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 .

Disclosing Medical Errors: Best Practices from the “Leading Edge”

By Eve Shapiro

Introduction

Mary McClinton went into VirginiaMasonMedicalCenterfor 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 Systemin 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 3 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 effortson 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 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 do 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 theerrors 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 organizationssuch as SorryWorks! (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 do not recur. The seven organizationshighlighted 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.
University of IllinoisMedicalCenter

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 do for several reasons. First, open disclosure is the most effective way to reduceerrors 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 sidewho 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, McDonaldand colleagues spenttwo and a half daysin Ann Arbor with Rick Boothman, learning about the University of Michigan policy,process, and experience in fully disclosingmedical errors to patients and families. When theyreturned to Illinois, McDonald says, they set out to develop their own process.

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 processwas 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 Systemand 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.
  • “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, VanderbiltUniversityMedicalCenter; 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, sevendays a week. Whoeveris 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, 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.”

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 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 do 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.
  • They systematically use mistakes as tools for learning and for making needed changes to their system.

“When we make an error,” Boothman says, “we do 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.