Dec. 1, 1999 WASHINGTON - Reducing one of the nation's leading causes of death and injury - medical errors - will require rigorous changes throughout the health care system, including mandatory reporting requirements, says a new report from the Institute of Medicine (IOM) of the National Academies. The report lays out a comprehensive strategy for government, industry, consumers, and health providers to reduce medical errors, and it calls on Congress to create a national patient safety center to develop new tools and systems needed to address persistent problems.
The human cost of medical errors is high. Based on the findings of one major study, medical errors kill some 44,000 people in U.S. hospitals each year. Another study puts the number much higher, at 98,000. Even using the lower estimate, more people die from medical mistakes each year than from highway accidents, breast cancer, or AIDS.
Moreover, while errors may be more easily detected in hospitals, they afflict every health care setting: day-surgery and outpatient clinics, retail pharmacies, nursing homes, as well as home care. Deaths from medication errors that take place both in and out of hospitals - more than 7,000 annually - exceed those from workplace injuries.
"These stunningly high rates of medical errors - resulting in deaths, permanent disability, and unnecessary suffering - are simply unacceptable in a medical system that promises first to 'do no harm,'" says William Richardson, chair of the committee that wrote the report and president and chief executive officer of the W.K. Kellogg Foundation, Battle Creek, Mich. "Our recommendations are intended to encourage the health care system to take the actions necessary to improve safety. We must have a health care system that makes it easy to do things right and hard to do them wrong."
The know-how exists to prevent many of these mistakes, and so the committee sets as a minimum goal a 50 percent reduction in errors over the next five years. "We believe that with adequate leadership, attention, and resources, improvements can be made," says Richardson. "As we say in the report, 'It may be part of human nature to err, but it is also part of human nature to create solutions, find better alternatives, and meet the challenges ahead.'"
The majority of medical errors do not result from individual recklessness, the report says, but from basic flaws in the way the health system is organized. Stocking patient-care units in hospitals, for example, with certain full-strength drugs - even though they are toxic unless diluted - has resulted in deadly mistakes. And illegible writing in medical records has resulted in administration of a drug for which the patient has a known allergy. Medical knowledge and technology grow so rapidly that it is difficult for practitioners to keep up. And the health care system itself is evolving so quickly that it often lacks coordination. For example, when a patient is treated by several practitioners, they often do not have complete information about the medicines prescribed or the patient's illnesses.
To achieve a better safety record, the committee recommends a four-part plan designed to create both financial and regulatory incentives that will lead to a safer health care system. Taken together, these recommendations and findings represent a systematic way to design safety into the process of care. They should be evaluated after five years to assess progress in making the health system safer.
A National Center for Patient Safety
Health care is a decade or more behind other high-risk industries in its attention to ensuring basic safety. The chance of dying in a domestic airline flight or at the workplace has declined dramatically in recent decades, in part because of the creation of federal agencies that focus on safety. Using that model, Congress should create a center for patient safety within the U.S. Department of Health and Human Services (HHS), the committee said. This center would set national safety goals, track progress in meeting them, and invest in research to learn more about preventing mistakes.
The center also would act as a clearinghouse, an objective source of the latest information on patient safety for the nation. For example, if a health care organization improves safety, its practices should be shared with a broad audience, and the center, working with others, would help provide the needed channel.
Administratively, the home for the center should be in the HHS Agency for Health Care Policy and Research; Congress would need to spend $30 million to $35 million to set it up, the committee says. This estimate is based on the kind of work the center would perform and on investments in issues of similar magnitude, as well as safety research by the public and private sectors. Funding would need to grow to at least $100 million, a little more than 1 percent of the $8.8 billion spent each year as a result of medical errors that cause serious harm.
Mandatory and Voluntary Reporting Systems
The committee defines "error" as the failure to complete a planned action as intended or the use of a wrong plan to achieve an aim, and notes that not all errors result in harm. To learn about medical treatments that lead to serious injury or death and to prevent future occurrences, the committee recommends establishing a nationwide, mandatory public reporting system. Hospitals first, and eventually other places where patients get care, would be responsible for reporting such events to state governments. Currently, about a third of the states have their own mandatory reporting requirements.
While the committee believes that the public has a right to know about errors resulting in serious harm, it nevertheless recommends federal legislation to protect the confidentiality of certain information. Specifically, data should be protected on medical mistakes that have no serious consequences, where the information is collected and analyzed solely for the purpose of improving safety and quality. This would encourage the growth of voluntary, confidential reporting systems so that practitioners and health care organizations can correct problems before serious harm occurs. Without such legislation, fears that reported information might ultimately be subpoenaed and used in lawsuits could discourage participation by health care organizations and providers.
Role of Consumers, Professionals, and Accreditation Groups
A top-down system won't be enough to bring about the kind of fundamental changes needed to improve patient safety, the report says. Pressure from all directions will be necessary. Public and private purchasers of health care insurance - such as businesses buying coverage for their workers - must make safety a prime concern in their contracting decisions. Doing so will create financial incentives for health care organizations and providers to make needed changes.
One reason consumers do not push harder for patient safety is that they assume accrediting and certifying organizations, as well as local and state regulators, do it for them. But regulators and accreditors should make patient safety a key component of their evaluations, the committee says. For most health care professionals, there is no assessment of clinical performance once they get their licenses to practice, for example. Licensing and certifying bodies should implement periodic re-examinations of doctors, nurses, and other key providers, based on both competence and knowledge of safety practices.
The U.S. Food and Drug Administration, which regulates prescription and over-the-counter drugs and medical devices, should increase its attention to public safety. Efforts should be made to eliminate similar-sounding drug names as well as confusing labels and packaging that foster mistakes. Numerous studies have documented errors in prescribing medications and dispensing by pharmacists and unintentional mistakes on the part of the patient.
Building a Culture of Safety
Health care organizations must create an environment in which safety will become a top priority. This culture of safety means designing systems geared to preventing, detecting, and minimizing hazards and the likelihood of error - not attaching blame to individuals. The report stresses the need for leadership by executives and clinicians, and for accountability for patient safety by boards of trustees. That means creating and adequately funding systems to monitor safety. Well-understood safety principles should be adopted, such as designing jobs and working conditions for safety; standardizing and simplifying equipment, supplies, and processes; and avoiding reliance on memory.
All hospitals and health care organizations should implement proven medication safety practices, the committee says, such as using automated drug-ordering systems. Medication errors occur frequently in hospitals, yet many are not making use of known methods for improving safety. Patients themselves could provide a major safety check in most hospitals, clinics, and practices. They need to know which medications they are taking, the appearance, and the side effects. They also should be responsible for notifying their doctors of medication discrepancies and the occurrence of side effects.
There are no "magic bullets," the report emphasizes; no one part of this plan will be sufficient to bring about the degree of change needed. And responsibility for taking action should not be borne by any single group of providers, but must be addressed by all parts of the health care enterprise.
This report is the first in a series expected to be released through an IOM initiative to develop a strategy for improving the quality of health care in America. The study was funded by the National Research Council and the Commonwealth Fund. The Institute of Medicine is a private, nonprofit institution that provides health policy advice under a congressional charter granted to the National Academy of Sciences.
Copies of To Err Is Human: Building a Safer Health System are available from the National Academy Press at the mailing address in the letterhead; tel. (202) 334-3313 or 1-800-624-6242. The cost of the pre-publication report is $45.00 (prepaid) plus shipping charges of $4.50 for the first copy and $.95 for each additional copy. Reporters may obtain a copy from the following contacts at the Office of News and Public Information:
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