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‘So here’s what I think we should do,” declared Donald Berwick, M.D., surveying the hundreds of health-care executives and physicians who had packed into a hotel ballroom in Orlando, Fla. “I think we should save 100,000 lives. I think we should do that by June 14, 2006.” A short pause. “9 AM.”

Say what? Did this guy you’ve never heard of just order the most important people in American health care to save a large number of lives by a fixed date? He did. And the leaders of American health care took him very seriously.

Berwick launched his 100,000 Lives Campaign on a pleasant (at least in Orlando) day last December. The challenge: Get at least 1,600 hospitals—one-third of all hospitals nationwide—to commit to using six “interventions” prepared by Berwick’s organization, the Institute for Healthcare Improvement. Each intervention has been shown in peer-reviewed literature to save lives and improve care.

Six months later, more than 2,200 hospitals nationwide have joined Berwick’s campaign, 40 percent of all hospitals nationwide. About three- quarters of New York state’s hospitals are participating, including every hospital in the Capital Region. Berwick’s partners include a few organizations you might have heard of, like the American Medical Association, the Centers for Disease Control, the Centers for Medicare and Medicaid Service (the government agency that runs Medicare and Medicaid), the Veterans Health Administration, the American Heart Association, the American College of Physicians, and a mind-numbing roster of state hospital and physician associations.

The 100,000 Lives Campaign—usually shorthanded as 100K Lives—has snowballed into the most ambitious collaborative campaign among hospitals since the Salk penicillin trials 50 years ago. If it succeeds, 100K Lives will be the greatest triumph for organized medicine in years—and a hundred thousand people will be alive who would otherwise be dead.

Health-care industry leaders seem thrilled without reservation to be launching such a promising initiative, and, not unreasonably, they want the public to give them a little credit. Says Kathy Ciccone of the Healthcare Association of New York State, the state hospital trade association: “I hope this campaign helps consumers develop an awareness of all the efforts that hospitals and providers undertake to improve quality of care.”

But the reality is a little more complicated. In fact, it’s rather embarrassing. Because Berwick was not exactly playing civic booster in that Orlando ballroom. “I’m losing patience,” he declared. Berwick’s patience was fraying over lack of progress in making the health-care system safe and effective. He acidly suggested that his beloved Red Sox might win another World Series before that happened—even if they had to wait another 85 years.

Donald Berwick is best known as the president and cofounder of the Institute for Healthcare Improvement, an organization devoted to finding the best innovations in all aspects of healthcare and spreading them throughout the industry. IHI runs dozens of workshops and conferences each year, including the conference in Orlando.

Many articles flow from Berwick’s pen each year, some careful studies appearing in the most respected medical journals, some passionate indictments of the status quo. Berwick is a graduate of Harvard University and Harvard Medical School, as well as a member of the faculty of Boston Children’s Hospital. Yet mere biography does not get at Berwick’s unique status in healthcare. Berwick has become the ultimate outside critic to healthcare while remaining an admired—even revered—insider. As an outsider, Berwick mercilessly criticizes the waste and negligence of today’s health-care delivery system and calls out the culprits, most often health-care managers. Yet he is anything but a gadfly. Berwick is perceived as a leader within health care, not an outside irritant. “He should get the Nobel Prize in Medicine,” suggested one doctor interviewed for this story.

The roll-out of 100K Lives in December 2004 marked the 10th anniversary of a death that launched the modern patient-safety movement. On Nov. 26, 1994, Betsy Lehman, a health-care columnist for The Boston Globe, checked into Dana Farber Cancer Institute for chemotherapy to stop the progression of breast cancer. She was the most informed and engaged patient imaginable, and Dana Farber one of the nation’s top cancer centers. Yet Lehman died of an overdose of a potent cancer drug. Worse, she received the overdose for four straight days, even though another woman in the same ward had collapsed of a drug overdose less than a week before.

Lehman’s death made national news. But reporters, lacking an incompetent doctor or goof-off nurse to blame, had trouble explaining what had happened at Dana Farber.

They got the explanation, and much more, from an article published two weeks later, in the Journal of the American Medical Association by Dr. Lucian Leape, a pediatric surgeon and researcher.

Leape’s article focused on a touchy subject among doctors—medical errors. Leape and his team had churned through 30,000 medical records at 51 New York state hospitals, looking for possible gaps in care. They found more than anyone could have imagined. Some 3.7 percent of hospital patients had been the victim of an injury caused by the hospital itself, and six in 10 of those cases resulted from mistakes. One in seven victims of an adverse event died. Multiplied nationwide, that would mean 98,000 people dying annually of preventable medical errors—the equivalent of a 747 airliner going down every day for a year.

Where Leape jumped most sharply from existing discussion was in focusing on systems of care rather than the traditional culprit, careless or negligent doctors. It was useless to blame bad doctors when mistakes were taking place every day at every hospital in America. Rather, gaps in the system of care were allowing patients to be harmed.

Reporters jumped on Leape’s study, which offered the most plausible explanation of what happened to Betsy Lehman: She was killed by a system that failed to make providers check medication dosage before administering it. In the process, they also publicized the Leape study’s startling findings on the wide prevalence of death by medical error.

Five years later, Leape and Berwick led a panel of the National Institute of Medicine that drafted a new study, To Err Is Human: Building a Safer Health Care System. The IOM study added new findings and a tone of urgency. For example, the study found that annual costs to the American economy ranged between $17 and $29 billion, and that more people died each year of medication errors alone (7,000) than workplace injuries (6,000). To Err Is Human sparked a media frenzy which made “medical error” a household word and forced the health-care industry to admit the existence of a serious problem.

To Err Is Human set a goal of reducing medical errors by 50 percent over five years, but it soon became evident that little was changing in the health-care industry. “The pace is astoundingly slow,” charges Michael Millenson, author of Demanding Medical Excellence and a leading critic of hospital quality standards. A recent survey of physicians by the Commonwealth Fund found, for example, that rates of several preventable adverse events and complications of hospital care actually went up from 1995 to 2002 among Medicare recipients. Commonwealth Fund researchers also found that only one-third of all physicians had been involved in efforts to “better manage patients’ clinical care.”

In the Capital Region, complaints of medical errors from former patients and family members are regularly reported. Yet there’s no way to estimate how common these errors really are. The state maintains a medical error reporting system called NYPORTS, but the system is not considered reliable due to chronic hospital underreporting.

So it’s not surprising that Berwick has lost patience with the healthcare status quo. Amazingly, however, he has succeeded in getting key actors to share his impatience and buy into his plan. How? By mimicking the structure of a political campaign. Berwick argues that political campaigns operate more efficiently because they’re always racing against a deadline, which is to say, Election Day. So he made up an arbitrary deadline and 2,200 hospital CEOs said OK. The six interventions are the platform, the slogan is a suitably cutting campaign proverb: “Some is not a number, soon is not a time.” The campaign even has a candidate. “We’re going to elect quality,” says Berwick, only half-kidding.

The other reason 100K Lives has launched so strongly is that the interventions just plain make sense. “The IHI campaign stands apart,” says Ciccone, “because it offers solutions. It says, this is the best care as we know it right now that we can deliver and here’s how to do it. It’s just a better idea.”

Each of Berwick’s interventions consists of a bundle of smaller reforms, such as “maintain perioperative glucose control” and “discontinue antibiotics within 24 hours of surgery end time.” Each item in the bundle must be carried out for a patient to count as having received “perfect care.” If a 500-bed hospital fully implemented all six interventions, says Berwick, it could save 230 lives each year. Participating hospitals turn over data to the Institute for Healthcare Improvement that document trends in patient mortality. If enough hospitals sign on to 100K Lives and apply the six interventions their collective drop in mortality rates should surpass 100,000 lives. Goal achieved! At least that’s the theory.

Dr. Robert Benton is testing the theory. Benton, a cardiologist affiliated with Northeast Health in Troy, is piloting an intervention to prevent acute myocardial infarctions. He chairs a multidisciplinary team that takes quality of care standards like “early administration of aspirin,” or “timely initiation of reperfusion,” and figures out how to incorporate them into providers’ work flow. His group spends a lot of time gathering and analyzing data and flow charts. Then they have to talk to doctors and other staff about pulling apart their daily routines and rebuilding them in a new model.

Breaking through with a difficult program like this one requires a zeal for numbers and a merciless look in the mirror. “I went through the denial phase myself. I said, how can I not be giving ACE-inhibitors to 100 percent of my patients?” recounts Benton. ACE-inhibitors are a class of medication that should be given to all chronic-heart- failure patients when they leave the hospital unless otherwise indicated. Studies show that patients who fail to get one are more likely to suffer a traumatic heart problem. “When we measured it, I was at about 80 to 85 percent. That’s not great. Some of these cases are just documentation, but that’s important too. And then there’s patients where I just don’t have them on ACE-inhibitors, and I say, what kind of a doctor am I?”

Benton’s question is revealing. Once upon a time, doctors reacted to every criticism of their profession as a personal criticism: “What kind of doctor are you?” Doctors are taught in medical school that they cannot ever afford to make a mistake, because a mistake can cost a life. Paradoxically, what would seem to be an admirable ethic of personal responsibility makes it all the harder for physicians to admit the possibility that mistakes happen. “Most doctors don’t believe that they themselves are responsible for errors,” says Millenson, “and it’s certainly not something they like to think about any more than you or I would.”

“Thou shalt make no assumptions about what it will take to change physician behavior,” declares Dr. John Collins, medical director of Northeast Health, which operates Samaritan Hospital and Albany Regional Hospital. He’s being modest. Collins, a genial bearded man with a tone of cheerful idealism and a subtle eye for human nature, actually has a pretty good idea of what it takes to change physician behavior.

“I have some credibility,” says Collins, “but it’s not the same as your partner sitting down with you and saying your data doesn’t quite look like it should.” He’s talking about people like Robert Benton, who can talk to other cardiologists heart to heart, as it were. Just as important, Collins sticks close to the data and talks about fixing systems, not doctors.

“Their minds are not closed about these issues,” Collins insists about his doctors, but his war stories are not totally reassuring on this count. Take the practice of shaving patients before surgery. IHI’s how-to guide on preventing surgical infections—the second most common mistake after medication errors—reports that “the use of razors (shaving) prior to surgery increases the incidence of wound infection when compared to clipping.”

This research finding dates back to 1971, preceding the IOM study, not to mention Watergate and the fall of Saigon. It’s that old. But still, plenty of surgeons allegedly continue to shave their patients before surgery. “There’s a subset of surgical colleagues who feel as though shaving is the right way to go,” says Collins. “They’ve always shaved, they don’t perceive it as a problem. There’s another group that says, ‘I’ll clip, but get me the best clippers, and the first time they don’t work I’m going back to shaving.’” From one facility to another, says the IHI guide, the use of shaving “can range from zero to nearly one hundred percent.”

Physicians may be coming around after all these years, but there are plenty of other obstacles to eliminating mistakes in medicine:

Antiquated payment structures: The straight payment-for-treatment system used by public and private insurers makes error reduction a sucker’s game. “If you have zero infections in the intensive care unit, you lose money,” complains John Morley, medical director of Albany Medical Center. For example, if an elderly patient gets an infection after surgery due to poor hand washing hygiene, Medicare pays the full cost of care. Fewer infections equal less money.

Lack of information technology: Many dangerous mistakes have resulted from illegible handwritten prescriptions. But what if doctors could print out prescriptions from their computers? What if doctors could pull up all the information on a patient at their computer instead of flipping through a bulky medical record that might or might not even be available? Fewer than 10 percent of hospitals in America have such systems. The hold-up is the vast expense of the information systems needed. “We need technology, and technology costs dollars,” says Morley.

Short staffing: Some causes of medical errors have been known for years, like inadequate hand washing by surgeons and other providers. Nancy Webber, a spokesperson for the New York State Nurses Association, says that nurses could improve hygiene standards—if only they weren’t so understaffed. A 2002 study in the New England Journal of Medicine found a parade of horrible outcomes, such as urinary tract infections, upper gastrointestinal bleeding, shock and longer hospital stays to be tied to inadequate nurse staffing levels.

The obstacles may seem overwhelming. But Berwick isn’t taking excuses, and no one wants to disappoint him. Collins, Benton and others from Northeast Health were in the audience for Berwick’s Orlando speech. For a few minutes they glimpsed the promised land of Safe and Effective Healthcare. When they returned home, Collins began organizing Northeast Health to implement all six interventions. Other hospitals in the Capital Region are starting more cautiously, rolling out one or two initiatives apiece.

As their spokespeople explain why they picked this or that intervention, it all sounds reasonable, thoughtful, mature. On the other hand, patients are dying every day who don’t have to.

After Berwick had finished speaking, he turned the microphone over to Sorell King, the mother of a little girl named Josie who died at Johns Hopkins Medical Center in 2001 of dehydration due to a remarkable series of mix-ups. She controlled a sob, and then told the audience: “If this campaign had been in place four or five years ago, that rapid-response team would have come when the nurse wanted or when I wanted and Josie would be alive.”

The rapid-response team King referred to is an intervention in which a provider team bypasses the chain of command to respond directly to patients whose condition seems to be deteriorating: chest pain, trouble breathing, altered mental state and so on. What happens today is that bedside staff observe the symptoms but often fail to call a doctor and the patient goes into cardiac arrest. Rapid-response teams have been shown to cut the rate of cardiac arrest and other traumatic events by as much as half.

Yet only 40 percent of the New York hospitals participating in 100K Lives are implementing the rapid-response team, including only Saratoga Hospital and Northeast Health in the Capital Region. Kathy Ciccone of the state hospital association points out that the rapid-response team is a newer idea with a thinner evidence base than the other five interventions, which is true. Nonetheless, it’s hard not to feel a sense of impatience. For all we know, another Josie King may be lying in a nearby hospital at this very moment.

Still, it should be understood that hospitals are looking for more from 100K Lives than saving lives. What really excites doctors and hospital managers is the tantalizing opportunity to transform their change-resistant, goof-prone cultures into change-friendly, goof-free cultures. So much of what hospital leaders gush about makes the eyes of regular people glaze over: bundling, checklists, protocols, aligning improvement indicators of various organizations, and so on. And yet, this is the mundane stuff of transformation. Says Collins: “It’s a great reordering in how we think about work.”

And on June 14, 2006, 9 AM, those of us on the outside will get a glimpse of what’s really changing inside those necessary but nerve-racking edifices called hospitals.

The Institute for Healthcare Improvement Web site, www.ihi.org/IHI/Programs/ Campaign, contains a wealth of information on the 100,000 Lives Campaign, including a video of Don Berwick’s Orlando speech and the full text of the how-to guides on each intervention. These how-to guides are recommended for people about to check into a hospital, especially surgery patients.

photocap:Embracing change: Dr. John Collins, medical director of Northeast Health.

Six Interventions to Change Health Care

Deploy rapid response teams at the first sign of patient decline.

Deliver reliable, evidence-based care for acute myocardial infarction [heart attack].

Prevent adverse drug events by implementing medication reconciliation.

Prevent central line infections by implementing a series of interdependent, scientifically grounded steps.

Prevent surgical site infections by reliably delivering the correct perioperative antibiotics at the proper time.

Prevent ventilator-associated pneumonia by implementing a series of interdependent, scientifically grounded steps.

Bonus Prize from 100K Lives

Yesterday an odd-couple coalition of hospital trade associations, employer associations, consumer groups, healthcare unions and lawmakers held a press conference to announce their support for a bill to establish a system for public reporting of hospital-acquired infections. The categories track IHI’s three infection-related targets: surgical-site infections, central line infections, and ventilator-associated pneumonia.

The bill mandates that each hospital maintain a program for reporting each infection acquired by a patient at the hospital, some resulting from errors and others considered unavoidable. Hospitals will transmit the information to the State Department of Health, which will compile it into comparative tables on hospital infection rates. Patients about to choose a hospital can check a Web site to find out which hospitals have the highest and lowest rates of post-surgery infections.

If successfully implemented, a system for reporting hospital-acquired infection systems would put New York state at the forefront of the hospital-safety movement. It would also radically energize hospitals to improve their infection-control systems. Consider the success of the Cardiac Surgery Reporting System. In 1989, New York became the first state to compile and release hospital-by-hospital mortality rates for cardiac surgery. Under the bright spotlight of publicity, hospitals around the state slashed their mortality rate by 41 percent over four years. In 1989, St. Peter’s Hospital in Albany was found to have an alarming 26 percent mortality rate for emergency cases. By 1993, the hospital had cut its mortality rate to 0 percent. That’s right, 0 percent.

But implementing hospital-acquired infection reporting won’t be simple. Dr. Edward Hannan, Chair of the Department of Health Policy, Management and Behavior at the University at Albany School of Public Health, helped devise and manage the Cardiac Surgery Reporting System. He warns of pitfalls ahead. For example, publicly reporting hospital-specific data could create incentives for hospitals to understate infection cases. “The state will need to identify which of the millions of hospital cases where no infections were reported should be audited,” says Dr. Hannan. That could be difficult and expensive. “It may not be rocket science, but it ain’t marbles either.”

One factor seems to herald good tidings to come: the support of the hospitals being asked to report. It might seem a little startling that the hospital industry would endorse a reporting system that may draw unfavorable publicity to a few hospitals each year. But Kathy Ciccone of the state hospital trade association waxes enthusiastic about the new bill. “Infections are an area that hospitals work very hard on,” argues Ciccone. “Our patients have told us they want more information about infections, and this gives us an opportunity to develop information that’s meaningful.”

So You’re Checking Into A Hospital

What would Don Berwick want you to know?

Much of the information that hospitals are using in the 100,000 Lives Campaign is, well, impenetrable to laypeople. But for patients concerned about getting a hospital-acquired infection—and if you’re not, you should be—100K Lives has valuable information for you.

Here are some questions to ask your surgeon from IHI’s How-To Guide on Preventing Surgical Site Infections. The right answer is in parentheses, although it should be noted that there are always patients for whom the standard procedure may be incorrect.

Do you give antibiotics within one hour of incision time? (Yes.)

Do you stop giving antibiotics within 24 hours of surgery end time? (Yes.)

Do you shave your patients with a razor prior to surgery? (No.)

Do you take steps to prevent patients from becoming hypothermic (cold) during and after surgery? (Yes.)

Do you maintain glucose control in your patients? (Yes.)

The full text of each how-to guide is on IHI’s Web site at www.ihi.org/IHI/Programs/Campaign. Also, Don Berwick wrote a request for proposals to find a surgeon to replace his right knee. Every hospital patient in America should have a copy. It’s available at: http://tinyurl.com/6ydk6.

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