report. REFERENCES: 1) Leslie KO, et al. Second opinions in surgical pathology. Am J Clin Pathol. 1996;106(suppl 1):S58-S64; 2) Tomaszewski JE, et al. Consensus conference on second opinions in diagnostic anatomic pathology. Who, what, and when. Am J Clin Pathol. 2000;114: ; 3) Hahm GK, et al. Quality assurance of second opinion in gastrointestinal and liver pathology. Am J Clin Pathol. 2000;114:631; 4) Renshaw AA, et al. Blinded review as a method of quality improvement in surgical pathology. Arch Pathol Lab Med. 2002;126: ANP Phase II YES NO Are EXTRA-departmental consultations documented, and are records of these consultations maintained in a systematic manner within the pathology department? NOTE: Documentation of extra-departmental consultations must be readily accessible within the pathology department. The method used to satisfy this requirement is at the discretion of the laboratory director, and can be expected to vary according to the organization of the department. These consultations can be maintained with the official surgical pathology reports or kept separately, so long as they can be readily linked. REFERENCES: 1) Leslie KO, et al. Second opinions in surgical pathology. Am J Clin Pathol. 1996;106(suppl 1):S58-S64; 2) Tomaszewski JE, et al. Consensus conference on second opinions in diagnostic anatomic pathology. Who, what, and when. Am J Clin Pathol. 2000;114: ; 3) Hahm GK, et al. Quality assurance of second opinion in gastrointestinal and liver pathology. Am J Clin Pathol. 2000;114:631; 4) Azam M, Nakhleh RE. Surgical pathology extradepartmental consultation practices. A College of American Pathologists Q-probes study of 2746 consultations from 180 laboratories. Arch Pathol Lab Med. 2002;126: ; 5) Cooper K, et al. Institutional consultations in surgical pathology. How should diagnostic disagreements be handled? Arch Pathol Lab Med. 2002;126: ANATOMIC PATHOLOGY Reporting-related questions only Page 4 of 4

5 **REVISED** 09/30/2004 ANP Phase I YES NO When extra-departmental cases are submitted to the laboratory for consultation, are they accessioned according to the standard practices of the laboratory, and is a documented report prepared, with a copy sent to the original pathologist? NOTE: Extra-departmental cases submitted for consultation should be accessioned according to the standard practices of the laboratory, and a report issued. A copy of this report should be sent to the original pathologist. In most cases, original materials including slides and blocks should be promptly returned to the original institution. However, in some situations (for example, when the patient is receiving ongoing care at the referral institution pending tumor resection, etc.) it may be appropriate for the referral laboratory to retain slides/blocks for a period of time. In such situations, a letter should be sent to the original pathologist along with the consultation report, requesting permission to retain the slides/blocks and accepting transfer of stewardship of the patient materials from the original laboratory to the referral institution. REFERENCE: Stewardship of Pathologic Specimens. Policy Statement. College of American Pathologists, Waukegan, IL. Adopted February Reaffirmed May **************************************************************************** QUALITY CONTROL **************************************************************************** SURGICAL SPECIMEN EXAMINATION Inspectors and laboratories are reminded that questions relating to collection and accessioning of specimens are covered in the Laboratory General Checklist. During the on-site inspection, the handling of surgical specimens must be evaluated. ANATOMIC PATHOLOGY Reporting-related questions only Page 5 of 5

6 ANP Phase I YES NO Are dictating facilities available and convenient to use? ANP Phase I YES NO Are photographic facilities available and convenient? NOTE: In addition to providing material for a teaching collection, such photographs can serve as valuable documentation for the report. ANP Phase I YES NO Are all gross specimens retained until at least 2 weeks after the final reports are signed and results reported to the referring physician? REFERENCES: 1) Travers H. Q&A Section. Northfield, IL: College of American Pathologists CAP Today, March 1992:63; 2) Travers H. Q&A Section. Savage RA, editor. CAP Today, November 1993:86-87; 3) Tracey ME. Hospital takes closer look at specimen returns. CAP Today, July 1992:81; 4) Lester SC. Manual of surgical pathology. New York, NY: Churchill Livingstone, 2001:18-20; 5) Nakhleh RE, Fitzgibbons PL. Quality improvement manual in anatomic pathology, second edition. Northfield, IL: CAP; 2002: INTRAOPERATIVE CONSULTATION (RAPID DIAGNOSIS OR FROZEN SECTION) ANATOMIC PATHOLOGY Reporting-related questions only Page 6 of 6

7 ANP Phase II YES NO Are the results of surgical consultations documented and signed by the pathologist who made the diagnosis? NOTE: The intent of this question is for the laboratory to maintain a contemporaneous report of the surgical consultation. This may be a handwritten, signed report or a computer-generated report with electronic signature. ANP Phase II YES NO If verbal reports are given, is the pathologist able to speak directly with the surgeon? ANP Phase II YES NO Is the patient's identification checked and confirmed before delivery of any verbal report? ANP Phase II YES NO Are all intraoperative consultation reports made a part of the final surgical pathology report? SURGICAL PATHOLOGY REPORTS ANATOMIC PATHOLOGY Reporting-related questions only Page 7 of 7

8 **REVISED** 04/28/2005 ANP Phase II YES NO Are all reports reviewed and signed by the pathologist? NOTE: The inspector must review recent surgical pathology reports. When diagnostic reports are generated by computer or telecommunications equipment, the actual signature or initials of the pathologist may not appear on the report. It is nevertheless essential that the laboratory have a procedure that ensures and documents that the responsible pathologist has reviewed and approved the completed report before its release. In the occasional situation when the diagnosing pathologist is not available for timely review and approval of the completed report, the laboratory may have a policy and procedure for review and approval of that report by another pathologist. In that circumstance, the names and responsibilities of both the pathologist who made the diagnosis and the pathologist who performs final verification must appear on the report. REFERENCE: ANP Phase II YES NO Are reports on routine cases completed within 2 working days? NOTE: Unusual, complex or special specimens may require prolonged fixation before dissecting and selecting tissue samples, additional time for special stains, etc., and the reporting time may extend beyond 2 working days of receipt by the laboratory conducting the surgical pathology examination. This question is primarily concerned with the majority of routine specimens, and applies to all laboratories. REFERENCES: 1) Zarbo RJ, et al. Intralaboratory timeliness of surgical pathology reports. Results of two College of American Pathologists Q-Probes studies of biopsies and complex specimens. Arch Pathol Lab Med. 1996;120: ; 2) Smith MT, Garvin AJ. Anatomic pathology turnaround times. Use and abuse. Am J Clin Pathol. 1996;106(suppl 1):S70-S73; 3) Novis DA, et al. Interinstitutional comparison of surgical biopsy diagnosis turnaround time. A College of American Pathologists Q- Probes study of 5384 surgical biopsies in 157 small hospitals. Arch Pathol Lab Med. 1998;122: ANATOMIC PATHOLOGY Reporting-related questions only Page 8 of 8

9 **NEW** 03/31/2004 ANP Phase I YES NO Is there a policy regarding the timely communication, and documentation thereof, of significant or unexpected surgical pathology findings? NOTE: Certain surgical pathology diagnoses may be considered particularly significant or unexpected. Such diagnoses may include: malignancy in an uncommon location or specimen type (e.g., hernia sac, intervertebral disk material, tonsil, etc.), absence of chorionic villi when clinically expected (potential ectopic pregnancy), change of a frozen section diagnosis after review of permanent sections, and/or mycobacterial, fungal or other significant infectious organisms identified on special stains. Diagnoses to be defined as significant or unexpected, if any, should be determined by the pathology department, in cooperation with local clinical medical staff. Consideration should be given to assuring, with reasonable effort, prompt communication of such results, by telephone, pager, or other system. There should be documentation of date and time of such special notification (which may be included in the pathology report or in laboratory files). REFERENCES: 1) Rosai J, Bonfiglio TA, Corson JM, et al. Standardization of the surgical pathology report. Mod Pathol.1992 Mar;5(2):197-9; 2) Zarbo RJ, Nakhleh RE, Walsh M; Quality Practices Committee, College of American Pathologists. Customer satisfaction in anatomic pathology. A College of American Pathologists Q-Probes study of 3065 physician surveys from 94 laboratories. Arch Pathol Lab Med Jan;127(1):23-9. ANP Phase II YES NO Do all surgical pathology reports include gross descriptions that contain adequate information regarding type, number, dimensions and/or weight of specimens, measurements and extent of gross lesions, and other information essential to the diagnosis and patient care? REFERENCES: 1) Association of Directors of Anatomic and Surgical Pathology. Recommendations for the reporting of resected large intestinal carcinomas. Am J Clin Pathol. 1996;106:12-15; 2) Imperato PJ, et al. Radical prostatectomy specimens among Medicare patients in New York State. A review of pathologists' reports. Arch Pathol Lab Med. 1998;122: ; 3) Cochran AJ, et al. Recommendations for the reporting of tissues removed as part of the surgical treatment of cutaneous ANATOMIC PATHOLOGY Reporting-related questions only Page 9 of 9

10 melanoma. Am J Clin Pathol. 1998;110: ; 4) Ruby SG. Clinician interpretation of pathology reports. Confusion or comprehension? Arch Pathol Lab Med. 2000;124: ; 5) Powsner SM, et al. Clinicians are from Mars and pathologists are from Venus. Clinician interpretation of pathology reports. Arch Pathol Lab Med. 2000;124: ANP Phase II YES NO When appropriate, do gross descriptions include a key or summary noting block and slide designations for special sections (e.g., margins of resection, deepest penetration of tumor, breast quadrants, lymph node levels, etc.)? REFERENCE: Imperato PJ, et al. Radical prostatectomy specimens among Medicare patients in New York State. A review of pathologists' reports. Arch Pathol Lab Med. 1998;122: ANP Phase II YES NO Do gross descriptions and microscopic findings (if included) support the pathologic diagnosis? REFERENCE: Rickert RR. Quality Assurance in Surgical Pathology. Arch Pathol Lab Med 1990;114: ANP Phase II YES NO In tumor cases, does the final report provide sufficient information as to tumor grade and its extent within the pathological specimen, for use in standard systems of grading and staging of neoplasms? NOTE: The pathology report must provide data that, within the confines of information available to the pathologist, is sufficient to allow appropriate grading and staging of neoplasms according to standard classification schemes. This information should be easily identifiable (e.g., bold type, distinctive font, or visually set apart from the descriptive text of the report). The use of checklists or synoptic diagnostic reports is recommended, to ensure that all information relevant to staging and grading is included, and to facilitate interpretation of pathology reports by clinicians. ANATOMIC PATHOLOGY Reporting-related questions only Page 10 of 10

11 REFERENCE: College of American Pathologists. Practicing Pathology: Cancer Protocols. ANP Phase II YES NO Is there a mechanism to correlate the results of specialized studies (e.g., electron microscopy, immunohistochemistry, nucleic acid probes, cytogenetics) with the morphologic diagnosis? NOTE: It is not in the best interests of the patient to have potentially conflicting diagnoses or interpretations rendered by different sections of the laboratory. The pathologist should correlate all of the special studies, reconcile conflicting data, and render a final interpretation of all correlated studies. REFERENCES: 1) Editorial. Incorporation of immunostaining data in anatomic pathology reports. Am J Clin Pathol. 1993;99:1; 2) Putti T, et al. Cost-effectiveness of immunohistochemistry in surgical pathology. Am J Clin Pathol. 1998;110:51; 3) Raab SS. The cost-effectiveness of immunohistochemistry. Arch Pathol Lab Med. 2000;124: **REVISED** 12/01/2003 ANP Phase II YES NO If patient testing is performed using Class I analyte-specific reagents (ASR s) obtained or purchased from an outside vendor, does the patient report include the disclaimer required by federal regulations? NOTE: ASR s are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. By definition, an ASR is the active ingredient of an in-house-developed ( home brew ) test system. ASR s may be obtained from outside vendors or synthesized in-house. ASR s from outside vendors are supplied individually. They are not bundled with other materials in kit form, and the accompanying product literature does not include any claims with respect to use or performance of the reagent. ANATOMIC PATHOLOGY Reporting-related questions only Page 11 of 11

12 Class I ASR s in use in the anatomic pathology laboratory include some antibodies for immunohistochemistry and nucleic acid probes for FISH and ISH. Class I ASR s are not subject to preclearance by the U.S. Food and Drug Administration or to special controls by FDA. Thus, if the laboratory performs patient testing using Class I ASR s obtained or purchased from an outside vendor, federal regulations require that the following disclaimer accompany the test result on the patient report: "This test was developed and its performance characteristics determined by (laboratory name). It has not been cleared or approved by the U.S. Food and Drug Administration." The CAP recommends additional language, such as "The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing." The above disclaimer is not required when using reagents that are sold in kit form with other materials and/or an instrument, and/or with instructions for use, and/or when labeled by the manufacturer as Class I for in vitro diagnostic use (IVD), Class II IVD, or Class III IVD. Most antibodies used in immunohistochemistry are labeled for in vitro diagnostic use and thus do NOT require the disclaimer. Antibodies, nucleic acid sequences, etc., labeled Research Use Only (RUO) purchased from commercial sources may be used in home brew tests only if the laboratory has made a reasonable effort to search for IVD or ASR class reagents. The results of that failed search should be documented by the laboratory director. The laboratory must establish or verify the performance characteristics of tests using Class I ASR s and RUO s in accordance with the Method Performance Specifications section of the Laboratory General checklist. The laboratory may put an ASR disclaimer on the pathology report for all immunostains, FISH and ISH studies collectively used in a particular case. Separately tracking each reagent used for a case and selectively applying the disclaimer to only the class I ASR s is unnecessary. REFERENCES: 1) Department of Health and Human Services, Food and Drug Administration. Medical devices; classification/reclassification; restricted devices; analyte specific reagents. Final rule. Fed Register. 1997(Nov 21); [21CFR809, 21CFR864]; 2) Caldwell CW. Analyte-specific reagents in the flow cytometry laboratory. Arch Pathol Lab Med. 1998;122: ; 3) Graziano. Disclaimer now needed for analyte-specific reagents. Northfield, IL: College of American Pathologists ANATOMIC PATHOLOGY Reporting-related questions only Page 12 of 12

13 CAP Today. 1998;12(11):5-11; 4) Analyte Specific Reagents; Small Entity Compliance Guidance. February 26, 2003; 5) Shapiro JD and Prebula RJ. FDA s Regulation of Analyte-Specific Reagents. Medical Devicelink, February ) U.S. Department of Health and Human Services, Food and Drug Administration. 7) U.S. Department of Health and Human Services, Food and Drug Administration. **REVISED** 12/01/2003 ANP Phase II YES NO Can surgical pathology report information be retrieved by patient identifier (e.g., name, medical record number, etc.)? NOTE: For computerized surgical pathology systems, software tools typically permit text-based searches for any element of the report, such as name and diagnosis. Or, these data elements may already be stored in an electronic database. For paper-based manual systems, it is acceptable to store reports by name. ANP Phase II YES NO Are surgical pathology records and materials retained for an appropriate period? NOTE: Minimum requirements for surgical pathology, providing these are not less stringent than state and federal regulations, are: 1. Accession log records - 2 years 2. Wet tissue (stock bottle) - 2 weeks after final report 3. Paraffin blocks - 10 years 4. Glass slides and reports - 10 years The retention period should be extended, when appropriate, to provide documentation for adequate quality control and medical care. There must be a documented policy for protecting and preserving the integrity and retrieval of surgical pathology materials and records. ANATOMIC PATHOLOGY Reporting-related questions only Page 13 of 13

14 REFERENCE: College of American Pathologists. ANATOMIC PATHOLOGY Reporting-related questions only Page 14 of 14

15 ############################################################################ HISTOLOGY LABORATORY ############################################################################ IMMUNOHISTOCHEMISTRY **NEW** 09/30/2004 ANP Phase I YES NO For immunohistochemistry tests that provide independent predictive/prognostic information, does the patient report include information on specimen processing, the antibody clone, and the scoring method used? NOTE: For immunohistochemical studies used to provide diagnostic predictive/prognostic information independent of other histopathologic findings (e.g., hormone receptors in breast carcinoma, HER-2/neu, EGFR), the laboratory should include the following information in the patient report: 1. The type of specimen fixation and processing (e.g., formalin-fixed paraffin-embedded sections, air-dried imprints, etc.) 2. The antibody clone and general form of detection system used (e.g., LSAB, polymer, proprietary kit, etc.) 3. Criteria used to determine a positive vs. negative result, and/or scoring system (e.g., percent of stained cells, staining pattern, etc.) The laboratory should periodically compare its patient results with published benchmarks, and also evaluate interobserver variability among the pathologists in the laboratory. ANATOMIC PATHOLOGY Reporting-related questions only Page 15 of 15

16 FLUORESCENCE AND NON-FLUORESCENCE IN SITU HYBRIDIZATION (FISH, ISH) This section is intended for the application of FISH (e.g., HER-2/neu) and ISH (e.g., HPV, HBV) techniques in histologic sections. **REVISED** 12/01/2003 ANP Phase I YES NO Is appropriate interpretation of FISH results provided in the report? ANATOMIC PATHOLOGY Reporting-related questions only Page 16 of 16

17 ########################################################################### AUTOPSY PATHOLOGY ########################################################################### **************************************************************************** QUALITY MANAGEMENT **************************************************************************** The purpose of this section is to determine if there is an active program of surveillance of the quality of autopsy diagnostic reports and utilization of the information obtained to enhance the quality of patient care. ANP Phase II YES NO Are formal intra- and extra-departmental consultations documented and the reports maintained with the patient's autopsy report? NOTE: When formal intra- and extra-departmental consultations are obtained, they must be documented and the reports kept with the patient autopsy report. REFERENCE: Tomaszewski JE, et al. Consensus conference on second opinions in diagnostic anatomic pathology. Who, what, and when. Am J Clin Pathol. 2000;114: ANP Phase II YES NO Are the findings of the postmortem examination used for correlative clinicopathological teaching purposes designed to enhance the quality of patient care? NOTE: The autopsy has an important role in medical education and quality improvement. The value of the final autopsy report is enhanced when the findings are used for teaching that emphasizes clinicopathological correlations. This teaching activity should be documented and may take any of several forms, including a correlative note in the autopsy report, interdepartmental note or summary, or a clinical teaching conference. ANATOMIC PATHOLOGY Reporting-related questions only Page 17 of 17

18 REFERENCES: 1) McPhee SJ. Maximizing the benefits of autopsy for clinicians and families. What needs to be done. Arch Pathol Lab Med. 1996;120: ; 2) Feinstein AR. Epidemiologic and clinical challenges in reviving the necropsy. Arch Pathol Lab Med. 1996;120: ; 3) Baker PB, et al. Quality assurance of autopsy face sheet reporting, final autopsy report turnaround time, and autopsy rates. A College of American Pathologists Q-Probes study of autopsies from 418 institutions. Arch Pathol Lab Med. 1996;120: ; 4) Nakhleh RE, et al. Autopsy result utilization. A College of American pathologists Q-Probes study of 256 laboratories. Arch Pathol Lab Med. 1999;123: ; 5) Hutchins GM, et al. Practice guidelines for autopsy pathology. Autopsy reporting. Arch Pathol Lab Med. 1999;123: ; 6) Hanzlick RL. The autopsy lexicon. Suggested headings for the autopsy report. Arch Pathol Lab Med. 2000;124: ; 7) Bayer-Garner IB, et al. Pathologists in a teaching institution assess the value of the autopsy. Arch Pathol Lab Med. 2002;126: ; 8) Baker PB. Communication of autopsy results. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 33; 9) Davis GJ, et al. The autopsy in medical education. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 34; 10) Hutchins GM, et al. Autopsy reporting. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 28. ANP Phase I YES NO Are the findings from autopsies incorporated into the institutional quality management program? REFERENCES: 1) Suchii-Bernal L, et al. Application of an autopsy report specifically designed for cardiovascular diseases. Arch Pathol Lab Med. 1994;118:71-78; 2) O'Leary DS. Relating autopsy requirements to the contemporary accreditation process. Arch Pathol Lab Med. 1996;120: ; 3) Nakhleh RE, et al. Autopsy result utilization. A College of American Pathologists Q-Probes study of 256 laboratories. Arch Pathol Lab Med. 1999;123: ; 4) Sens MA, et al. Quality assurance in autopsy pathology. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 37. **REVISED** 12/01/2003 ANP Phase II YES NO Are autopsy findings that were clinically inapparent but important specifically documented and communicated interdepartmentally? ANATOMIC PATHOLOGY Reporting-related questions only Page 18 of 18

19 NOTE: The form in which this is accomplished is at the discretion of the laboratory director. For example, presentation at a clinical conference or specifically highlighting these findings in the discussion/case summary of the autopsy report would meet this requirement. The goal is to enhance the quality of patient care by documenting findings that were not detected antemortem. REFERENCES: 1) Anderson RE, et al. A model for autopsy based quality assessment of medical diagnostics. Hum Pathol.1990;21: ; 2) Hill RB, et al. Autopsy-based quality assessment program for improvement of diagnostic accuracy. Qual Assur Health Care. 1993;5: ; 3) Nakhleh RE, et al. Autopsy result utilization. a College of American Pathologists Q-Probes study of 256 laboratories. Arch Pathol Lab Med. 1999;123: ; 4) Sinard J, Blood D. Quality Improvement on an academic autopsy service. Arch Pathol Lab Med. 2001;125: ; 5) Baker PB. Communication of autopsy results. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 33; 6) Hutchins GM, et al. Autopsy reporting. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 28. **************************************************************************** AUTOPSY PERFORMANCE AND DOCUMENTATION **************************************************************************** ANP Phase II YES NO Is a documented preliminary report of the gross pathologic diagnoses submitted to the attending physician and the institutional record within a reasonable time (2 working days)? REFERENCES: 1) Zarbo RJ, et al. Quality assurance of autopsy permit form information, timeliness of performance, and issuance of preliminary report. Arch Pathol Lab Med. 1996;120: ; 2) Adickes ED, Sims KL. Enhancing autopsy performance and reporting. A system for a 5-day completion time. Arch Pathol Lab Med. 1996;120: ; 3) Smith MT, Garvin AJ. Anatomic pathology turnaround times. Use and abuse. Am J Clin Pathol 1996;106(Suppl 1):S70-S73; 4) Baker PB, et al. Quality assurance of autopsy face sheet reporting, final autopsy report turnaround time, and autopsy rates. A College of American Pathologists Q-Probes study of autopsies from 418 ANATOMIC PATHOLOGY Reporting-related questions only Page 19 of 19

20 institutions. Arch Pathol Lab Med. 1996;120: ; 5) Hanzlick RL. The autopsy lexicon. Suggested headings for the autopsy report. Arch Pathol Lab Med. 2000;124: ; 6) Hutchins GM, et al. Autopsy reporting. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 28; 7) Baker PB. Communication of autopsy results. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 33. ANP Phase I YES NO Are the majority of autopsy final reports produced within 30 working days? NOTE: The clinical and quality management value of the autopsy is enhanced by prompt reporting of results to the referring physician and the institutional record. REFERENCES: 1) Adickes ED, Sims KL. Enhancing autopsy performance and reporting. A system for a 5-day completion time. Arch Pathol Lab Med. 1996;120: ; 2) Smith MT, Garvin AJ. Anatomic pathology turnaround times. Use and abuse. Am J Clin Pathol 1996;106(Suppl 1):S70-S73; 3) Baker PB, et al. Quality assurance of autopsy face sheet reporting, final autopsy report turnaround time, and autopsy rates. A College of American Pathologists Q-Probes study of autopsies from 418 institutions. Arch Pathol Lab Med. 1996;120: ; 4) Hanzlick RL. The autopsy lexicon. Suggested headings for the autopsy report. Arch Pathol Lab Med. 2000;124: ; 5) Bove KE, et al. The role of the autopsy in medical malpractice cases, II. Controversy related to autopsy performance and reporting. Arch Pathol Lab Med. 2002;126: ; 6) Hutchins GM, et al. Autopsy reporting. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 28; 7) Baker PB. Communication of autopsy results. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 33. ANP Phase II YES NO For all cases, is the final autopsy report produced within 60 working days? NOTE: Allowance may be needed if portions of a case are referred for external consultation, and completion of the case is dependent upon information from such consultations (e.g., complex neuropathology). If cases exceed 60 days, there should be documentation of the reason for the delay and of ongoing review of this information by the director of the service. ANATOMIC PATHOLOGY Reporting-related questions only Page 20 of 20

21 REFERENCES: 1) Adickes ED, Sims KL. Enhancing autopsy performance and reporting. A system for a 5-day completion time. Arch Pathol Lab Med. 1996;120: ; 2) Smith MT, Garvin AJ. Anatomic pathology turnaround times. Use and abuse. Am J Clin Pathol 1996;106(Suppl 1):S70-S73; 3) Baker PB, et al. Quality assurance of autopsy face sheet reporting, final autopsy report turnaround time, and autopsy rates. A College of American Pathologists Q-Probes study of autopsies from 418 institutions. Arch Pathol Lab Med. 1996;120: ; 4) Hanzlick RL. The autopsy lexicon. Suggested headings for the autopsy report. Arch Pathol Lab Med. 2000;124: ; 5) Bove KE, et al. The role of the autopsy in medical malpractice cases, II. Controversy related to autopsy performance and reporting. Arch Pathol Lab Med. 2002;126: ; 6) Hutchins GM, et al. Autopsy reporting. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 28; 7) Baker PB. Communication of autopsy results. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 33. ANP Phase II YES NO Are gross descriptions clear and concise, are all pertinent findings adequately described and do the descriptions support the diagnosis? REFERENCES: 1) Hutchins GM, et al. Autopsy reporting. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 28; 2) Hanzlick RL, et al. The autopsy lexicon: suggested headings for the autopsy report. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 29. ANP Phase II YES NO If microscopic descriptions are included in the report, are they clear and concise, and do they support the diagnosis? ANP Phase II YES NO When appropriate, does the report include a key or summary noting block and slide designations to allow identification of the source of specific microscopic sections? ANATOMIC PATHOLOGY Reporting-related questions only Page 21 of 21

22 NOTE: At a minimum, the key should include information on laterality and on specific lesions sampled. REFERENCES: 1) Hutchins GM, et al. Autopsy reporting. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 28; 2) Hanzlick RL, et al. The autopsy lexicon: suggested headings for the autopsy report. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 29. ANP Phase II YES NO Does the final autopsy report contain sufficient information in an appropriate format so that a physician may ascertain the patient's major disease processes and probable cause of death? REFERENCES: 1) Hutchins GM, et al. Autopsy reporting. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 28; 2) Hanzlick RL, et al. The autopsy lexicon: suggested headings for the autopsy report. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 29; 3) Hanzlick RL. Medical certification of death and cause-of-death statements. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 30. ANP Phase I YES NO Are autopsy records organized and readily available for review? REFERENCE: Moore GW. Computer-based indexing. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 32. ANATOMIC PATHOLOGY Reporting-related questions only Page 22 of 22

23 ANP Phase I YES NO Are major diagnoses entered into a database that allows prompt retrieval? NOTE: At the facility s discretion, this could be accomplished through the use of an electronic database, card file, or log book, depending on the size of the database. REFERENCES: 1) Moore GW. Computer-based indexing. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 32; 2) Hutchins GM, et al. Autopsy reporting. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 28. ANP Phase II YES NO Are autopsy pathology records and materials retained for an appropriate period? NOTE: There must be a documented policy for preserving the integrity of retained autopsy service materials. The laboratory must define the period of time that such materials are retained. The retention period shall provide for adequate quality control and potential medical care of other individuals. In establishing retention requirements, care should be taken to comply with state and federal regulations. Minimum requirements for autopsy pathology, providing these are not less stringent than state and federal regulations, are: 1. Accession log records - 2 years 2. Wet tissue (stock bottle) - 3 months after final report 3. Paraffin blocks - 10 years 4. Glass slides and reports - 10 years REFERENCES: 1) College of American Pathologists. Guidelines for the retention of laboratory records and materials. Northfield, IL: CAP, current edition; 2) College of American Pathologists documents pertaining to the autopsy. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2 nd ed. Northfield, IL: College of American Pathologists: 2003; chap 5. ANATOMIC PATHOLOGY Reporting-related questions only Page 23 of 23

24 ############################################################################ ELECTRON MICROSCOPY ############################################################################ **************************************************************************** QUALITY CONTROL **************************************************************************** REPORTS ANP Phase II YES NO Does the report format provide for correlation with routine light microscope and other (e.g., immunohistochemical and immunofluorescent) studies? ANP Phase II YES NO Are all reports signed by the pathologist? NOTE: Where diagnostic reports are generated by computer or telecommunications equipment, the actual signature or initials of the pathologist may not appear. It is nevertheless essential that the laboratory have a procedure that ensures and documents that the responsible pathologist has reviewed and approved the completed report before its release. ANATOMIC PATHOLOGY Reporting-related questions only Page 24 of 24

25 ANP Phase II YES NO Are copies of all reports retained by the laboratory? ANATOMIC PATHOLOGY Reporting-related questions only Page 25 of 25