Error Reduction and Prevention in Surgical Pathology Raouf E. Nakhleh Keith E. Volmar Editors Second Edition 123 Error Reduction and Prevention in Surgical Pathology Raouf E. Nakhleh • Keith E. Volmar Editors Error Reduction and Prevention in Surgical Pathology Second Edition Editors Raouf E. Nakhleh Keith E. Volmar Mayo Clinic Florida Rex Healthcare Jacksonville, FL Raleigh, NC USA USA ISBN 978-3-030-18463-6 ISBN 978-3-030-18464-3 (eBook) https://doi.org/10.1007/978-3-030-18464-3 © Mayo Foundation for Medical Education and Research 2019 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors, and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Switzerland AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland Preface The first edition of Error Reduction and Prevention in Surgical Pathology was an opportunity to pull together into one place all the ideas related to errors in surgical pathology and to organize a discipline in error reduction. The second edition is an opportunity to refine this information. Most notably, the second edition has a second editor that brings a fresh and younger perspective. In this edition, we wanted to continue to include what works and to improve sections that have not met the mark. We tried to reorganize the book to improve its usability and practicality and to include topics that were not previously addressed. In the introductory section, we include general principles and ideas that are nec- essary to understand the context of error reduction. In addition to general principles of error reduction and legal and regulatory responsibilities, we added a chapter on regulatory affairs and payment systems which increasingly may be impacted by error reduction and improvement activities. This later chapter is particularly impor- tant in view of the implementation of various value-based payment programs, such as the Medicare Merit-Based Incentive Payment System, that became law in 2015. The remainder of the book is organized in a similar manor to the first edition with chapters devoted to all aspects of the test cycle, including pre-analytic, analytic, and post-analytic. The pre-analytic section is focused on specimen identification before the speci- men gets to the lab as well as within the lab. Tissue processing, routine histology, and immunostains are addressed in this section from the technical and procedural aspect of the work. The analytic section emphasizes how pathologists do their work and how diag- noses are made. There is an attempt to understand the factors that are necessary to achieve an accurate diagnosis. The practice of medicine for pathologists is depen- dent greatly on a pathologist’s subjective ability to interpret tissue and manage cases appropriately to arrive at an accurate diagnosis. Central to this is the pathologist’s knowledge and experience. Other factors that may be needed in any particular case include clinical correlation, standardized criteria and terminology, ancillary studies, and a system of review. v vi Preface In the first edition, the post-analytic section was focused on the creation and delivery of reports as well as other aspects of communication. While this is main- tained with emphasis on procedures, structures, and delivery systems of pathology reports, new chapters were added to focus other important factors that significantly enhance patient care by reducing error. These include the leveraging of information technology to understand fully how error occur within a laboratory, tracking and managing these problems over time and conducting root cause analysis to continu- ously improve the system. The final chapter is devoted to disclosure of errors. This topic has only recently been introduced to the field of pathology but is important to understand because patient outcomes is what really matters, and the pathology community has to under- stand the effect of errors on patients. We also have to be prepared for the possibility of being involved with error disclosures. Jacksonville, FL, USA Raouf E. Nakhleh Raleigh, NC, USA Keith E. Volmar Contents Part I I ntroduction and General Principles 1 General Principles of How Errors Occur and How They May Be Reduced . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Maxwell L. Smith and Stephen S. Raab 2 Error Management: Legal and Regulatory Responsibilities . . . . . . . 17 Timothy Craig Allen 3 Quality Performance and Compensation Considerations . . . . . . . . . . 33 Diana M. Cardona and Jonathan L. Myles Part II P re-analytic Factors Contributing to Error 4 Error Reduction in the Preanalytical Process . . . . . . . . . . . . . . . . . . . 55 Richard W. Brown 5 Ancillary Studies: Contribution to Error and Error Prevention . . . . 77 Dhananjay Chitale Part III A nalytic Factors Contributing to Error 6 Work Habits Contributing to Error in Surgical Pathology . . . . . . . . 109 Keith E. Volmar 7 Clinical History and Clinical Correlation . . . . . . . . . . . . . . . . . . . . . . . 123 Keith E. Volmar 8 Standardization of Diagnostic Terminology and Criteria: A Prelude for Error Reduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139 Raouf E. Nakhleh 9 Optimization of Case Reviews in Different Practice Settings . . . . . . . 151 Raouf E. Nakhleh vii viii Contents 10 Pathologists’ Knowledge, Experience, and Judgment in Diagnostic Error Prevention (Pathologists’ Competence) . . . . . . . 163 Raouf E. Nakhleh Part IV P ost-analytic Factors Contributing to Error 11 The Complete Surgical Pathology Report . . . . . . . . . . . . . . . . . . . . . . 173 Bryce S. Hatfield and Michael O. Idowu 12 Communicating Effectively in Surgical Pathology . . . . . . . . . . . . . . . 187 Carolyn Mies 13 Error Prevention in Transcription and Report Distribution . . . . . . . 199 Shannon J. McCall 14 Leveraging Information Technology in Error Prevention . . . . . . . . . 215 Anil Vasdev Parwani 15 Tracking of Report Defects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243 Keith E. Volmar 16 Root Cause Analysis in Surgical Pathology . . . . . . . . . . . . . . . . . . . . . 257 Y. Chen and Yael K. Heher 17 D isclosure of Pathology Error to Treating Clinicians and Patients . . . 275 Suzanne M. Dintzis and Yael K. Heher Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 289 Contributors Timothy Craig Allen, MD, JD Department of Pathology, The University of Mississippi Medical Center, Jackson, MS, USA Richard W. Brown, MD System Laboratory Services, Memorial Hermann Health System, Houston, TX, USA Diana M. Cardona, MD Department of Pathology, Duke University Medical Center, Durham, NC, USA Y. Chen, MPH, PSSP Department of Pathology and Laboratory Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA Dhananjay Chitale Department of Pathology, Henry Ford Health System, Detroit, MI, USA Suzanne M. Dintzis Department of Pathology, University of Washington Medical Center, Seattle, WA, USA Bryce  S.  Hatfield, MD Department of Pathology, Virginia Commonwealth University Health, Richmond, VA, USA Yael K. Heher, MD, MPH, FRCPC Department of Pathology and Laboratory Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA Michael O. Idowu, MD, MPH Department of Pathology, Virginia Commonwealth University Health, Richmond, VA, USA Shannon J. McCall, MD Department of Pathology, Duke University, Durham, NC, USA Carolyn Mies, MD Department of Pathology and Laboratory medicine, University of Pennsylvania, Philadelphia, PA, USA Jonathan L. Myles, MD Department of Pathology, Robert J. Tomsich Institute of Pathology and Laboratory Medicine, Cleveland Clinic, Cleveland, OH, USA ix x Contributors Raouf E. Nakhleh, MD Mayo Clinic Florida, Jacksonville, FL, USA Anil  Vasdev  Parwani, MD, PhD, MBA Division of Pathology Informatics, Department of Pathology, The Ohio State University, Columbus, OH, USA Stephen  S.  Raab, MD Department of Pathology, University of Mississippi Medical Center, Jackson, MS, USA Maxwell L. Smith, MD Department of Laboratory Medicine and Pathology, Mayo Clinic Arizona, Scottsdale, AZ, USA Keith E. Volmar, MD Rex Healthcare, Raleigh, NC, USA