Disclosing Medical Errors Best Practices from the “Leading Edge”

This paper was contracted by the Robert Wood Johnson Foundation Preliminary interviews were conducted in support of the workshop entitled, “Disclosure: What’s Morally Right Is Organizationally Right,” at the 18th Annual IHI National Forum on Quality Improvement in Health Care, December 10-13, 2006, Orlando, Florida, USA For more information, contact Eve Shapiro, Medical Writer, at eveshapiro@aol.com Disclosing Medical Errors: Best Practices from the “Leading Edge” By Eve Shapiro Introduction Mary McClinton went into Virginia Mason Medical Center for a relatively routine procedure in 2004 While there she died after receiving an injection of chlorhexidine, a caustic cleaning solution, instead of normal saline Both were clear liquids and had been placed side by side in unlabelled cups in the operating room A 9-year-old girl who had just undergone surgery at the University of Michigan Health System in 2001 gave herself a lethal dose of dilaudid because she was given a miscalibrated PCA pump Betsey Lehman, a Boston Globe reporter, and Maureen Bateman were being treated for breast cancer at the Dana-Farber Cancer Institute in late November 1994 Lehman died on December and Bateman suffered permanent heart damage because, in one day, they received four times the daily dose of the anticancer drug cyclophosphamide In 1999, the Institute of Medicine shocked the nation by reporting that between 44,000 and 98,000 people die in hospitals each year as a result of medical errors That report, To Err Is Human,1 raised awareness about the prevalence of medical errors in our nation’s hospitals Six years later, in 2006, the Institute of Medicine released the report, Preventing Medication Errors,2 which revealed that a hospitalized patient can expect to experience, on average, one medication error per day Dr Donald Berwick, president of the Institute for Healthcare Improvement, experienced such errors himself when his wife was a patient in a well-known Boston hospital “It was not just how she was treated,” Berwick told Time magazine,3 “it was that so little of what happened to her was unusual.” Despite Berwick’s best efforts on his wife’s behalf, he says, “tests were repeated unnecessarily, data were misread, information was misplaced Things weren’t just slipping through the cracks; the cracks were so big there was no solid ground.” The prevalence of medical errors and their impact on the lives of patients and their families is profound Why, eight years after the IOM issued its indictment of the health Institute of Medicine To Err Is Human: Building a Safer Health Care System Washington, DC: National Academies Press; 1999 Institute of Medicine Preventing Medication Errors Washington, DC: National Academies Press, 2006 Gibbs N, Bower A Q: What Scares Doctors? A: Being the Patient Time, April 23, 2006 Shapiro: Disclosing Medical Errors (2008) care system challenging it to reduce medical errors, are errors still a common fact of life in our nation’s hospitals? What is being done to turn the tide? The answer to the question “why” medical errors are still taking place may lie in the IOM’s recognition that medical errors are not usually the fault of a single person delivering health care The problem, the report pointed out, instead has more to with flawed systems So, for example, if a hospital’s practice is to pour solutions that look alike into clear cups before an operation without clearly distinguishing one from another, an error is almost inevitable It would be easy for someone to reach for the wrong cup without realizing it Preventing such an error would require not punishing the person who reached for the wrong cup, but changing the way the hospital prepares liquids before surgery Doing so would be considered a systems change Changing systems is more complex than punishing a person who makes an error But, ultimately, fixing flaws in the system is the only way to prevent the same errors from happening over and over again Medical institutions have been slow to change their systems because doing so requires at least three things: first, admitting that errors are made; second, communicating the errors to patients and families, throughout the institution and, often, to the media; and third, suffering the uncertain consequences of an error’s disclosure, which are commonly thought to include malpractice lawsuits The answer to the question, “What is being done to turn the tide?” is, at least, twofold: first, patients and family members who have been harmed through medical errors are demanding to be told the truth when something goes wrong in their care; and second, some medical institutions, such as the Harvard Hospitals, are promoting open communication, full disclosure of medical errors, and apologies to patients and their families when something goes wrong.4 Patients and families have banded together to push for full disclosure of medical errors, along with apologies, by establishing patient advocacy groups Grass-roots organizations such as Sorry Works! (sorryworks.net), Patients United Limiting Substandards and Errors in Healthcare (PULSE), Medically Induced Trauma Support Services (MITTS), Consumers Advancing Patient Safety (CAPS), and others are raising the awareness of political leaders, legislators, and the medical community about the urgent need for change Some medical institutions are seeking to turn the tide of medical errors by doing what medical institutions have been historically afraid to do: that is, to confront and openly admit their mistakes, to disclose them to patients and families and throughout their institutions, to investigate their causes, and to use what they learn to improve their processes and their systems so these errors not recur The seven organizations highlighted here have begun this journey What they’re doing, how they’re doing it, and what they’re learning in the process is the subject of this white paper Harvard Hospitals When Things Go Wrong: Responding to Adverse Events A Consensus Statement of the Harvard Hospitals Burlington, Massachusetts: Massachusetts Coalition for the Prevention of Medical Error; March 2006 Shapiro: Disclosing Medical Errors (2008) University of Illinois Medical Center Nikki Centomani, R.N., Director, Department of Safety and Risk Management at the University of Illinois Medical Center, has long believed that confronting and openly disclosing medical errors as soon as they are discovered is the right thing to for several reasons First, open disclosure is the most effective way to reduce errors because it begins the process of learning Second, open disclosure begins the process of healing for all involved: for patients, families, and health care providers Third, she intuited, open disclosure would lead to fewer, rather than more, lawsuits Bolstered by these beliefs, Centomani began in 2002 what would be a four-year campaign to convince hospital administrators and leaders to adopt a policy of full disclosure What made this a four-year effort instead of something much shorter was fear, according to Timothy McDonald, M.D., J.D., Associate Professor in the Department of Anesthesiology “The hospital’s defense bar and claims management lawyers resisted for years,” McDonald says, “advising the hospital and its physicians to ‘deny, deny, deny,’ even in such cases as wrong-site surgery.” As McDonald describes it, their own defense lawyers were the biggest barriers of all “We had one horrendous sentinel event and I pushed for full disclosure,” McDonald recalls “We’d done a wrong site surgery in a neurosurgery case Nikki and the physician said, ‘Isn’t this a case where we should just tell the family we made a mistake and settle it instead of it letting it become a lawsuit?’” The answer was “No,” McDonald relates, because there was no institution-wide process in place to disclose an error What finally convinced the leadership at the University of Illinois Medical Center to adopt a policy of full disclosure in 2006? As McDonald explains, it was a combination of Centomani’s persistence and a little luck First, an Attitude Shift The luck came in the form of shifting personnel New people came in on the business side who had heard about the positive outcomes of the full disclosure policies at the University of Michigan and the Lexington, Kentucky, Veterans Administration The new staff members took those results seriously and, McDonald recalls, thought it would be worth considering a process for full disclosure “When we decided to establish a policy and process for disclosure, we interviewed 16 law firms,” says McDonald “Twelve of the 16 told us that medical errors should not be disclosed and advised us to continue denying errors when they occurred Four of the firms approved of full disclosure These are the four we chose to represent us,” he says Then, in 2005, McDonald and colleagues spent two and a half days in Ann Arbor with Rick Boothman, learning about the University of Michigan policy, process, and experience in fully disclosing medical errors to patients and families When they returned to Illinois, McDonald says, they set out to develop their own process Shapiro: Disclosing Medical Errors (2008) The Process McDonald and colleagues developed a process for disclosing medical errors to be followed by everyone within the University of Illinois Medical Center every time an error occurs The process begins at the point an error is discovered and ends at the point, McDonald says, “the organization has assured itself that the likelihood of it occurring again is nil From top to bottom,” he says, “that is what we did.” According to the process, an investigation begins to determine whether a further investigation is warranted as soon as an error is discovered If it is, the process follows steps outlined by McDonald:       If it’s a probable error, a rapid investigation team determines whether it’s a clear error If it’s a clear error, the case meets our criteria for an apology with full disclosure If an apology is delivered with full disclosure, the remedy (that is, compensation) is considered If a remedy is offered, a liaison is created between the patient and family and the claims department, since physicians and nurses shouldn’t manage the process of financial compensation for medical errors If a claim is large, the organization must decide how the claim will travel through the administrative approval process Contemporaneous with the steps involving remedy, the organization must decide how to put process improvements in place to prevent future error Developing the process was only the beginning Next, McDonald and colleagues would have to convince others that disclosing medical errors using this process was the right thing to do, both ethically and financially The Right Thing to Do “Slowly but surely, we started meeting with all the stakeholders whose buy-in we needed,” McDonald says “These were everyone in the organization from top to bottom: the president of the university, then the chancellor, the provost, the dean of the college of medicine, the chief executive officer of the health care system, the chief medical officer, and the chief nursing officer We then vetted the process through the board of trustees We drilled down to the grass roots,” he says Next, McDonald and his colleagues held small group meetings throughout the medical center to explain the process and to highlight the positive experiences of the University of Michigan Health System and the Lexington, Kentucky, VA in disclosing medical errors “Then,” McDonald says, “we pushed for transparency by stating the following concepts:  “We are not just providing full disclosure and rapid settlement; we’re taking each of these cases and learning from it Shapiro: Disclosing Medical Errors (2008)    “The way we’re going to successfully manage the medical malpractice crisis is through safer care, not tort reform “The best risk management strategy is patient safety “One important way to improve patient safety is to not make the same mistakes over and over again.” “At the end of one of our presentations on patient safety and full disclosure,” McDonald recalls, “the president of the university, B Joseph White, looked at us and said, ‘At the end of the day, isn’t it just the right thing to do?’” McDonald and his colleagues adopted the president’s words and combined them with the principles Rick Boothman followed at the University of Michigan Health System:    When we hurt someone through unreasonable medical care, we need to make it right When the care our staff provides is reasonable, we need to support them even when something goes wrong We need to learn something from medical errors that will help us to improve our care Their next step, McDonald says, would be to help their physicians put the policy and process into practice Training and Consultation McDonald and his colleagues knew that disclosing medical errors doesn’t come easily to all clinicians Some are better natural communicators than others, but training for everyone would be essential The type of training they decided to provide was twofold: first, classroom training given by Gerald Hickson, M.D., associate dean for Clinical Affairs and director of the Center for Patient and Professional Advocacy, Vanderbilt University Medical Center; and then, on-the-spot training available whenever something goes wrong They called this on-the-spot training their Patient Communication Consult Service The telephone number for the Patient Communication Consult Service hotline is posted all over the organization and it works this way, as McDonald explains: “Anytime there’s an adverse event of any kind, clinicians can call a hotline 24 hours a day, seven days a week Whoever is carrying a pager in the office of safety and risk management will get an immediate page and be notified that someone in the organization has been involved in an adverse event and needs help talking to patients and families It may or may not involve a clear error If it appears to be a clear error, we prepare the possibility of a remedy If the case does not involve a medical error, we give the clinician advice, based on our level of experience and training, on communicating with patients.” “To create the communication consult service we hand-picked people we wanted to train in all our departments, including medicine, nursing, pharmacy, guest services, Shapiro: Disclosing Medical Errors (2008) administration, legal, and so on,” McDonald continues “This was a ‘train the trainer’ process, whereby the people we trained went back and trained other personnel in their departments.” Remedies “We meet with patients, apologize, and provide a remedy whether patients want to file a claim or not,” says McDonald “The first important case in which we put our policy and process into practice involved the unfortunate death of a young patient,” McDonald recalls “Within 90 days,” he says, “we settled the case for a large amount We’ve had many other, smaller cases in which remedies ranged from waiving a small hospital fee, to $75,000 We have waived fees for professional services, hospital and other medical services, drug costs, and more These are real remedies and they impact the lives of our patients.” McDonald explains their centralized hospital and professional billing offices have the ability to put a hold on billing of the patient in case of an error or a potential error Spreading the Word Putting a process in place to disclose medical errors would be effective only if everyone in the organization were familiar with the process and would follow it “We held a huge symposium on the full disclosure process that was open to the entire hospital,” McDonald recalls, “which 110 people attended.” But staff awareness requires more; it requires continual reinforcement “We have monthly symposia where issues related to full disclosure and communication come up, where we can talk about big wins and losses, what went well and what didn’t We created a form on which the staff can evaluate the effectiveness of full disclosure with patients and families, and we discuss these at the monthly group meetings,” McDonald says “We also hold seminars with the ethics department on the second victim,” McDonald continues, “the person who has made the error, to discuss how badly they feel and what the impact the error may be Putting in a system where there’s employee assistance for everyone is important.” Outcomes What outcomes has the University of Illinois Medical Center experienced since implementing their full disclosure process? The results have been positive:   Families who have experienced an error or an adverse outcome at the University of Illinois Medical Center continue to seek care there That includes the case they settled for a large amount Patient safety has improved As McDonald says, “Each and every one of our cases has its own associated process improvements and we’re tracking them all We Shapiro: Disclosing Medical Errors (2008)   have been able to show through root cause analysis, for example, that the failure to supervise residents led to many medical errors With our new process there has been greater engagement by attending physicians with resident physicians, and education and supervision on patient safety-related issues.” The time it takes for clinicians to receive critical test results and to communicate those results to patients has been reduced Employee attitudes have improved “People are glad to finally be in an organization in which clinicians can openly disclose errors in an organized way and offer remedies to patients and families when appropriate,” says McDonald Lessons Learned McDonald shares the following lessons learned:    Persuade your lawyers that disclosing medical errors is the right thing to ethically, legally, and financially, despite their fears related to admitting liability Recognize that shifting the culture of an organization is not easy and takes time Get buy-in from all the stakeholders once you decide on a process University of Michigan Health System The University of Michigan always considered itself ethical and open with its patients about mistakes and patient injuries, but in 2001 it systematically began to initiate conversations with patients who complained and threatened to sue To Rick Boothman, Chief Risk Officer, open disclosure first made common sense as a way to save money: if you knew you made an error and would have to settle anyway, wouldn’t it make more sense simply to admit the error and compensate patients, saving hundreds of thousands of dollars in court costs and attorneys’ fees? But for Boothman and his colleagues, what started out as a pragmatic approach to managing claims soon became much more “There is no question in my mind that the culture of open disclosure paves the way for clinical improvement in ways that we have never seen before,” Boothman explains “The culture of deny-and-defend prevents us from improving Being open with patients starts with being honest with ourselves about our failings—that is a necessary prerequisite to any real improvement That is where the real gold lies,” he says Guiding Principles There are three principles that guide the University of Michigan Health System’s approach to a claim of medical error:   They compensate patients and families when they’ve made an error They fight to defend themselves when their care was reasonable Shapiro: Disclosing Medical Errors (2008)  They systematically use mistakes as tools for learning and for making needed changes to their system “When we make an error,” Boothman says, “we not hesitate to accept responsibility, apologize directly to the patient, and move quickly to compensate them without their having to file a malpractice suit But when we think our care was reasonable, we explain to the patient and family, and their lawyers, why we don’t think they have a case,” Boothman says Boothman spent much of his time that first year meeting with medical staff, faculty, University of Michigan trial attorneys, the courts, and the plaintiff’s bar in Southeastern Michigan to explain and gain acceptance for this approach In his meetings with plaintiff’s attorneys, Boothman presented the essence and significance of this new approach: he explained the University of Michigan’s commitment to compensate quickly and fairly when they felt the medical care was unreasonable, but he cautioned that they would defend their staff and institution vigorously when they felt the care was reasonable He committed to working with plaintiff’s attorneys so they would understand the difference between reasonable and unreasonable care before litigation was filed What enabled Boothman to take this unusual approach in response to medical errors? “Leadership and faith that we were doing the right thing,” Boothman says “There are corporate cultures in every organization Some cultures will make this easier to than others For some, deny, defend, and scorched earth is the way they choose to things It’s tougher to get those organizations to say, ‘Maybe we did make a mistake and maybe we ought to be courageous enough to confront it and tell people that.’ I happen to be blessed with an institution that has an historically open culture and medical leadership in the form of Skip Campbell, chief of staff, who is unflinching about patient safety and honesty,” Boothman says The Process Michigan laws have created the ideal circumstances for Boothman’s approach The University of Michigan Health System takes advantage of the compulsory six-month presuit notice period the law allows (Michigan Compiled Law 600.2912) Before a malpractice suit may be filed against any health care practitioner or facility in Michigan, the patient or patient’s family is required, by law, to present details of their claims in writing Once this notice is served, a suit cannot be filed for 182 days This pre-suit notice period allows prospective defendants time to investigate the claim, gives them the opportunity to meet with the patient or family, and offers patients and families time to reconsider their decision to sue The University of Michigan Health System strives to thoroughly review the required written claims within three months or less (see Figure 1) Every suspected injury and claim is triaged and a focused investigation planned Each case undergoes internal and, often, external expert reviews The patient care at issue is submitted to the Medical Liability Review Committee, which reaches conclusions about the reasonableness of the Shapiro: Disclosing Medical Errors (2008) care delivered and its impact on the patient’s outcome The committee also considers every submitted case for peer review, clinical quality improvement, and educational opportunities The committee’s role is purposefully restricted to medical issues and quality of care concerns Its conclusions inform claims management, but this committee does not oversee litigation or involve itself in the financial aspects of claims management Figure Once the issues have been clarified, the University of Michigan Health System openly discusses them with the patient and his or her lawyer Often, patients and lawyers are invited to meet with the doctors or nurses they are threatening to sue, or with experts whose opinions are pivotal to the assessment Discussions usually occur between the Chief Risk Officer or a Risk Management consultant and the patient and his or her lawyer This disclosure is vital to the success of the program: parties have a chance to reconcile their recollections and analyses about the patient’s care and complaints Questions are answered Factual information is supplied and misinformation corrected Other perspectives are communicated and explored Expert reviews are shared Frequently, patients and their lawyers are satisfied with the explanations and neither suit nor settlement follows If the Medical Liability Review Committee concludes the care was unreasonable and the patient’s outcome suffered, and the patient is interested in compensation, there is an Shapiro: Disclosing Medical Errors (2008) attempt at resolution In some cases, discussions are extended by agreement to offer the parties more time to explore the issues In one case, for example, a patient suffered an errant nerve transection that was grafted An interim payment was made to help the patient with his immediate business needs, and the parties regrouped 14 months later to evaluate the outcome of his nerve repair The University of Michigan Health System’s commitment to its principles opens the door to immediate and decisive quality improvement measures and peer review opportunities Fear of adversely impacting subsequent litigation is virtually non-existent because the University of Michigan Health System is committed to acting consistently with its own conclusions about the reasonableness of care Unfettered by fear of litigation, patients’ complaints travel through a process designed to prompt all involved to ask whether the care could have been better, whether anything can be done to avoid such complaints in the future, and whether there are lessons to be learned (See Figure 2.) Figure Barriers to Full Disclosure The biggest barriers to implementing their full disclosure policy were, first, the perception that openly disclosing medical errors would adversely impact the health system’s ability to defend itself and, second, according to Boothman, those within the university who still worry about adverse consequences of open disclosure Fear of lawsuits and fear of disclosing medical errors to irate patients and their families can be powerful deterrents to doctors Despite the logic and common sense of Boothman’s Shapiro: Disclosing Medical Errors (2008) 10 Barriers Fear of legal repercussions is the biggest barrier to the full disclosure movement and can lead to a defensive posture, according to Bothe “To its credit,” he says, “the state spread an umbrella over disclosure that provided some protection, or at least peer review coverage, so we could the right thing while minimizing the effect of lawsuits.” Training Is Essential Despite the fact that communicating serious or sentinel events became law in Pennsylvania in 2002, many physicians lacked training in how to have such conversations “We did a lot of education and skill-building to bring front-line staff along,” says McKinley “We provided training to teams from each of the hospitals in our patient safety collaborative with the Institute for Healthcare Improvement,” McKinley says Geisinger used story-telling and videotaped interviews to help clinicians understand what, in the wake of a negative outcome, patients want and deserve Geisinger doesn’t have a formal program to train staff in disclosing medical errors or serious adverse outcomes, according to McKinley, but they make training opportunities available through a number of different forums throughout the year, including the following:       Incorporating training into the Geisinger Quality Institute; Providing ad hoc training; Training through electronic education programs; Facilitating physicians’ ability to take annual courses that are mandated by CMS or the Department of Health; Offering training during morbidity and mortality rounds throughout the organization; and Participating in multiple and diverse educational opportunities through the Institute for Healthcare Improvement’s Million Lives Campaign Training during staff orientation and ongoing annual training in “service dialogue”—that is, how to interact with patients, families, and other customers—is required at Geisinger This training does not include discussion of errors or apology, but “training in service dialogue certainly enhances physicians’ ability to have these difficult discussions,” McKinley says “One hundred percent of our physicians go through training of one kind or another in how to disclose medical errors and adverse events,” says McKinley “That is our expectation.” Shapiro: Disclosing Medical Errors (2008) 24 Outcomes Since they began to implement Act 13 in 2003, according to McKinley and Bothe, Geisinger has experienced positive outcomes They are quick to point out, however, that these outcomes cannot be directly attributed to the policy of full disclosure:  Geisinger has experienced a significant increase in the reporting of serious events, sentinel events and near misses, and an increase in the number of conversations physicians have had with patients about these events  Geisinger has had fewer claims filed than the national average When they observe the trends in their own data, the number of claims has decreased McKinley believes a case is less likely to become a lawsuit because they’ve had early discussions with the patient or family “Patients and families get a full explanation, a commitment from us that we’re going to correct the problem, and feedback after the root cause analysis to let them know what we’ve done,” she says Lessons Learned McKinley and Bothe share three of the lessons learned at Geisinger:  Adopt a patient-centered, rather than a legalistic, philosophy toward disclosure This will allow physicians to follow their ethical instincts, rather than being constrained by fear of lawsuits  Use patient stories to help clinicians understand the importance of open, honest communication “It is easy to respond empathetically when patients share their stories,” McKinley says  Eight times, eight ways Repeat the same message and the same set of principles repeatedly, using different methods, to drive change in your organization Catholic Health Initiatives Catholic Health Initiatives, headquartered in Denver with offices in the Cincinnati area and Minneapolis, is a religious-lay partnership and the product of four Catholic health systems that merged in the mid-1990s Its core values are reverence, integrity, compassion, and excellence “We attempt, and are expected, to live out these core values in our everyday work life,” says Mitch Melfi, Esq., Senior Vice President and Chief Risk Officer, and President and Chief Executive Officer of First Initiatives Insurance Ltd Shapiro: Disclosing Medical Errors (2008) 25 “Compassionate Disclosure” The concept of compassionate disclosure has been ingrained into their organization, according to Melfi Catholic Health Initiatives gradually codified their long-held beliefs and unveiled, in 2006, their compassionate disclosure policy, a “how to” document for their clinicians in the wake of an error or an adverse outcome Their compassionate disclosure policy addresses all aspects of what should be disclosed to patients and families, according to Melfi, from the perspectives of culture, ethics, clinical care, law, and risk Their compassionate disclosure policy, Melfi says, offers some guidance to staff about how to disclose, who should disclose, and more, since this is “obviously not an easy thing for people to It’s not so much around the ‘what,’” he says “It’s really more about the ‘how.’” With a policy to guide them, he says, everyone knows what’s expected “The reason we decided to create this compassionate disclosure policy,” Melfi says, “was to give people permission to what they should have been doing all along, and what in most cases they were doing all along.” In their culture, Melfi explains, compassionate disclosure is, and feels like, the right thing to It’s the right thing to for two reasons, Melfi says One is that it’s what patients and families want and deserve The other is that admitting and confronting errors is the only way to improve care “We took a more aggressive position about opening up the black box and openly sharing information with our patients and with each other when an error or adverse outcome occurs so we can learn from it,” says Melfi “We recognize that lawyers want to zealously represent what they believe to be in their client’s best interest That representation may well include advice to not share information with a potential adversary, namely the patient, when that information could compromise the hospital’s or the doctor’s interests in subsequent litigation.” That, according to Melfi, has a chilling effect on disclosing medical errors to patients and families This approach can prevent information about adverse events and patient injuries from being reported, thereby diminishing the chance to learn and improve “How are we going to get better if we don’t know what we have to to get better?” he asks “We have to admit that we made a mistake, we have a problem, and we have to fix it,” he adds Catholic Health Initiatives’ staff is available to assist facilities in managing the process of compassionate disclosure in the wake of a medical error “Individuals with training in disciplines such as ethics, law, risk management, and clinical care have been providing guidance during national system meetings and at local facilities, such as during Grand Rounds,” Melfi says Whenever there is an adverse event, according to Melfi, there is a system in place that provides for the rapid reporting and dissemination of critical information “It is our expectation,” Melfi says, “that all adverse events will be reported to my risk team within Shapiro: Disclosing Medical Errors (2008) 26 48 hours of the event’s occurrence.” Melfi’s team then “makes this information available to key individuals within the organization, those in a position to something about it, those who can help us learn and improve our care.” Meeting this expectation was incorporated into the annual incentive compensation program for the organization’s leadership, including the hospital CEOs Catholic Health Initiatives’ policy of compassionate disclosure isn’t, however, mandatory, Melfi notes “We developed a model policy around compassionate disclosure that each of our facilities can adopt as their own as they feel they need to We want to emphasize the compassionate part of the disclosure and specifically incorporate the concept of an apology We want to allow flexibility for our facilities that are in states with existing disclosure and reporting laws,” he says Compassionate Disclosure and Risk “It’s a legal myth that if you say you’re sorry you’re admitting fault or that you’re going to get sued,” Melfi says “We absolutely are sorry when someone is injured in one of our facilities It’s not what we intend to happen when patients are in our facilities We need to empower and give permission to caregivers to behave in a just and compassionate way, which is how most caregivers otherwise behave absent legal obstacles,” he says “Our position is that we want to fully disclose what happens, when it happens If we get sued, that’s just the way it has to be We deal with that if we have to We must what is right, not what we think we can get away with,” Melfi explains Every facility in the Catholic Health Initiatives system participates in their risk program “It’s not optional within the various hospitals We manage centrally all of the litigation when a hospital gets sued for malpractice, as well as the reporting of those events,” Melfi says Whenever an error or adverse event occurs and is reported, Melfi’s advice is to manage the event, not necessarily to manage the claim “And part of managing the event has always been to be very up front with the families or the patients about what happened,” he says “It’s about doing what’s best for the patient rather than doing what’s best for the bottom line,” he adds Barriers The biggest barriers to openly disclosing medical errors and adverse outcomes, Melfi says, “can be lawyers and the fear of being sued, the fear of negative publicity, and the threat of financial losses Hospitals are competitive as well as compassionate entities We don’t want the good work we to be overshadowed in the media by stories of injured patients suing us.” Addressing the financial barriers to disclosing errors, Melfi says, “Our legal system is not perfect When medical errors are litigated, the outcome can often be an unreasonable and unrealistic economic award for the loss We support reasonable and fair compensation Shapiro: Disclosing Medical Errors (2008) 27 for injuries that are the result of our medical errors, but the potential for unreasonable and highly inflated jury awards is an economic reality that we must also deal with.” “To get staff buy-in,” Melfi says, “we tell our staff, ‘these barriers exist There is a potential down side to full disclosure and information sharing But there is also an up side: that is, we learn from our mistakes, we get better, we manage expectations better Even if you are sued, your outcomes will be better because people typically aren’t out to damage people they like and who they think are being honest with them.’” The up side far outweighs the down side, Melfi believes, and their experience with compassionate disclosure has borne this out Mitch Melfi recalls a talk he gave at a national Risk Management meeting: “I said that in health care, we’re human and we make mistakes A man in the audience was clearly bothered by my comments and he offered, ‘We don’t make mistakes We get sued for bad outcomes.’ My response was that we have to be able to admit we make mistakes and everything we can to learn from them and not make those mistakes again Part of that includes working with the family You’ve got to be able to admit to them you made a mistake and to say, ‘We’re very sorry we made a mistake; it certainly wasn’t our intention.’ My experience has been that, for the most part, patients can accept that we make mistakes.” Melfi says, “What they can’t accept is that we don’t accept that we make mistakes or that we try to hide the fact that we do.” Overcoming Barriers To get the word out to everyone in their health system about their intention to implement their compassionate disclosure policy, Melfi says, they have addressed the issue at various system meetings and conferences, including their annual Risk Management conference “We knew we needed to get buy-in from the litigators we retain to represent our facilities,” he says At their annual defense counsel meeting, Melfi addressed the topic of disclosure with the attorneys, telling them, “This isn’t going to feel right to you because it’s not the way lawyers are trained.” He went on to tell them, “Don’t advise the facilities you represent to not disclose information out of fear of having it used against them in litigation We fully recognize that it could be used against them, but we think that the benefit of disclosure and information sharing outweighs the risk.” Melfi continues, “We told our lawyers, ‘This is what we’re doing, this is why we’re doing it, and if you can’t get comfortable with it, then we’ll need to retain someone else to represent these facilities in litigation.’ I’ve actually had litigators call me after the fact and say, ‘You know what? You really get it It really does work Outcomes are better.’” Melfi says they offer guidance to caregivers in how to disclose medical errors For example, “When you sit down with a patient and talk about what happened, you don’t want to engage in speculation such as, ‘Well, I think the reason this happened was that the nurse was incompetent.’ No…you deal factually in a compassionate way: ‘This is what we know….,’” he says Outcomes Shapiro: Disclosing Medical Errors (2008) 28 “Although it’s only one part of the picture, there is a business case for disclosing errors, too,” Melfi says “Our losses when somebody sues us are coming down We still make mistakes, we still get sued, but the outcomes are better,” he says “When you clearly made a mistake and you’re either pointing fingers or denying you did it, you inflame the situation That causes plaintiffs to demand more money, it inflames juries, it just doesn’t get better,” Melfi adds Instead, Melfi continues, “Our policy and our practice is that, if we made a mistake for which we think we have liability, the objective is not to fight that What’s important to ask is, ‘How best can we compensate the patient?’ We sit down and say, ‘We know this happened We’re sorry that it happened If money can make this right, how can we that? What is reasonable and fair compensation?’” Melfi recalls this discussion and its outcome: “I recently dealt with a case involving the death of a newborn In the course of the delivery, the expectant father, a physician, thought something was wrong and he said something to the obstetrician The obstetrician told him, ‘I don’t tell you how to practice, don’t you tell me how to practice obstetrics.’ “That was the wrong thing to say in that situation The outcome was devastating The cord was wrapped around the baby’s neck and the baby was stillborn Now, there were things that showed up on the monitor that our nurses should have picked up Had they picked up these things, the outcome might have been different “In addition to all this, we’re dealing with two physicians who apparently disliked each other We believed that the obstetrician, other than perhaps saying the wrong thing, didn’t anything wrong medically If anything, it was our nurse, and we recognized that The case went to mediation because both sides were polarized and we felt this was a case that needed to be settled “How you compensate someone for the death of a newborn? Somehow, you’ve got to put a value on it At this mediation, the first thing our claims person did was to approach the mother and say, ‘I just want you to know we’re sorry this happened.’ According to our defense counsel who was there, her apology immediately broke down the barriers Melfi explains the way they resolved the case Money wasn’t necessarily the issue, but they offered to provide the family with a sum of money for the loss of their child In addition, Melfi recalls, “We offered to endow a fund at the hospital that guarantees, on an annual basis, the ongoing training of nurses in how to read fetal monitoring strips We invited the parents to participate in the process, and we proposed to make the endowment in the name of the deceased child With that, we settled the case.” “In doing this, we took a catastrophe and at least made it manageable,” Melfi concludes Lessons Learned Shapiro: Disclosing Medical Errors (2008) 29 Melfi shares the following lessons learned at Catholic Health Initiatives:  Identify the obstacles at the outset and strategize about how to overcome them Because they knew the lawyers would be the biggest barriers, “we told them what we were doing, why we were doing it, and invited them to work with us to accomplish our objectives,” says Melfi  Tie the organization’s disclosure policy back to its mission, core values, and vision Whatever an organization’s mission, Melfi notes, a policy of open, compassionate disclosure is embodied in it “Staff will be able to say, ‘This isn’t just something I’m being told we have to do…this is why we’re here,’” Melfi says  Be as quick to explain the “how” as the “what.” They were a little slow to define the “how” of disclosure, Melfi admits Clinicians, he says, need the tools to it COPIC Insurance Company COPIC, a Colorado-based, primarily physician-led malpractice carrier, began to openly communicate medical errors in October 2000 They were disillusioned with the inefficient, slow, adversarial tort system that, according to Richert Quinn, M.D., Physician Risk Manager, “destroys relationships between physicians and patients We were looking for an alternative that would result in a higher degree of satisfaction from physicians and patients after an adverse outcome occurs,” he says The COPIC philosophy is to aggressively defend care they believe meets the standard of care but to compensate negligently injured patients in an adequate and timely way “Our experience with the traditional tort system,” says Quinn, “led us to believe it was largely not achieving these goals.” The COPIC Alternative The COPIC alternative to the tort system is their no-fault, early intervention “3Rs” program, which stands for:    Recognize an unanticipated event Respond soon after the event Resolve related issues The COPIC 3Rs intervention begins with a telephone call by a physician to the COPIC risk management department to report a patient’s adverse outcome, injury, or anger about some aspect of the care they’ve received “Cases involving, for example, wrong-site surgery, patient death, or obvious negligence are ineligible for the 3Rs program,” Quinn explains, “and are instead handled by the COPIC claims department.” Shapiro: Disclosing Medical Errors (2008) 30 But if a patient has been injured during the course of his or her care, has made no written demand for compensation, has not issued a complaint to the licensing board, and has not involved an attorney, the COPIC risk management staff encourages, trains, and supports physicians to:      Communicate with their patients, addressing their needs for information, emotional support, financial assistance, and more Openly disclose what is known about how an injury occurred Apologize when appropriate Explain what they will to prevent the error from happening again Offer to cover expenses not covered by the patient’s insurance and time lost from work because of the injury “If a case lends itself to this intervention, the physician approaches the patient to discuss the program As of March 31, 2007, more than 4,100 occurrences have met our criteria,” Quinn says “Of these, just over 875 have resulted in payment.” Under the 3Rs program, Quinn notes, patients can be reimbursed for expenses up to $30,000: $25,000 for expenses not covered by insurance and $5,000 for loss of time on a per diem basis of $100 COPIC does not ask patients to sign a release or waiver in return for accepting reimbursement Patients are free to file a lawsuit after accepting payment if they choose to so So far, Quinn says, eight have done so How COPIC Was Able to Develop This Alternative COPIC was able to introduce and sustain their early intervention program because, according to Quinn, the following situations had developed over time, in addition to their history of early reporting:       Colorado has had historically good tort reform with a cap on non-economic and global damages COPIC has had open and collaborative relationships with the state legislature, state Department of Insurance, and Board of Medical Examiners, and support from senior management and the board of directors Colorado has a strong “I’m sorry” statute, which Quinn believes has given physicians greater confidence to participate in their 3Rs program Physicians are given incentives to attend training workshops The COPIC risk management department has historically had close, collaborative relationships with their physicians, which has created “a level of trust that is quite remarkable,” Quinn says COPIC conducts communication training seminars all over the state, regularly and often, attended by several hundred physicians a year Shapiro: Disclosing Medical Errors (2008) 31 “You need all these things in place to what we did,” says Quinn “We didn’t think of all the different barriers beforehand We started small with a few cases early on, and we just moved forward,” he says Challenges COPIC’s biggest challenge was, and still is, the reticence among many physicians to have candid and open discussions with their patients, according to Jeffrey Varnell, M.D., because mentors and malpractice carriers have discouraged them from being open in the past “About half of our Colorado-insured physicians—3,210 out of about 6,000—participate in our program,” says Quinn “Half don’t participate, sometimes because they’re skeptical about open disclosure and feel as though they’re admitting guilt Then something happens and they say, ‘How about putting me in that program?’” The COPIC program is voluntary The number of physicians who participate, Quinn says, climbs steadily each quarter “Word of mouth” has proven to be the most powerful tool for overcoming physicians’ reticence, Quinn has found “Once someone goes through a case, they’re pleased,” Quinn says, “and they’re happy they’ve been able to help their patients.” COPIC’s Outcomes What has been the impact of the 3Rs program on claims and premiums? “We have compared the physicians who participate in the 3Rs program with those who don’t Although the data is immature, our preliminary view is that those who participate have had fewer claims filed against them,” says Quinn He continues, “We did this in the first place because it’s the right thing to I think that’s a compelling enough argument It doesn’t seem to have had a negative fiscal effect on our operations Our alternative to the tort system appears to be associated with a high degree of satisfaction on the part of the consumer and provider and it does seem to save relationships.” More than 95 percent of COPIC patients and physicians surveyed when the files are closed, Quinn says, have rated their satisfaction with the program as or on a scale of 1-5 Lessons Learned Quinn and Varnell share their lessons learned:  Developing and nurturing good relationships with patients is essential If patients feel they have a good relationship with their physician, then if something goes wrong the patient is more likely to say, “That’s a mistake; everyone makes mistakes and can be forgiven.” Shapiro: Disclosing Medical Errors (2008) 32   Strong backing from senior management is key The organization’s leadership must be supportive of such efforts for physicians to feel comfortable participating Have faith in patients’ ability to forgive their physicians When COPIC started this program, they were taking a risk that patients would use the money COPIC paid them to finance a lawsuit To a large extent, this has not occurred Brigham and Women’s Hospital Brigham and Women’s Hospital, a 747-bed teaching affiliate of Harvard Medical School, adopted a policy and a process for routinely disclosing adverse outcomes and medical errors to patients and families when The Joint Commission released National Patient Safety Standard RI.2.90 in 2001, which states, “Patients and, when appropriate, their families are informed about the outcomes of care, treatment, and services that have been provided, including unanticipated outcomes.” “Initially we adopted our policy in 2002 because it is what The Joint Commission expected,” says Janet Barnes, Executive Director, Risk Management, Brigham and Women’s Hospital “But over time we realized communicating adverse outcomes and medical errors is the right thing to do,” she says The risk managers at the Brigham and Women’s Hospital wanted to draft a policy and an institutional process for disclosing medical errors, and to involve their Chief Counsel and members of other departments in doing so “Before we put a written policy and process in place,” Barnes says, “lots of people were hearing they needed to disclose medical errors but not everyone was doing it.” And not everyone had the same understanding about when to communicate, what to communicate, and how to communicate with patients and families when something went wrong Getting the Staff on Board To get staff support for their open disclosure policy, Barnes and her colleagues met weekly with groups throughout the hospital, emphasizing that disclosing medical errors to patients and families was the right thing to “We told our health care providers to think of themselves as patients and to put themselves in the patient’s shoes Then we asked them what they would want to know if they were the patient,” says Barnes Support from leadership is essential to elicit the support of staff and to be able to implement a policy throughout the hospital, according to Barnes “Our Chief Medical Officer sits with the physician and has that difficult conversation with the patient and family,” she says The real push was within the first year, according to Barnes, but the staff of Brigham and Women’s Hospital continues to talk about the policy and process “Before this policy, we were concerned about telling patients and families too much; now, we tend to be Shapiro: Disclosing Medical Errors (2008) 33 concerned about telling them too little There’s been a huge sea change There’s no such thing as too much information,” she says Barriers Physicians’ fear of lawsuits was a formidable barrier to Brigham and Women’s ability to openly and transparently communicate adverse outcomes and medical errors, Barnes believes “But,” she says, “the common theme that runs through patient-family depositions has been that patients and families didn’t think they were given complete information Or they had questions that were never answered Once something bad happened, they never saw the doctor again.” Barnes tries to help physicians understand that if they don’t communicate openly about an adverse outcome, they are more likely, not less likely, to be sued Another barrier to physicians’ willingness to communicate adverse outcomes and medical errors is their lack of training in having these conversations Although it may be easier for some, everyone would benefit from such training, Barnes believes Brigham and Women’s Hospital does not have a formal training program, although Barnes says their insurance carrier is developing one In the absence of formal training, Barnes says, their communications policy provides some very basic guidelines about what to say “Our advice to the medical staff is, ‘If an error or adverse outcome is obvious to the patient or family member, you should tell them, whether there is a bad outcome or not,” Barnes continues “If a nurse makes a medication error, the nurse must tell the patient If it reached the patient, that is all it takes to trigger disclosure Our risk management department offers support for these conversations to help nurses feel more comfortable,” she says Barnes suggests clinicians might find it reassuring to have a tip sheet handy before walking into a room to have a disclosure conversation with a patient and family For example, she says, a tip sheet could have prompts to guide discussion, such as, “Thank you all for being here This is the patient’s current condition I’ve asked you here because it’s important for me to tell you something that involves the care of your husband I’m really sorry that I have to tell you this right now but I’m going to explain what happened, what we know thus far, and I will give you an opportunity to ask questions I want to assure you that we’re taking care of your husband at the moment, but this is what happened….” “We recognize that patients and families can become extremely angry” after such conversations, according to Barnes “We need to help physicians deal with that emotional fallout,” she says Facilitating Communication Shapiro: Disclosing Medical Errors (2008) 34 Close contact between physicians and their risk management department facilitates physician-patient communication at Brigham and Women’s “Physicians tend to call risk management before the patient knows about a problem,” Barnes continues “I’ve gotten calls in the middle of the night, with physicians saying, ‘This just happened I need to talk with the spouse This is what I plan on saying to the patient and family Do you think that sounds right?’ “Disclosure conversations happen every day,” Barnes continues “Some are more complicated and require more support than others,” she says “Those that are most difficult revolve around a medical error In such cases, we want to hear about it either right before or right after the patient and family are told,” she says The Brigham and Women’s Hospital risk management department involves their patientfamily relations department in setting up meetings with the patient and family “The patient-family relations department staff circles back to the physician about what the patient or family wants to know or have clarified,” Barnes explains “Our investigations and follow-up are very detailed in response to serious complaints,” Barnes says “Our disclosure is not only verbal, but it can also be written The president may be the one to extend an apology to the patient, or it may be the provider or the director of patient-family relations who communicates the results of our investigation,” she says Outcomes More physicians are communicating adverse outcomes and medical errors because they know it’s the hospital’s policy, according to Barnes “We’ve seen a decline in lawsuits since we implemented this policy, but I’d be the last person to say it’s because of this process Many other factors could influence this reduction But there definitely hasn’t been an increase in the claims as a result I think we’ve been able to resolve some cases more quickly because we’ve taken on the problems at the very beginning,” she says Brigham and Women’s goal in openly communicating with patients and their families “is not to decrease lawsuits but, rather, to save the relationship” with patients and families “We want patients to continue to come to us rather than go elsewhere to seek care,” Barnes says Discussion Fear can be a powerful deterrent to doing the right thing Openly disclosing medical errors or adverse outcomes to patients and their families as soon as they are discovered is, inarguably, the right thing to When a physician’s instinct to the right thing is subverted by the fear of legal repercussions for doing so, the resulting tension can engender anxiety and guilt on the part of the doctor that is often difficult to live with and Shapiro: Disclosing Medical Errors (2008) 35 often impossible to overcome For patients and families who have experienced a medical error or adverse outcome that may be life-altering, not being told the truth engenders anger, frustration, and distrust A mother never gets over the grief caused by her child’s death But when her child dies in the hospital and she is never told—openly, honestly, and completely—why her child died, profound and life-long anger is added to her grief And, as a large and growing body of evidence shows, anger at not being told the truth about an error, rather than the error itself, is why people sue physicians and hospitals for malpractice Yet, as the leaders of the organizations highlighted in this white paper explain, this evidence-based advice is not what lawyers tend to give to the physicians and hospitals they represent Instead, they give advice based on fear: “Deny, deny, deny.” Such advice ensures that physicians’ relationships with patients will be frayed or worse, that patients will go elsewhere to seek future care, and that nothing will change to improve the system and prevent such mistakes from happening again Such misguided advice also may cause physicians to carry an emotional burden that can last a lifetime No one can predict with certainty what will happen when a physician tells a mother her child died because of an error that occurred in her care But based on evidence and experience, we can predict that not telling a mother why her child died is more likely to lead to a malpractice suit, more likely to ensure that a similar error will happen again, and more likely to cause the physician added grief and anxiety The experiences of organizations that have rejected fear and embraced open disclosure indicate that openness and transparency not lead to increased lawsuits All have, in fact, experienced a decline in lawsuits, although these organizations will not directly link their new policies to the decline They have also reported increased clinician and patient satisfaction, the preservation of physician-patient relationships, and more Physicians fear not only lawsuits, as the representatives of these organizations explain, but they fear having what can be emotionally charged conversations with patients and families in the wake of a medical error Not all clinicians communicate effectively with patients under ordinary circumstances But when a clinician contemplates telling a mother her child has just died, and what is known about the reasons for his death, it is no wonder that the “fight-or-flight” mechanism is apt to take over To overcome the impulse to flee, clinicians must be trained to have such highly specialized and sensitive conversations and must have the support of their hospital’s leaders and colleagues The organizations highlighted in this white paper understand the importance of such training and provide it in a variety of ways The biggest challenge organizations may face in developing a process by which errors will be disclosed routinely may be getting physicians on board Story-telling about patients’ and families’ experiences is essential for creating empathy and understanding And story-telling for staff about positive changes resulting from open disclosure is key to gaining acceptance and increasing the commitment to and momentum for change Shapiro: Disclosing Medical Errors (2008) 36 Despite their having embraced a policy of open disclosure and all such disclosure entails, the organizations highlighted here still face challenges, physician resistance being but one Nonetheless, their experiences, though still formative, can inspire others who are ready to develop similar policies and processes In the words of Eleanor Roosevelt, “You gain courage and confidence by every experience in which you must stop and look fear in the face You must the thing you think you cannot do.” Shapiro: Disclosing Medical Errors (2008) 37 ... president of the university, then the chancellor, the provost, the dean of the college of medicine, the chief executive officer of the health care system, the chief medical officer, and the chief... disclosing medical errors to patients and families When they returned to Illinois, McDonald says, they set out to develop their own process Shapiro: Disclosing Medical Errors (2008) The Process... Shapiro: Disclosing Medical Errors (2008) 11 Like the other organizations in the early stages of implementing processes for disclosing medical errors, Boothman is reluctant to attribute their declines