New York Medical College Department of Family Medicine

New York Medical College Department of Family Medicine
Error in Medicine Joseph L. Halbach, M.D., M.P.H. Laurie Sullivan, Ph.D., CSW Department of Family Medicine New York Medical College and Saint Joseph’s Medical Center 2003 – 2004 Note to presenter: Ask a participant to read the selected parts of the “New York Times Magazine” article on the death of Jose Martinez Good Morning Thank you for inviting me to speak with you today about an issue that is front and center in the news these days and that affects all of us, as patients ourselves as well as providers. I believe the example of Jose Martinez illustrates so many of the issues surrounding error in medicine. New York Medical College Department of Family Medicine

Jose Eric Martinez The tragedy and suffering of an error A reminder that errors result from a chain of events in a system The fallibility of physicians The compassion that is required to continue to practice The hope that we can do better This example reminds us of the tragedy and suffering that error can bring to both the patient and family – and the health care providers. It is a reminder that we work in a less than perfect system and it highlights how injuries to patients frequently result from a series of errors – a PROBLEM IN THE SYSTEMS It forces us to examine our fallibility Reminds us that compassion is required to survive the error- especially compassion from colleagues. And it provides us with an opportunity, if we choose to use it, to hope and work toward prevention of such suffering in the future. These are some of the things I’d like to speak with you about today. New York Medical College Department of Family Medicine

Error in Medicine Today’s Agenda The Institute of Medicine (IOM) Epidemiology of Error Our Role in Patient Safety What I’d like to give you today is a bit about the background on how this issue was brought to national attention in the last few years- Beginning with IOM report on Patient Safety and its impact. I’ll review some of the epidemiology of errors – their definitions, and prevalence as we currently understand them. Then I’d like to describe how we might increase patient safety as providers. New York Medical College Department of Family Medicine

Error in Medicine The Medical Errors/Patient Safety Movement Hilfiker article NEJM 1984 Mid 1990s incidents By way of introduction, I would like to briefly highlight the evolution of the current frenzy about medical errors and patient safety- what is called the Patient Safety Movement. My agenda is to convince you, if you need convincing, that this topic is important for all of us in healthcare AND should be included in the education of medical students and residents. While there have been many articles and comments on this topic prior to 1984, many have identified David Hilfiker’s article “Facing Our Mistakes” in the New England Journal of Medicine as a pivotal moment in this movement. His 1984 article described a few of his mistakes including the mistaken abortion of a live fetus at 13 weeks, after four negative pregnancy tests. Responses to this disclosure from the medical community ranged from compassion and acknowledgement of personal experiences with error to denial that errors occur and contempt for physicians who disclose such incidents. Although dialogue on this matter did not flourish with this powerful disclosure of a physician error, the acknowledgement that such events occur shattered the pristine culture of medicine. This article appears to have spawned the earliest discussions of medical errors in medical school and residency curricula. This was followed by many highly visible events in the 1990s. Most notably the reports about the deaths of Libby Zion in New York, Betsy Lehman, who died due to mistakes in chemotherapy, in Boston, Willie King, whose wrong leg was amputated in Florida, and two year old Jose Martinez, who died after a Digoxin overdose. Also, the report in the New England Journal of Medicine in 1991 from the Harvard Medical Practice Study on “adverse events and negligence” in New York State hospitals. New York Medical College Department of Family Medicine

Error in Medicine The Medical Errors/Patient Safety Movement The Committee on the Quality of Health Care in America (1998) In 1998, The Committee on the Quality of Health Care in America was appointment to identify strategies for achieving substantial improvement in the quality of health care delivered to all Americans- This project was initiated by the Institute of Medicine in June of 1998 with the goal of developing recommendations for “threshold improvement in quality over the next ten years.” New York Medical College Department of Family Medicine

Error in Medicine IOM Reports To Err is Human: Building a Safer Health System Crossing the Quality Chasm: A new Health Care system for the 21st Century Health Professions Education: A Bridge to Quality To date the Committee has produced 3 reports. To Err is Human – released in late 1999 focused on a specific quality concern – Patient Safety. The second report – Crossing the Quality Chasm was released in 2001 and focuses broadly on how the healthcare delivery system can be designed to innovate and improve care. The third report – Health Professions Education: a bridge to quality – was released in It lists the competencies for training of all health professionals, not just for physicians. The findings of the first report (To Err is Human) created a flurry of activity and a mobilization of government and private organizations toward reduction of medical errors and an increase in patient safety. New York Medical College Department of Family Medicine

Error in Medicine Institutions Institute for Healthcare Improvement (IHI) 1991 National Patient Safety Foundation 1996 Two of the many institutions that are very active in pushing the patient safety movement include - IHI, and - the National Patient Safety Foundation New York Medical College Department of Family Medicine

Error in Medicine Institutions Institute for Safe Medication Practices (ISMP) Patient Safety Improvement Initiative of the Veterans Health Administration 1997 National Quality Forum (NQF) and these are just a few more of the most visible and most active, New York Medical College Department of Family Medicine

Error in Medicine Agency for Healthcare Research and Quality – (AHRQ) July 2001 “Making Healthcare Safer: A Critical Analysis of Patient Safety Practices” October $50 Million grant funding including a grant to the AAFP Policy Center to study outpatient medical errors. A major example of the Federal Government’s response to the MOVEMENT is The Agency for Healthcare Research and Quality which over the past few years has redirected a major part of its efforts – and money – to Patient Safety. In July 2001, they put out a huge book “Making Healthcare Safer: A Critical Analysis of Patient Safety Practices.” AHRQ had commissioned the Evidence-based Practice Center at UCSF and Stanford University to review the literature and make specific recommendations on which interventions in healthcare have been demonstrated to improve patient safety outcomes. They reviewed 79 interventions and concluded that 11 practices were rated most highly in terms of evidence that would support their widespread implementation in all hospitals. These included use of prophylaxis to prevent DVTs, use of peri-operative beta-blockers, and asking patients to restate what they had been told during the informed consent process. Then in October, AHRQ became the single largest funder of Patient Safety research. New York Medical College Department of Family Medicine

Error in Medicine The Leapfrog Group Require hospitals to adopt computerized physician order entry. Steer patients to hospitals/doctors with high volume of high-risk procedures. Require ICUs to be staffed with critical care specialists. Let me mention one major player on the industry side. The Leapfrog group was formed in California by a group of major corporations concerned about influencing the quality of healthcare for their employees. There are now over 140 major corporate and other members who insure over 34 million people and control over $50 billion dollars a year in health care expenditures. And they are using their ability to direct patients to sources of care to demand improvement. They have started with these 3 goals. New York Medical College Department of Family Medicine

Error in Medicine Medical Literature Another pretty clear reflection of the growing impact of Medical Error and Patient Safety is in the volume of publications on these topics. After reviewing the patient safety/medical error literature, one group (NYMC-DFM) found a sudden marked increase in articles in referreed journals in 2001. Articles on Medical Error/Patient Safety in Refereed Journals by year of publication (as of 4/15/02). New York Medical College Department of Family Medicine

Error in Medicine To Err is Human Establish a national focus on the issues of patient safety & medical error. Let me go back to the now-famous IOM Report. To Err is Human, laid out a four-tier approach to arriving at workable solutions: The first goal was to bring the issues of patient safety and medical error to the forefront and encourage dialogue within the healthcare system as well as among the users of the system. New York Medical College Department of Family Medicine

Error in Medicine To Err is Human Identify & learn from errors through mandatory reporting efforts & encouragement of voluntary efforts. Second, they wanted to ensure that medical errors were used as opportunities to learn and make changes to systems that would enhance patient safety in the future-hence an expanded system for reporting errors. New York Medical College Department of Family Medicine

Error in Medicine To Err is Human Raise standards and expectations for improvement in safety. Third, while healthcare organizations are currently subject to compliance with licensing and accreditation standards- there is an opportunity to strengthen these efforts. Essentially, healthcare organizations will be expected to develop specific and far reaching patient safety programs. And these patient safety programs, as of a few years ago, are required by the Joint Commission for all hospitals. New York Medical College Department of Family Medicine

Error in Medicine To Err is Human Create safety systems inside health care organizations through the implementation of safe practices at the delivery level. The final critical component of the proposed strategy to improve patient safety is to create an environment that encourages organizations to identify error, evaluate causes and take appropriate action to improve performance in the future. The success of this approach to patient safety is predicated on many forces, not the least of which is the physician’s willingness to examine their own practice with attention to the issue of error. To do this we must share some common understanding of what constitutes an error. New York Medical College Department of Family Medicine

Error in Medicine IOM Definition of Error The failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. The IOM Report defines error as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. REPEAT DEFINITION New York Medical College Department of Family Medicine

Error in Medicine An Adverse Event An injury caused by medical management rather than the underlying condition of the patient. An adverse event attributable to error is a “preventable adverse event.” They describe an Adverse Event as an injury caused by medical management rather than the underlying condition of the patient. An adverse event attributable to error is a “preventable adverse event.” New York Medical College Department of Family Medicine

Error in Medicine Wu’s Definition A Medical Error is “…a commission or omission with potentially negative consequences for the patient that would have been judged wrong by skilled and knowledgeable peers at the time it occurred, independent of whether there were any negative consequences.” (Wu, 1997) There a a number of other definitions; one of the most quoted authorities on this subject offers the definition of a Medical Error as “…a commission or omission with potentially negative consequences for the patient that would have been judged wrong by skilled and knowledgeable peers at the time it occurred, independent of whether there were any negative consequences.” Wu encourages disclosure of all errors to patients- regardless of whether the error had any adverse consequences. New York Medical College Department of Family Medicine

Error in Medicine Why Errors Occur “The more complex the behavior, the less likely that it can be repeated successfully.” There are a myriad of reasons why errors occur – not the least of which is that medicine is inherently complex, and complex behavior is difficult to replicate and harder to standardize. New York Medical College Department of Family Medicine

Error in Medicine Why Errors Occur Lack of Standardization Failure to design with error in mind A medical culture that resists admitting to error and so cannot work to prevent error. (Schenkel S Promoting safety and preventing medical error in emergency departments. Academic Emergency Medicine, Nov 7: 11, ). In addition to complexity, a lack of standardization may contribute to error; inattention to error reduction in the development of systems; and a medical culture that resists acknowledging that errors do occur. The industry that patient safety advocates have examined as an example for us is commercial aviation. The aviation industry’s success at minimizing error helped them avoid even a single death in 1998. Using a focus on redesigning systems, the specialty of Anesthesia reduced the death rate from one in 20,000 two decades ago to one in 200,000 today. (Leape, Error in Medicine; Johnson Boston Globe 1998; Runciman, Sellen, Web, et al; Anaesth Intensive Care 1993; 21: ) New York Medical College Department of Family Medicine

Error in Medicine Common Causes of Errors Ignorance Inexperience Faulty judgment Hesitation Fatigue Job overload Breaks in concentration System flaws (Wu AW, McPhee SJ, and Christensen JF. Mistakes in Medical Practice, Chapter 32 in Behavioral Medicine in Primary Care Appleton and Lange, Stamford CT. Edited by MD Feldman and JF Christensen). I’d like to mention what we know to be some of the more common reasons that errors occur. Ignorance Inexperience Faulty judgment Hesitation Fatigue Job overload Breaks in concentration System flaws A significant underlying cause of errors that demands special note here is the enormous number of errors that occur as a result of poor communication between physicians and among the health care team. and It is important to note that much of the literature on patient safety and decreasing medical error suggests that an examination of the systems – both organizational and cultural – is the first step toward improvement. New York Medical College Department of Family Medicine

Error in Medicine Who Makes Errors “The reality is that most errors are made by good people with good training, skills, and intentions who inadvertently commit errors despite their best efforts because of an unfortunate confluence of individual, workplace, communication, technologic, psychological, and organizational factors.” (Annals of Emergency Medicine, July 2000, 59) Who makes errors- we all do. Errors are excellent teachers. Widespread dissemination of knowledge about common errors and their precursors could reduce the incidence of their occurrence. The goal is to engender a culture where we say “Let’s look at what happened so it won’t happen again.” New York Medical College Department of Family Medicine

Error in Medicine About the Numbers In-Patient Out-Patient The numbers of errors made have been hotly contested. And the data we do have is primarily about In-Patient settings; we have very little on errors in Out-Patient settings. Since most primary care takes place in the office setting – we have a good deal of work ahead of us if we are to increase patient safety and decrease errors in our practice. New York Medical College Department of Family Medicine

Error in Medicine The Numbers 50:1 Ratio Bates DW, O’Neil AC, Boyle D, et al. Potential identifiability and preventability of adverse events using information systems. J Am Med Inform Assoc. 1994; 1: Jha AK, Kuperman GJ, Teich JM, et al., Identifying adverse drug events: development of a computer-based monitor and comparison with chart review and stimulated voluntary report. J. Am Med Inform Assoc. 1998; 5; Cullen DJ, Bates DW, Small SD, et al. The incident reporting system does not detect adverse drug events: a problem for quality improvement . Jt Comm J Qual Improv. 1995; 21: Let’s look at some of the numbers. There is approximately a 50:1 ratio between errors detected by the most intensive means and those detected through ordinary mechanisms such as incident reports. So for every one we know, 49 went unnoticed. New York Medical College Department of Family Medicine

Error in Medicine The Numbers 44,000-98,000 Americans die in hospitals each year as the result of medical errors. (To Err is Human, p. 44) The most widely quoted number on errors is that 44 to 98,000 Americans die annually in hospitals as a result of errors. New York Medical College Department of Family Medicine

Error in Medicine The Studies (1984) New York State hospital admissions/chart review (1994) Colorado and Utah The numbers were derived from two studies and are a source of continuing debate. Essentially, the Colorado & Utah study found that adverse events occurred in 2.9% of all hospitalizations and the New York study found that adverse event occurred in 3.7% of all admissions. In the Colorado and Utah hospitals, 6.6 % of the adverse events led to death, as compared to 13.6% in New York hospitals. Given the 33.6 million admissions to hospital per year in the US this puts the numbers between 44,000 and 98,000 deaths. New York Medical College Department of Family Medicine

Error in Medicine Worker Safety 6,000 Americans die from workplace injuries every year 1993, medication errors alone are estimated to have accounted for 7,000 deaths (To Err is Human, p. 44) To give these numbers some context, we can compare them to safety in the workplace. Approximately 6,000 Americans die from workplace injuries every year. In 1993, medication errors alone are estimated to have accounted for 7,000 deaths. Workplace Safety has an oversight agency that governs and tracks injuries – OSHA There is no such agency for Patient Safety. New York Medical College Department of Family Medicine

Error in Medicine Preventable Adverse Events 8th leading cause of death motor vehicle accidents (43, 458) breast cancer (42,297) AIDS (16, 516) Even using the lower number, deaths in hospitals due to preventable adverse events make it the 8th leading cause of death. Deaths due to preventable adverse events exceed those attributable to motor vehicle accidents (43, 458), breast cancer (42,297) or AIDS (16, 516). New York Medical College Department of Family Medicine

Error in Medicine Costs Estimated at between $37.6 & $50 billion for adverse events $17-29 billion for PREVENTABLE adverse events Total national costs –(lost income, lost household production, disability, heath care costs) estimated to be between 37.6 and 50 billion for adverse events and between billion for preventable adverse events. This is an expensive problem. New York Medical College Department of Family Medicine

Error in Medicine Our Role in Patient Safety What can you do to increase patient safety in your practice? New York Medical College Department of Family Medicine

Error in Medicine Prevention Openly acknowledge error in Medicine Analysis of systems rather than individuals Vincent C. Risk, safety, and the dark side of quality. 1997: 314: First – General Approaches to preventing errors. First, acknowledge that errors do occur and do this openly within your practice. Talk about it. Second – consider that experts in the field emphasize that to reduce errors we have to focus on systems not individuals. New York Medical College Department of Family Medicine

Error in Medicine Specific Suggestions Plan a response to your next error. Become familiar with your institution’s policies. Recognize your role as an Educator. Some specific suggestions: - think about a plan for responding to your next error, and in a minute I will give a suggested format for responding to an error. - know your institution’s policies. (Do you?) May physicians are unaware that the Joint Commission has extensive requirements for hospitals on patient safety. They require that errors resulting in harm be disclosed to the patient and/or family. I’ll talk about some of their other efforts later. - Recognize that your behavior in handling an error will be the way other doctors will learn about how errors are handled (correctly or not). New York Medical College Department of Family Medicine

Error in Medicine What Patients Want What happened? That we are sorry How are we going to prevent error in the future? We need to address the management of the adverse events and our response to patients and their families. The literature suggests that patients affected want three things. They want to know what happened. There is evidence that full disclosure of error, even minor ones, is both desired by patients, and better for institutions. 2. They want to hear that we are sorry, that both the institution and people involved feel sincere regret for what happened. 3. They want to know how we are going to prevent recurrence. A policy of timely, full, honest disclosure of what happened is ethically required and will be necessary to establish trust. New York Medical College Department of Family Medicine

Error in Medicine Responding to Unanticipated Outcomes CARE: Take Care of the Patient PRESERVE: Preserve the Evidence DOCUMENT: Document in the Medical Record With this in mind, you may want to keep the following steps in mind as you manage an unanticipated outcome (possible error) as recommended by risk management professionals. Take Care of Patient: correct the error and treat any complications. Preserve any evidence – like faulty equipment. Document what happened and what was done to address the problem. New York Medical College Department of Family Medicine

Error in Medicine Responding to Unanticipated Outcomes REPORT: Complete Mandatory Reports if Required NOTIFY: Notify Claims Department of Your Malpractice Carrier DISCLOSE:The Initial Disclosure Discussion Report and Notify In NY State we have to comply with NYPORTS reporting and the Joint Commission Sentinel Events. Most of us will call the hospital’s Safety Manager or Risk Management. Then Disclose the error to the patient and/or the family. New York Medical College Department of Family Medicine

Error in Medicine Responding to Unanticipated Outcomes ANALYZE: Analyze Unanticipated Outcome to Prevent Recurrence and /or Improve Outcome (Root Cause Analysis) After the event, you should participate in analyzing what went wrong. One commonly used tool is the ROOT CAUSE ANALYSIS. New York Medical College Department of Family Medicine

Error in Medicine Responding to Unanticipated Outcomes FOLLOW THROUGH: Subsequent Disclosure Discussions HEAL: Heal the Health Care Team (Norcal Risk Management) Follow through; continue to discuss the error and follow up with the patient. Finally Heal – It is essential for all those involved – or who think they’re involved – to be supported, not shunned. Everybody will be in that Spot sooner or later. New York Medical College Department of Family Medicine

Error in Medicine As an Educator Recognize you are a role model. Medical students and residents see errors made, make errors, do not see them discussed, and are greatly affected by medical errors. As an Educator, your actions instruct. If students and residents do not see errors discussed as an opportunity to learn, the culture of blame that currently exists will continue. We know from experience with students that they see errors made, make errors, do not see them discussed, and are greatly affected by medical errors. New York Medical College Department of Family Medicine

Error in Medicine JCAHO National Patient Safety Goals 2003 and 2004 Improve Patient Identification Improve communication among caregivers Improve Safety of high-alert medications Eliminate wrong-site, wrong-patient, wrong-procedure surgery Improve safety of Infusion Pumps Improve clinical alarm systems Reduce Healthcare – acquired infections I mentioned before the Joint Commission is very active in patient safety. In addition to requiring that all hospitals develop a culture of safety and their requirement for disclosure, they have 7 National Patient Safety Goals. READ THE TOPICS Discuss one or two. New York Medical College Department of Family Medicine

Error in Medicine The “New Look” “The term…is being applied to a growing body of research on human and system performance aimed at learning how complex systems fail and how people contribute to safety.” To summarize what the important elements I have tried to cover this morning – it has been said we need to take a NEW LOOK at patient safety. From: Phillips DF JAMA 1999; 281: 217 New York Medical College Department of Family Medicine

Error in Medicine The “New Look” Emphasis on systems rather than people Nonpunitive approach Emphasis on the multifactorial nature of error Assumption that errors will occur Emphasis on caregiver interactions Sharp end, blunt end The NEW LOOK has been summarized with these 6 messages. Emphasis on systems rather than people Taking nonpunitive approach to error reporting to encourge reporting and disclosure An emphasis on the multifactorial nature of error The basic assumption that can and WILL occur Emphasis on interactions between doctors, between doctors and nurses And sharp end, blunt end. We have traditionally focused on the sharp end – that final step which led to the patient injury. It is recommended that it is more important to examine the blunt end – all those latent problems and systems errors that led up to the final step that cause the injury. From Wears RL and Leap LL Ann Emerg Med 1999; 34: New York Medical College Department of Family Medicine

Error in Medicine “The paradox of modern quality improvement is that only by admitting and forgiving error can its rate be minimized.” (D. Blumenthal, Editorial: Making medical errors into treasures. JAMA, 1994; 272: ) I hope this gives you a snapshot of the current fury over medical errors today. While complex and challenging, patient safety initiatives are here to stay. It is likely that the examination of the day to day operations of the physician will come under more and more scrutiny in the interest of patient safety. Are you ready? Thank you for your attention. New York Medical College Department of Family Medicine

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