January 2000
WASHINGTON D.C. - Preventable medical mistakes in hospitals are a "systemwide" problem and need broad solutions that include mandatory reporting and revamped licensing, not finger pointing at the managed care system, said a panel of the Institute of Medicine (IOM).
The IOM released a 223-page report titled To Err is Human indicating that nearly 98,000 preventable hospital errors result in death or serious injury, about 2%-3% of all hospital admissions, every year.
"That would put it as the eighth leading cause of death in America, greater than breast cancer, traffic accidents and AIDS. And this includes only hospitals; not what goes on in other medical settings," said William C. Richardson, MD, chairman of the report committee and president and CEO of the W.K. Kellogg Foundation.
To Err is Human is the first in a series of reports that will be produced by the IOM Committee on the Quality of Health Care in America. IOM President Kenneth I. Shine, MD, said in the coming years the committee would be releasing reports on health infrastructure, communications and individual consumer choices.
The IOM hopes that rather than scare patient consumers away from the health care system, these reports will "empower them to ask questions and expect the best from their health care.
"This committee has a charge of looking at health care in the broadest sense. In the United States we achieve a very high quality of health care, but there is a substantial gap between average care and best," said Shine.
During a briefing held here, the IOM fielded many questions on how the "managed care regime" is responsible for the high rate of preventable errors.
"We looked at that, but we did not feel that there was any evidence on that point that could lead to the conclusion that managed care was responsible. In fact it's only been with the advent of managed care that we've begun to accumulate data on quality so we can see patterns in practice," said Molly Joel Coye, MD, vice president and director of the West Coast office of the Levin Group.
The committee did concede that increased stress and workload is certainly associated with higher error rates. "What we don't know is the association between that and managed care," said Coye.
The report committee said no solutions would be reached by finger pointing or blame directed at "bad apples" or "poor performers" in the health care system. For any method to work, it would have to address the situation "systemwide" and create a "culture of safety."
"Quality of care in managed care has been better than fee-for-service in some cases, and in some cases not as good. It is a systemwide problem, and we should take the report at its findings, not just come to it with preconceived notions," said Shine.
To create this "culture of safety," the committee called for both voluntary and mandatory reporting of errors, a federal budget appropriation for a new research foundation, equipment standardization and some sort of new licensing requirements for health care providers.
To collect data on medical errors, the committee proposed that "serious errors" resulting in death or serious injury be reported to a state authority. Richardson said currently only about one-third of the states have a mandatory reporting system for serious medical errors.
"We feel it's important that it be mandatory in all states, and it should be standardized across the states, so that the information can be aggregated in a way that makes it useful in terms of tracking our progress and recommending further improvement," said Richardson.
This mandatory reporting would be disclosed so it could be used in research, although it would not include individual names.
"I think we all agree that if patients have been seriously injured by mistake they have a right to know that and that doctors have an obligation to tell them. The concept of external reporting to a state authority is that serious injuries should be reported as part of accountability for an institution," said Lucian Leape, MD, adjunct professor of health policy at the Harvard School of Public Health.
"Near misses" or errors that don't result in a permanent disability or death would be voluntarily reported to the individual institution or a medical association to refine procedures. This reporting would be confidential and protected from legal discovery in the event of a lawsuit. Reporting parties would also not be disciplined.
"We're frightened to talk about errors in institutions, but it's a necessity for a culture of safety that errors be open and discussible without fear of blame," said Donald M. Berwick, MD, president and CEO of the Institute for Health Care Improvement.
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One of the main obstacles to solving the problem of medical errors is that so little is known about what causes them.
"There is virtually no research, $3 million to $4 million perhaps, at the federal level on the issue of patient safety," said Richardson.
The committee recommended that a "Center for Patient Safety" be established within the Agency for Health Care Policy and Research to monitor information, disseminate research, set standards and sponsor its own projects.
The committee suggested that it begin with a $30 million appropriation growing to $100 million over the next several years, which Richardson said is less than 1% of the direct medical costs associated with the results of medical errors in any given year.
"A budget request of $30 million per year to get it started is modest to say the least, and should be merely the beginning of what would be a much greater effort," said Leape.
Beyond the sweeping calls for a new federal agency and reporting programs, the committee has called for several minor improvements to hospitals that may affect large change.
"We know that there are automated ordering systems in many hospitals," Richardson said. "We think they should be in all. We know that anesthesiologists have been very successful in standardizing their equipment, we feel that should be mandatory across the board."
A stickier issue, the committee said, will be reform of drug naming practices.
"It's going to be hard to drag the pharmaceutical industry to the table on this one because this is an industry where they have a lot of promotional marketing and effort. Names are important in association of a drug with a particular indication," said Arthur Levin, MPH, director of the Center for Medical Consumers.
"However, we would hope that quality and safety become competitive issues and that when we have a publicly accountable health care system, safety becomes important to health care organizations because it has something to do with their competitive advantage," Levin added.
The committee also called for possible new licensing and training requirements for health care professionals. The report calls for a licensing body to implement periodic re-examinations and re-licensing of doctors, nurses and other key providers, based on both competence and knowledge of safety procedures. Certifying organizations would also develop more effective methods to identify unsafe providers and take action.
What that means for the individual provider pragmatically has yet to be "fleshed out."
"We need not to assume that once you have the report in hand the problem is solved," Berwick said. "That's not true. Once you have the report in hand you get a chance to start on the scientific and technical aspects of these policies."
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