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THE HANDBOOK OF PATIENT SAFETY COMPLIANCE

A Practical Guide for Health Care Organizations

Fay A. Rozovsky and James R. Woods Jr., Editors

Foreword by Maree Bellamy

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FIGURES, TABLES, AND EXHIBITS

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FOREWORD

Patient safety is making the transition from infancy and is entering a tumultuous adolescence, with all the resultant challenges.

Ensuring patient safety is the first critical step in improving quality of care. At all levels, health care workers make decisions every day involving patient safety. Patient safety is about protecting patients from incurring harm while they are receiving health care. It is an international issue. Although safe care has always been a priority, in recent times we have seen a growing realization of how unsafe care affects all the key stakeholder groups in the health care sector. Recognition and open acknowledgement have generated lively discussion as well as a search for solutions to the problem of unsafe care.

This book provides helpful perspectives on the evolution of patient safety, and suggestions for future activities geared to lessening the risk of harm. As discussed in this volume, several national studies, conducted in various countries, have identified unacceptable levels of adverse patient events, leading to the establishment of national and local strategies aimed at reducing the incidence of such events. Indeed, throughout the world new trends are emerging, including steps taken by organizations to appoint individuals with patient safety responsibilities, and the specific dedication of funds to patient safety projects and research. Many workshops and conferences have been held, and more are on the horizon. Standards for patient safety have been set by national groups and more are in the process of being set, and in some locations such standards are already an integral part of health care accreditation programs.

Accompanying this activity is a growing awareness of the importance of effective governance and risk management dedicated to the provision of safe health care services. In some settings the emphasis is on clinical risk management and clinical governance. In others it is on enterprise-wide or integrated risk management and health care governance strategies. As discussed throughout this book, national and international frameworks have been established. Examples also illustrate how risk management, patient safety, and quality improvement are intrinsically linked, rather than functioning as separate activities.

Many organizations find it difficult to strategize beyond the identification of error, risks, and adverse outcomes. It is essential that the right systems, protocols, standards, and incentives be in place to address the issues that are identified. This book provides a practical understanding of why patient safety is everyone’s responsibility. It provides a framework for developing a patient safety program, effectively examining the adverse events that do occur, and ensuring that appropriate corrective and preventive actions are reviewed for effectiveness.

When patient safety is managed properly, it requires rigorous, forward thinking and encourages an organization to manage proactively rather than reactively. It requires a thorough understanding and appreciation of clinical and other processes in the health care organization, including knowledge of key business operations and the various standards and legislative requirements that have to be met. Patient safety must be managed continuously. The material provided in this book offers insight into a variety of patient safety tools and techniques and guidance for implementing these tools and techniques to manage patient safety in a consistent and systematic way. The underlying principles are generic, but each organization’s unique environment determines which of these tools and techniques are likely to yield the greatest results in the local setting.

Although health care is a high-risk and complex industry, until recently it was lagging behind other industries that experience similar consumer safety expectations. We still have much more to learn from those groups about how to create an effective culture of safety, but the quest has begun. We now also have good information available from our own sector. The contributors to this book present resources and examples from health care as well as other industries to assist health care organizations to develop and implement patient safety programs successfully. Some of the most eminent patient safety specialists in the world are contributors to this volume. They have provided enormous depth and diversity of expertise to the wider health care community and to the development of innovative patient safety concepts.

This book also recognizes the impact of legislative and regulatory initiatives that have helped to shape contemporary patient safety efforts in the United States. Equally apparent in some of the chapters is the need for legislative change, especially with regard to the use of patient safety and quality data in litigation involving health care professionals.

Going forward, the goal is to create a culture of safety across the continuum of care, supported by continuous improvement initiatives and effective governance and risk management strategies. Known already are many of the important ingredients in the recipe for patient safety. We know that the right culture can develop only where there is strong leadership from senior managers and boards of governance. These components must be accompanied by effective clinician involvement, using techniques that capture the enthusiasm of those who deliver care. And each of these elements must unite within the boundaries set by local medicolegal and regulatory conditions. A cohesive national strategy is imperative if we are to succeed in increasing patient safety. This book draws together important information and case studies that exemplify such initiatives, in the hope of stimulating practical interventions to further patient safety.

January 2005

Maree Bellamy
Australia

Note

THE EDITORS

Fay A. Rozovsky has over twenty-five years of experience as a health care risk management consultant and attorney. She has lectured extensively and authored or coauthored over five hundred articles and several books including Consent to Treatment: A Practical Guide; Clinical Trials and Human Research (with Rodney Adams); and What Do I Say? Communicating Intended or Unanticipated Outcomes in Obstetrics (with James R. Woods Jr.). Her expertise in consent law has been recognized by several courts, including the U.S. Supreme Court in the Cruzan decision and the highest courts in Hawaii, Kentucky, West Virginia, and several other states. A graduate of Providence College, she received a JD degree from Boston College Law School and an MPH degree from the Harvard School of Public Health. She is an adjunct associate professor of Medical Humanities at the University of Rochester School of Medicine and Dentistry and an affiliate associate professor in the Department of Legal Medicine at the Medical College of Virginia. She is admitted to the practice of law in Florida and Massachusetts. A Distinguished Fellow of the American Society for Healthcare Risk Management, she is also a past president of the society. In 1998, she was awarded ASHRM’s Distinguished Service Award, the highest honor bestowed on a member of ASHRM. Currently, she is the chair of the Professional Technical Advisory Committee for Hospitals of the Joint Commission on Accreditation of Healthcare Organizations.

James R. Woods Jr. is the Henry A. Thiede Professor and chair of the Department of Obstetrics and Gynecology at the University of Rochester School of Medicine, Rochester, New York. He completed medical school at the Bowman Gray School of Medicine, his residency in obstetrics and gynecology at Tripler Army Medical Center in Hawaii, and his perinatal fellowship at the UCLA School of Medicine. He has authored or coauthored over one hundred and forty articles on maternal-fetal medicine, maternal drug addiction, complications of pregnancy, and clinical research. His books include What Do I Say? Communicating Intended or Unanticipated Events in Obstetrics (with Fay A. Rozovsky). He has served as a regular member of an NIH Study Section (NIDA) and as guest editor for Clinical Obstetrics and Gynecology and Obstetrics and Gynecology Clinics of North America. In 1996, an endowed chair honoring Dr. Woods was established at the University of Rochester. He has been named in Best Doctors in America for many years, most recently 2003. He has lectured extensively on loss and grief in the medical setting. He has pioneered strategies for transforming some of the most challenging clinical interactions with patients after adverse outcomes into extraordinary opportunities for compassionate connection between clinicians and their patients and family members.

THE CONTRIBUTORS

Rodney K. Adams is an attorney with LeClair Ryan, A Professional Corporation, where he specializes in patient care issues and health care litigation. He represented several large hospitals and medical colleges in Chicago before moving to Richmond in 1991. He currently counsels and defends hospitals, nursing homes, physicians, and other health care providers in court and administrative forums, having defended more than thirty trials in Virginia. He has taught health law at the IIT-Kent College of Law and trial advocacy at the University of Richmond School of Law. He graduated from Millikin University; the University of Glasgow, Scotland (with an LLM degree in forensic medicine); and the University of Illinois College of Law. He is admitted to the state and federal courts of Virginia, District of Columbia, and Illinois. A member of the American Health Lawyers Association and the Virginia Association of Defense Attorneys, he serves on a hospital system bioethics committee and the board of directors for the St. Francis Home, a nonprofit assisted-living residence. He is cochair of the Medical Ethics Subcommittee, American Bar Association. A frequent speaker at state and national health care meetings, he is also the author of Virginia Medical Law (2000) and coauthor of Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance (with Fay A. Rozovsky, 2003).

David M. Benjamin is a PhD-trained clinical pharmacologist and toxicologist and a nationally recognized scholar in legal medicine and the reduction of medication errors. He is adjunct assistant professor in the Department of Pharmacology and Experimental Therapeutics at Tufts University School of Medicine and is a guest lecturer at Harvard Medical School, Stetson University College of Law, and George Washington University Law School. A Fellow of the American College of Clinical Pharmacology, the American College of Legal Medicine, the American Academy of Forensic Sciences (Toxicology), and the American Society for Healthcare Risk Management, he has published or presented over 180 papers and has been featured on “Forensics Files” and Court-TV. He also serves on the editorial boards of the Journal of Clinical Pharmacology and the Journal of Healthcare Risk Management.

Christina W. Giles is the principal in Medical Staff Solutions, a consulting firm specializing in education and training medical staff administrative functions such as credentialing and privileging, assessment and development of medical staff governance documents, and survey preparation. She serves as an adviser to multiple medical staff publications, including Brownstone’s Credentialing and Peer Review Legal Insider; and is a contributing editor to The Handbook of Medical and Professional Staff Management. She is an instructor for El Centro College’s Medical Staff Services associate’s degree program and has presented nationally on such topics as accreditation preparation, credentialing, privileging, and medical staff office management. She is a certified professional medical services management (CPMSM) and holds an MS degree.

Mark A. Kadzielski is the partner in charge of the West Coast Health Law Practice at Fulbright & Jaworski LLP. His practice focuses on the representation of hospitals, medical staffs, managed care enterprises, and institutional and individual health care providers throughout the United States in a broad spectrum of matters, including governmental regulatory investigations, managed care, credentialing, licensing, medical staff bylaws, Joint Commission accreditation and Medicare certification. He speaks and publishes frequently on matters of health law. He has been selected through peer evaluations for inclusion in the healthcare law section of The Best Lawyers in America for the past several years. He has served on the board of directors of both the American Academy of Healthcare Attorneys and the American Health Lawyers Association. He has also served on many advisory bodies in the healthcare industry. He earned his JD degree from the University of Pennsylvania Law School.

Susan Durbin Kinter is director of claims, litigation and risk management with the Maryland Medicine Comprehensive Insurance Program, a joint venture between the University of Maryland Medical System and University Physicians, Inc. Prior to joining the Maryland Medicine Comprehensive Insurance Program, she was an associate with Miles & Stockbridge, P.C., where her practice focused on medical malpractice defense litigation. She holds an RN degree, and she received her JD degree from the University of Maryland School of Law and her BSN degree from Michigan State University. She is a member of the American Society for Healthcare Risk Management, the Maryland Society for Healthcare Risk Management, and the Maryland Bar Association.

Robert J. Latino is executive vice president of strategic development for Reliability Center, Inc. (RCI). RCI is a consulting firm specializing in improving equipment, process, and human reliability. He has been facilitating RCA, FMEA, and OA analyses with his Fortune 500 clientele around the world for twenty years and has taught over 10,000 students in the PROACT Methodology, resulting in billions of dollars in documented savings. He has spent the last four years doing research on the health care culture as it contrasts to the industrial culture, in order to make appropriate modifications to methodologies and successfully bridge the proactive technologies from industry to health care. He is a coauthor of Root Cause Analysis: Improving Performance for Bottom Line Results (with Kenneth Latino, 2002) and a contributor to Error Reduction in Healthcare: A Systems Approach to Improving Patient Safety (1999). He has been published in numerous trade magazines and journals on the topics of RCA, FMEA, and OA and is also a frequent speaker on these topics at trade meetings and conferences. He received his bachelor’s degree in business administration and management from Virginia Commonwealth University.

Jane C. McConnell is executive director of the Maryland Medicine Comprehensive Insurance Program, a joint venture between the University of Maryland Medical System and University Physicians, Inc. Her past positions include vice president, insurance and risk management, for the Franciscan Sisters of Allegheny Health System, Inc. in Tampa, Florida, vice president for risk management for FOJP Service Corporation in New York City, deputy director of the New York County Professional Review Organization, director of nursing at the Brooklyn Cumberland Medical Center, and director of quality assurance with the New York City Health Department. She received her JD degree from Fordham University School of Law, two master’s degrees including an MBA degree from New York University, an RN degree from St. Vincent’s Hospital in New York, and an Associate in Risk Management designation from the Insurance Institute of America. She is a past president of the American Society for Healthcare Risk Management and a member of the Maryland Society for Healthcare Risk Management and the American Bar Association.

Lara E. Parkin is an associate with the Health Care Practice group in Fulbright & Jaworski’s Washington, D.C., office. Her practice focuses on litigation defense of pharmaceutical companies and regulatory matters involving the protection of human subjects in research. She received her BS degree with highest honors from the Florida Institute of Technology and her JD degree with high honors from the University of Florida, where she was managing editor of the Journal of Law and Public Policy. She is a member of the Virginia and District of Columbia bars.

Pamela L. Popp has over twenty years of health care risk and claims management experience. She will serve as president in 2005 for the American Society for Healthcare Risk Management (ASHRM). She is also on the board of directors, and serving as president, for the AHA Certification Center, which develops and administers the Certified Professional in Healthcare Risk Management (CPHRM) exam. She has held leadership positions in local, state, and national risk management organizations throughout her career. She obtained her bachelor’s degree from Truman University, her M.A. degree from Webster University, and her JD degree from St. Louis University School of Law, and she is a Certified Professional in Healthcare Risk Management and a Fellow of ASHRM.

Peter J. Pronovost is a practicing anesthesiologist and critical care physician, a lecturer, a patient safety researcher, and leader. He is associate professor in the Departments of Anesthesiology and Critical Care Medicine and Surgery in the School of Medicine, Nursing in the School of Nursing and Health Policy and Management in the Bloomberg School of Public Health at the Johns Hopkins University. He has written more than 100 articles and chapters in the fields of patient safety, intensive care unit (ICU) care, quality health care, and evidence-based medicine. Within the Johns Hopkins community he is medical director for the Center for Innovations in Quality Patient Care and cochairs the hospital’s Patient Safety Committee. Nationwide, he is chair of the ICU Advisory Panel for Quality Measures for the Joint Commission on Accreditation of Healthcare Organizations and chair of the ICU Physician Staffing Committee for the Leapfrog Group, is helping lead an effort to develop the ideal ICU design with the Institute for Healthcare Improvement, and is developing standards for ICU quality nationwide. He is currently leading two large, nationwide safety projects, funded by the Agency for Healthcare Research and Quality. In the first he is implementing an error-reporting system in 30 ICUs in the United States. In the second he is working with the Keystone Center for Patient Safety and Quality at the MHA Health Foundation to improve care in over 107 ICUs in the state of Michigan. His evaluation of the association between ICU organizational characteristics and outcomes formed the basis for the Leapfrog Group’s ICU purchasing specification. In addition to his MD degree, he holds a PhD degree in clinical investigation from the Johns Hopkins Graduate Training Program in Clinical Investigation at the Bloomberg School of Public Health.

Frederick Robinson is the partner in charge of the Health Law Practice in Fulbright & Jaworski’s Washington, D.C., office. His cases cover all phases of trial and appellate practice in both criminal and civil cases, including qui tam, or “whistle-blower,” lawsuits under the federal False Claims Act, and represents major corporations and their officers in white-collar criminal cases. He also assists health care providers with the creation and implementation of corporate compliance programs and with voluntary disclosure matters. He has written numerous articles and is a regular speaker at seminars and conferences regarding health care compliance matters. He graduated with honors from Duke University School of Law in 1982 and is admitted to the Maryland and District of Columbia bars.

John P. Santell is director of educational program initiatives at the United States Pharmacopeia (USP) Center for the Advancement of Patient Safety, developing programs and publications to advance the scientific understanding of medication errors. He uses data collected through USP’s two medication error-reporting programs—MEDMARX and the Medication Errors Reporting (MER) programs—to develop regular informative articles for several journals for health professionals. He is also the editor of CAPSLink, an e-newsletter that delivers the latest information and research on patient safety issues. Prior to taking his current position, he spent nine years with the American Society of Health-System Pharmacists (ASHP) as director, Center on Pharmacy Practice Management. His practice work experience also includes eleven years of hospital pharmacy positions, including director of pharmacy. He has extensively researched, authored, and published articles and made numerous presentations on topics related to patient safety and is a member of the ASHP and the Federation of International Pharmacy. A registered pharmacist, he earned his B.S. degree in pharmacy from Duquesne University and his M.S. degree from Ohio State University, and completed a two-year, ASHP-accredited residency in hospital pharmacy administration, also at Ohio State.

Ronni P. Solomon is executive vice president and general counsel of ECRI, a health services research agency in suburban Philadelphia that focuses on patient safety, evidence-based medicine, and health care technology. She has over twenty years of experience in developing and leading initiatives for both the public and private sectors on patient safety, adverse-event reporting systems, clinical guidelines development, quality assessments, and risk management in the United states and internationally. She has lectured extensively and authored numerous book chapters and articles on these topics. She received her JD degree from Widener University School of Law and completed undergraduate studies at Temple University.