In April 1987 the heart transplant team at University Medical Center in Tucson, Ariz., transplanted a heart from a blood type O cadaver into a blood type A patient.
"It was a significant news event, a hellacious screw-up," recalls surgeon Timothy Icenogle. "It happened because we used recollection." A nurse was relying on memory when she assigned the patient the wrong blood type.
Icenogle recognized this as a systemic error, something that could potentially be designed out of the loop so it couldn't happen again.
Icenogle was reminded of the Arizona incident last December when he read about the Institute of Medicine's report on medical errors and the industry's response. That blood-type error was exactly the kind of problem the IOM report was talking about, he says. It was a human error that should have been prevented by a fail-safe system.
In 1989 Icenogle moved to 607-bed Sacred Heart Medical Center in Spokane, Wash., and created a heart transplant program there. His program, though small, achieves some of the best results in heart transplant in the country, according to an unpublished study by HHS. The study is available on the World Wide Web site of U.S. Rep. Henry Waxman (D-Calif.) at www.house.gov/waxman. The United Network for Organ Sharing collected the data for 21/2 years beginning in 1994.
Solid success. Of the patients who were placed on the waiting list for a heart transplant at Sacred Heart, 93.9% were still alive after one year, regardless of whether they had a transplant. That was the highest percentage in the U.S. The national average was 75.8%.
Of those on the waiting list at Sacred Heart, 64.8% received transplants within one year compared with the national average of 53.7%.
And while 16.5% of people on the waiting lists at all U.S. transplant centers died after one year, only 6.5% on the waiting list at Sacred Heart died.
"(It seems) to be pretty good overall," UNOS spokesman Bob Spieldenner says of the Sacred Heart program. One reservation about the study is whether it is adequately adjusted for case complexity, Spieldenner says. "Nevertheless a 94% survival on the waiting list is good."
Icenogle attributes his program's success to the development of protocols to manage the very complex systems in transplants and reduce the error rate. Ten years ago, long before the IOM report was recommending it, he adopted a risk-reduction model developed by the aerospace industry.
Icenogle says that after seeing a television show covering risk reduction in the aviation industry, "we started looking at fault-tree analysis," introduced in the Minuteman missile project. "They looked at ways to reduce mission-critical errors. If valve A fails, then valve B opens, and the mission continues."
The difference between aviation and medicine is primarily in outlook, the surgeon notes. "Aviation says, `You will screw up; you will have mechanical failure. We will devise a system to prevent it.' In medicine we say, `We will educate the brightest and best, and punish them unmercifully when they mess up.' "
An aircraft carrier, for example, is a high-reliability, high-risk organization in which lots of uneducated young people make critical decisions that can result in disaster, Icenogle says, yet disaster rarely occurs. Two people are often doing the same job; that's a redundant loop.
Shadowing blood. In medicine, one of the few redundant loops is typing of blood. Two people must sign off on the blood type before it can be transfused. "Nobody deals with a blood type alone," transplant coordinator Pam Hester says. "It's a shadow thing."
At Sacred Heart, this redundancy is implemented every step along the way. "In our case," Icenogle says, "we have three patient coordinators and three people in the device program who are all doing redundant work. All of these people are looking over our shoulders."
Two, Dave Sato and Steve Himley, are trained engineers who refine the artificial hearts that are implanted to keep people alive until a donor heart becomes available. Himley, who worked at a solid-rocket propulsion company, adapts medical devices and artificial hearts for patients who otherwise couldn't take them.
"We add some systems thinking," he says. "We've done things to improve survival by trying things that other places might not think of."
It's unusual to have two mechanical engineers on a heart transplant team payroll. But Himley and Sato are in the operating room during surgery, and they train nurses and patients in the finer points of the complex equipment.
"Largely the success of the program here is continuous quality improvement," Himley says. "Those are the questions we ask: `What went wrong? How can we keep it from going wrong in the future?' "
The transplant team meets regularly to discuss process improvement. Elaborate protocols determine every step, but they can be changed. "We empower people to make suggestions for change. Pharmacists, nurses, assistants bring it to committee, and (they) can change it," Icenogle says.
But one thing that isn't subject to change is review of physician decisionmaking by transplant team doctors and nurses. Each patient awaiting a transplant is cared for by a personal physician, and if the patient is in the cardiac intensive-care unit, he or she may be seen by a pulmonologist, a cardiologist, a nephrologist and an infectious disease expert. Each of those doctors may issue orders that conflict in some way with the patient's overall good.
In the transplant program, however, Icenogle or his partner must review every physician's order.
For some docs, alienation. This redundant loop helps keep patients alive but at the cost of alienating some physicians. In 90% of cases, Icenogle says, he does what the other physicians want. In 8% of the cases he changes their orders. "But 2% of the time, I say, `lethal error.' "
Likewise, transplanted patients at home are supposed to call their coordinator any time another doctor alters their medication.
All this redundancy comes at a high price. Yet Sacred Heart transplants cost about $150,000, less than half the national average of $303,000 in billed charges, according to Milliman & Robertson, Seattle. "We're achieving economy because we're avoiding complications that occur through screw-ups," Icenogle says. "Because we have these engineers around, we've been able to do creative things." Patients with a mechanical heart can go home while awaiting a transplant, saving tens of thousands of dollars.
Ironically, success must be its own reward at Sacred Heart. The program is not growing; it's shrinking. The number of transplants is gradually declining because of better medical management and fewer donor hearts.
Icenogle's program contravenes two of the cherished beliefs of the medical-quality community. The first is that better quality will generate more referrals. "Nobody really looks at quality data," he says. The government's belief that publication of the UNOS data will lead people to choose the better programs is mistaken, he says.
Second, volume correlates to high outcomes. In the two years when Sacred Heart led the nation in one-year survivability, it performed only 50 transplants. According to prevailing theory, a team that does so few surgeries should be less proficient than a "factory" that's turning them out every other day.