Risk Eliminators

Risk Eliminators

startup by Janet Leiser | Senior Editor

Surgeon and pilot Richard C. Karl expects his startup to play an important role in the national trend to reduce operating room mistakes. The company is working with hospitals to make surgery safer.

An orthopedic surgeon in blue scrubs and mask walks into the operating room after meticulously cleaning his hands and arms. He picks up a scalpel and cuts through the skin. In the background, rock music blasts from a boom box.

After the doctor cuts into the unconscious patient draped in sterile cloths, he realizes a tool is missing. He turns to others in the operating room, talks over the music, and waits about 10 minutes until a nurse returns with what he needs.

That scenario, including the music, is typical of those that play out daily in about 6,000 plus hospitals across Florida and the nation as surgeons, nurses and anesthesiologists, who often don't even know each other's names, are entrusted with the lives of patients.

It's shown in a video made by a Tampa-based Surgical Safety Institute (SSI) to demonstrate the dearth of communication in operating rooms - a problem that greatly contributes to an estimated 98,000 annual deaths in the U.S.

In addition, there are the untold hundreds of millions of dollars that physicians, hospitals and other medical providers pay to settle claims connected to health care mistakes. One error can result in a multimillion-dollar judgment.

Richard C. Karl, chairman of the surgical department at the University of South Florida College of Medicine and co-founder of SSI, suspects the 98,000 figure is much lower than the actual number of deaths that occur each year as a result of surgical errors.

Plus, there are another estimated 15 million incidents of harm each year in hospitals, according to the Institute for Healthcare Improvement. Those result in brain damage, removal of the wrong body part, the leaving behind of a surgical object in a patient or even surgery on the wrong patient, among others.

In Florida, the state's Agency for Health Care Administration records show that surgeons operated on the wrong patient five times in 2005, the latest year available.

It really hit Karl that there was a problem in his industry as he learned more and more about commercial aviation over the past 10 or so years. A pilot with a Boeing 737 type-rating, Karl also writes a column for Flying magazine.

When it comes to safety, many experts say the medical industry lags aviation by at least a decade. In fact, aviation has improved its safety record significantly in the 30 years since it implemented what's called Crew Resource Management training. The U.S. Food & Drug Administration estimates a person would have to fly on average nonstop 438 years before he'd suffer a fatal plane crash.

"I'm working in the operating room every day and the anesthesiologist is not even talking to me," says Karl, 61, who specializes in cancer of the liver, colon, pancreas and esophagus at H. Lee Moffitt Cancer Center and Research Institute.

"I thought, 'What's up with this?' "

In contrast, a coffee pot on a commercial airplane isn't turned on until an extensive checklist has been completed, he says. And an airliner doesn't take off or land until the pilots carefully complete checklists.

About four years ago, Karl and his wife, Catherine Karl, a former chief financial officer for the St. Petersburg Times, started working on Surgical Safety Institute, a consulting firm that teaches doctors and nurses the right way to communicate in the operating room, before, after and during surgery.

The company created checklists, white boards and other aids to verify all is a "go" before an operation begins. Any discordance, even in listed allergies to medicines, and a red flag is raised, delaying surgery until it's resolved.

Last year, the startup was named emerging technology company of the year by the Tampa Bay Technology Forum.

Cathy Karl, chief executive officer of SSI, says: "It's as simple as a whiteboard. Just have this up in the room so everybody can see at a glance what's going on so they can maintain situational awareness, and know each other's names. It's much better if I need something from you if I say your name."

SSI is now working with four hospitals, including the University of Chicago Medical Center and Cedars-Sinai Medical Center in Los Angeles.

Cultural change

"At the beginning of a case, I tell everyone, 'If you see something going wrong, tell me about it,' " Karl says.

He tells of an incident where a nurse dangled the right sized catheter in front of a cardiologist as he inserted the wrong-sized one into a patient's aorta.

"Nurses will say, 'He can do whatever he wants. I'm not going to help him. I'm not going to protect him,' " Karl says. "We've heard this in many hospitals."

Too often, the patient's wellbeing isn't the top priority, he says.

In the incident where the too-large catheter was used, the nurse later said: "He (cardiologist) was poking the aorta, I could see it on the X ray and I kept dangling the right catheter in front of him, but he didn't take the hint. Sure enough, we punctured the aorta. We had to rush the guy into surgery, and then he [the doctor] went out and told the family it was because "I didn't have the right equipment.' You think I'm ever going to help him again? No way."

When Karl first started talking to anesthesiologists prior to surgery, they were surprised.

In a typical pre-op briefing, Karl might say, "This is going to take about three and a half hours and I'd like the patient not to get too much fluid. And if I get in any trouble, I'll let you know. Can you let me know about blood pressure, pulse and urine output every 30 minutes?"

In many operating rooms today, the anesthesiologist or his assistant gives fluids without consulting the surgeon. But that's not always in a patient's best interests.

'Whole enchilada'

The safety screen, or whiteboard, is just the beginning.

"It's not just the checklist, it's the whole enchilada," Karl says. "Most of it is cultural change. We think the safety screen gives them a tool or focal point on which to make that change."

Karl says his friends, including other surgeons, tell him it's so simple.

"Precisely," the surgeon says. "If it's so simple, why aren't we doing it?"

SSI has applied for a patent on its software for use on a wireless tablet PC and large flat-screen monitor. The application is still pending.

If any questions on the checklist have conflicting answers, a red flag appears, stopping or delaying surgery until it's addressed. There are also checklists to follow if an emergency occurs during surgery.

The company works with about eight consultants, including Southwest Airlines' training director and one of its chief pilots, to train hospitals in the procedures.

SSI does have competition, including LifeWings Partners of Memphis, Tenn., which was started by pilots.

"But I'm probably the only guy that chairs an academic surgery department, operates turboprops and is type-rated in a 737," Karl says. "There may be others. But there aren't many. We do training expert to expert. It's not a pilot telling you how to run the operating room."

At USF, Karl is responsible for about 80 employees, 25 faculty members and an $18 million annual budget.

Cutting costs

SSI is not yet profitable.

Karl estimates he has invested nearly $450,000 in getting it going. But he expects it to become self-supporting before long. The business model doesn't require a lot of money to keep the company going since it relies on consultants. Much of the upfront costs were for software development and legal fees.

While Karl says he initially started the company for altruistic reasons - to improve the state of health care. He expects the company to become profitable.

"We want this to stand on its own," he says. "It is valuable. We think we can demonstrate we'll save hospitals a lot of money."

When a hospital signs up for the service, after the initial training, SSI charges about $20 for each surgical case, even those where the surgeons don't use the company's system.

Otherwise, there'd be no incentive for the hospital to use the system each and every time. "They'd say, 'Oh, this is just a knee. I don't need it,' " Karl says.

The Karls considered looking for an angel investor to pay the costs of a sales and marketing team. They decided against it.

"What I really want to do is do this well," he says. "I want to be able to develop a bunch of people that are going to be able to go in there and tell the story, explain how the system works."

He says he knows he's blessed.

"If you think about it, if you can take your great two loves, marry them and do some good, that's pretty cool," he says.

It's in a hospital's best interest to adopt the surgery safety program, he says. Although many institutions aren't always ready to do it. Sometimes it takes a multimillion-dollar lawsuit for a hospital to realize it has a problem.

He points to the high cost and bad publicity associated with the removal of the wrong foot at Tampa's University Community Hospital about 12 years ago. Many people still associate the hospital with the incident.

The Willie F. King case in 1995 set off a firestorm of negative news coverage. Surgeon Rolando Sanchez lost his license for amputating the wrong foot, and King later received a settlement of $1.15 million.

In addition, he says, checklists potentially save medical providers money in another way.

"If you have the briefing before the operation and the nursing staff knows exactly what the surgeon needs in the way of equipment, they don't have to open five extra pieces of stuff they don't need that will have to be re-sterilized or thrown out," he says.

Karl provides an aviation related analogy.

"The airlines don't fill up every airplane with gas," he says. "They look at how far they're going, how many people are on the airplane and what the maximum takeoff weight is, and they make a judgment about how they're going to do it. We don't have much of that in medicine."

REVIEW SUMMARY

Who. Co-founders Richard and Kathy Carl

Company. Surgical Safety Institute LLC

Key. To prevent deaths and serious injury, the medical industry must make systemic changes, not play the blame and shame game.

Setting

the Tone

A hospital that uses Surgical Safety Institute's program won't ask a patient if he's there for a particular procedure or operation.

Instead, the nurse or doctor will ask the patient what procedure do they think they're having at the hospital.

"By the fifth time, somebody asked you that, you wonder don't you know what you're doing?" says Richard Karl, who co-founded the company with his wife, Cathy Karl, a CPA.

"You have to tell them, I think I know why you're here today," he says. "But we've found out that people who are getting ready for an operation are so anxious, they'll say yes to anything. I'm asking you to tell me."

It's an explanation that takes about 16 seconds, he says, adding, "But it changes the tenor of the relationship."

And it helps eliminate errors.