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A scathing report on medical errors released by an influential congressional advisory body generated quick action from policymakers and some grumbles from industry groups.

Just days after the Institute of Medicine released its call to action on reducing the nation's startlingly high medical-error rate, President Clinton called for a series of government steps to address the problem. He directed agencies administering federal health programs to consider which of the IOM's recommendations could be implemented in their areas. He wants a report back in 60 days.

Arguing that the government should set an example for other health care purchasers, Clinton said the 300 private health plans that contract with the Federal Employees Health Benefits Program must institute patient safety initiatives. And he'll be looking for effective safety initiatives to fund in the 2001 federal budget.

The error rate publicized by the IOM does not call into question whether the United States has the best health care system in the world, the president said from the Rose Garden, but it does question "whether we've done everything we can to invest the kind of money in avoiding errors that other big complex systems have," such as aviation and occupational safety.

At the same time, Sen. James Jeffords (R, Vt.), chair of the Senate Health and Education Committee, immediately scheduled hearings on the issue. And Sen. Edward M. Kennedy (D, Mass.) said he would introduce legislation as soon as Congress reconvened to implement the IOM's recommendations. Kennedy said he expected quick, bipartisan action on the bill because "the magnitude of the problem so exceeds what anyone understood to be the case that the American people will demand that we do this this year."

Actually, the numbers cited by the IOM have been around for nearly a decade. The Harvard Medical Practice Study and other research in the early '90s pegged the number of deaths from medical errors at 44,000 to 98,000 per year, data that only generated blaring headlines nationwide now because of the IOM report. A flurry of well-publicized errors in 1995 also brought attention to the problem and sparked a number of industrywide efforts from the AMA and others.

The IOM report, however, clearly heightened awareness of the issue and added concrete recommendations to a debate that, to date, largely has been stuck on theory.

"No hospital CEO, no health plan president, no physician, no regulatory agency, no government bureaucrat can any longer say they don't think this is a problem or don't know what can be done about it," said renowned patient safety expert Lucian Leape, MD, of the Harvard School of Public Health and a member of the IOM committee that drafted the report. "This report offers a very specific call to action. Ignore it at your peril."

Safety center, mandated reports

Clearly, no one was taking it lightly. But the IOM recommendations generated some controversy. Chief among the recommendations:

• A National Center for Patient Safety: The center would set national safety goals, track progress, fund research on error rates and prevention strategies, and serve as a clearinghouse of educational information and best practices.
• Mandatory reporting: A nationwide, public reporting system should be established. Hospitals and, eventually, other health care groups should be required to report to state governments errors that caused serious harm or death. Although individuals should not be cited in such reports, institutions should be held accountable. Currently, only about a third of states require such reporting.
• Voluntary reporting: Another level of systems should be established to analyze data on near-misses or errors that do not have serious consequences. Peer-review protections should be extended to cover this level of reporting. Data would be collected and analyzed solely to improve safety.
• Stepped-up attention by standards setters: Groups that license and certify physicians and other health care providers should implement periodic reexaminations to document both practitioners' competence and knowledge of safety practices. Other regulators and accreditors should make patient safety a key component of evaluations.

The IOM also called on private purchasers to make patient safety a priority in their contracting decisions. It called on hospitals and other health care organizations to independently implement established medication safety practices and other methods known to reduce errors.

The group did not call for a regulatory agency to monitor patient safety, although some experts have said health care needs its equivalent of the Federal Aviation Administration. IOM committee member Donald M. Berwick, MD, head of the Boston-based Institute for Healthcare Improvement, emphasized that the group's approach assumed that key components of the health system would step up to the plate voluntarily. He's optimistic that the panel's goal of a 50% reduction in medical errors within five years is doable without more government intervention.

"We're now betting that there's a willingness on the part of the profession that will get us a long way toward where we need to go. We're not recommending a heavy-handed regulatory approach," he said.

Fear of reporting

Nevertheless, some experts were wary about any level of mandatory public reporting and the potential for a federal agency too mired in bureaucracy to function.

Physician and hospital leaders warned that the liability risks posed by public reporting -- even limited to the most egregious incidents, as the IOM recommended -- could drive errors further underground.

"For reporting to work effectively, the information needs to be private," said Nancy W. Dickey, MD, past chair of the National Patient Safety Foundation at the AMA.

Officials at the Medical Group Management Assn., which recently launched its own patient safety initiative, said that a "culture of blame" has undercut previous attempts to address the problem. "We do not believe that mandatory reporting of incidents and public disclosure of those data will solve the problem," said MGMA President and CEO William F. Jessee, MD. "We must avoid a flood of new regulations that constrain creative and constructive approaches to increase patient safety."

Rick Wade, a senior vice president for the American Hospital Assn., agreed that confidentiality for hospitals, physicians and patients would be key to the success of any mandatory reporting system. "No one disagrees with the notion that we need much better reporting, tracking and analysis of medical errors. To get meaningful data, that may even require some sort of mandatory reporting," Wade said. "But without adequate protections you'll have the specter of the trial lawyer lurking in the background to find the smallest thing, and people will be afraid to report."

IOM committee members argued that the most serious errors typically already are public. And patients' right to know as well as physicians' ethical obligation to disclose outweigh any added liability risks. Their recommendation to limit public reporting to institutions -- not individuals -- fits into a systems approach to reducing errors by placing the responsibility on those who create the systems. "There has to be some way to hold health care organizations accountable," Dr. Leape said. "Obviously hospitals won't like this, but we need to create some pressure for them to correct unsafe situations."

President Clinton seemed to agree that liability concerns should not block public reporting. States that currently mandate reporting have shown no increased liability risks, he noted, adding: "I do not believe that systematic improvement in safety -- hospital after hospital, clinic after clinic -- will increase liability. But once you know about a problem, you're under a moral obligation to deal with it."

Safety expert Martin Hatlie, former NPSF head, agreed that better industrywide coordination of today's myriad independent reporting efforts should be welcomed. The IOM's approach clearly is not about "nailing people," since it focuses on data at the institutional level, noted Hatlie, now with Partners for Performance Solutions. "But mandatory reporting will only work if it's put in the right context, as a public health initiative, not a feeding frenzy for trial lawyers."

Is agency route a safe approach?

Industry leaders also expressed qualms about the IOM's call for a federal agency to coordinate research and education about medical errors.

"Making this the role of a federal agency may doom it to fail," said the AHA's Wade. He worried that the effort would get mired in political and funding battles.

He and the AMA's Dr. Dickey suggested that a public-private partnership may prove more workable. The goal of a federal center, Dr. Dickey said, "is reasonable," although the AMA has some concerns that it could become too regulatory. At the same time, she acknowledged that federal involvement could provide "a deep pocket" for building a central data repository and other safety initiatives that have proved too costly for the NPSF and other private-sector initiatives. And she would expect the NPSF to become a partner to any new agency rather than be replaced by it.

"We're not calling for a new government bureaucracy but a center for research similar to what we already have in other areas where safety's a concern," Dr. Leape said. "We currently don't spend anything on health [safety], and that's the area with the greatest risk by far."

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