After 5 'never' events, observer, taping required

Rhode Island Hospital, the teaching hospital for Brown University's Alpert Medical School in Providence, is facing unprecedented sanctions from the state health department after its fifth wrong-site surgery since 2007.

The health department responded to the fifth wrong-site surgery by not only imposing a $150,000 fine, but also imposing requirements intended to prevent a sixth from 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. 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, state health director David Gifford, MD, MPH, 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 the 2009 president of the American Society for Healthcare Risk Management (ASHRM). Saliba 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 fifth wrong-site surgery, because the timeout is the final opportunity for identifying any errors. "That's the last time you can catch something that might have been missed at 16 other steps along the way," she says. "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, Saliba 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." [The fifth wrong-site surgery originally was covered in Same-Day Surgery Weekly Alert, Nov. 6, 2009. To subscribe to this free weekly ezine, click here.]


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, Allentown, PA. Phone: (610) 402-3005. E-mail:
  • Don Hannaford, Senior Vice President, Levick Strategic Communications, Washington, DC. Telephone: (202) 973-1300. E-mail: