AP Discrepancy Rates - College of American Pathologists

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Primary reason for review (P .001) Request by clinician All other reasons Discrepancy type: change in categoric interpretation Specimen type (P .001) Cytology Surgical pathology Primary reason for secondary review (P .03) Extradepartmental review All other reasons for review Discrepancy type: change in same category of diagnosis Specimen type (P .001) Cytology Surgical pathology Discrepancy type: change in patient information Primary reason for secondary review (P .001) Request by clinician All other reasons for review Effect on patient outcome: near miss Primary reason for secondary review (P .001) Extradepartmental review All other reasons for review Effect on patient outcome: no harm Primary reason for secondary review (P .001) Intradepartmental review All other reasons for review Response to a discrepancy: report change Primary reason for secondary review (P .001) Interdepartmental conference Request by clinician All other reasons for review Table 8. Statistically Significant Associations No. of Specimens No. With Discrepancy 464 Arch Pathol Lab Med—Vol 129, April 2005 Patient Safety in Anatomic Pathology—Raab et al 348 5812 54 349 89 317 349 54 79 327 80 299 44 335 43 77 250 Table 9. Reason for Review Correlated With Effect on Patient Outcome Errors Detected, No. Effect on Patient Outcome (% of Cases Harm, Near Miss, No Harm, Reason for Review Reviewed) No. (%) No. (%) No. (%) Total Intradepartmental review 47 (7.1) 2 (5.3) 2 (5.3) 34 (89.5) 38 Request by clinician 80 (23.0) 12 (23.5) 3 (5.9) 36 (70.6) 51 Interdepartmental review 48 (4.8) 8 (25.0) 2 (6.3) 22 (68.8) 32 Selected by quality assurance review 127 (4.3) 13 (14.6) 8 (9.0) 68 (76.4) 89 Extradepartmental review 92 (8.6) 8 (14.0) 12 (21.1) 37 (64.9) 57 Total 43 27 197 267 of case review that involve clinical input are a better means to detect error but are harder to perform. Pathologists have studied error frequency using intralaboratory quality assurance methods in some detail. The most commonly studied review method is correlation, such as frozen-permanent section correlation or cytologichistologic correlation, a form of review mandated by the Clinical Laboratory Improvement Amendments of 1988. 20 Using this review process and the total number of cases as the denominator, Clary et al 6 reported that 2.26% and 0.44% of nongynecologic cytology and histology cases were discrepant. This Q-Probes study showed that the error frequency based on extradepartmental conference review was 7.1%, whereas Raab et al 30 reported an error frequency of 8.9%, with severe significant events occurring in 7.0% of all errors. McBroom and Ramsay 11 reported that 80 335 27 56 26 59 179 15 24 13 15 18 40 243 33 53 103 9.0% of cases reviewed at a clinicopathologic conference had a change in diagnosis. This similarity in error frequency across studies and across many institutions may indicate a true benchmark. Benchmarking and reducing anatomic pathology error frequency clearly is just beginning, and prior to this study, the benchmarks were based on single-institution or anecdotal data. 2 The correlation of error frequencies with particular secondary review practices and existing laboratory error reduction programs is largely unknown. Lack of subspecialty expertise may contribute to higher error frequencies, although error data detected using extradepartmental specialty academic institution review may be biased and may overreport error. 4,7,31 Underreporting of error because of biased review methods, lack of understandable error taxonomy, and individual fears invariably exists,
ut this has not been thoroughly studied in pathology laboratories. Some leading patient safety researchers, such as Resar et al, 32 have argued that error prevention programs should target errors that have an effect on patient outcome, rather than all errors. These Q-Probes study data show that the majority of anatomic pathology discrepancies do not result in harm, similar to the data reported in nonpathology fields. 1 Determining the effect of a pathology error on patient outcome is challenging because of contact and temporal barriers between pathology and clinical care. Thorough medical record review generally is not performed after a pathology error has occurred, and health care systems invariably lack personnel trained in the intricacies of the triad of pathology reporting, patient safety, and assessing patient outcomes. Grzybicki et al 27 reported that even with data from medical record review, pathologists showed poor agreement in determining if harm actually occurred. We used pathologist self-assessment to determine error severity, and acknowledging the biases inherent in this process, we found that 16.6% of all errors resulted in some form of patient harm. This indicates that 1.1% of all anatomic pathology cases that underwent secondary review were associated with a harmful significant event. Because secondary review processes tend to be varied across institutions, the probability is high that a relatively large percentage of pathology errors resulting in harm go undetected. Statistical significance testing did not show that any body site was most likely to be associated with an error. However, some organs (eg, female genital tract and breast) tended to have higher associations with a discrepancy resulting in clinical harm compared with other organs. Using medical chart review to determine clinical follow-up of errors detected through cytologic-histologic correlation, Clary et al 6 reported that the most common cytology specimens associated with harm were pulmonary and breast specimens. In a study examining errors associated with malpractice claims, Troxel and Sabella 15 also identified that diagnostic errors in breast cytology specimens were associated with harm; in addition, they identified other organ or specimen types, such as prostate needle biopsies, Papanicolaou tests, and melanocytic skin lesions, as being associated with errors resulting in harm. In this Q-Probes study, discrepancies detected in cytology specimens were more likely (compared with surgical pathology specimens) to have a 2-step change in diagnosis, and this change often meant that the original diagnosis was either a false-negative or false-positive diagnosis. These types of errors are more likely to have a clinical effect than other types of errors. 2 Harm was more likely to be associated with cases reviewed at the behest of a clinician and cases sent for extradepartmental review. Although researchers have studied anatomic pathology diagnostic variability, the relationship of variability and error is not sufficiently addressed in the pathology literature. Strictly speaking, variability is a form of error, and secondary case review is simply a means to unearth differences in diagnosis or errors. In practice, some pathologists would like to maintain that ‘‘true’’ diagnostic errors are errors that most reasonable pathologists would agree are errors. However, establishing the ‘‘true’’ diagnosis is a complex and controversial task (eg, do we use a panel of practicing pathologists or experts?) that has not been well studied in anatomic pathology. Our study did not address methods of establishing the accuracy of the original and review diagnoses. However, some methods of secondary review were performed with knowledge of clinical outcome, which, although biasing the review pathologist (compared with the original pathologist, who lacked this bias), provides a window on the actual effect of the diagnosis. This Q-Probes study recorded errors other than interpretive errors. Typographic errors and changes in patient information infrequently result in harm, but when harm occurs, it may be severe, with far-reaching consequences (eg, switching of patient specimens). Pathology laboratories place checks in the system in order to limit these error types, although these safeguards are generally not formally shared across laboratories. The frequency of marked harm as a result of these errors is known only through small studies or anecdotally, 9,33,34 resulting in a lack of widespread system learning. Our study was not detailed enough to drill down into these error types. The lack of report clarity is an example of error that is difficult to quantify and falls within the realm of communication error. Poor communication is an important source of error in clinical medicine and may result in severe harm 35 ; Dovey et al 25 reported that 5.8% of family practice errors were a result of miscommunication. Report clarity is subjective, and Powsner et al 28 reported that surgeons misunderstood 30% of pathology reports. As expected, in this Q-Probes study, pathologists believed that the majority of reports were clear, and less than 1% were perceived as markedly unclear. This confirms the conclusion by Powsner et al 28 that a communication gap exists between pathologists and clinicians. The fact that clinicians request that a certain percentage of cases be reviewed underscores a potential communication problem but shows as well a functioning means of detecting error. Conclusions Using secondary pathologist review, the mean anatomic pathology diagnostic discrepancy frequency was 6.7%. More than 1% of all reviewed anatomic pathology cases may be associated with an error associated with patient harm. The College of American Pathologists provided financial support. The statistical reviewer was Molly Walsh, PhD, College of American Pathologists. References 1. Kohn LT, Corrigan JM, Donaldson MS, eds. To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press; 1999. 2. Raab SS. Improving patient safety by examining pathology errors. Clin Lab Med. 2004;24:849–863. 3. Adad SJ, Souza MA, Etchebehere RM, et al. Cyto-histological correlation of 219 patients submitted to surgical treatment due to diagnosis of cervical intraepithelial neoplasia. Sao Paulo Med J. 1999;117:81–84. 4. Arbiser ZK, Folpe AL, Weiss SW. Consultative (expert) second opinions in soft tissue pathology: analysis of problem-prone diagnostic situations. Am J Clin Pathol. 2001;116:473–476. 5. Chan YM, Cheung AN, Cheng DK, et al. Pathology slide review in gynecologic oncology: routine or selective? Gynecol Oncol. 1999;75:267–271. 6. Clary KM, Silverman JF, Liu Y, et al. Cytohistologic discrepancies: a means to improve pathology practice and patient outcomes. Am J Clin Pathol. 2002; 117:567–573. 7. Hahm GK, Niemann TH, Lucas JG, et al. The value of second opinion in gastrointestinal and liver pathology. Arch Pathol Lab Med. 2001;125:736–739. 8. Furness PN, Lauder I. A questionnaire-based survey of errors in diagnostic histopathology throughout the United Kingdom. J Clin Pathol. 1997;50:457–460. 9. Hocking GR, Niteckis N, Cairns BJ, Hayman JA. Departmental audit in surgical anatomical pathology. Pathology. 1997;29:418–421. 10. Labbe S, Petitjean A. False negatives and quality assurance in cervicouterine cytology. Ann Pathol. 1999;19:457–462. Arch Pathol Lab Med—Vol 129, April 2005 Patient Safety in Anatomic Pathology—Raab et al 465
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