Fifth wrong-site surgery brings harsh penalties, scrutiny

Hospital must install surveillance cameras in OR

When the same "never event" happens five times in two years at the same hospital, something is terribly wrong. Risk managers and patient safety experts are aghast at the reports coming from Rhode Island's largest hospital and wondering what it means about the culture of that institution and the state of patient safety efforts across the country.

But at the same time, they are sympathetic to the challenges facing Rhode Island Hospital, the teaching hospital for Brown University's Alpert Medical School in Providence. The hospital is facing unprecedented sanctions from the state health department after admitting to its fifth wrong-site surgery since 2007.

State health director David Gifford recently announced that the hospital had agreed to unusually strict oversight after a wrong-site surgery involving hand surgery. That incident occurred in October 2009, with a patient who was scheduled to have surgery on two fingers. Instead, the surgeon performed both operations on the same finger. Gifford says the surgery site was not marked, and the surgical team did not take a timeout to ensure it was operating on the right patient, the right part of the patient's body, and doing the correct procedure.

According to Gifford, the surgical team marked the wrist, rather than each finger, and the surgeon did not mark the site himself.

After completing the first procedure, the team did not take a timeout before the second surgery and mistakenly performed it on the same finger as the first. (The hospital has released few details about the exact nature of the mistake, but some news reports indicated that the second procedure was done on the correct hand and finger but the wrong joint.) When the team discovered the error, they asked the patient's family whether they should go ahead and perform the surgery on the correct site.

The family said yes, and the surgical team proceeded. But amazingly, Gifford says, the team still did not do a timeout before proceeding with the third procedure, which was completed on the correct finger.

The October 2009 incident was the fifth to happen at the same hospital in two years. The state fined Rhode Island Hospital $50,000 after neurosurgeons operated on the wrong part of patients' heads on three occasions in 2007, and there was a fourth wrong-site surgery that has been acknowledged but not described by the hospital. The Joint Commission estimates that wrong-site, wrong-side, and wrong-patient procedures occur more than 40 times every week in the United States.

When the hand surgery error was reported, Rhode Island Hospital CEO Timothy Babineau issued a statement saying the hospital is conducting "a thorough analysis" of what went wrong. "Thus far, we have identified an ambiguity in the timeout process for hand surgery when more than one procedure is being performed, which may have contributed to the error," he wrote.

Hospital officials declined a request from Healthcare Risk Management for further comment.

The health department responded to the fifth wrong-site surgery by imposing a $150,000 fine and requirements intended to prevent a sixth from ever happening. A compliance order from the department requires Rhode Island Hospital to assign a clinical employee who is not part of the surgical team to observe all surgeries at the hospital for at least one year. That person will monitor whether doctors are marking the site to be operated on and taking a timeout before operating to ensure they're operating on the proper body part.

The order also requires the surgeon to be involved in marking the surgical site, which already is recommended by patient safety protocols. The state also gave the hospital 45 days to install video and audio recording equipment in all its operating rooms. The cameras do not have to record every surgery, but each doctor must be taped performing surgery at least twice every year. The hospital can decide whether to tell surgeons when the cameras are recording, but it will obtain permission from patients or their families.

In a press conference regarding the sanctions, Gifford said he had never heard of such requirements, but that they were necessary in this case.

"Clearly, there's a culture of making mistakes, so if they're hesitant to have someone to look over their shoulder, that says to me that we're doing the right thing," he said.

Repeated never events should prompt a review of the hospital's culture, says Georgene Saliba, RN, HRM, CPHRM, FASHRM, administrator for claims and risk management at Lehigh Valley Hospital & Health Network in Allentown, PA, and 2009 president of the American Society for Healthcare Risk Management (ASHRM) in Chicago. She wonders what the string of errors might suggest regarding the culture at Rhode Island Hospital, particularly whether patient safety protocols are truly valued vs. being seen as just window dressing, and whether staff feel empowered to speak up.

"We have the Universal Protocol, and we can use the aviation model with the checklists; but people have to be engaged in the checklists," she says. "We can give them the tools and the processes, but they have to actually do it. They can't just go through the motions."

Saliba says she is particularly troubled by the reports that there was no timeout before the hand procedures, because the timeout is the final opportunity to catch any errors that might have crept in earlier.

"That's the last time you can catch something that might have been missed at 16 other steps along the way," Saliba say. "You absolutely cannot skip this final, crucial step, where you have a last chance to catch a problem before it becomes a serious, possibly tragic mistake. You should have a culture in which no one in that OR would ever allow you to skip that step, a culture in which you'd have a chorus of voices piping up to stop that procedure, because you didn't do a timeout."

Most never events are tied to a breakdown in communication, she says.

"We have to be a team. Without that team approach, there will be a break in process, and errors will occur," she says. "And you have to have a culture with a 'stop-the-line' mentality, where people will speak up even if the surgeon is the biggest surgeon who brings in the most revenue. Even if he huffs and puffs and blows your house down, you have to be willing to stop that procedure."

The negative publicity from not just one never event, but a string of incidents, can be crippling, says Don Hannaford, senior vice president of Levick Strategic Communications, in Washington, DC, who has extensive experience as a crisis management counselor for health care providers. In this respect, he says, Rhode Island hospital is doing the right thing by publicly acknowledging the incident and not trying to make excuses.

The best approach is to admit that it happened. You never increase the patient's comfort that it is unlikely to happen in the future if you don't acknowledge something that clearly happened in the past, Hannaford says.

The hospital also must go along with the state's corrective action with no complaints, he advises.

"Rhode Island Hospital has to take their medicine, with the video cameras and the other requirements. And they have to tell their doctors to shut up and stop acting like whining brats who don't want Big Brother looking over their shoulders. They deserve to have Big Brother looking over their shoulders because they [made significant errors] five times in two years," Hannaford says.

The unusual and extensive sanctions actually can work in the hospital's favor, he says. After such an egregious error, it is not enough to say that you already had the right policies and procedures in place and admit that you did not follow them. To make amends and promote confidence, the provider must take additional steps beyond whatever precautions already were in place — even if those existing precautions should have been adequate.

The only exception would be if the hospital were willing to fire the one person who violated policy, Hannaford says. But that would only work when the error can be pinned on an individual, and the incident happened once. After five never events, even the general public gets the idea that there is some sort of systemic problem.

"You must do something more to show that there is heightened attention," he says. "That could be an extra step, an additional person, some additional measure. You can't just say you had all the right policies in place and you didn't follow them, but you promise you will next time. That doesn't inspire confidence in anybody."

Sources

For more information on wrong-site surgery, contact:

• Georgene Saliba, RN, HRM, CPHRM, FASHRM, Administrator for Claims and Risk Management, Lehigh Valley Hospital & Health Network, Allen- town, PA. Telephone: (610) 402-3005. E-mail: georgene.saliba@lvh.com.

• Don Hannaford, Senior Vice President, Levick Strategic Communications, Washington, DC. Telephone: (202) 973-1300. E-mail: Dhannaford@levick.com.