Medical errors in U.S. hospitals kill tens of thousands of patients each year, and even more suffer injury because of mistakes by doctors or nurses. Not every case of harm is avoidable—patients may get an infection even if doctors do everything they should. But when hospitals are at fault, most of the time they never tell you.
Afraid of getting sued, they deny wrongdoing, hide information from patients or families, and exclude them from internal investigations. Hospital staff review the events in private conferences. Sometimes they send reports to third-party safety groups, but those, too, are privileged. This means attorneys for the injured or the families of patients who died can't get them.
Patients usually get compensated only if they can persuade a lawyer their case is good enough to take. Then comes the arduous, expensive, and emotional fight to prove the medical professionals, despite what the Hippocratic oath says, did some harm. If the hospital's lawyers see too much risk, they settle. If not, they go to trial.
This is how it works now. For years, a few doctors and hospital leaders have been trying to change this by bypassing the judicial system. They contend honesty in the event of mistakes can reduce hospital liability and improve safety by throwing light on an opaque internal process. Recently, the federal government threw its weight behind the idea, publishing detailed guidelines for hospitals that want to adopt this more open way of dealing with medical errors.
The new approach promoted by the federal Agency for Healthcare Research and Quality (AHRQ) is explicitly aimed at saving hospitals money on malpractice litigation while encouraging more robust scrutiny of what went wrong. It also aims to support patients, families, and clinicians after an event that can be traumatic for all involved. It's called Communication and Optimal Resolution, or Candor for short, and was developed with a $23 million federal research grant and tested at 14 hospitals in three health systems.
Under Candor, when a case involving patient harm is identified, trained hospital staff tell victims or their families what happened within one hour. At the same time, they reach out to caregivers. The hospital stays in touch with patients and relatives as the event is investigated and interviews them about what happened. It also pauses its billing process so injured patients or grieving families aren’t dealing with the cost of care received, an emotionally fraught experience when that "care" injured or killed a loved one.
Hospitals are supposed to complete the investigation within about two months and share the findings with the patients. At that time, they’ll discuss how to prevent future incidents. If the inquiry determines the harm resulted from a breach in the standard of care, something a lawyer might call negligence, the hospital and patient will negotiate financial compensation.
Patients should have attorneys with them to help negotiate a fair deal, said Steve Kraman, a doctor who pioneered the approach in 1987 at the Lexington, Ky., VA Medical Center.
Without Candor, "what normally is done is people meet behind closed doors and talk about it with no names," Kraman said. The process discourages people from reporting mistakes, making it harder to improve. This process by which medical professionals shut out everyone else while looking for answers isn't optimal, he said. "It becomes very difficult to fix problems when secrecy is that important."
The Candor process doesn't limit patients' power to sue if they think a hospital's offer of compensation is unfair. And it offers potential resolution for people who might never be able to persuade a lawyer working on contingency to take their case. "I can’t tell you how many patients I turn down where I think there probably is clear negligence involved," said Laura Sharp, a partner at the Sharp Firm in Austin, who used to defend health-care providers before switching sides to represent injured patients.
Sharp and other plaintiff's attorneys have reservations about the Candor approach. The information hospitals gather during an investigation may remain privileged from legal discovery, the exchange of evidence before trial. "They swoop in immediately and gather all the documents," Sharp said, after reviewing the Candor protocol. If a patient doesn't reach a negotiated agreement with the hospital, that could make it harder to bring a lawsuit. She was also concerned that patients offered compensation for an injury might not be advised to have an attorney evaluate the offer.
Lawrence Schlachter, a former surgeon who became a malpractice attorney, cautioned that Candor's end run around the courts may allow hospitals to dodge accountability that might come from an outside investigation. "If the hospital is investigating patient safety glitches, who is supervising them in their internal investigation?” he said.
Even proponents worry that some hospitals might adopt Candor only when it suits them—as in a case they would expect to lose. "My concern is that people might cherry-pick,” said Kraman. "We didn’t. We took every single case."
Beyond the obvious financial incentives for hospitals, the program gives many would-be plaintiffs something simple: a frank acknowledgement that something went wrong. Sometimes that's all they really want.
"Their No. 1 complaint is, 'I wish they had just said they felt bad or they’re sorry,'" Sharp said.
Helen Haskell’s son died from a medication error after a routine elective surgery in 2000. Now a patient advocate and founder of Mothers Against Medical Error, she said she had hoped "we could do more in terms of improvement by not filing a lawsuit.” It took about a year to reach a settlement. The hospital kept sending bills while she waited.
“We took our child in for elective surgery. He just died through utter negligence,” Haskell said. “And they were billing me? Until we settled with them, the bills kept coming. It went to collections."
The biggest barrier to hospitals being more transparent is their legal departments, she said. "These are people who are very vested in this process," she said. "When [Candor is] implemented well, hospitals save tons of money, and what they’re saving on is defense."
Haskell said ending hospital secrecy is a prerequisite to making them safer for patients. "Without disclosure, without accountability it never gets fixed,” she said.
Candor has its roots in that idea. Kraman was newly appointed chief of staff at the Lexington VA when an internal review indicated that a patient’s death weeks before had been caused by a medication error. The family had no idea. “We decided that we could put it together in a dossier and hide it, and hope they never come back. We didn’t feel comfortable doing that,” he said.
Instead, they called the family, advised them to bring an attorney, and told them what happened. Then they negotiated a settlement. “It didn’t excessively punish the hospital or excessively compensate the family,” said Kraman, now a professor at University of Kentucky College of Medicine. "It was fair all around.” In 1999, he published an analysis that suggested such “extreme honesty,” in addition to being more humane for patients, could also reduce hospitals’ legal expenses.
Rick Boothman, an attorney who defended doctors and hospitals in malpractice suits, formalized the Candor approach at the University of Michigan Health System when he joined in 2001. “The great fear at the time was if you’re honest, the sky was going to fall in financially,” said Boothman, now the health system's chief risk officer. “We have decades of 'conventional wisdom' that says we can’t afford to be honest."
In practice, Boothman said, hospitals need to "normalize honesty" to improve patient safety. When he was defending hospitals at trial, "nobody ever said, 'What should we have learned from the cases you handled?'" he said. "Those things are changing."
“This is a lot of culture change for people," said Seth Krevat, assistant vice president for Safety at MedStar Health, a 10-hospital system in Maryland that helped test and develop the Candor protocols. Typically, the aftermath of patient harm is to reprimand an individual. "You blame one person, you move on. You haven’t fixed the system problem,” he said.
Instead, such events warrant the kind of rigorous investigation that follows an airplane crash. “These events are like plane crashes for patients and families,” Krevat said.
“One of the challenges is working with insurance companies … to educate them around the benefits not only for patients but for physicians as well,” said Linda Ubaldi, a top patient safety official with Dignity Health in Sacramento. The 39-hospital health system based in California tested Candor in four hospitals and is now deploying it more widely.
Some malpractice insurers support the approach. Robin Diamond, senior vice president of patient safety and risk management at the Doctor's Company, a malpractice insurer, advised on the development of the Candor process. "A patient who’s satisfied with their physician and believes their physician is as honest as possible is less likely to sue," she said.