Journal of the American Society of Cytopathology (2018) 7,61e78 Available online at www.sciencedirect.com ScienceDirect journal homepage: www.jascyto.org/ REVIEW ARTICLE Laboratory management curriculum for cytopathology subspecialty training Ritu Nayar, MDa,*,**, Güliz A. Barkan, MDb,*, Cynthia Benedict, MDc,*, Christine Booth, MDd,*, David C. Chhieng, MDe,*, Dina Mody, MDf,*, Momin T. Siddiqui, MDg,*, Laura Z. Tabatabai, MDh,*, Rebecca Johnson, MDi a Northwestern University, Feinberg School of Medicine, Department of Pathology and Northwestern Memorial Hospital, Chicago, Illinois b Loyola University Healthcare System, Department of Pathology, Maywood, Illinois c DCL Pathology, LLC, Indianapolis, Indiana d Cleveland Clinic, Department of Pathology, Cleveland, Ohio e Department of Pathology, University of Washington, School of Medicine, Seattle, Washington f Department of Pathology, Houston Methodist Hospital, Houston, Texas g Department of Pathology, Weill Cornell School of Medicine, New York, New York h Department of Pathology, University of California San Francisco and San Francisco VA Medical Centers, San Francisco, California i American Board of Pathology, Tampa, Florida ** Chair and * Members of The American Board of Pathology’s Cytopathology Test Development Committee. Received 17 October 2017; received in revised form 7 December 2017; accepted 11 December 2017 KEYWORDS Laboratory management should be an integral part of training in pathology residency and fellowships. Here- Laboratory management; in, we have outlined some basic laboratory management topics a graduating cytopathology fellow should be Cytopathology; familiar with. An overview of regulatory agencies that have oversight over laboratory testing, cytopathology Curriculum; laboratory accreditation, pre-analytic, analytic and post-analytic quality assurance, billing/coding, basic sta- Fellowship training; tistics, verification/validation of testing, physician credentialing, board certification/maintenance of certifica- Pathology tion, and malpractice in cytopathology are addressed. This review is by no means all inclusive, but rather a guide to the basic management related topics to be covered during cytopathology subspecialty training. Ó 2017 The Authors. Published by Elsevier Inc. on behalf of American Society of Cytopathology. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). *Corresponding author: Ritu Nayar, MD; Department of Pathology, Northwestern University, Feinberg School of Medicine, 251 East Huron Street, Galter 7-132B, Chicago, IL 60611; Tel.: (312) 926-7002. E-mail address: [email protected] (R. Nayar). 2213-2945/Ó 2017 The Authors. Published by Elsevier Inc. on behalf of American Society of Cytopathology. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). https://doi.org/10.1016/j.jasc.2017.12.003 Downloaded for Anonymous User (n/a) at SAN FRANCISCO VA MEDICAL CENTER from ClinicalKey.com by Elsevier on January 14, 2020. For personal use only. No other uses without permission. Copyright ©2020. Elsevier Inc. All rights reserved. 62 R. Nayar et al. Contents Introduction ....................................................................................................62 Agencies involved in laboratory regulation ...........................................................................62 General aspects and basis of cytopathology laboratory accreditation .......................................................62 Specific laboratory pre-analytic, analytic, and post-analytic quality assurance measures in cytopathology laboratories ...............66 Specimen collection, receipt, and preparation ......................................................................66 Gynecologic cytology ......................................................................................66 Nongynecologic cytology . .................................................................................66 Diagnostic interpretation .......................................................................................67 Cytology histology correlation ...............................................................................67 Management implications of cytopathology results ..................................................................67 Federally mandated gynecologic cytology proficiency testing .........................................................68 Additional laboratory management essentials for cytopathology fellows . ..................................................68 Test validation and verification . .................................................................................68 Informatics and telemedicine . .................................................................................69 Statistics ....................................................................................................69 Physician/professional regulation . .................................................................................71 Professional practice evaluation (PPE) ............................................................................71 Certification by the American Board of Pathology (ABP) ............................................................71 Maintenance of certification for pathologists .......................................................................72 Billing and coding with applicable health care laws . ..................................................................73 Stark Law . ................................................................................................73 The Sunshine Act ............................................................................................74 Malpractice in cytopathology ......................................................................................75 Conclusion ....................................................................................................76 References .....................................................................................................76 Introduction and to provide safe health care to every individual who accesses the system. There are a number of historical ex- Laboratory management should be an integral part of training amples in medicine in which lack of standards led to in pathology residency and fellowships. Since 2014, the adverse outcomes. Specific to cytology is the exposé on American Board of Pathology has participated in surveys of “Pap mills” in the Wall Street Journal by investigative new in practice (10 years) pathologists that asked about how journalist Walt Bogdanich that played a major role in the residency and fellowship training correlates with the needs in implementation of the Clinical Laboratory Improvement 2 practice. The feedback has consistently shown that laboratory Amendments of 1988. Federal, state, and local regulatory management, billing and coding, informatics, and molecular agencies often establish rules and regulations for the diagnostics are areas in which training was perceived to be less health-care industry, and their oversight is mandatory. than needed, but important or very important areas for practice. Some other agencies, such as those for accreditation, Similar findings were published in 2007.1 Herein, we have require voluntary participation but are important because outlined some basic laboratory management topics with which they provide rankings or certification of quality and serve a graduating cytopathology fellow should be familiar. An as additional oversight, ensuring that health-care organi- overview of regulatory agencies that have oversight over lab- zations promote and provide quality care (Table 1). oratory testing, cytopathology laboratory accreditation, pre- analytic, analytic and post-analytic quality assurance, billing/ coding, basic statistics, verification/validation of testing, General aspects and basis of cytopathology physician credentialing, board certification/maintenance of laboratory accreditation certification, and malpractice in cytopathology are addressed. This review is by no means all inclusive, but rather a guide to Fundamentally, accreditation is a way to ensure that clinical the basic management related topics to be covered during laboratories meet best practices for proficiency, quality, cytopathology subspecialty training. accuracy, and record keeping. To be accredited, a laboratory must set up and maintain mechanisms that are evaluated regularly by an outside entity. Accreditation signals to pa- Agencies involved in laboratory regulation tients, doctors, and insurers that the laboratory is making every effort to provide them with high-quality, accurate Health care is subject to extensive regulation at both the results and that those results are reasonably translatable federal and the state level in order to ensure compliance across accredited laboratories.3 Downloaded for Anonymous User (n/a) at SAN FRANCISCO VA MEDICAL CENTER from ClinicalKey.com by Elsevier on January 14, 2020. For personal use only. No other uses without permission. Copyright ©2020. Elsevier Inc. All rights reserved. Laboratory management curriculum for cytopathology training 63 Table 1 Selected federal agencies and acts related to health care. Agency Acronym Function Centers for Medicare and Medicaid Services CMS CMS is part of the Department of Health and Human Services (HHS) and oversees most of the regulations related directly to the health care system. Centers