Many medical students believe that if they study hard in medical school, train with the best physicians, and perfect their skills, they will never make a mistake. At least that's what Timothy McDonald, M.D., J.D., chief safety and risk officer for health affairs at the University of Illinois Hospital and Health Sciences System (UIHHSS), thought. When he did make a mistake, it was devastating.
"The first time I made a mistake, I was horrified and terrified all at the same time. It was so clear to me when it happened. I had just started my anesthesiology residency and I had done what is called a syringe swap, where I had given the patient the wrong medication. It had an absolutely profound effect on the patient, who almost went into complete respiratory arrest. It was incredibly difficult just to steady my hands and try to take care of her. And everything you could possibly imagine was going through my head."
The reality is that despite health care providers' dedication and best efforts, an alarming number of patients are harmed by medical mistakes in the health care system and far too many die prematurely as a result. Michelle Malizzo Ballog, a young mother, was one of them. In 2008, she died of cardiac arrest on the operating table due to an error in monitoring her sedation. When her family asked how this could have happened, officials at UIHHSS in Chicago did not defer the question to their lawyers. Instead, they investigated the source of the problem, told the truth and shared the facts, apologized, accepted accountability, and provided a financial settlement for Ms. Ballog's young children. They also changed their sedation monitoring and anesthesia scheduling processes. This is a total turnaround from the "deny and defend" response to medical errors in the past, according to Dr. McDonald.
The approach at UIHHSS is called the Seven Pillars and includes:
- Patient safety incident reporting.
- Investigation of the event.
- Communication and disclosure to the patient.
- Apology and remediation, including waivers of hospital and physician fees.
- System process and performance improvement.
- Data tracking and performance evaluation.
- Education and training of staff.
UIHHSS's Seven Pillars Program, begun in 2006 and led by Dr. McDonald, is being expanded to nine other Chicago-area hospitals as part of a 3-year demonstration project funded in June 2010 under AHRQ's Medical Liability and Patient Safety Initiative. It is one of 7 demonstration grants, 13 1-year planning grants, and an evaluation contract funded by AHRQ. The goal of the demonstration projects, a few of which are discussed in this article, is to improve the quality of care and patient safety, compensate patients fairly and expeditiously when they are harmed, reduce liability premiums and the costs associated with defensive medicine, and reduce the number of malpractice suits filed in the first place. The projects focus on a number of areas, including improving communication with patients, preventing harm through best practices, and providing alternative methods of dispute resolution.
Improving communication with patients
Improving communication with patients is critical to maintaining patient trust and avoiding lawsuits. In fact, a June 2012 Health Affairs article by Dwight Golann, J.D., of Suffolk University Law School, shows that a large percentage of lawsuits get dropped once both parties share all the information. "To me, that's critical," says Dr. McDonald. "That's the biggest point of the Seven Pillars [Program]—to provide immediate sharing of information so people don't feel they have to sue you just to get that information and then drop the suit later after spending lots of money on both sides." Once an incident occurs, the communication and emotional support for both patients and families and caregivers gets jumpstarted immediately with the UIHHSS crisis management team and its 24-hour/7-day hotline. Recently the head of the hospital's risk management team was out of the hospital and staffing the patient safety hotline via a pager.
"We had a patient go into cardiac arrest in a part of our hospital where that almost never happens, and the person helping that patient had never even seen a cardiac arrest," recounts Dr. McDonald. "They called a code, and the team responded appropriately. The hotline call allowed us to get the right people onsite to both support the patient and family through this outcome…, but also help the care professional who was distraught. The whole thing was kicked into play in 15 minutes even though the risk manager was out of the hospital."
The number of hotline calls has soared from 40 calls a year to 500 or 600 calls a year, or about 10 to 15 calls a week, according to Dr. McDonald. "A lot of time they need our help to prevent something from happening, or getting us there may help diffuse a situation or help with conflict management or any clinical situation where they want help right away," he says. "There's no doubt that we're able to prevent errors this way. And importantly, it allows us to provide emotional support." Reports of safety incidents have also risen from 2,000 to nearly 9,000 at UIHHSS over the last several years.
"It is a great measure of culture when people are comfortable reporting things that they see and are not as fearful that shame and blame is going to kick in," says Dr. McDonald. The Seven Pillars Program focuses on rectifying system problems that lead to most errors, rather than judging and blaming individuals. As a result, more health care professionals are reporting safety problems, allowing them to be resolved. And when harm from errors does occur, apologies are accompanied by remediation and a commitment to improve, as well as a waiver of fees for inappropriate care. Once the hospital has determined that a medical error has harmed the patient, the patient is given a card that exempts them from paying all fees at UIHHSS and that can also be used to cover all related costs if they go to a different hospital.
As a result, UIHHSS has shown:
- At least a 40 to 50 percent reduction in claims and lawsuits per quarter compared with 6 or 7 years ago.
- The medical malpractice premium for FY 2013 for UIHHSS is 22 percent ($10 million) less than the $42 million high mark 4 years ago before the impact of the Seven Pillars Program.
- $3 million in annual savings to payers, including Medicare and Medicaid, from waiver of all hospital and professional fees for inappropriate care cases, and in copay savings to patients.
- Substantially reduced costs associated with the practice of defensive medicine compared with other area hospitals not participating in the project.
- Significantly reduced time and costs associated with malpractice litigation.
- Identification and resolution of unanticipated outcomes of care, which are not always due to poor care.
Dr. McDonald wants the next generation of health care professionals to have a more realistic approach to medical errors and learn how to cope with them. His team works to educate medical students and resident physicians, who he says are very energized about the Seven Pillars and its "principled approach" to patient harm.
Preventing harm through best practices
A project to reduce preventable birth-related injuries and related malpractice claims at Fairview Health Services, a health system of hospitals and clinics in Minnesota, is led by Stanley Davis, M.D., medical director for simulation and teamwork at Fairview. Birth-related injuries typically result from failure to recognize an infant in distress, initiate a timely cesarean birth, or properly resuscitate a baby in distress, as well as inappropriate use of labor-inducing drugs and inappropriate use of vacuum or forceps during delivery. The Fairview project uses perinatal best practices, including checklists, techniques to improve communication, teamwork training for health care providers, and use of health care simulation of high-risk clinical situations. With AHRQ funding, Fairview expanded its program from 2 to 6 of its hospitals, with a total of 14 hospitals in several States participating in the demonstration project.
"The biggest problem we see is that people on the labor and delivery unit don't use closed-loop communication," says Dr. Davis. "It's like what fast food restaurants do when they call back your order. You then acknowledge that they got the order right."
Davis says that often doctors say the order aloud, but nurses or other team members don't always affirm that they heard it. The result is that either no one or several people will carry out the same order. "So communication ends up being a big part of making mistakes. That's where AHRQ's TeamSTEPPS® comes in with its communications techniques," says Dr. Davis. Simulation of high-risk situations, such as fetal distress, includes communication techniques, identification of each person's role, and course of action. "When you simulate something like that and videotape it, people can see how to correct problems and work better in those situations," notes Dr. Davis. Fairview's simulation exercises have been effective. For example, benefits of practicing kicked in when a nurse manager's daughter came into the emergency department with a prolapsed umbilical cord, which can be compressed, cutting off the baby's blood supply.
An emergency c-section was needed, and the team had done c-sections in the simulations prior to this event. The team went into action quickly, and the baby did well. Checklists are also important. One example is the checklist for elective induction of labor. The first thing on the checklist is to confirm that the pregnancy is at least 39 weeks, by doing a cervical exam and measuring cervical dilation. This confirmation is needed to prevent harm before starting a medication that starts labor contractions too quickly, which can lead to a baby with slowed respiration. By using the checklist, health care professionals know to monitor the contractions and follow other steps to help ensure that the baby is healthy.
Since the project began, Fairview's six hospitals have seen a:
- 74 percent reduction in preventable birth trauma to full-term newborns, preventing 30 cases of trauma over 4 years (birth trauma accounts for the biggest payouts against obstetrician defendants).
- 38 percent reduction in preventable neonatal intensive care unit admissions of full-term babies over 4 years.
- 12 percent reduction in the rate of preventable birth-related maternal complications at term, preventing 172 cases of birth-related maternal complications over 4 years.
Alternative resolution of disputes
To reduce the cost of medical malpractice in New York's courts and mediate fair compensation for patients injured due to medical errors, the New York State Unified Court System began a judge-directed negotiation program in select areas of New York City in 2004. As part of an AHRQ demonstration grant, the existing program was expanded and coupled with a new hospital early disclosure and settlement model under the direction of Judge Judy Harris Kluger, chief of policy and planning for New York State Courts. Key stakeholders are involved in the program through a consortium of five major teaching hospitals in New York City, the New York State Department of Health, and New York City medical liability insurers. The intial focus of the project involved the New York Unified Court system. If a lawsuit is filed naming one of the participating grant hospitals as a defendant, the case is sent to a judge with specialized training. The judge supervises the entire process, beginning with the very first appearance before the court. This judge takes an active role in setting regular case conferences, monitoring discovery, and establishing a schedule for pretrial activity.
Additionally, while the case is pending, the court will convene the parties to discuss the case and, if appropriate, help to broker a settlement (though the judge does not impose a settlement amount). The project has trained about 50 judges from around the State to mediate these cases in New York courts.
"The judges don't need a medical background, but they do have to have some understanding about the kinds of medical issues that may come up in these cases," says Judge Kluger. "Our training was quite extensive. Lawyers and doctors who are experts in the field addressed medical issues the judges might see, as well as settlement skills and mediation skills."
This program has begun to shift the dynamic of civil medical malpractice actions from an attorney-driven process to a judge-managed process, and does not require any changes in the law. The goal of the program is to reach a fair and expeditious resolution in significantly less time than under the previous system, where resolution could take 4 to 5 years.
"We've saved time and money by closely managing these cases from the outset and, whenever possible, limiting the number of costly depositions and the need to retain expert witnesses in preparation for trial," explains Judge Kluger. "That's the goal. The earlier the case is resolved, the lower the litigation costs." AHRQ funding connected the court project to a new hospital early disclosure and settlement model. This model is essentially a communication and resolution program, says Susan Senecal, R.N., M.B.A., project director for the New York State Patient Safety and Medical Liability Reform Demonstration Project. She manages, directs, and coordinates activities of the project partners. The model uses a checklist that covers three areas: awareness, investigation, and resolution.
Once there is an event, whether it is a medical error or a serious known complication of care (for example, return to the operating room or an unanticipated colostomy following surgery), a person is assigned to coordinate the investigation of the patient's care experience. There is an initial discussion with the patient generally within 24 hours of the event by the physician, and the risk manager is notified. Following the investigation, the conclusions are communicated to the patient—whether there was an error or rather a complication related to the underlying disease, and not through fault of the patient's hospital or the practitioner. These swift investigations can uncover process-of-care areas that need improvement, preventing them from happening again, and thus improving patient safety. They also enable the patient to receive information about what happened to them.
"The communication and closure with the patient in and of itself is the resolution in most of our cases," says Ms. Senecal. "It's not to say, 'Okay, here's x amount of dollars. Will that prevent you from filing a lawsuit?' The resolution part is identifying what happened and making sure the patient understands that, and ensuring that the patient receives fair and quick compensation where there was medical injury due to an error."
She agrees with Dr. McDonald, that often it is the pursuit of information about their care that drives patients to file lawsuits. The hospitals' early disclosure and settlement programs aim to avoid that. But sometimes, says Ms. Senecal, people just shut down when something tragic happens and don't hear what they are being told, so the hospital cannot resolve the situation. That's when the case goes to the courts. To date, more than 200 cases have gone through the judge-directed negotiations program. This number is expected to increase as more judges are trained, and the initiative is fully implemented in other parts of New York.
What has been the response of hospitals and families to this approach? Says Judge Kluger, "We've had very positive feedback from both sides, especially once hospitals and families understand what is involved—that ultimately the goal is to get to an earlier resolution that is fair to both sides."
Editor's note: For details on AHRQ's medical malpractice and patient safety initiative, go to Medical Liability Reform & Patient Safety Initiative.