Use of Formal Root Causes Analysis of Anatomic Pathology Errors to Classify System and Active Components
JB Thomison, H Currens, SS Raab. University of Colorado Denver, Aurora, CO
Background: Anatomic pathology error evaluation and root cause analysis historically has focused on the misdiagnoses of unusual entities or diagnostic pitfalls for more common diseases, suggesting that error cause is associated with cognitive or performance deficiencies of specific pathologists or clinicians. We evaluated the effectiveness of formal root cause analysis to determine the frequency of specific causes in errors detected by the cytologic-histologic correlation process.
Design: We examined 50 consecutive cytologic-histologic correlation-detected errors in 34 gynecologic and 16 non-gynecologic specimens over a 3 month interval. initially, we used a method that graded discrepant histologic and cytologic specimens in terms of quality and the amount of tumor. We then performed a modified Eindhoven method of root cause analysis to determine latent (system) and active (personnel) causes of error. These causes were then evalauted to examine which error causes could be addressed by process improvement.
Results: In our initial assessment, 48% of cytology/surgical specimens were of low quality consisting of the relative absence of tumor cells, obscuring blood, or other artifacts that limited interpretation. In 33% of these cases, some reviewers retrospectively identified possible tumor although generally classified the sample as non-definitive. Of cases in which the specimen was of sufficient quality, at least some tumor cells were identified in 78% of cases and generally was of low volume. The overwhelming cause of error was multiple system failures. Laboratory sources of error included poor preparation (40% of cases), lack of standardized criteria for classifying specimens as less than optimal (50%), lack of training in the interpretation of challenging samples (60%), and lack of protocols to handle small samples (10%). Clinical sources of error included inadequate handling of bloody samples (30%), lack of clinical standardization in obtaining samples (100%), inexperience, and inadequate transport techniques. Although redesign could address many of these factors, overall systems that resulted in busy schedules, lack of a patient safety focus, and inadeqaute training in improvement techniques hampered actual reorganization.
Conclusions: Pathology errors are almost always multifactorial and results from defective laboratory and clinical systems. Although there is a tendency to attribute error to personnel failures, 100% of individual diagnostic errors occur when systems do not address a vast array of error-prone processes and protocols.
Category: Quality Assurance
Tuesday, March 10, 2009 9:00 AM
Platform Session: Section F 1, Tuesday Morning