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Office of Oversight, Risk and Ethics

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Leadership

Alan Hirshberg, MD, MPH, FACEP

Acting Associate Deputy Under Secretary for Health for Oversight, Risk and Ethics (10ORE), Veterans Health Administration

Erica M. Scavella, MD, FACP, FACHE

Dr. Hirshberg has over 14 years of dedicated service and clinical experience within VA. He most recently served as the Acting Medical Inspector in the Office of the Medical Inspector (OMI) from January 25, 2021 through October 23, 2021. Prior to that role, he served as the OMI Chief Medical Investigator beginning in 2018. Dr. Hirshberg joined OMI in 2016 as a Senior Medical Investigator and has conducted site visits to VHA facilities since then as well as serving on national VA and Emergency Medicine committees related to clinical practice and quality. He began his VA career at the Lebanon VA Medical Center in 2007 as the chief of the emergency department and was appointed to the position of Associate Chief of Staff for Acute Care and Specialty Services in 2008, managing a busy service of 17 specialties including medical and surgical subspecialties with medical student and resident education.

Prior to joining the VA, Dr. Hirshberg had extensive clinical and leadership experience in the field of emergency medicine. He has worked in public and private sector hospitals since 1993, ranging in size from critical access to level one academic trauma centers. He has also assisted the U.S. Coast Guard as a volunteer flight physician on medical evacuations (medevacs) in inclement weather. Dr. Hirshberg has published numerous articles in peer-reviewed medical literature related to emergency medicine and informatics. He is certified by the American Board of Emergency Medicine and previously served as an Associate Professor of Emergency Medicine at the Penn State University Hershey Medical Center, Hershey, PA.

Dr. Hirshberg graduated from Tufts University School of Medicine in Boston with a combined MD/MPH degree in 1990. He has been a fellow of the American College of Emergency Physicians (ACEP) since 1996. He completed the VA Executive Career Field program in 2012, (AMIA) 10X10 Informatics Program in 2015 and 131st Interagency Institute for Federal Health Care Executives in 2017.

National Center for Ethics in Health Care

Toby Schonfeld

Executive Director

Toby Schonfeld, Executive Director

Dr. Toby Schonfeld joined the National Center for Ethics in Health Care as executive director in March 2020. Prior to this appointment, she directed Prime Review Board, where she was responsible for the oversight, maintenance, and improvement of the Human Research Protection Program. Dr. Schonfeld previously served as NCEHC's deputy director then as acting executive director from 2016 to 2018. Before these positions, she served as the Human Subjects Research Review Official at the US Environmental Protection Agency (EPA). In that role, she was responsible for the oversight of all human subjects research conducted or supported by the agency, and for the Human Studies Review Board, a Federal Advisory Committee established by regulation to review third-party human subjects research submitted to the EPA for consideration. She also has 13 years of experience in academic medicine, serving as faculty in two different medical schools and directing a variety of programs in each.

Dr. Schonfeld is a national leader in bioethics, with over 50 national and international presentations and 75 publications. The second edition of her co-edited book (w/D. Micah Hester), Guidance for Healthcare Ethics Committees (Cambridge University Press), is expected in 2020. She is a board member of the American Society for Bioethics and Humanities and is a frequent grant reviewer for the US Department of Defense Congressionally Directed Medical Research Program.

Office of Integrity and Compliance

Tracy Davis Bradley, PhD

Chief Integrity and Compliance Officer, Veterans Health Administration

Tracy Davis Bradley, PhD

Tracy Davis-Bradley, Ph.D. serves as the Chief Integrity and Compliance Officer for VHA. In this role, Dr. Davis-Bradley leads the Office of Integrity and Compliance (OIC) for VHA which provides enterprise leadership, service, support and oversight of compliance activities throughout the VHA. Dr. Davis-Bradley joined Veterans Affairs in 2018 after 25+ years in academia and as a consultant for private and public sector organizations in the areas of risk management, compliance program management, building as culture of integrity and organizational change. She is a published thought leader in integrity, compliance, and risk. Her work has been featured in Harvard Business Review, BusinessWeek, Risk Management Magazine, NYSE Magazine, and Corporate Secretary.

Internal Audit

Robert McMillan, MBA, MS, CIA, CICA, PCP

Chief Audit Executive and Executive Director

Robert McMillan

Robert McMillan, MBA, MS, CIA, CICA, PCP serves as the Chief Audit Executive and Executive Director. Robert previously served as the Executive Director of Regulatory Audit and Agency Advisory Services for the Department of Homeland Security, U.S. Customs and Border Protections, Office of Trade. In this role, he provided executive oversight of the domestic and international Annual Audit Plan and Risk Management Audit Strategy and operated as the principal representative and advisor for his office at interagency and international meetings. During his tenure, Robert's teams identified more than $1 billion in identified loss of international trade revenue due the U.S. government.

Prior to this role, Robert served in various leadership capacities in the private sector, including roles within the health care, financial services and consumer products industries. Most recently, he served as Chief Financial Officer and Deputy Chief Financial Officer for AmeriHealth Caritas/Chartered Health Plan. Prior to that role, he served as the Chief Executive Director of Audit, Finance, Privacy and Compliance and Integrity for Blue Cross Blue Shield Association, where he oversaw the global administration of the Federal Employee Health Benefit Plan, managing contractual relationships with the U.S. Office of Personnel Management. During his career with Blue Cross Blue Shield, Robert also served as Director of Sarbanes-Oxley and Compliance and Manager of e-Commerce. He began his career as an internal auditor in 1995 with Blue Cross Blue Shield of Maryland.

Robert earned a Bachelor of Science degree from Virginia State University. He earned a Master of Business Administration and Master of Science in Information Technology from Johns Hopkins University. He is a Certified Internal Auditor, Certified Internal Controls Auditor and Professional Certified Coach, credentialed from the International Coaching Federation. He completed Harvard Kennedy School Executive Education Certificates in Public Policy and Public Leadership in 2021 and 2020, respectively. He also completed the Harvard Kennedy School Senior Managers in Government program in 2017.

Office of the Medical Inspector

Frederick Kotler, MD

Interim Medical Inspector, Office of the Medical Inspector

Frederick Kotler, MD

Dr. Frederick Kotler graduated from Wesleyan University in Middletown, CT with a B.A. in Biology in 1989, and the University of Maryland School of Medicine in 1993. He completed his internship and residency in Internal Medicine at the University of Pittsburgh Medical Center from 1993-96. He is board certified by the American Board of Internal Medicine. He has worked for the VA for 23 years in various roles. He was a primary care provider at the Baltimore VAMC, the lead physician of the Baltimore Primary Care Clinic, and the Deputy Director of Ambulatory Care for VA Maryland Health Care System from 1998-2010. He was also a Clinical Instructor at the University of Maryland School of Medicine from 2000-2012, with resident teaching privileges at the Baltimore VAMC. In January of 2011, he transitioned to the VISN 5 Network Office as the VISN 5 Primary Care Officer. He was named VISN 5 Deputy Chief Medical Officer in August 2013 with direct responsibilities for Primary Care, Specialty Care, Compensation and Pension, the Integrated Disability Evaluation System, and Transition Care Management. He also served as the Acting Network Homeless Coordinator and supervised the VISN 5 program managers for Women’s Health, Rural Health, and Geriatrics and Extended Care. He chaired or served on multiple VISN 5 boards and committees, including Clinical Services Board, Quality Leadership Board, Primary Care Committee, Pharmacy and Therapeutics Committee, Pain Committee, and Strategic Planning Committee. He joined the VHA Office of Strategic Integration as a Senior Medical Advisor in October 2016 and worked on multiple national level projects. In 2018, he joined the Office of the Medical Inspector as a Senior Medical Investigator and has participated or led over 35 investigations. In October 2021 he was named the VHA Medical Inspector.

Office of Research Oversight

Douglas Bannerman, PhD

Executive Director, Office of Research Oversight (10R), Veterans Health Administration

Douglas Bannerman, PhD

Doug Bannerman, PhD, was appointed Executive Director of the Office of Research Oversight (ORO) in the Department of Veterans Affairs (VA) Veterans Health Administration (VHA) in 2017. In this role, Doug leads the primary VHA office responsible for providing oversight of research program compliance with VA and other Federal requirements pertaining to: the protection of human subjects; research information security; laboratory animal welfare; research safety; research laboratory security; research misconduct; and Federal government-wide debarment for impropriety in VA research. He also serves as the principal adviser to the Under Secretary for Health on matters of research compliance. Doug previously worked at ORO from 2008 to 2015, where he directed the Research Misconduct Oversight Program, and conducted compliance oversight reviews of the research safety, laboratory security, and animal care programs at VA medical centers. Prior to returning to VA as the ORO Executive Director, Doug served as the Senior Advisor on Scientific Integrity and Departmental Scientific Integrity Officer for the U.S. Department of Agriculture (USDA). In that role, Doug developed USDA's scientific integrity program, formulated Department-wide policy on scientific integrity, and provided oversight of responses to resolve scientific integrity concerns. He also served as the principal advisor to the Under Secretary for Research, Education, and Economics on scientific integrity matters. Before becoming involved in policy development and research oversight, Doug conducted biomedical and veterinary research for over 15 years, including several years as a Principal Investigator. He has co-authored 68 peer-reviewed journal articles, received numerous invitations to present his research at national and international scientific meetings, and obtained competitively funded Federal grants and industry funding to support his research. Doug has served on journal editorial boards and grant review panels; served as the primary research adviser for several undergraduate, graduate, and post-doctoral research trainees; chaired an Institutional Animal Care and Use Committee (IACUC); and was elected President of the American Association of Veterinary Immunologists. In recognition of his research, mentoring, and outreach efforts, he was awarded the 2006 Presidential Early Career Award for Scientists and Engineers (PECASE). Doug earned his doctorate (Ph.D.) in Pathology from the University of Maryland at Baltimore,and completed a post-doctoral research fellowship at the University of Washington School of Medicine in Seattle.