‘It’s never just one thing’ that leads to serious harm

A technician mistakes an “a” for an “o” in a drug name. A doctor misplaces a decimal point in a prescription order. A nurse reaches for a vial in a cabinet as she’s done hundreds of times before, only this time the light is dim and she fails to notice that the powder-blue label is more of a sky blue. The slip-ups are often simple, and always human, and all have happened in U.S. hospitals.

Each simple mistake is supposed to be countered by a recommended backup, a second or third set of eyes -- in other words, guidelines to reduce human error. A lot has to be overlooked in the cascade of errors that result in serious patient harm.

“It’s never just one thing that goes wrong when a serious event happens,” says Michael Cohen, president of the Institute for Safe Medication Practices, an organization that tracks prescribing errors and is sometimes called in to examine a hospital’s mistake. “We’ve detailed a situation where we found over 50 mistakes in the system before an infant was killed.” The incident, he said, was a 1,000-fold overdose of the blood thinner heparin in an Indianapolis neonatal intensive care unit that resulted in the deaths of three infants in 2006.

Late last year, the infant twins of actor Dennis Quaid and his wife, Kimberly, were the victims of a nearly identical mistake, an overdose of heparin at Cedars-Sinai Medical Center. “It was the exact same situation in a hospital in Indianapolis that we investigated a year earlier,” Cohen says. “The pharmacy dispensed the wrong dose to the nursing station.”

The Quaids’ newborns, who were being treated for a staph infection, have since been released, and the hospital has been cited by state regulators for its handling of drugs. Its practice, regulators say, had placed pediatric patients in jeopardy.

The mistake calls attention to how far hospitals have to go in preventing medical errors and in learning from the mistakes of others, even though many have made progress in protecting patients within their own institutions. Despite a decade of rising public awareness of such mistakes and research into how to prevent them, even one of the country’s premier institutions and a celebrity couple were not immune. Hospitals still have a long way to go to avoid mistakenly hurting their charges.

“People used to say that hospital mistakes are kind of like the poor -- they’re always with you,” says Dr. Lucien Leape, one of the authors of a 1999 Institute of Medicine report that estimated 100,000 people died each year in the U.S. from preventable hospital errors. “Well, no, they don’t have to be.”

Hospitals are trying. In a program called the 100,000 Lives Campaign, some 3,000 of the nation’s 5,000 acute care hospitals, including Cedars-Sinai, have voluntarily instituted up to six changes in practices aimed at reducing errors. The Joint Commission, a national organization that accredits hospitals and other healthcare facilities, now requires that patients be informed of “unanticipated outcomes.”

But while accountability is improving, hospitals still face increasingly complex technology. And medical culture, built on individual excellence, not teamwork, is slow to change.

Unfortunately, Cohen says, few hospitals learn from the mistakes, or improvements, of others. His organization published the results of the Indianapolis incident in a newsletter sent to every hospital in the country. If hospitals are to improve, he says, they have to study errors that have happened elsewhere.

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First instinct: Denial

The mid-1990s saw a rash of medical errors that caught the attention of the public, and the medical profession: A Florida man had the wrong leg amputated, a New York woman had surgery on the wrong side of her brain, and Betsy Lehman, a newspaper reporter whose beat was health, died of an accidental chemotherapy overdose at one of the nation’s top cancer centers, Boston’s Dana Farber.

At first, the American Medical Assn. responded with a public relations campaign, calling the incidents “isolated” mistakes, according to an analysis of the era published in the April 27, 2002, British Medical Journal. By 1996, however, the AMA launched a National Patient Safety Foundation and changed its stance, admitting that such errors were “common.”

But it was the 1999 Institute of Medicine Report that shocked the country, and shamed the medical profession into voluntarily adopting systems changes. The report estimated that 100,000 patients died annually from preventable hospital errors -- about the same as the yearly tally of deaths from motor vehicle accidents, breast cancer and AIDS combined.

Leape, a leading researcher on medical mistakes, had long said the number was a conservative estimate. Sure enough, five years later, a review of Medicare records by the Denver-based healthcare ranking group HealthGrades found nearly twice as many deaths from preventable errors -- up to 195,000 -- in the country’s healthcare facilities. The higher estimate was never published in a peer-reviewed journal and included deaths in settings other than hospitals, such as nursing homes.

But since then, hospitals have begun responding to their state’s reporting laws, and, individually and voluntarily, launching their own efforts to improve. One of the most notable is an effort sponsored by the Institute for Healthcare Improvement, a nonprofit group based in Cambridge, Mass., whose aim is to improve healthcare. In that push, called the 100,000 Lives Campaign, 3,000 of the nation’s 5,000 hospitals volunteered to concentrate on one or more of six changes statistically proven to reduce errors. Those changes included following evidence-based guidelines to reduce infections and improve care for heart attack patients and to assemble teams to respond to the earliest signs of a patient crisis.

After a year, the institute reported that the changes made within the participating hospitals probably saved more than 120,000 lives, even more that what the IOM said was its conservative estimate of accidental deaths.

A death related to a medical error can be proven, but a death avoided is more difficult to document. In the November 2006 Journal on Quality and Patient Safety, the 100,000 Lives Campaign compared the volunteer hospitals’ actual deaths in one year with statistically expected deaths, based on data from the base year 2004. Based on the analysis, 122,300 people walked out of hospitals in 2005 unscathed -- and never knew it might have been otherwise.

Now, all those hospitals and 700 others are signing up for a follow-up campaign called the 5 Million Lives Campaign, aimed to halt not just deaths, but also injuries and near misses.

Even simple changes can make a difference. One statewide hospital group in Michigan followed a plan devised by Dr. Peter Pronovost, a critical-care specialist at Johns Hopkins Hospital, that involved a simple checklist, fashioned after the kind of safety list pilots are required to check on each takeoff and landing. A landmark study in the Dec. 28, 2006, New England Journal of Medicine of 108 ICUs in Michigan hospitals found that by using the checklist unfailingly, common infections from medical tubing could be reduced by two-thirds. Wash hands with soap. Check. Clean patient’s skin with antiseptic. Check. Wear sterile mask, gown, glove. Check. Put sterile drapes over entire patient. Check.

The Michigan hospitals initiated safety programs involving education, in-hospital safety teams, and the daily check-off lists. The improvement in infection rate was sustained for 18 months, according to the study.

“Instead of business as usual, [the Michigan ICU teams] deployed a basic checklist,” says Jonah Frohlich, senior program office at the California HealthCare Foundation. He was not involved with the Michigan study. “It was simple stuff. Nurses could stop physicians from proceeding if they weren’t doing what they were supposed to be doing on the checklist. That’s completely counter to medical culture.”

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A price for mistakes

A changing bottom line may spur the effort to change. After Oct. 1, 2008, Medicare rules will make it more worthwhile for hospitals to avoid mistakes. The federal insurance program will no longer pay for follow-up care for several preventable problems. For example, the government will not reimburse a hospital for retrieving scissors, scalpels or sponges left in a patient’s body cavity following surgery. Nor will the federal insurer pay if a patient is transfused with the wrong blood type, or acquires a pressure ulcer while in the hospital. And, the new rules say, the hospital cannot pass the bill for a mistake on to the patient.

Private insurers may follow suit and refuse to pay for preventable mistakes.

The first step in controlling errors is to know how many there are and where they occur. Reporting is becoming more stringent. “One of the interesting developments is that state after state has announced that hospitals have to report these serious, preventable adverse events,” says Leape. California, since 2006, has required reporting of 27 serious medical errors listed by the National Quality Forum, a group of consumers, doctors, insurers and institutions promoting improved quality in healthcare.

If mistakes must be reported, then insurers can insist that hospitals eat the cost of the error, says Leape. “The next step is to say that we won’t pay for preventable infections,” he says. “If that sort of thing happens, we’re going to move from doing the right thing simply because it’s the right thing to doing it, because if we don’t, we’ll be out of business.”

One impediment to admitting mistakes has been the fear that an apology would lead to a lawsuit. That, too, is changing. Mistakes, and their solutions, says Dr. Thomas Gallagher, professor of medical ethics at the University of Washington School of Medicine, are human. Wronged patients, and their families, want someone to sincerely say they are sorry, studies show. Gallagher, in a Feb. 26, 2003, report in the Journal of the American Medical Assn., talked with 52 patients and 46 doctors in 13 focus groups. He found that patients wanted full disclosure of harmful errors; an explanation for why it happened; information on what the institution was doing to prevent the mistake from happening again; and an apology.

The apology, a response long mangled and silenced by fear of malpractice litigation, is making a legally protected comeback. Thirty-six states, including California, have passed apology laws. They take different forms, but at the very least they mean a hospital’s or a physician’s apology cannot be used against them in court.

“You can say the words, ‘I’m sorry,’ ” says Gallagher. “The hope is that if you can’t use an apology in court to prove that a doctor has been negligent, then there will be more apologies.”

So far, technology is a poorly utilized partner in helping humans reduce errors. A 2005 study by the RAND Corp. found that computerizing medical records could save the healthcare system $81 billion -- and $4 billion of that savings would come from improved safety, largely by reducing prescription errors.

But computerized records and prescriptions are notoriously slow in coming to physicians’ offices and hospitals. In the first comprehensive look at health Internet technology in the state, a Jan. 17 report by the California HealthCare Foundation found that only 13% of hospitals in the state use electronic health records, and only 11% use bar-code administration of drugs. Such bar codes, as those seen in supermarket checkout lines, would signal an alert if a healthcare worker grabbed, and scanned, the wrong drug or the wrong dose for the wrong patient.

Until more hospitals acquire the technological means to double-check providers’ actions, nurses like those at Cedars will still reach for vials as they’ve done thousands of times. They may fail to notice a decimal point or a different colored label. “I can easily see how a nurse, especially an experienced one who has always done it right, can overlook the label,” Cohen says. “Just like you and I do at the supermarket, reaching for what we’ve always known, not realizing it has changed.

“This same incident that affected the Quaids, it could happen again at another hospital in another place.”

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