Necessity of Clinical Information in Surgical Pathology

Necessity of Clinical Information in Surgical Pathology A College of American Pathologists Q-Probes Study of 771 475 Surgical Pathology From 341 Institutions Raouf E. Nakhleh, MD; Gordon Gephardt, MD; Richard J. Zarbo, MD, DMD Objectives. To examine the frequency and nature of problems caused by inadequate clinical data provided on surgical pathology requisition forms. Design. Participants in the 1996 Q-Probes voluntary quality improvement program of the College of American Pathologists were asked to document prospectively all surgical pathology cases with inadequate information. Inadequate clinical information was defined as the pathologist s need for additional clinical information before a diagnosis could be rendered, regardless of the amount of information already present on the requisition slip. that had no clinical information on a requisition slip were not counted if the lack of history did not hinder diagnosis. The study concluded when 3 months had elapsed or 40 surgical pathology cases were documented. The following data were recorded for each case: anatomic site, type of procedure, nature of disease, method of obtaining additional information, importance of obtained information, and the length of delay in the final diagnosis. Participants. Three hundred forty-one laboratories, 322 of which were from the United States. Results. A total of 5594 cases (0.73%) required additional clinical information for diagnosis (10th through 90th percentile range, 3.01% to 0.08%). Institutions with greater average occupied bedsize, a greater number of cases accessioned per year, and a greater number of pathologists had a lower percentage of cases with inadequate clinical data (P.05). Sixty-eight percent of these cases had no delay in completion of a case, 16.2% had a delay of 1 day or less, and 15.1% of cases were delayed more than 1 day. In 59.4% of cases, the additional clinical information obtained confirmed the initial diagnostic impression. In.1%, the information was not relevant to the pathologic diagnosis. In 6.1% there was a substantial change in the diagnosis or a revised report was issued, and in 2.2% no additional information could be obtained. Specific anatomic sites that correlated with a higher rate of changed diagnoses or revised reports in cases with inadequate information included the small bowel, the bronchus/lung, and the ovary. Resection specimens were also significantly associated with a higher rate of changed diagnoses or revised reports when additional information was obtained, as were malignant neoplasms and therapy-induced changes. Conclusions. This study establishes an aggregate rate of cases with inadequate clinical information for diagnosis (0.73%) and documents the extent of problems caused by inadequate clinical information. The criticality of appropriate clinical information provided to the pathologist is identified for specific anatomic sites and disease processes and is reflected in changed diagnoses or revised reports. (Arch Pathol Lab Med. 1999;123:615 619) To our knowledge, there have been no studies examining the nature and extent of diagnostic and reporting problems occurring secondary to lack of information in surgical pathology. As Juan Rosai, MD, eloquently stated: By its very nature, surgical pathology depends heavily on the input of clinicians and surgeons who are fully aware of the potentials and limitations of the specialty. They should know that a microscopic diagnosis is a subjective evaluation that acquires full meaning only when the pathologist is fully cognizant of the essential clinical data, surgical findings and type of surgery. The requisition slip for pathological study should ideally be completed by a physician familiar with the case.... 1 These principles are understood in surgical pathology and are satisfied by the majority of clinical physicians. They are codified in the laboratory accreditation standards outlined by the Laboratory Accreditation Program of the Accepted for publication February 15, 1999. From the Departments of Pathology, Henry Ford Hospital, Detroit, Mich (Drs Nakhleh and Zarbo) and Promina Kennestone Hospital, Marietta, Ga (Dr Gephardt). Reprints: Raouf E. Nakhleh, MD, Department of Pathology, Henry Ford Hospital, 2799 W Grand Blvd, Detroit, MI 48202. College of American Pathologists (question 08.1105 of the 1998 Laboratory Checklist) and the Joint Commission on Accreditation of Healthcare Organizations 1998 Standard QC.2.1.1. 2,3 Both standards require that each surgically removed specimen is accompanied by pertinent clinical information and, to the degree known, by the preoperative and postoperative diagnosis. In a previous Q-Probes study concerning surgical pathology specimen identification and accessioning, 4 we noted that no clinical history or clinical diagnosis was present on requisition slips in 2.4% of cases. In the current study, we examine the effects of inadequate clinical information. Our focus, however, is on cases in which the pathologist felt that more clinical information was necessary to render an appropriate diagnosis, regardless of the information that was present on the requisition slip. Therefore, the deficiency rate differs from the previous Q-Probes study. 4 Our aims are to (1) define the magnitude of the problem, (2) determine problematic organ systems or types of specimens where clinical information is essential for accurate diagnosis, (3) assess delay in diagnosis attributed to this lack of communication, (4) evaluate the methods of obtaining additional information, and (5) correlate these data Arch Pathol Lab Med Vol 123, July 1999 Clinical Information in Surgical Pathology Nakhleh et al 615

Table 1. Association of 3 Practice Characteristics With the Rate of Requisitions Lacking Adequate Clinical Information Percentage of Lacking Adequate Clinical Data, All Institutions Percentiles 50th Institutions 10th th (Median) 75th 90th All laboratories 341 3.01 1.57 0.62 0.22 0.08 Occupied bedsize 1 150 151 300 300 106 120 78 4.38 2.29 2.30 surgical pathology cases accessioned in 1995 0 5000 5001 9000 9001 13 000 13 000 92 97 70 82 5.80 2.52 2.86 2.00 full-time equivalent pathologists 0.0 1.9 2.0 2.9 3.0 3.9 4.0 4.9 5.0 62 87 66 53 73 4.45 3.12 2.71 1.94 2.46 2.30 1.31 1.12 2.41 1.38 1.21 0.73 2.56 1.96 1.24 1.02 0.80 0.97 0.60 1.27 0.70 0.55 0.35 1.13 0.87 0.47 0.65 0.40 0.17 0.21 0.43 0.16 0.21 0.17 0.27 0.12 0.15 0.22 0.08 0.14 0.06 0.00 with practice parameters for peer group comparison and benchmarking. changes in diagnosis or a revised report. Statistical significance was assumed for P.05 for all of these analyses. METHODS In 1996, 341 participants in the College of American Pathologists voluntary subscription quality improvement program, Q- Probes, prospectively documented all surgical pathology cases in which the requisition slip failed to provide adequate clinical data. The Q-Probes format for data collection and handling has been described in detail previously. were considered to have inadequate clinical data on the requisition slip if the pathologist required additional clinical information before a diagnosis could be made, regardless of the amount of information already present. that had no clinical information on a requisition slip were not counted if the lack of history did not prevent the rendering of a diagnosis and the sign-out of the case. The data collection period lasted for 3 months or until data were collected on 40 surgical pathology cases that required additional clinical information, whichever occurred first. The following data were recorded for each case: (1) anatomic site of specimen, (2) type of procedure used to obtain the specimen, (3) the nature of the disease, (4) method of obtaining additional information, (5) the importance of the clinical information obtained, and (6) the length of delay in the final diagnosis due to the need for additional clinical information. Participants selected answers to these various parameters from a predetermined menu of items. Participants also completed a questionnaire regarding their surgical pathology practices, including the surgical pathology volume accessioned by the laboratory in 1995, the number of cases accessioned during the study period, the number of full-time equivalent surgical pathologists, whether space was available on the requisition slip for clinical history, whether special requisitions were used for specific organs, whether specific policies existed requiring that clinical information be included on requisition forms, and how this policy was enforced. Univariate nonparametric Wilcoxon and Kruskal-Wallis analyses were used to test for a difference in the distribution of the rate of inadequate clinical information with respect to multiple variables. A semiparametric multiple regression analysis was performed to determine which combinations of variables were significantly associated with the ranked values of the rate of inadequate clinical information. Fisher exact tests were performed to test whether proportions were significantly different for 2 groups, namely, the overall number of surgical pathology cases and the cases in which additional information led to substantial RESULTS Of the 341 institutions that submitted data for this study, 322 were from the United States, 7 from Canada, 5 from the United Kingdom, 2 from Australia, and 1 each from Hong Kong, Belgium, and New Zealand. Eighty-four percent reported that their laboratories were accredited by the College of American Pathologists, and 69% were accredited by the Joint Commission on Accreditation of Healthcare Organizations. The average occupied bedsizes of participating institutions were categorized as follows: 1 150 beds (34.8%), 151 300 beds (39.3%), 301 450 beds (14.8%), 451 600 beds (5.6%), and more than 600 beds (5.6%). Private nonprofit organizations accounted for 65.8% of the institutions; 7.5% were private, for profit; 4.0% were independent laboratories; 3.1% were university hospitals; 18.9% were governmental (county, 5.6%; city, 3.4%; state, 1.9%; veterans, 4.0%; armed forces, 1.2%); and 1.9% were from other nongovernmental organizations. City hospitals accounted for 61.5%, 21.7% were suburban, 15.2% rural, 1.2% federal, and 0.3% were other. A total of 34.1% considered themselves to be teaching hospitals, 65.9% did not, and 16.8% had a pathology residency program. During the study period, participants accessioned and signed out a total of 771 475 surgical pathology cases. Of these, 5594 (0.73%) required additional clinical information before the case could be completed. The median institutional rate of cases with inadequate clinical information for diagnosis was 0.62%, the rate at the 10th percentile was 3.01%, and at the 90th percentile, 0.08%. The highest rate of cases with inadequate clinical information was 20%. Three factors showed a significant inverse relationship with the rate of requisitions lacking adequate clinical information. Institutions with greater average occupied bedsize, a greater number of cases accessioned per year, and a greater number of pathologists in the practice all had lower percentages of cases lacking adequate clinical data 616 Arch Pathol Lab Med Vol 123, July 1999 Clinical Information in Surgical Pathology Nakhleh et al

Table 2. Frequency of in Which Requested Clinical Information Led to a Change in Preparation of a, According to Anatomic Site (n 5473 cases) Anatomic Site Urethra Breast (male) Mediastinum Ovary* Small bowel* Pleura Fallopian tube Bronchus/lung* Penis Anus Muscle 6 13 20 47 146 45 28 237 10 30 31 1 (16.7) 2 (15.4) 3 (15.0) 7 (14.9) 17 (11.6) 5 (11.1) 3 (10.7) 24 (10.1) 1 (10.0) 3 (10.0) 3 (9.7) Esophagus Ear/nose/throat (larynx) Thyroid Other urinary Testis Other female genital Oral cavity Bladder Liver Soft tissue Appendix 116 119 37 103 65 65 263 194 43 11 (9.5) 10 (8.4) 3 (8.1) 2 (8.0) 2 (8.0) 8 (7.8) 5 (7.7) 5 (7.7) 19 (7.2) 14 (7.2) 3 (7.0) Uterus Skin Large bowel Breast (female) Bone/joint Kidney Stomach Not on list provided Central nervous system Gallbladder 123 7 407 263 243 57 171 287 64 69 8 (6.5) 42 (5.8) 23 (5.7) 15 (5.7) 13 (5.3) 3 (5.3) 9 (5.3) 14 (4.9) 3 (4.7) 3 (4.3) Prostate Blood vessel Lymph node Endometrium Other gastrointestinal tract Bone marrow Omentum/peritoneum Placenta Cervix Thymus 141 158 268 85 199 34 130 271 8 6 (4.3) 1 (4.0) 6 (3.8) 10 (3.7) 3 (3.5) 6 (3.0) 1 (2.9) 2 (1.5) 3 (1.1) Myometrium Ureter Adrenal gland Parathyroid Biliary tree Peripheral nerve Pancreas Spleen Other male genital 3 5 7 7 1 4 9 18 23 Total 5473 322 (5.9) (Table 1). Multiple practice characteristics were not associated with the rate of surgical pathology requisitions lacking adequate clinical information, including using special requisition slips for certain anatomic sites or organs, allowing sufficient space on requisition slips for clinical history, and having a policy requiring clinical information before sign-out. A written departmental policy requiring documentation of clinical history on the requisition slip before sign-out of the case was in place in 60.7% of the institutions. Enforcement of this policy was accomplished by various mechanisms, including telephoning the appropriate nurse or physician for the missing information (16 institutions), specimens rejected and returned to the submitting physician for completion (23 institutions), documentation or report to a quality assurance committee or surgical case review committee (26 institutions), and other multiple responses in 42 institutions. The remaining 100 institutions did not respond to this question. In the assessment of reporting delay associated with obtaining additional clinical information required for diagnosis, 32% of cases were judged to have been delayed; 15.1% of cases experienced a delay of more than 1 day. The vast majority (68%) had no delay, and 16.2% experienced a delay that was 1 day or less. The most common method of obtaining additional clinical information was through direct communication with the physician (49.6%), followed by obtaining information through a computerized medical information system (11.9%), communication with nursing (10.5%), previous surgical pathology reports (8.0%), communication with other health care personnel (5.8%), chart review (5.3%), and other (8.9%). In 59.4% of cases the additional clinical information confirmed the initial diagnostic impression, and in.1% of the cases it was not relevant to the pathologic diagnosis. In 4.2% of the cases the diagnosis was substantially changed because of the additional clinical information, and a revised report was issued in 1.9% of cases. Thus, 6.1% of cases that required additional clinical information for diagnosis were substantially changed or a revised report was issued once the adequate information was obtained. In 2.2% of cases no additional information could be obtained. In 7.2% of cases the response was other. Two practice characteristics were found to be statistically associated with the impact of the additional clinical information on the diagnosis. Institutions with a greater number of surgical pathology cases accessioned in 1995 had a significant association with an increased percentage of cases in which the additional clinical information helped to confirm the initial diagnosis (P.0104). A greater number of surgical pathology cases accessioned in 1995 (P.0015) and a greater number of full-time equivalent pathologists (P.0031) were significantly associated with a greater percentage of cases in which the obtained information led to a substantial change in diagnosis. Anatomic sites significantly associated with a changed diagnosis or a revised report included the small bowel, the bronchus/lung, and the ovary (Table 2). Resections and segmental resections were also significantly associated with a higher rate of changed diagnoses or revised reports (Table 3), as were 2 disease conditions, malignant neoplasms and therapy-induced changes (Table 4). For cases in which the specimen was obtained through biopsies and curettings, significantly more cases with inadequate clinical information were found to result in a changed diagnosis or a revised report if a malignant neoplasm or therapy-induced change was present (Table 5). in which the specimen was obtained through resection procedures were also significantly more likely to result in a changed diagnosis or revised report if a malignant neoplasm was involved (Table 6). Arch Pathol Lab Med Vol 123, July 1999 Clinical Information in Surgical Pathology Nakhleh et al 617

Table 3. Frequency of in Which Requested Clinical Information Led to a Change in Preparation of a, According to Type of Procedure Endoscopic biopsy Incisional biopsy Needle biopsy Excisional biopsy Not specified Curettings Forceps 726 295 615 1005 744 347 67 54 (7.4) 21 (7.1) 33 (5.4) 54 (5.4) 35 (4.7) 12 (3.5) 2 (3.0) Total biopsies and curettings 3799 211 (5.6) Segmental resection* Resection* 176 811 21 (11.9) 69 (8.5) Total resections* 987 90 (9.1) Other Unknown 448 117 20 (4.5) 1 (0.9) All procedures 5351 322 (6.0) Table 4. Frequency of in Which Requested Clinical Information Led to a Change in Preparation of a, According to Nature of Disease Process Nature of Disease Process Therapy-induced change* 164 18 (11.0) Malignant neoplasm* 1092 105 (9.6) or infection 1270 84 (6.6) Benign neoplasm 375 21 (5.6) Other 884 41 (4.6) Benign prolifeation/ hyperplasia 752 30 (4.0) Hereditary/congenital disease 28 1 (3.6) Unknown 462 13 (2.8) Premalignant neoplasia 282 8 (2.8) Metabolic disease 34 Total 5343 321 (6.0) COMMENT In his article Limitations of Histologic Diagnosis, Rambo 6 states: Table 5. Frequency of With Biopsy Procedures in Which Requested Clinical Information Led to a Change in Preparation of a Revised Report, Divided by Nature of Disease Process Nature of Disease Procedure 618 Arch Pathol Lab Med Vol 123, July 1999 Clinical Information in Surgical Pathology Nakhleh et al Therapy-induced change* 127 15 (11.8) Malignant neoplasm* 784 61 (7.8) or infection 923 59 (6.4) Benign neoplasm 283 16 (5.7) Other 482 22 (4.6) Benign proliferation/ hyperplasia 608 22 (3.6) Premalignant neoplasia 241 7 (2.9) Unknown 270 6 (2.2) Hereditary/congenital disease 13 Metabolic disease 26 Total 3757 208 (...) Table 6. Frequency of With Resection Procedures in Which Requested Clinical Information Led to a Change in Preparation of a, Divided by Nature of Disease Process Nature of Disease Procedure With Changed Diagnosis or Malignant neoplasm* 4 37 (14.6) or infection 248 21 (8.5) Hereditary/congenital disease 12 1 (8.3) Unknown 67 5 (7.5) Other 166 12 (7.2) Therapy-induced change 28 2 (7.1) Benign proliferation/ hyperplasia 99 7 (7.1) Premalignant neoplasia 15 1 (6.7) Benign neoplasm 82 4 (4.9) Metabolic disease 5 Total 976 90 (...) Because of certain nineteenth century dogmas and because the teaching of pathology used to be relegated primarily to the longforgotten preclinical phase, pathologists traditionally have been regarded to be more scientific than many of their colleagues. A mystic perversion of this assumption prevails among those clinicians who believe that the pathologists, given only a piece of a patient s tissue, have all the other ingredients necessary to produce a statement of absolute truth at the end of his report. More dangerous to mankind is a pathologist with the same concept... Incomplete communication between the clinician and the pathologist may make diagnosis difficult or impossible. To perform intelligently, a consultant must know all the facts that have any bearings on the case. To render a diagnosis of an inherently puzzling bit of tissue with only vague knowledge of its source and no concept of the clinical problem is as foolhardy as to undertake an appendectomy on the basis of hearsay evidence that the patient had a pain in his belly. Published in 1962, these words faithfully echo the essence of this study. 6 In this Q-Probes study we examined the extent and severity of problems arising from inadequate clinical information, and to our knowledge, this is the first multi-institutional study of its kind. Using this multi-institutional design, we have established the magnitude of the problem (0.73% of cases), which may serve as a benchmark applicable for future comparisons in quality improvement programs. We have also demonstrated that smaller hospitals and smaller laboratories tend to have higher rates of cases with inadequate clinical information than larger hospitals and laboratories. This is important for peer group comparisons. The difference may be due to the more general nature of practice in a smaller hospital and to a lack of

specific clinical specialists and pathologist experts in various organ systems who form close working relationships with small groups of clinicians. It may also be postulated that additional clinical information may be less of an issue in larger hospitals and in multipathologist groups staffed by subspecialized pathologists, who have enhanced diagnostic abilities and a more in-depth understanding of disease processes and clinical situations in specific clinical areas. 7 This is best exemplified in settings in which the pathologist is an integral part of a clinical treatment team, where knowledge is shared on a continual basis. A multipathologist group is also more likely to have routine intradepartmental consultation between members. 8 Larger laboratories were also associated with a higher percentage of cases in which obtained clinical information helped confirm the initial diagnosis and led to a changed diagnosis. In other words, the additional information was more often useful. While the reasons for these findings are not clear, some of the characteristics of larger groups may also contribute to the pathologist s ability to find useful clinical information more often. Another aim of the study was to identify anatomic sites for which additional clinical information was more likely to lead to a change in diagnosis. We identified 3 organ systems (small bowel, lung, and ovary) that were more often associated with a change in diagnosis or a revised report when additional clinical information was obtained. In addition, resection specimens were more likely to lead to a changed diagnosis or a revised report if additional information was obtained. Furthermore, cases involving malignant neoplasms and therapy-induced changes had significantly higher rates of changed diagnoses or revised reports when additional information was obtained. The reasons that these characteristics were associated with a revised report or changed diagnosis were not specifically evaluated in this study and are likely to be multifactorial. From our own experience, therapy-induced changes in biopsy tissue best exemplifies the pathologist s need for clinical information. In numerous conditions (eg, inflammatory bowel disease, prostate cancer, and allograft rejection), therapy has been shown to change the histologic appearance of the lesion and may lead to an improper diagnosis. 9 11 Recently, several articles have highlighted the role of inadequate clinical information contributing to diagnostic errors and amended reports in surgical pathology. In a College of American Pathologists Q-Probes study addressing specimen identification and accessioning, 2.4% of cases submitted to surgical pathology had no clinical history provided on the requisition slip at all. 4 In a subsequent Q-Probes study, which quantitated amended surgical pathology reports, it was noted that 10% of the amended reports resulted directly from additional clinical information unknown to the pathologist at the time of original sign-out. An additional 20% of cases came to the pathologist s attention because of a clinicopathologic discrepancy recognized by the clinician. 12 In our practice, when clinicians ask for a review of a case, they usually bring additional clinical information to the pathologist. Inadequate clinical information has also been the underlying cause of malpractice claims brought against pathologists. In a review of 53 pathology malpractice claims, Troxel and Sabella 13 documented that failure to obtain all relevant information (which often is not provided on the pathology request slip) contributed to one fifth of the diagnostic errors (11 cases). Similarly, McBroom and Ramsay 14 noted that clinical information affected 7.5% of surgical pathology reports that were amended during review of cases for clinicopathologic conferences. They also pointed out that a significant proportion of cases that were amended were the result of the special expertise of the pathologists reviewing these cases. This expertise very likely reflects the expert s enhanced visual diagnostic ability and also reflects his or her knowledge of the clinical disease process occurring in the particular area of interest. 7,8 In other words, a full understanding of the clinical picture optimizes the pathologist s ability to see his or her way to the most accurate diagnosis. As Goethe said, you only see what you know. References 1. Rosai J. Introduction. In: Rosai J, ed. Ackerman s Surgical Pathology. St Louis, Mo: Mosby; 1996:1 12. 2. Commission on Laboratory Accreditation. Anatomic pathology. In: 1997 Inspection Checklist. Section 8. Northfield, Ill: College of American Pathologists; 1997. 3. 1998 99 Comprehensive Accreditation Manual for Pathology and Laboratory Services. Oakbrook Terrace, Ill: Joint Commission on Accreditation of Healthcare Organizations; 1998. 4. Nakhleh RE, Zarbo RJ. Surgical pathology specimen identification and accessioning: a College of American Pathologists Q-Probes study of 1 004 115 cases from 417 institutions. Arch Pathol Lab Med. 1996;120:227 233. 5. Schifman RB, Howanitz PJ, Zarbo RJ. Q-Probes: a College of American Pathologists benchmarking program for quality management in pathology and laboratory medicine. In: Weinstein RS, ed. Advances in Pathology and Laboratory Medicine. Chicago, Ill: Mosby-Yearbook, Inc; 1996:83 120. 6. Rambo ON. Limitations of histologic diagnosis. Prog Radiat Ther. 1962;2: 215 224. 7. Black-Shaffer WS, Young RH, Harris NS. Subspecialization of surgical pathology at the Massachusetts General Hospital. Am J Clin Pathol. 1996;106(suppl 1):S33 S42. 8. Watts JC. Is there still a need for the general surgical pathologist? Am J Clin Pathol. 1996;106(suppl 1):S74 S76. 9. Civantos F, Soloway MS. Prostatic pathology after androgen blockade: effects on prostatic carcinoma and on nontumor prostate. Adv Anat Pathol. 1996; 4:9 265. 10. Snover DC. Pathology of Liver Transplantation in Solid Organ Transplantation. Solez K, Racusen LC, Billingham ME, eds. New York, NY: Marcel Dekker; 1996:187 206. 11. Lewin KJ, Riddell RH, Weinstein WM. Inflammatory Bowel Disease in Gastrointestinal Pathology and Its Clinical Implications. Lewin KJ, Riddell RH, Weinstein WM, eds. New York, NY: Igaku-Shoin; 1992:812 989. 12. 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 1 667 547 accessioned cases in 359 laboratories. Arch Pathol Lab Med. 1998;122:303 309. 13. Troxel DB, Sabella JD. Problem areas in pathology practice: uncovered by review of malpractice claims. Am J Surg Pathol. 1994;18:821 831. 14. McBroom HM, Ramsay AD. The clinicopathological meeting: a means of auditing diagnostic performance. Am J Surg Pathol. 1993;17:75 80. Arch Pathol Lab Med Vol 123, July 1999 Clinical Information in Surgical Pathology Nakhleh et al 619