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Reporting Requirements Cloud Consensus on Curbing Medical Errors

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Health providers and patient safety experts are split over whether mandatory reporting of serious errors to State and Federal agencies would usher in a new culture of accountability.

Editor's note: The following is the first of two articles about medical errors and the search for solutions by policymakers and health providers. Select for Second Article.

Used with permission from Medscape Money & Medicine, © 2000 Medscape, Inc.

By Cathy Tokarski

How to reduce the occurrence of medical errors and serious mistakes that jeopardize a patient's life or well-being has moved from the anonymity of hospital safety review committees to the spotlight of the U.S. Congress.

Since the landmark Institute of Medicine (IOM) report was unveiled late last year, revealing that up to 98,000 Americans die each year as a result of preventable medical errors, two Senate bills (S. 2038 and S. 2378) and one in the House (H.R. 3672) have been introduced to address the issue. Predictions about passage are uncertain in a politically charged election year, but congressional interest in medical error reduction has fueled momentum for action.

Patient safety experts and health care providers say there's much agreement in the strategies outlined in the November 1999, IOM report, entitled To Err Is Human. Those approaches formed the basis of recommendations unveiled in late February by the Clinton Administration's health care quality task force and in recent congressional proposals.

However, groups are sharply split over whether health care organizations should be mandated to report serious or "sentinel" medical events to State agencies. Such information would be grouped together and submitted to a Federal agency, which would report the data to the public while maintaining the confidentiality of the patients and health care professionals involved. Data reported to a Federal entity would be analyzed to determine why the error occurred and how to reduce or eliminate the likelihood that such an event would be repeated.

Both Senate bills call for mandatory reporting of sentinel events, although S. 2038 calls for demonstration projects that use both voluntary and mandatory approaches. The House measure calls for voluntary reporting.

A 3-year timetable before data collected by State agencies would be sent to a Federal entity was proposed to give policymakers "the time we need to learn about the systems in place," said John Eisenberg, M.D., Director of the Agency for Healthcare Research and Quality. Some 22 State programs now collect data on medical errors, but these programs "are in their infancy, and we need to know what they're doing now, not what they did 10 years ago," he said.

Changing Health Care's Culture

The split over mandatory reporting cuts to the core of the health care system's traditional reluctance to identify hospital procedures that contribute to serious medical errors. Patient-safety experts say such reporting will force a change in the culture of finger-pointing that typically follows such events. Health care providers, on the other hand, predict it would create new liability nightmares and drive voluntary efforts to admit and correct mistakes underground.

"The purpose of mandatory reporting was essentially for accountability" among hospitals, said Lucian Leape, M.D., a medical safety researcher and professor at the Harvard School of Public Health who helped author the IOM study. "Most people don't believe hospitals are held accountable, and that there's a tendency to cover things up."

The IOM committee purposefully distinguished between voluntary reporting for medical mistakes (such as misreading a doctor's prescription order) and mandatory reporting for serious, life-threatening events (such as operating on the wrong side of a patient's brain), Dr. Leape said.

"We're not talking about little mistakes, but the bad things that shouldn't happen. The public has a right to know about them. And hospitals have a responsibility to investigate and be sure that something is done about them."

Educating health care professionals, not punishing or fixing blame, is crucial for mandatory reporting to be successful, according to the National Patient Safety Foundation (NPSF), a Chicago-based research and education organization that backed the IOM's call for mandatory reporting.

"All of us in the health care community—providers, consumers, administrators, policymakers—are accountable. NPSF believes that the vast majority of errors result from problems in the system, not individual behavior," said Henri R. Manasse, the foundation's board chair.

Counting Mistakes vs. Improving Safety

But reporting to new State and Federal entities would not further the goal of identifying and correcting those errors, says Carmela Coyle, senior vice-president for policy at the American Hospital Association, Washington, DC.

"If all we do is create a big data base in the sky to collect reports, all you're doing is counting mistakes, not improving patient safety and reducing medical errors. What we want is information in the hands of experts to understand what happened and to make the changes that are needed immediately."

Liability is another major concern. "One of the important factors that drives this debate is whether or not the information that is provided to a reporting system would be kept confidential as well as protected from discovery in a legal liability context," Coyle said.

Breaches of confidentiality could quickly turn physicians against participating in reporting serious medical errors to a State or Federal agency, predicted Tejal Gandhi, MD, an associate physician at Brigham & Women's Hospital, Boston. The IOM report called for mandatory reporting of sentinel events by health systems, not by physicians.

"You won't get them to report if they fear they will be punished." But, she added, "if [the data that's mandated] was guaranteed to be completely confidential, people wouldn't have that much of an issue of it."

Role for Federal Government

Like many health policy debates, the outcome of the medical errors issue promises to be shaped by views of whether the Federal Government can craft solutions that improve the quality of care without adding burdensome costs or bureaucratic hurdles.

The IOM's ambitious goal of reducing medical errors by 50 percent in the next 5 years could be achieved without new oversight or regulation if the Clinton Administration committed more funding to patient safety research, said Harvard's Dr. Leape. New Federal regulations could also be avoided if expert medical specialty panels were quickly convened to develop and implement best practices, such as computerized order entry systems and bar codes to identify different medications.

But, he added, "I don't see that happening here."

For example, President Clinton's Fiscal Year 2001 budget called for $20 million to be spent on medical errors reduction, including the creation of the new patient safety center, one-third below the $30 million proposed by the IOM. "He should have recommended $100 million," Dr. Leape said.

Others question how the Federal Government can measure a 50 percent error reduction when no one can identify the current incidence rate. "I'm not convinced the Federal Government is where this is going to come from," said Dr. Gandhi, suggesting State and local initiatives seemed more promising. But Federal involvement is desirable because its data-collecting and analysis capabilities could yield recommendations that would be difficult and costly for health systems to develop on their own, she said.

New Federal regulations may be the only guarantee that the safest and most effective practices will be followed by all health care providers, other insist.

"I don't believe for a minute than the automotive industry would have put in airbags if it were not mandated by the Federal Government," said Steve Meisel, Pharm.D., assistant director for clinical pharmacy services at Fairview Southdale Hospital, Edina, MN. The hospital has made impressive gains in reducing medication errors and improving patient outcomes since it launched a tracking program for high-risk drugs in 1996.

"If the Health Care Finanancing Administration (HCFA) or the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) says we're going to have bar codes or do all sorts of things listed in the IOM report, then all the excuses are off the table."

IOM Recommendations at a Glance

  • Creation of a Federal Center for Patient Safety that sets national goals for medication error rates and tracks progress toward meeting those goals.
  • A national mandatory medical error reporting system to collect data on errors that result in serious harm or death to patients.
  • Federal and State laws that encourage the creation of voluntary medical error reporting systems in all health care facilities.
  • Legal protection of data and information on medical errors when used by professional peer review organizations to improve health care quality.
  • More focus on patient safety by professional medical societies and health care licensing organizations.
  • Increased attention to the safe use of drugs by the Food and Drug Administration.

Used with permission from Medscape. Adapted from the original article posted May 8, 2000, at:

Current as of May 2000


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