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Testimony of Lucien Leape, MD

Statement of Lucian Leape, M.D.
Member, Quality of Health Care in America Committee
Institute of Medicine
Adjunct Professor, Harvard School of Public Health

Concerning Patient Safety and Medical Errors

Before the
United States Senate
Subcommittee on Labor, Health and Human Services, and Education

January 25, 2000

Good morning, Mr. Chairman and Senator Kennedy, and members of the committee. My name is Lucian Leape and I am a faculty member at the Harvard School of Public Health. I practiced as a pediatric surgeon for much of my career, but in recent years have focused my attention on research into medical errors. I am here today representing the Institute of Medicine's Committee on the Quality of Health Care in America which recently released the report To Err is Human: Building a Safer Health System.

In my testimony today, I will address two questions: 1) Why is health care so hazardous? 2) What needs to be done to improve safety?

Why is health care so hazardous?

Findings from several studies of large numbers of hospitalized patients indicate that each year a million or more people are injured and as many as 100,000 die as a result of errors in their care. This makes medical care one of the leading causes of death, accounting for more lost lives than automobile accidents, breast cancer or AIDS. While these findings are not new, and some hospitals have improved their error reduction activities, clearly a much greater effort is needed to make health care safe.

No physician or nurse wants to hurt patients, and doctors, nurses, and other health workers are highly trained to be careful and take precautions to prevent mistakes. They are held and hold themselves to high standards. Paradoxically, it is precisely this exclusive focus on the individual's responsibility not to make mistakes, reinforced by punishment, that makes health care so unsafe.

The reason is that errors are seldom due to carelessness or lack of trying hard enough. More commonly, errors are caused by faulty systems, processes and conditions that lead people to make mistakes. They can be prevented by designing systems that make it hard for people to do something wrong and easy to do it right. Safe industries, such as aviation, chemical manufacturing, and nuclear power, learned this lesson long ago. While insisting on training and high standards of performance, they recognize these are insufficient to insure safety. They also pay attention to factors that affect performance, such as hours and work loads, work conditions, team relationships, and the design of tasks to make errors difficult to make. They create safety by design. Health care must do likewise.

Approaches that focus on punishing individuals instead of changing systems provide strong incentives for people to report only those errors they cannot hide. Thus, a punitive approach shuts off the information that is needed to identify faulty systems and create safer ones. In a punitive system, no one learns from their mistakes.

What needs to be done?

The IOM calls on leaders of health care organizations to launch a major effort to reduce medical errors. They must make safety "Job 1", creating non-punitive environments and radically redesigning virtually all of their systems. The challenge is enormous.

While the responsibility for making the necessary changes must rest with health care organizations themselves, there is much that Congress can do to facilitate and accelerate those changes. The IOM calls for two specific actions: creation of a Center for Patient Safety and establishment of error reporting systems.

Center for Patient Safety

We call upon Congress to establish and fund a Center for Patient Safety within the Agency for Healthcare Research and Quality to demonstrate a national commitment to improving patient safety. We cannot expect health care organizations to make patient safety a local priority if we do not make patient safety a national priority. Such a center would provide the national leadership and visibility the patient safety movement desperately needs. More than any other action the government could take, establishing the Center would officially put patient safety on the national agenda.

We envisage the Center for Patient Safety as the focal point for a host of activities that will aid health care organizations as they redesign themselves for safety. The report recommends a broad agenda for the Center, encompassing four functions, all essential to making progress in reducing errors in health care: goal-setting, research and development, education and dissemination of information, and evaluation.

Goal-setting. At present, there is no national visibility for patient safety, and no stimulus or encouragement for health care organizations to implement safe practices. We cannot achieve safety unless we know what we are striving for. By setting national goals, much like the U.S. Preventive Services Task Force, or Healthy People 2000, the Center for Patient Safety can "raise the bar" for achievement by all organizations.

Research and development. While much is known from prior research and industrial experience about theories of error causation and prevention, relatively little is known about the application of those theories and methods in medical practice. Because principles of safety have been so sparsely used in health care, their usage needs to be studied in a number of applications (medication safety, surgical operations, new technologies, etc.) and in a variety of settings (e.g., emergency rooms, intensive care units, doctors' offices). The Center for Patient Safety would set a research agenda and fund both intramural and extramural research projects to address those needs. The need is enormous. The funding should be generous. One method for accelerating this process would be to fund several Centers of Excellence to focus on specific types of problems.

For its development role, the Center for Patient Safety would lead and facilitate the application of known principles and research findings in the definition of best practices and processes. These would apply to both clinical care and management, and are needed for virtually all systems in health care organizations: medication systems, operating rooms, emergency departments, diagnostic testing, care of the elderly, etc. Some of these activities can, and should, be led by professional societies who can mobilize the expertise and commitment of their members. Again, the need is great and funding should be generous.

Education and dissemination of information. A major limitation to the advance of patient safety in health care is that we often don't do what we know to do to reduce errors. Health care organizations have not implemented most of the practices and procedures that are known to reduce the likelihood of errors. Educating doctors, nurses, hospital managers, and CEOs about what can and should be done to improve safety would be a major responsibility of the Center It should develop instructional methods, sponsor demonstration projects, and provide technical support to encourage and facilitate the adoption of systems and practices that are known to work and, in the future, disseminate information about new practices as they are developed and shown to be effective.

The Center would also develop methods for consumer education and be responsible for disseminating safety information widely, as appropriate. An example of useful consumer education is the patient medication safety brochure recently prepared by the Massachusetts Hospital Association and distributed to doctors' offices and pharmacies.

The need to develop these research, education, dissemination, and facilitation activities is the principal reason for recommending that the Center for Patient Safety be lodged in the Agency for Healthcare Research and Quality. These functions are similar to those that the Agency has traditionally carried out over the past decade under its quality improvement agenda. It can easily provide both the leadership and the expertise needed by the Center for Patient Safety to establish new programs.

Evaluation. The Center for Patient Safety would also perform the valuable function of coordinating, collecting and analyzing data provided by both voluntary and mandatory reporting systems. It would monitor national progress in improving patient safety and provide an annual report to Congress, including recommendations to health care organizations and the various agencies and associations for improving patient safety.

The IOM Committee recommends initial funding of $30 million for the Center for Patient Safety, with anticipated annual increases to a level comparable to funding for aviation safety programs.

Reporting Systems

There are two types of reporting systems: mandatory reporting systems and voluntary reporting systems. Mandatory reporting systems are used by state authorities or accrediting organizations as part of their safety oversight function. Voluntary reporting systems are widely used in hospitals and by a variety of professional organizations to obtain information to improve safety.

Mandatory Reporting. Mandatory reporting systems are typically restricted to "sentinel events", defined as serious injuries and deaths that "should not happen", e.g., maternal deaths, suicides, death in restraints, removal of the wrong organ. Occurrence of a sentinel event does not necessarily indicate safety problems in a hospital, but does raise the question and justifies inquiry. Supporters of mandatory programs maintain they are necessary 1) to hold health care organizations accountable for safety, 2) to learn from the events, and 3) to satisfy the public's right to know.

The committee believes there is a serious problem of accountability for safety in health care and that current mechanisms for holding health care organizations accountable for safety are inadequate. We use the phrase "holding accountable" not as code for blame and punishment, but to mean insuring responsibility, i.e., making sure that health care organizations are doing everything they reasonably can for patient safety. Properly administered, mandatory programs can be used by state departments of public health, boards, or the JCAHO to identify potentially hazardous situations and make sure the institutional response is appropriate and adequate. Information may also be obtained that indicates a need to alert other institutions to potential hazards. However, if mandatory reporting systems are perceived as unfairly punitive, or embarrassing for the organization, compliance will be reluctant and incomplete.

Reporting, alone, does not improve safety or reduce hazards. Unless reporting is followed by understanding and change, safety will not improve. Investigation of the circumstances surrounding incidents is required to determine the underlying causes. Improvements only occur if the analysis identifies systems failures and they are corrected. Success of the investigation and analysis depends in large measure on the degree to which individuals feel it is safe to participate. Systems that have been most successful in bringing about changes for safety combine mandatory reporting with some degree of confidentiality and protection of individual providers.

The IOM Committee recommends that reporting of sentinel events be required of all health care organizations, that the adverse events to be reported be narrowly and explicitly defined, and that national standards be developed for what is reported. Reporting systems have traditionally been run at the state level, which should continue, but standard definitions would reduce the burden on respondents, facilitate communication with consumers, and permit aggregation of data from multiple sources to enhance learning. The Committee felt that the public has a right to know about serious adverse events and, where indicated, to be informed of what has been done to prevent recurrence in that or other institutions.

The IOM Committee recommends that Congress designate the Forum for Health Care Quality Measurement and Reporting as the entity responsible for developing, promulgating, and maintaining these standards. In addition, it recommends

that the Center for Patient Safety be authorized to collect and analyze aggregate data to identify hazards and issue periodic alerts and recommendations for safety measures to all health care organizations.

Voluntary reporting. The IOM recommends that the development of voluntary reporting programs be encouraged and that the Center for Patient Safety facilitate this by disseminating information about voluntary programs, convening sponsors and users to evaluate what works, and by periodically assessing whether additional efforts are needed to address gaps in information to improve patient safety. It should also fund and evaluate pilot projects for reporting systems within individual health care organizations and in collaborative efforts.

Finally, to encourage learning from reporting we strongly recommend that Congress pass legislation to extend peer review protections to voluntary reporting system data related to patient safety and quality improvement that are collected and analyzed by health care organizations for internal use or shared with others for improving safety.

Thank you for this opportunity to testify. I would be happy to answer any questions the Committee may have.

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