12/14/1999

Medical Error Report Galvanizes Public, Health Care Community

Nancy Tarleton Landis

The Institute of Medicine (IOM) report "To Err Is Human: Building a Safer Health System" has caught the attention of the public and health care providers alike, helping to make reduction of medical errors a top priority for the nation. In releasing the 223-page report by IOM's Committee on Quality of Health Care in America, committee chair William C. Richardson said that while error is part of human nature "it is also part of human nature to create solutions, find better alternatives, and meet the challenges ahead." Reducing error will require rigorous changes throughout the health care system, including mandatory reporting requirements, said the IOM committee. The report outlines a comprehensive strategy for government, industry, consumers, and health care providers, and it calls on Congress to create a national patient safety center to develop new tools and systems for attacking the problem.

Richardson called the rate of medical error "stunningly high" and "simply unacceptable." Yet silence surrounds the issue, said the committee, and the report aims to "break [the] cycle of inaction." The combined goal of its recommendations is for the external environment to create sufficient pressure to make errors costly to health care organizations and providers, so that they are compelled to take action and improve safety. 

Four-pronged approach. The committee called for reducing errors by 50% over the next five years through a four-part plan designed to create both financial and regulatory incentives for a safer health care system. 

1. Creation of a national Center for Patient Safety within the Agency for Health Care Research and Quality (formerly called the Agency for Health Care Policy and Research). The center would set national goals, track progress toward these goals, and issue an annual report to the President and Congress on patient safety. The committee estimated that Congress would need to spend $30 million to $35 million to set up the center and that funding would need to grow to at least $100 million, "a little more than 1% of the $8.8 billion spent each year as a result of medical errors that cause serious harm." 

2. Federal legislation establishing mandatory reporting systems and nonlegislative encouragement of voluntary reporting systems (box). First hospitals and eventually other health care sites would be responsible for reporting to state governments the occurrence of serious injury or death associated with medical treatment. The report notes that about one third of the states currently have their own mandatory reporting requirements; characteristics of state adverse event reporting systems are given in an appendix. 

The committee said that "the public has a right to know about errors resulting in serious harm." However, it called for voluntary, confidential reporting systems for "medical mistakes that have no serious consequences, where information is collected and analyzed solely for the purpose of improving safety and quality." Legislation is recommended to extend peer review protections to reports submitted to voluntary reporting systems. The committee said protection is needed for the original reporters, the recipients of the information, and the information itself. 

According to the Philadelphia Inquirer, panel members Lucian Leape of the Harvard School of Public Health and Donald Berwick of the Institute for Healthcare Improvement had originally opposed public disclosure but eventually accepted the argument by panel member Arthur Levin of the Center for Medical Consumers that the public has the right to know about serious injuries or deaths resulting from medical errors. 

3. Payer and regulatory incentives to improve safety practices. Public and private purchasers of health care must make safety a prime concern in contracting decisions, the committee said. Regulators and accreditors should make patient safety a key component of their evaluations. Licensing and credentialing bodies should implement periodic reexaminations of health professionals, based on both performance skills and knowledge. FDA should increase its attention to public safety in postmarketing as well as premarketing processes. It should develop and enforce standards for package design and labeling and require manufacturers to identify and remedy potential look-alike and sound-alike drug names. 

4. Development of a "culture of safety" in health care organizations. The committee said organizations need to design systems geared to preventing, detecting, and minimizing hazards and the likelihood of error—not attaching blame to individuals (box). Further, "Health care organizations should implement proven medication safety practices." 

Safety systems in health care organizations. The committee proposed principles for organizations to follow in designing and implementing patient safety systems. The principle "respect human limits in process design" includes the use of "constraints and forcing functions." For example, a constraint in medication ordering would be "pharmacy computers that will not fill an order unless allergy information, patient weight, and patient height are entered." The principle "anticipate the unexpected" includes improving access to accurate, timely information; an example is to "have a pharmacist available on nursing units and on rounds." 

Health care organizations and others are urged to standardize patient records; this includes the establishment of uniform standards for connectivity, terminology, and data sharing. 

Medication safety is discussed at length, and pharmacists' positive contributions are featured. ASHP provided IOM with background information for the report, and many of the IOM recommendations appear to be consistent with ASHP policy, including implementing computer order entry by physicians and ensuring the availability of pharmaceutical decision support. A table in the report compares recommendations for safe medication practices from ASHP, the National Coordinating Council for Medication Error Reporting and Prevention, the Institute for Healthcare Improvement, the National Patient Safety Partnership, and the Massachusetts Coalition for the Prevention of Medical Errors. 

A boost for existing efforts. Public attention to the IOM report provides an opportunity to push the agenda of groups like the National Patient Safety Foundation (see December 15, 1999, AJHP News) and the Harvard Executive Session on Medical Error and Patient Safety. The importance given in the IOM report to pharmacy's role underscores concerns ASHP has previously expressed to the Health Care Financing Administration about failure to mention pharmacists in the Medicare and Medicaid conditions of participation for hospitals. Consistent with the IOM recommendation on peer review for voluntary reporting is an ASHP policy recommendation that will be presented to the House of Delegates for ratification in June; it supports federal initiatives to provide liability protection for reporting by individuals and providers. 

Reactions. Within days after issuance of the report, James Jeffords (R-VT), chair of the Senate Health, Education, Labor, and Pensions Committee, and Arlen Specter (R-PA), chair of the Senate appropriations subcommittee on labor, health and human services, and education, both announced plans for hearings on the report. Jeffords noted that a General Accounting Office report on adverse drug events is expected in early 2000. 

President Clinton directed a federal quality task force to analyze the IOM report and suggest, within 60 days, ways of implementing the recommendations. Clinton asked the task force to evaluate the extent to which errors are caused by misuse of medications and devices and to develop additional strategies for reducing such errors. He said government agencies that administer health plans should apply existing recommendations for reducing medical error—and do so in a way that protects patient privacy. Private health plans that cover federal employees will be required to institute quality improvement and patient safety initiatives. Clinton said the government was increasing funding for research on patient safety, noting new legislation reauthorizing the Agency for Health Care Policy and Research—now named the Agency for Healthcare Research and Quality. He announced that a national conference in March will bring state health officials together to promote best practices in preventing medical errors. Finally, he asked advisers to include patient safety initiatives in next year's federal budget. 

In conjunction with the President's remarks on the IOM report, the American Hospital Association (AHA) announced a new initiative on medication errors in partnership with the Institute for Safe Medication Practices (ISMP). According to an AHA statement, ISMP "will help AHA provide hospital leaders with an inventory of successful practices for reducing errors," a medication safety awareness test for hospitals will be created, implementation of error-prevention practices will be tracked, and a "nonpunitive model medication error reporting process" will be developed. 

ASHP has asked for a meeting with AHA to share perspectives on medication-related safety initiatives. 

"The IOM report and the attendant public discussion may in time result in the saving of more lives and the prevention of more suffering than many of the medical advances that have contributed to the problem," opined Sherwin B. Nuland in the December 2 Wall Street Journal. Nuland is professor of surgery at Yale Medical School and author of How We Die: Reflections on Life's Final Chapter and How We Live. Nuland said the complex nature of modern medicine makes some error inevitable. He rejects comparisons, made in the IOM report and elsewhere, between safety measures in health care and those in aviation and other industries—saying that the level of personal attention needed by each patient precludes total efficiency but is "the best defense against error." 

More reports planned. IOM is part of the National Academies. The health care quality committee was formed in 1998 to develop a strategy that will result in a threshold improvement in quality over the next 10 years. Its report on patient safety is the first in a series addressing overall quality-related concerns. 

—Nancy Tarleton Landis

Recommendations for Error Reporting

Mandatory
A nationwide mandatory reporting system should be established that provides for the collection of standardized information by state governments about adverse events that result in death or serious harm. Reporting should initially be required of hospitals and eventually be required of other institutional and ambulatory care delivery settings. Congress should
  • Designate the Forum for Health Care Quality Measurement and Reporting as the entity responsible for promulgating and maintaining a core set of reporting standards to be used by states, including a nomenclature and taxonomy for reporting.  
  • Require all health care organizations to report standardized information on a defined list of adverse events.  
  • Provide funds and technical expertise for state governments to establish or adapt their current error reporting systems to collect the standardized information, analyze it, and conduct follow-up action as needed with health care organizations. Should a state choose not to implement the mandatory reporting system, the Department of Health and Human Services should be designated as the responsible entity.  
  • Designate the Center for Patient Safety to (1) convene states to share information and expertise, and to evaluate alternative approaches taken for implementing reporting programs, identify best practices for implementation, and assess the impact of state programs; and (2) receive and analyze aggregate reports from states to identify persistent safety issues that require more intensive analysis and/or a broader-based response (e.g., designing prototype systems or requesting a response by agencies, manufacturers or others).

Voluntary
The development of voluntary reporting efforts should be encouraged. The Center for Patient Safety should 

  • Describe and disseminate information on external voluntary reporting programs to encourage greater participation in them and track the development of new reporting systems as they form.  
  • Convene sponsors and users of external reporting systems to evaluate what works and what does not work well in the programs, and ways to make them more effective.  
  • Periodically assess whether additional efforts are needed to address gaps in information to improve patient safety and to encourage health care organizations to participate in voluntary reporting programs.  
  • Fund and evaluate pilot projects for reporting systems, both within individual health care organizations and collaborative efforts among health care organizations.

Safety Systems in Health Care Organizations

Health care organizations and the professionals affiliated with them should make continually improved patient safety a declared and serious aim by establishing patient safety programs with defined executive responsibility. Patient safety programs should
  • Provide strong, clear, and visible attention to safety. 
  • Implement nonpunitive systems for reporting and analyzing errors within their organizations. 
  • Incorporate well-understood safety principles, such as standardizing and simplifying equipment, supplies, and processes. 
  • Establish interdisciplinary team training programs that incorporate proven methods of team training, such as simulation.

IOM's Definitions

Error: The failure to complete a planned action as intended or the use of a wrong plan to achieve an aim.
Safety: Freedom from accidental injury. 


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