DAVENPORT, Iowa. (KWQC) – When you check into a hospital for surgery, you’re placing your life into another person’s hands. You trust that they’re taking every precaution to keep you safe. But hospital memos and state inspection reports dug up by TV-6 show a number of mistakes occurred in recent months at Genesis hospitals – mistakes medical experts say should never happen. Four times in 40 days last year, surgeons at Genesis Health System mistakenly operated on the wrong side of patients.
Wrong site surgeries are part of a group of medical mistakes called never events; that means they’re never supposed to happen. In a letter obtained by TV-6 Investigates, Genesis Health System wrote to its employees that four wrong site surgeries had occurred within 40 days, and that practitioners didn’t always follow the hospital procedures meant to protect patients. TV-6 Investigates asked to speak with both the CEO and the Chief Medical Officer to find out what happened and what the system was doing to prevent it in the future. Genesis had us talk to its Vice President of Corporate Communications, Ken Croken.
“The severity of the error is critical to understand, in the case of these four errors, no serious consequence reached the patient, relatively speaking,” Croken told KWQC.
He said no one died, and no one had the wrong limb amputated. The Iowa Department of Inspections and Appeals found two wrong-site surgeries occurred at Genesis hospitals within two weeks. On October 23, a surgeon at Genesis West cut into the left hip of an 80-year-old patient. The patient needed surgery on a broken right hip.
“The surgeon began the initial incision, no muscle no bone, that would position the surgery to go forward,” said Croken.
The inspector found no written evidence that a key safety procedure, called a time out, had been performed. A time out is when the operating team double checks the patient, the procedure, and the site before cutting. The surgeon said he didn’t participate in a time out, and didn’t remember if the team did either. A nurse said she did a time out, but didn’t write it down. Croken said there’s no proof a time out didn’t occur.
“The nurse noted there had been a time out but clearly it had not been an effective time out, because if it had been effective it would not have happened,” said Croken.
The nurse stopped the surgery and the team figured out the mistake. The surgeon closed the cut, and did the surgery on the correct side.
“I think there’s no doubt that every person would conclude that more attention should have been paid, to are we on the right side,” said Croken.
On November 5, a patient came in to Genesis East for thyroid surgery. They had a suspicious mass on the right half and were supposed to have the right half removed. But the doctor mistakenly ordered the left half removed. Nobody caught the error until after the surgery was done.
“The surgeon removed the side suggested it should be removed, but when the physician got into the surgery, he became suspicious, went back to the original pathology report and determined that it was the other side,” said Croken.
The surgical team reopened the patient’s neck, and removed the rest of the patient’s thyroid. That half turned out to be cancerous. Standard procedure would have called for the entire thyroid’s removal when that part was found to be cancerous.
“We take very seriously there had been a miscommunication, that occurred outside our four walls and had been brought inside, but in this case that patient avoided a second surgery,” Croken told TV-6.
Croken told us he didn’t have details on the remaining two wrong site surgeries Genesis discussed in its letter, but said, “They were also not serious safety events in that no lasting or serious harm occurred to the patient.”
So what happened? In its letter to staff, Genesis found doctors were not fully participating in time outs. At times there were distractions such as music playing in the background and that markings on a patient were covered up. Croken said staff members involved in a wrong site surgery are going through a disciplinary process.
“I can assure you and the public that we take these time outs very seriously and privileges to work in this hospital are determined by compliance with our safety regulations,” said Croken.
The Iowa inspector also found Genesis failed to immediately implement a system to ensure time outs occurred after these wrong-site surgeries at Genesis East and West. The state called it an immediate jeopardy. It meant patients were at risk.
TV-6 investigator Mark Stevens asked Croken, “Why wasn’t it addressed before a state survey agency ever got involved?”
The response from Croken – “It was addressed which is how we came up with the plan, we reported it to the state survey team, during their visit, but that doesn’t suggest that we didn’t react immediately.”
Patient safety expert Dr. David Nash told KWQC, “A four in a one-month or two-month period is completely unacceptable.”
Nash is the editor in chief of the Journal of American Medical Quality. He says modern medicine has worked to eliminate wrong site surgeries for decades. A 2013 study estimates wrong site surgeries occur as often as 50 times a week across the country. Nash says it only takes simple errors to accumulate for a wrong-site surgery to occur.
“Very busy surgeon, very busy operating room, some change in standard procedures of the day, and lo and behold, we get what’s called the Swiss Cheese effect, an error occurs that could in fact lead to wrong site surgery,” said Nash.
There are multiple reasons wrong site surgeries happen. Researchers studying them in Colorado blamed poor planning and not following the time out. Nash says it boils down to a hospital’s patient safety culture.
“In a culture that is a just culture that recognizes human fallibility that questions each other in a professional and appropriate manner, there should be zero wrong-site surgeries,” said Nash.
“We do audits, we self audit ourselves, all the time,” said Center for Health Ambulatory Surgery Center CEO Tom Feldman.
Staff at his Peoria-based surgery center participated in a Joint Commission study a year and a half ago. The goal: figure out more ways to prevent wrong site surgery.
“It’s important to just refocus and get with a couple true patient identifiers a name a date a of birth, restate the procedure, and then go forward,” said Feldman.
One process Feldman’s surgery center found could lead to errors were doctors marking their patient’s slightly differently. Some used a dot, some their initials, some a “yes.” With 85 doctors doing surgery, Feldman decided to set a standard. Everyone must use their initials – period.
“I think that’s helped draw attention to how important the marking really is,” said Feldman.
The study also found the center’s time out had grown too complicated. So they simplified it to the three steps we saw. Feldman says he’s glad they took part in the study. Overall, the Joint Commission found the eight medical facilities that participated cut their risks of wrong site surgery in half. The Joint Commission created a tool for hospitals to use to cut their risks too.
“It’s everything from the surgeon’s office, to when it hits our scheduling, to when it comes in here and the patient is prepped for surgery and then ultimately when a surgeon goes to make a cut or begin the surgery,” said Feldman.
Genesis submitted a plan of corrections to regulators addressing the problems the inspector found.
VP of Corporate Communications Ken Croken said, “We have done so and they have agreed that our plan is effective.”
Fixes include the following: everyone must participate in a time out; a patient’s skin marking must be visible; and, time outs will be audited in person.
“It’s our philosophy here and again it has earned us national recognition, safety is the most important of all of our objectives,” said Croken.
Inspectors conducted a follow-up inspection at Genesis in early February. They found Genesis was back in compliance with federal regulations. Had they found otherwise, Genesis would have been terminated from participating in the Medicare program.