Doing What Counts for Patient Safety:

Contents

Quality Interagency Coordination Task Force

Executive Summary and Actions

A National Problem of Epidemic Proportion
The Clinton–Gore Administration's Commitment to Improving Patient Safety
Institute of Medicine Recommendations
A Road Map for Action: The Federal Response
Creating a National Focus to Enhance the Knowledge Base on Patient Safety
Setting Performance Standards and Expectations for Safety
Implementing Safety Systems in Health Care Organizations
Additional Federal Actions to Improve Patient Safety
Conclusion

Compendium of Action Items

Introduction—Errors: Part of a Broader Quality Agenda

The IOM Report
The President’s Directive

Growing Concerns About Medical Errors
Definitions and Context

Figure 1. Framework for Identifying Errors
A Framework for Thinking About Errors

Lessons from other industries
Unique aspects of health care errors
Impact of organizational and professional culture
A global challenge

Evidence of Errors

The epidemiology of medical errors
Adverse events and medical products use or misuse
Current programs to prevent errors
Accomplishments of programs to prevent medical errors
Insufficiency of existing programs

National Focus and Leadership

Center for Patient Safety-- Actions
Research Planning-- Actions
Identifying and Learning From Errors

Accountability-- Actions
Learning from Errors
Characteristics of an Ideal Reporting System for Learning-- Actions
Analysis and Feedback
Peer Review Protections --Actions
Setting Performance Standards and Expectations for Safety

Raising the Standards for Health Care Organizations-- Actions
Raising the Standards for Health Care Professionals-- Actions
Safe Use of Drugs and Devices-- Actions
Implementing Safety Systems in Health Care Organizations-- Actions
Framework for Reporting Systems

Building Public Awareness of Medical Errors-- Actions
Building Purchasers’ Awareness of the Problem-- Actions
Working with Providers to Improve Patient Safety-- Actions
Using Decision-support Systems and Information Technologies-- Actions
Using Standardized Procedures, Checklists, and the Results of Human Factors Research-- Actions

Standards -- Actions
Data Integration--Actions

References

Glossary

Organization and Acronym Guide
Glossary of Terms

Co-Chairs

Donna Shalala, Secretary, Department of Health and Human Services
Alexis Herman, Secretary, Department of Labor

Operating Chair

John Eisenberg, Director, Agency for Healthcare Research and Quality

Participating Departments and Agencies

Coordination Officer

Nancy Foster, Agency for Healthcare Research and Quality

Acknowledgments

The development of this report by the Quality Interagency Coordination Task Force involved the efforts of many people from many agencies. Those individuals listed below, alphabetically by agency, made significant contributions to the content and form of the report. Many others commented on drafts of the report and made important contributions to it.

Department of Health and Human Services

Agency for Healthcare Research and Quality: Raghu Bukkapatnam, Carolyn Clancy, John M. Eisenberg, Nancy Foster, Irene Fraser, Howard Holland, Marge Keyes, David I. Lewin, Karen J. Midgail, Gregg Meyer, Ronald Rabbu, Heddy Reid, Mary Rolston, Ning Tang, Christine Williams, Paula Zeller

Centers for Disease Control and Prevention: Irma Arispi, Blake M. Caldwell, Scott Deitchman, Linda Delmo, Julie Gerberding, Roger Rosa, Kenneth Schachter, Dana Silverman, Steven L. Solomon, Rosemary Sokas

Food and Drug Administration: Rosalie Bright, Nancy Derr, Susan Ellenberg, Marilyn Flack, Susan Gardner, Melvyn Greberman, Anne Henig, Mary Leary, Catherine Lorraine, Susan K. Meadows, Karen Meister, Theresa Mullin, Jerry Phillips, Chester Trybus, Janet Woodcock

Health Care Financing Administration: Robert Berenson, Judith L. Bragdon, Valerie Mattison Brown, Carol Cronin, Tim Cuerdon, Stephanie Dyson, Frank Emerson, Connie Forster, Stephen Jencks, Jeffrey L. Kang, Larry Kessler, David Miranda, Barbara Paul, Doug Rimel, Ideanna Sarsitis, Alfreda Staton, Aaron Stopak, Rachael Weinstein

Health Resources and Services Administration: Barbara Brookmyer, Forrest W. Calico, Felicia Collins, M. Ann Drum, David E. Heppel, Michael Johnson, Ruth Kahn, Joel T. Levine, Suzanne M. Leous, Louis Emmet Mahoney, Laura A. McNally, William A. Robinson, Vincent C. Rogers, David B. Snyder

National Institutes of Health: David K. Henderson, Laura M. Lee

Office of the Secretary: Gary Claxton, Jane Horvath, Nicole Lurie, Beverly Malone, Lisa Rovin

Substance Abuse and Mental Health Services Administration: Paolo del Vecchio, Jennifer Fiedelholtz, Alan Trachtenberg

United States Coast Guard

Gary Kaplowitz

Department of Commerce

Paul London

Department of Defense

Sue Bailey, Timothy Corcoran, Frank Maguire, John Mazzuchi, Aron Primack, Wyatt Smith, Frances Stewart

Department of Labor

Patricia Arzuaga, Jordan Barab, Charles Cortinovis, Elise Handelman, Leslie Kramerich, Deborah Milne

Office of Personnel Management

Abby Block, W. Edward Flynn, Frank Titus, Ellen Tunstall

Department of Veterans Affairs

James P. Bagian, Thomas Garthwaite, John Gosbee, Caryl Z. Lee, Jonathan Perlin

Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact

To Err is Human: Building a Safer Health System, a report released late last year by the Institute of Medicine (IOM), shocked the Nation by estimating that up to 98,000 Americans die each year as a result of preventable medical errors. The report concludes that the majority of these errors are the result of systemic problems rather than poor performance by individual providers, and outlined a four-pronged approach to prevent medical mistakes and improve patient safety.

On December 7, President Clinton directed the Quality Interagency Coordination Task Force (QuIC) to evaluate the recommendations in To Err is Human and to respond with a strategy to identify prevalent threats to patient safety and reduce medical errors. This report responds to the President’s request and provides an action plan to implement Administration initiatives designed to help prevent mistakes in the Nation’s health care delivery system.

A National Problem of Epidemic Proportion

It is clear that, although the United States provides some of the best health care in the world, the numbers of errors in health care are at unacceptably high levels. The Institute of Medicine’s report estimates that more than half of the adverse medical events occurring each year are due to preventable medical errors, causing the death of tens of thousands. The cost associated with these errors in lost income, disability, and health care costs is as much as $29 billion annually. The consequences of medical mistakes are often more severe than the consequences of mistakes in other industries—leading to death or disability rather than inconvenience on the part of consumers—underscoring the need for aggressive action in this area.

A wide body of research, including many studies funded by AHRQ, supports the IOM conclusions. The two seminal studies on medical error (Brennan, 1991; Thomas, 1999) have shown that adverse events occur to approximately 3–4 percent of patients. In another study (Leape, 1994), the average intensive care unit (ICU) patient experienced almost two errors per day. This translates to a level of proficiency of approximately 99 percent. One out of five of these errors were potentially serious or fatal. If performance levels of 99.9 percent—substantially better than those found in the ICU—applied to the airline and banking industries, it would equate to two dangerous landings per day at O'Hare International Airport and 32,000 checks deducted from the wrong account per hour (Leape, 1994).

Many of these adverse events are associated with the use of pharmaceuticals, and are potentially preventable. The IOM estimates the number of lives lost to preventable medication errors alone represents over 7,000 deaths annually—more than the number of Americans injured in the workplace each year. In addition, preventable medication errors are estimated to increase hospital costs by about $2 billion nationwide. A 1995 study estimated that problems related to the use of pharmaceutical drugs account for nearly 10 percent of all hospital admissions, and significantly contribute to increased morbidity and mortality in the United States (Bates, 1995). A 1991 study of hospitals in New York State indicated that drug complications represent 19 percent of all adverse events, and that 45 percent of these adverse events were caused by medical errors. In this study, 30 percent of the individuals with drug-related injuries died (Leape, 1991).

The Clinton-Gore Administration’s Commitment to Improving Patient Safety

In early 1997, the President established the Advisory Commission on Consumer Protection and Quality in the Health Care Industry (Quality Commission) and appointed Health and Human Services Secretary Shalala and Labor Secretary Herman as co-chairs. The Quality Commission released two seminal reports focusing on patient protections and quality improvement. Subsequent to the Commission’s second report on patient safety and quality improvement and consistent with its recommendations, the President established the Quality Interagency Coordination Task Force (QuIC), a umbrella organization also co-chaired by Secretary Shalala and Secretary Herman, to coordinate Administration efforts to improve quality. As he established the QuIC, the President stated that "For all of its strengths, our health care system still is plagued by avoidable errors."

Also consistent with the Quality Commission’s recommendations, Vice President Gore launched the National Forum for Health Care Quality Measurement and Reporting. Known as the Quality Forum, it is a broad-based, widely representative private body that establishes standard quality measurement tools to help all purchasers, providers, and consumers of health care better evaluate and ensure the delivery of quality services. In addition to the work and significant potential of the QuIC and Quality Forum, other Federal agencies have made significant efforts to reduce medical errors and increase attention on patient safety.

In accordance with its recent reauthorization, the AHRQ is the lead agency for the Federal government on quality in health care. It sponsors research examining the frequency and cause of medical errors and tests techniques designed to reduce these mistakes. It also examines issues generally related to health care quality, including overuse and underuse of services.

The Department of Defense (DoD) and the Department of Veterans Affairs (VA), serving over 11 million patients nationwide, have begun to implement computerized physician order entry systems, proven effective in reducing medical errors. In addition, Veterans Affairs has implemented a computerized medical record in all their 172 hospitals, making it possible to reduce errors by providing complete information about patients at the point of care. Over the past 3 years, the VA created an error reporting system, established four Centers of Inquiry for Patient Safety, and began to use barcode technology to reduce medication errors.

The Health Care Financing Administration (HCFA), through its Peer Review Organizations (PROs), is working to reduce errors of omission for the 39 million Medicare beneficiaries. Under their current performance-based contracts, the PROs are working to prevent failures and delays in delivering services for breast cancer, diabetes, heart attack, heart failure, pneumonia, and stroke. These efforts have already decreased mortality for heart attack victims.

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) collect data on adverse events that are the result of treatment, such as hospital-acquired infections and the unintended effects of drugs and medical devices. CDC's National Nosocomial Infections Surveillance (NNIS) system is a hospital-based reporting system that monitors hospital-acquired infections that afflict more than two million patients every year. Among participating hospitals, bloodstream infection rates have decreased by more than 30 percent since 1990, and wound infections following surgery have decreased by 60 percent among high-risk patients. FDA receives approximately 100,000 reports per year of adverse events associated with medical devices and over 250,000 reports associated with pharmaceuticals. FDA estimates that over one-third of the adverse events associated with medical devices and pharmaceuticals are preventable.

In all of these efforts, the Administration has worked closely with the private sector and the States. Many States and members of the private sector are moving ahead with actions to reduce the number of medical errors. Currently, almost 20 States have implemented mandatory reporting systems to improve patient safety and hold health care organizations responsible for the quality of care they provide. The private sector has also taken large strides to address the issue of patient safety, most recently with the creation of the Leapfrog Group by executives of some of the Nation’s biggest companies, including General Motors and General Electric. This group encourages all employers to make safe medicine a top priority of the health insurance they provide and to steer workers to the hospitals that make the fewest mistakes.

While both the public and private sectors have made notable contributions to reducing preventable medical errors, additional and aggressive efforts are needed in and outside of the Federal government to further reduce these mistakes.

Institute of Medicine Recommendations

The IOM report recommends the establishment of a national goal of reducing the number of medical errors by 50 percent over 5 years. To that end, it outlined a four-tiered approach to reduce medical mistakes nationwide, including actions to:

• Establish a national focus to create leadership, research, tools, and protocols to enhance the knowledge base about safety.
• Identify and learn from medical errors through both mandatory and voluntary reporting systems.
• Raise standards and expectations for improvements in safety through the actions of oversight organizations, group purchasers, and professional groups.
• Implement safe practices at the delivery level.

A Road Map for Action: The Federal Response

The QuIC agencies join the IOM’s call for action to reduce errors, implement a system of public accountability, develop a robust knowledge base about medical errors, and change the culture in health care organizations to promote the recognition of errors and improvement in patient safety. This report describes the actions that the QuIC agencies will take to build on current programs and develop new initiatives to reduce errors.

The QuIC fully endorses the IOM’s goal of reducing the number of medical mistakes by 50 percent over 5 years and has developed a strategy that builds on the IOM recommendations and, in some cases, goes beyond them. This strategy is detailed below.

Creating a National Focus to Enhance the Knowledge Base on Patient Safety

IOM Recommendation: Creating a Center for Patient Safety. The IOM recommends that Congress fund a Center for Patient Safety within the Agency for Healthcare Research and Quality (AHRQ) that will set national goals for patient safety, track progress in meeting these goals, and issue an annual report to the President and Congress on patient safety. The Center should also enhance the current knowledge base on patient safety by developing a research agenda, disseminating grants for research on patient safety, funding Centers of Excellence, evaluating methods for identifying and preventing errors, and funding dissemination and communication activities to improve patient safety.

QuIC Response. The Administration endorses the IOM recommendation and the President has included $20 million in the Fiscal Year (FY) 2001 budget to support a Center for Quality Improvement and Patient Safety at the AHRQ, as part of the Agency’s broader quality agenda. The Center will fund research on medical errors, principally through extramural grants and contracts. It will work with private-sector entities and public sector partners, including the Quality Forum, to develop national goals for patient safety; issue an annual report on the state of patient safety nationally; promote the translation of research findings into improved practices and policies; and educate patients, consumers, and health care providers about patient safety.

IOM Recommendation: Establishing reporting systems nationwide. The IOM recommends that the Administration and the Congress move to establish a nationwide system of error reporting that includes both mandatory and voluntary components.

Mandatory Reporting Systems. The IOM recommends the development of a nationwide mandatory reporting system to provide for the collection of standardized information by state governments about adverse events that result in death or serious harm. The report states that adverse event reporting should initially be required of hospitals and eventually be required of other institutional and ambulatory care delivery systems. It recommends that this system should be implemented nationwide, linked to systems of accountability, and made available to the public. The IOM concludes that if States choose not to implement the mandatory reporting system, the Department of Health and Human Services (DHHS) should serve as the responsible entity.

Voluntary Reporting Systems. The IOM report does not propose the establishment of a national voluntary reporting system; rather, it offers a variety of options for more limited voluntary reporting systems that function in all 50 States and build on currently existing options, including the development of systems focused on selected areas, such as medications, surgery, and pediatrics or using a sampling technique to collect the full range of information from a limited subset of health care providers. The IOM recommends that more research be conducted to determine the best way to develop voluntary reporting systems that complement proposed mandatory reporting systems and can identify potential precursors to errors, thus preventing patient harm. It also recommends that the Congress extend peer review protections to data related to patient safety and quality improvement collected through voluntary reporting systems.

QuIC response. The Administration agrees with the IOM that error reporting systems should be established in all 50 States, and that these systems should have both mandatory and voluntary components. Such an effort should establish important complementary approaches to both learning and accountability on errors. Well-designed patient safety programs include reporting systems that both hold health systems accountable for delivering high quality health care and provide important information to health care decision-makers that improves patient safety.

The QuIC agrees with the IOM that individuals should have access to information leading up to and including the occurrence of a preventable error that caused their serious injury or the death of a family member. However, we believe that subsequent "root-cause" analyses undertaken to determine the internal shortcomings of the hospital’s delivery system should not be subject to discovery in litigation and that appropriate legislation should be enacted in conjunction with or prior to the implementation of mandatory or voluntary reporting systems.

It is important to note that the QuIC believes that any legislation or administrative intervention in this area should not undermine individuals’ rights to redress for criminal activity, malpractice, or negligence. The QuIC does not support legislation that would allow safety reporting systems to serve as a shield for providers engaging in illegal or negligent behavior.

Mandatory Reporting Systems. The QuIC supports the development of State-based systems to require the collection of standardized information on preventable, adverse events that result in death or serious harm, and believes that the development of these systems are ultimately in the best interests of patients. We agree with the IOM that the scope of events targeted by mandatory reporting systems that contain public disclosure components should be limited to serious, preventable, and identifiable adverse events. By limiting required reporting systems to the most serious of errors—those causing life-long disability or death—this approach will most effectively target egregious problems and minimize the cost of operating such a system. The QuIC believes that, once mandatory systems are fully implemented, such information for each health system should be consolidated and made public, but that there should be no identification of patients or individual health care professionals. The QuIC believes that mandatory reporting systems that contain public disclosure components should not be used as a tool for punitive action by State and local authorities, but should be used as a mechanism to provide the public with information about the safety of its health systems and to highlight errors that can and should be prevented.

The IOM has a set of specific recommendations for the structure of a nationwide mandatory reporting system. The QuIC believes that there are a number of issues that need to be addressed prior to determining the best mechanism to ensure the establishment of State-based mandatory reporting systems. The Administration will work with the Congress to outline the appropriate Federal role in such a system. However, while these issues are being resolved, the Administration will take the following actions to demonstrate the importance of implementing mandatory reporting systems and to create an environment in which there is more widespread support for their use.

• Implement a mandatory reporting system in the over 500 hospitals and clinics operated by the Department of Defense. Beginning this spring, the Department of Defense will implement a new reporting system in its 500 hospitals and clinics serving approximately 8 million patients. This confidential reporting system will be modeled on the system in operation at the Department of Veterans Affairs and will be used to provide health care professionals and facilities with the information necessary to protect patient safety. This system will begin to be pilot tested in August of 2000, will collect information on adverse events, medication errors, close calls, and other patient safety issues. DoD providers will inform affected patients or their families when serious medical errors occur.

• Expand mandatory reporting requirements for blood banks and establishments that deal with blood products nationwide. By the end of the year, the Food and Drug Administration (FDA) will release regulations to improve the safety of blood transfusions by requiring the over 3,000 blood banks and establishments dealing with blood products to report errors and accidents, such as mistyping blood products and adverse events affecting donors, that affect patient safety. Currently, only 400 blood banks are required to report such errors.

In addition to Federal action to integrate mandatory reporting systems into Federal agencies delivering care and strengthen the mandatory systems that currently exist, there is a critical need for Federal leadership in the development of patient safety standards. To that end, the Federal government will:

• Identify a set of patient safety measurements critical to the identification of medical errors. The QuIC will ask the Quality Forum to identify a set of patient safety measurements that should be a basic component of any medical errors reporting system. Developing standardized measures lays the foundation for a uniform system of data collection and facilitates the development of these systems.
• Identify a set of patient safety practices critical to prevention of medical errors. The QuIC will ask the Quality Forum to identify, within 12 months, patient safety practices that should be adopted by all hospitals and health systems, and will undertake activities to encourage their widespread use. The QuIC suggests that mandatory reporting systems include information on whether hospitals and health systems' adopt these patient safety practices.
• Identify issues related to the implementation of mandatory reporting for error reduction. Using the Quality Forum’s recommendations for medical error reporting, HCFA will develop a pilot project, through the PRO program, for up to 100 hospitals that volunteer to implement penalty-free, confidential, mandatory reporting systems. These pilot projects will assist hospitals in changing their medical delivery systems to reduce or eliminate errors. This pilot project will include a rigorous evaluation component and identify issues related to the implementation of medical error reporting systems.
• Determine the most effective way to present information on the incidence of medical errors to the public. HCFA, OPM, and AHRQ will lead a QuIC effort to work with the Quality Forum and States that have mandatory reporting systems to determine how data on medical errors can be collected, validated, and presented to the general public and local policy officials—and to determine the impact of providing such information. Since informing the public about the safety of their health care systems is a critical component of mandatory reporting systems, this pilot project will provide insights on presenting this information to the public.
• Examine existing mandatory reporting systems. The Center for Quality Improvement and Patient Safety, in collaboration with other QuIC agencies, will evaluate the effectiveness of currently existing mandatory reporting systems at the Federal and State levels and develop recommendations to improve them. This information will be presented to States and other organizations considering developing such systems or that currently have existing systems, to help them design effective reporting systems likely to improve patient safety.

The QuIC believes that these actions will encourage States to begin implementing their own mandatory reporting systems for preventable adverse events, with the goal that all 50 States have mandatory reporting systems for preventable adverse events within 3 years. This time frame will enable the Federal government, working with the Congress and other private-sector stakeholders, to conclusively resolve outstanding implementation issues. If all states have not implemented mandatory reporting systems within three years, the QuIC will deliver recommendations to the President that assure all health care institutions are reporting serious, preventable adverse events.

Although currently the QuIC believes that moving towards a mandatory reporting system is the appropriate course of action, if research conducted by AHRQ and other agencies indicates that the implementation of these systems does not enhance (or detracts from) patient safety, these results will be reported to the QuIC. Special emphasis will be placed on efforts to determine whether making information public serves to hold health systems accountable and reduce preventable errors, or whether it only stifles reporting.

Voluntary Reporting Systems. The QuIC agrees with the IOM that voluntary reporting systems are a critical component of a national strategy to reduce errors. Information from voluntary reporting systems is usually gathered by an independent entity and is used to identify patterns of errors. The QuIC proposes to integrate existing Federal voluntary reporting systems with data collection efforts by States and private organizations. The QuIC agrees with the IOM that these programs should be confidential to protect the privacy of patients, institutions, and providers reporting errors and close calls. Experience in other industries demonstrates that confidentiality encourages reporting. In order to encourage the development of voluntary reporting systems, the Administration will:

• Implement a voluntary reporting system nationwide for veterans’ hospitals. The VA currently operates a mandatory reporting system. By the end of the year, the VA will implement a voluntary reporting system for both adverse events and close calls nationwide. Information will be collected by an independent external entity, analyzed, and disseminated to all VA health care networks to help prevent medical errors. Implementing this system is likely to lead to a richer database of information, as incidents are reported on a de-identified basis, and will allow researchers to compare the effectiveness of identified systems to de-identified ones.
• Examine existing voluntary systems. The Center for Quality Improvement and Patient Safety, with its QuIC partners, will evaluate the effectiveness of existing voluntary reporting systems at the Federal and State levels and develop recommendations to improve them. This study will demonstrate which entity or entities would be best to collect, analyze, and disseminate information on frequently occurring errors and the best interventions to prevent them.

Setting Performance Standards and Expectations for Safety

IOM Recommendation: Include patient safety in performance standards and expectation for health care organizations. The IOM recommends that regulators and accreditors should require health care organizations to implement meaningful patient safety programs with defined executive responsibility. Public and private purchasers should provide incentives to health care organizations to demonstrate continuous improvement in patient safety.

QuIC response. The QuIC reviewed current Federal activities and proposed several ways to improve safety through current oversight activities. These include:

• Assuring that all hospitals participating in the Medicare program implement patient safety programs. The Health Care Financing Administration intends to publish regulations this year requiring the over 6000 hospitals participating in the Medicare program to have ongoing medical error reduction programs that would include, among other interventions, mechanisms to reduce medication errors. To comply with this new regulation, most hospitals are likely to implement systems such as automated pharmacy order-entry systems and automatic safeguards against harmful drug interactions and other adverse events.
• Requiring the almost 300 health plans in the Federal Employees Health Benefits Program to implement patient safety programs. In its annual call letter, to be issued this April, the Office of Personnel Management will announce that, beginning in 2001, all health plans participating in the program will be required to implement patient safety initiatives. OPM will encourage health plans to collaborate with their providers to reduce errors and improve the quality of care.
• Working with private-sector employers and employees to incorporate patient safety into purchasing decisions. This year, the Department of Labor will include information on medical errors in the Health Benefits Education Campaign. This national effort educates employees about issues of quality and safety under their employer-provided health benefits so that they can make informed health benefits decisions and educates employers in order to facilitate the provision of high-quality, affordable health benefits to their employees.

IOM Recommendation: Performance standards and expectations for health professionals should focus greater attention on patient safety. Periodic re-examination and re-licensing of doctors, nurses, and other key providers should be conducted based on both competence and knowledge of safety practices. Professional societies should make a visible commitment to patient safety by establishing a permanent committee dedicated to safety improvement.

QuIC response. The QuIC is supportive of these goals, but recognizes and agrees with the IOM that they appropriately fall under State jurisdiction and oversight. However, the QuIC agencies will provide technical assistance to State or professional agencies seeking to ensure a basic level of knowledge for health care providers on patient safety issues, promote model patient safety programs that include evidence-based best patient safety practices to provider organizations, or help agencies encourage the cultural change necessary to make reporting systems a success.

IOM Recommendation: FDA should increase attention to the safe use of drugs. Both pre- and postmarketing processes should be improved to maximize safe drug use. FDA should develop and enforce standards for the design of drug packaging and labeling that will maximize safety in use and require pharmaceutical companies to test proposed drug names to identify potential sources of confusion with existing drug names. In addition, the Agency should work with physicians, pharmacists, consumers, and others to establish appropriate responses to problems identified through post-marketing surveillance activities.

QuIC response. The QuIC endorses the IOM recommendation. FDA currently has a strong program of pre- and post-market surveillance, and is pleased that the President is committing $33 million, an increase of 65 percent over last year’s funding level, in his FY 2001 budget to prevent medical errors associated with drugs and medical devices. Among other things, it would:

Initiate new efforts to ensure that pharmaceuticals are packaged and marketed in a manner that promotes patient safety. Within one year, FDA will develop new standards to help prevent medical errors caused by proprietary drug names that sound similar or packaging that looks similar, making it easy for health care providers to confuse medications. The Agency will also develop new label standards by the end of the year that highlight common drug-drug interactions and dosage errors related to medications.

Implementing Safety Systems in Health Care Organizations

IOM Recommendation: Health care organizations should make continually improved patient safety a declared and serious aim. Patient safety programs should provide strong, clear, and visible attention to safety; implement non-punitive systems for reporting and analyzing errors within their organizations; and incorporate well-understood safety principles.

QuIC response. The QuIC supports this recommendation, and Federal agencies will take the following actions:

The Department of Veterans Affairs. The VA is considered one of the Nation’s leaders in patient safety, having instituted patient safety programs in all of its health care facilities serving 3.8 million patients nationwide. This year, the VA will invest over $47.6 million to increase the requirement for patient safety training for staff from 15 to 20 hours a year, provide "VA Quality Scholars" fellowships for 10 physicians, implement a patient safety awards program, and place "patient safety checklists" in operating rooms in every hospital nationwide.

The Department of Defense. Beginning this fall, the Department of Defense will invest $64 million in FY 2001 to begin the implementation of a new computerized medical record, including an automated entry order system for pharmaceuticals, that makes all relevant clinical information on a patient available when and where it is needed. It will be phased in at all DoD facilities over 3 years.

The QuIC Task Force. This summer, the QuIC member agencies, including DoD, VA, AHRQ, and HCFA, will begin a collaborative project with the QuIC Task Force and the Institute for Healthcare Improvement to reduce errors in "high hazard areas," such as emergency rooms, operating rooms, intensive care units, and labor and delivery units.

IOM Recommendation: Improve medication safety. Health care organizations should implement proven medication safety practices.

QuIC Response. The QuIC endorses this recommendation. This year, VA will invest $75.1 million to complete the implementation of an automated order entry system in all of its health care facilities, along with a barcoding system for blood transfusions and medication administration. A 1999 evaluation of this system indicates that it has reduced medication errors by 67 percent since its implementation. The Department of Defense will invest $12 million to implement an integrated pharmacy system that creates a single profile for all the medications a patient takes, regardless of whether the prescriptions were filled at military and private pharmacies serving DoD beneficiaries worldwide by the end of 2000.

In addition, to comply with the new proposed requirement that hospitals participating in the Medicare program have error reduction programs, hospitals are likely to implement programs such as automated pharmacy order-entry systems. Furthermore, as highlighted in the prescription drug provisions in the President’s Medicare reform initiative, any outpatient drug benefit for Medicare beneficiaries should require private contractors administering the program to use the latest patient safety techniques, including drug utilization review and patient counseling.

Additional Federal Actions to Improve Patient Safety

The President asked the QuIC to identify additional strategies to reduce medical errors and ensure patient safety in Federal health care programs. This report includes several additional recommendations, including an emphasis on the application of information systems and computer-based initiatives to improve patient safety. The President has requested $20 million in his FY 2001 budget to develop a consistent structure for health care information technology that incorporates strong privacy protections for patients and providers. Investments in information technology are one of the most effective and efficient ways to improve the quality of health care. This Health Informatics Initiative will address the problem of medical errors as a part of the Administration's efforts to improve health care quality through enhanced information technology.

Conclusion

In this report, the QuIC proposes to take strong action on each and every one of the IOM recommendations to promote safer health care. While some of the IOM’s recommendations can be addressed individually by specific agencies, the majority of the proposed actions require joint effort. The QuIC and its participating agencies are eager to partner with a broad array of public, state, and private organizations in a national effort to reduce medical errors and improve patient safety.

National Focus and Leadership

Center for Patient Safety

• AHRQ will take immediate action to establish the Center for Quality Improvement and Patient Safety (CQuIPS), which will replace and broaden the mission of AHRQ’s Center for Quality Measurement and Improvement.
• CQuIPS will coordinate with and complement other public- and private-sector initiatives to improve patient safety.
• QuIC will coordinate Federal activities on patient safety, as it does on the broader quality agenda. This will include both regular meetings of the QuIC and use of its current structure to redirect QuIC working group efforts towards enhancing patient safety.
• AHRQ will sponsor a program to educate personnel of QuIC member agencies about patient safety, bringing them together with leading researchers on human factors analysis, systems design, error reporting, and quality improvement. This curriculum will serve as a model and be expanded for future educational activities with private-sector partners.
• QuIC agencies such as OPM, HCFA, DoD, and VA will demonstrate their national leadership as purchasers and providers of care, developing model programs that use information on errors to improve patient safety.
• Federal agencies and other bodies, including AHRQ, FDA, CDC, and HCFA, will collaborate to provide national leadership in developing and testing systems of mandatory reporting for public accountability.

Research Planning

• Hold national summits on medical error and patient safety research: AHRQ will lead the convening of conferences and expert meetings to review the information needs of those who wish to improve safety, assess the current state of patient safety research, set coordinated research agendas, and develop adequate reporting mechanisms. VA will lead a summit on lessons learned from its experiences in improving patient safety, and the FDA will lead a summit on drug errors. These summits will take place within 1 year.
• Establish joint research solicitations (including partnerships between AHRQ, CDC, FDA, and VA) for:

—Fundamental Research on Errors: Investigate root causes analysis, informatics, the role(s) of human factors, and legal/judicial issues.
—Research on Reporting Systems: Identify critical components of successful reporting systems used for learning, examine options for voluntary and mandatory reporting systems, implement and evaluate demonstration programs for reporting, evaluate existing State mandatory reporting systems, and investigate techniques and methods for analyzing and disseminating patient safety data (including integration into a National Quality Report being prepared by DHHS under the leadership of AHRQ and CDC).
—Applied Research on Patient Safety: Test the application of human factors knowledge to the design of health care products, processes, and systems; identify best practices in reducing errors; fund patient safety "Centers of Research Excellence"; and support research and demonstrations on-site, as well as level-of-care and cross-cutting research, such as in diagnostic accuracy, informatics applications, and systems re-engineering.
• Develop tools for the public and private sector to support efforts to enhance patient safety, including:
—Applications: Identify tools and approaches from other industries that could be applied to the health care sector and develop community-based settings that can serve as laboratories for error reduction through medical specialty societies, primary care networks, and integrated service delivery networks.
—Measures: Develop and evaluate data specifications for reporting on patient safety and work with the Quality Forum and other private- and public-sector efforts on developing consensus around a core set of measures for patient safety.

• Finalize a QuIC Research Agenda on Working Conditions and Patient Safety. The QuIC will finalize a research agenda to explore the relationship between health care workers’ working conditions and the quality of patient care, including patient safety. CDC and AHRQ will coordinate this activity with VA and other agencies.

Identifying and Learning From Errors

Accountability

• The QuIC will ask the Quality Forum to define unambiguously, within 12 months, a set of egregious errors that are preventable and should never occur. These measures will serve as criteria for a HCFA-sponsored mandatory reporting demonstration project with a State that already has an existing mandatory reporting requirement. HCFA will publish the hospital rates for these events without patient identifiers.
• HCFA and its QuIC partners will evaluate whether consumers found this information valuable and what they understood about it. Based on these results, HCFA will move towards a national mandatory reporting system, with publication of findings, for all hospitals participating in Medicare.
• Federal agencies, in partnership with other organizations, will develop options for mandatory reporting systems that provide the public and purchasers with publicly available information about programs and procedures in place to reduce errors. This work will require the development of evidence-based, systems-level measures in collaboration with the Quality Forum.
• OPM will require that health plans have error reduction plans and will report on its web site whether the health plans have reliable patient safety initiatives in place.
• QuIC will ask the Quality Forum to identify, within 12 months, patient safety practices that institutions should undertake and urges that information about whether the measures are in place be made available to the public.
• FDA will report to the public on the safety of drugs, devices, and biologic products.
• QuIC proposes that State and Federal mandatory reporting systems, as well as those of private accrediting and other oversight groups, be evaluated to determine the ways in which they are helpful in assuring public accountability for patient safety, and that these results be used to develop future reporting systems.
• AHRQ will include information on patient safety in the National Quality Report it is developing in collaboration with other agencies, in particular, the National Center for Health Statistics.
• OPM will require that health plans describe their patient safety initiatives, will make patient safety information available in both print and electronic formats for the open enrollment period in Fall, 2000, and will expand its Web site to include information about programs designed to reduce errors and enhance patient safety.
• OPM will encourage health plans to annotate Preferred Provider Organization (PPO) directories to indicate which hospitals and physicians’ offices use automated information systems.
• FDA will improve the safety of transfusions by expanding mandatory reporting requirements for blood bank errors and accidents, so that they apply to all registered blood establishments.

Learning from Errors

• The new Center for Quality Improvement and Patient Safety (CQuIPS) at AHRQ will identify existing State and Federal reporting systems (both mandatory and voluntary), evaluate their suitability in helping to build a national system of errors reporting, and evaluate how their data collection or enforcement efforts can be enhanced to improve the value of those systems.
• QuIC will work with the Quality Forum to develop reporting criteria that assure that information can be pooled and shared as needed across organizations.
• CQuIPS, working with the QuIC, will describe and disseminate information on characteristics of existing voluntary reporting programs associated with successful error reduction and patient safety improvement efforts. FDA, CDC, and NASA will provide expertise in the development of these nonpunitive systems.
• Within six months, HCFA, working with a Peer Review Organization (PRO) program, will develop a pilot of a confidential, penalty-free learning system with several hospitals on a voluntary basis.
• Federal agencies, including the FDA, VA, DoD, CDC, HCFA, and AHRQ, will integrate data from different sources and conduct and support analysis to identify error prone procedures, products, and systems.
• By August 2000, the DoD will complete development of a patient safety improvement program based on a reporting system modeled on that of the VA.
• VA will establish a voluntary reporting system to supplement its existing mandatory system.
• AHRQ, in collaboration with other Federal agencies, will investigate, develop and test strategies to provide effective feedback to clinicians and institutions on methods for improving patient safety.
• Federal agencies will assist health care providers to develop the skills necessary for analyzing adverse events and near misses (e.g., root cause analysis, trending, search tools). Federal agencies providing health care will develop internal systems to 1) identify and report errors to clinicians and other decision makers, and 2) learn from those errors and near misses to prevent future events.
• Outreach to Stakeholders: QuIC will develop programs to foster the dissemination of research findings to end users through activities such as AHRQ’s User Liaison Program; provide support to the Quality Forum to increase the national discussion on errors, their reduction, and standardized measures of errors; and fund collaborative agreements with health care professional organizations that foster education, track patient safety initiatives, provide input to the new patient safety research centers, and translate, disseminate, and promote adoption of research findings.
• Patient Safety Clearinghouse: AHRQ will develop a clearinghouse in partnership with other Federal agencies and private-sector organizations to provide an objective source of state-of-the art information on patient safety.
• AHRQ will initiate a "National Morbidity & Mortality Conference" posting selected cases (stripped of identifying information) in a public forum via Internet technology, and establish a Web site where patients can report incidents that will be analyzed to identify emerging problems.

Peer Review Protections

• The QuIC supports the extension of peer review protections to facilitate reporting of errors in a blame-free environment, and will propose considerations of confidentiality that will not undermine current mechanisms to address criminal activity or negligence.
• As part the development of the national reporting system, appropriate electronic protections (i.e., firewalls and encryption) will be constructed to ensure that the confidentiality of the patients involved and the clinician or institution providing the information is maintained, and that the information gathered will not be used for punitive purposes. Experience with reporting systems in other industries demonstrates that this approach encourages reporting of errors.

Setting Performance Standards and Expectations for Safety

Raising the Standards for Health Care Organizations

• HCFA will use its power as a purchaser and regulator to promote the use of effective error-reduction initiatives in the health care institutions with which it deals.
• HCFA will publish regulations this year requiring hospitals participating in the Medicare Program to ongoing medical error reduction programs.
• OPM will follow the lead of selected private purchasers to raise the standard for participation by requiring that all health plans with which it contracts seek accreditation from an independent, national accrediting organization that includes evaluation of patient safety and programs to reduce errors in health care.
• In its call letter for the 2001 contract year, OPM will ask health plans to encourage their preferred hospitals to use automated prescription systems and other integrated data systems. OPM will encourage health plans to annotate PPO directories to indicate which hospitals and physicians’ offices use such automated programs.

Raising the Standards for Health Care Professionals

The QuIC will:

• Develop and evaluate programs introducing health professionals to errors analysis and the challenges of practicing in a technically complex environment, explore the use and testing of simulators and automation as education tools, support training in errors research and evaluation, and develop patient safety expertise at the State level using the CDC’s Epidemic Intelligence Service as a model.
• Convene a meeting of the accrediting, licensing, and certifying bodies of the health professions to review information on medical errors in the context of current practice requirements and propose methods of strengthening health professions’ education in the areas of medical error prevention and medical error evaluation as a means of improving patient safety.
• Collaborate with the Federation of State Medical Boards and other entities to encourage that error reduction and prevention education be a provision for relicensing of health professionals.
• Collaborate in the planning, implementation, and evaluation of a national summit addressing patient safety and medical error reduction programs, and in producing directives for the future.
• Provide training within the QuIC agencies that provide care to encourage use of patient safety information and encourage enhanced reporting in partnership with private-sector accreditors, purchasers, and providers.
• Provide technical assistance to State or professional agencies seeking to ensure a basic level of knowledge for health care providers on patient safety issues.

Safe Use of Drugs and Devices

Within 1 year, the FDA will initiate programs to:

• Develop additional standards for proprietary drug names to avoid name confusion.
• Develop standards for packaging to prevent dosing and drug mix-ups.
• Develop new label standards for drugs, highlight drug–drug interactions, potential dosing errors, and address other common errors related to medications.
• Implement the Phase II pilot study of the Congressionally mandated Medical Product Surveillance Network (MedSUN).
• Intensify efforts to ensure manufacturers’ compliance with FDA programs, specifically naming, labeling, and packaging.
• Provide access to databases linked to health care systems and other sources of adverse-event and marketing data, and link these to existing registries of product users.
• Complete the on-line Adverse Event Reporting Systems (AERS) for drugs and biologics.
• Strengthen FDA's analytical and investigative capacities.
• Strengthen FDA outreach activities and collaboration with other Government agencies and stakeholders.

Implementing Safety Systems in Health Care Organizations

• Under the leadership of the CQuIPS, the QuIC will promote, at the executive level, the development and dissemination of evidence-based, best patient-safety practices to provider organizations.
• QuIC participants, including HCFA, VA, DoD, AHRQ, CDC, and FDA, will explore opportunities with private-sector accreditation, purchaser, and provider organizations to develop organization-based, patient-safety models that could be evaluated, and if found effective, disseminated widely. In addition, these stakeholders will be engaged in a regular dialogue with QuIC participants to ensure that the stakeholders’organizational needs are being met through Federal research and reporting initiatives.
• Through its exemplary patient safety program, VA will continue to scrutinize its care provision for opportunities to improve safety, and develop and expand its reporting system.
• VA will invest $47.6 million this year to increase patient safety training for staff (select for details in Chapter 3).
• DoD will invest $64 million in FY 2001 to begin implementation of a new computerized medical record system, including an automated order entry system for pharmaceuticals (details in Chapter 3).
• Other QuIC direct-care providers will initiate patient safety programs (e.g., HRSA’s community health care centers are investigating the most effective programs that can be implemented in their health care delivery systems).
• QuIC member agencies will begin a collaborative project this summer with the Institute for Healthcare Improvement to reduce errors in high-hazard health care delivery settings.

Building Public Awareness of Medical Errors

• Through the QuIC’s Enhancing Patient and Consumer Information Working Group, led by OPM and HCFA, Federal agencies will develop and coordinate an information campaign for their constituencies and beneficiaries to increase their awareness of the problem of medical errors and patient safety.
• AHRQ will develop generic material for the public on preventing medical errors that Federal agencies can disseminate, reprint, or adapt. This material will enable patients to become more involved in their care and to be more active participants in the decisionmaking surrounding their care.
• The CQuIPS will develop and test patient safety questions for inclusion in the patient survey now being developed for provider-level assessment of health care.
• HCFA will conduct research aimed at shaping programs to educate beneficiaries about medical errors.
• Within 1 year, FDA will increase collaborative programs with patient and consumer groups regarding patient safety.
• FDA will enhance its interactions with the public through meetings with consumer and patient organizations, and through grass-roots informational meetings. The meetings will focus on patient needs and the safe use of medical products, particularly for home use. The meetings will also discuss how to reach patients with important information on safe use of medical products—including through the use of local networks, the Internet, and electronic and print media. This will occur within 1 year.
• Patient safety and reducing medical errors will be a featured topic at OPM’s Fall 2000 annual health plan conference.

Building Purchasers’ Awareness of the Problem

• Building on existing relationships with purchasers and business coalitions, such as the National Business Coalition on Health, and the Washington (DC) and Midwest Business Coalitions on Health, DOL, HCFA, OPM, and AHRQ will spearhead the QuIC’s efforts to promote collaborative programs with other public- and private-sector partners to increase purchasers’ and providers’ awareness of medical errors as a health care problem and of steps that each can take to address this problem, such as addressing patients’ health literacy skills.
• At the Federal Benefits Conference (June 2000), OPM will share information about patient safety with representatives from Federal agencies throughout the Nation.

Working with Providers to Improve Patient Safety

• Through the QuIC, Federal agencies will take advantage of existing resources to promote collaborative patient safety programs involving agency constituents, the health professions community, the public, academia, and other stakeholders, such as the American Medical Association, the American Nurses Association, NPSF, NPSP, and the Quality Forum.
• VA will develop and run pilot patient safety education programs for medical residents and students.

Using Decision-support Systems and Information Technologies

• AHRQ and CDC will expand research efforts in the area of informatics to include initiatives aimed at developing and evaluating electronic systems to identify, track, and address patient safety concerns.
• CQuIPS at AHRQ, along with VA, DoD, FDA and other QuIC member agencies, will evaluate the effectiveness of automated physician order entry systems in hospitals.
• DoD, VA, and IHS will introduce electronic patient records to offer structured documentation and a common clinical lexicon for practitioners working throughout those systems. The QuIC will encourage other potential Federal participants to do likewise.

Using Standardized Procedures, Checklists, and the Results of Human Factors Research

• CDC and FDA will work with the DHHS Advisory Committee on Blood Safety and Availability to help ensure that the highest quality standards are met in blood collection and transfusion.
• Within 1 year, FDA will begin working with manufacturers of medical products to explore incorporating standards, including human factors standards, into guidance to ensure that medical products are designed to minimize the chance of errors.
• NASA will be invited to become a participant in QuIC activities and bring its understanding and experience in redesigning processes and procedures to enhance safety. Linkages between NASA and the CQuIPS will be established through the NASA Medical Policy Board.
• The QuIC will sponsor an educational program, noted in the section on research above, to increase the awareness of Federal regulators and policymakers regarding patient safety, human factors, and systems-based improvement.
• VA will continue to work with private-sector organizations (e. g., the American Hospital Association and JCAHO) to explore the utility of its comprehensive error analysis and corrective action system.

Standards

• The QuIC and its member agencies will ask independent accrediting organizations to demonstrate how they are coordinating and strengthening their patient safety standards.
• AHRQ’s CQuIPS, through the research agenda articulated above, will develop evidence-based measures that integrate human factors and lessons from other industries.
• As with the DQIP measurement set, the QuIC will solicit formal adoption and use by member agencies of common, validated, and standardized performance measures in the area of error reduction. The QuIC will work with certifying boards for healthcare professionals to incorporate these measures into certification and recertification programs where appropriate.
• QuIC agencies will encourage their private-sector partner organizations to support the implementation of more rigorous safety standards and will act to facilitate the ability of private-sector partners to do so.
• The QuIC will work through the Quality Forum, the NPSF, and the NPSP to collaborate with private-sector organizations, industry representatives, academic institutions, and scientific and health care professionals to examine issues related to standards, to test standards of performance measurement, and to establish a set of core standards.
• DOL will build on an existing collaboration with the National Association of Insurance Commissioners (NAIC) to exchange information between DOL, the States, employers, plans, and individual patients on medical errors and safe, high-quality health care.
• OPM will participate with private-sector organizations in the development of standards and measures, will share QuIC-adopted standards and measures with its health plans, and advocate the use of such standards and measures throughout plan networks.
• OPM will also begin collecting performance measurement data from its participating plans, and will make performance information available to beneficiaries of the Federal Employees Health Benefits Program.
• Patient safety and reducing medical errors will be a featured topic at OPM’s Fall 2000 annual health plan conference.

Data Integration

• The QuIC members will work with and support the Quality Forum in its identification of a core set of errors reporting data.
• AHRQ, working with its QuIC partners, will identify existing data sets (such as the State mandatory errors reporting data) that can be brought together to enhance the Nation’s knowledge and understanding of errors. Based upon experience with the HCUP and the CDC’s data integration efforts, AHRQ will work with those entities that have the data, to determine the feasibility of pooling the data and using this resource to learn about opportunities to reduce errors and enhance patient safety.
• OPM will discuss with health plans and preferred provider organizations the development of strategies for focusing disease management programs and integrated data systems on the goal of avoiding medical errors and improving patient outcomes.
• HCFA, in collaboration with FDA and AHRQ, will develop a strategy for incorporating initiatives to increase patient safety into the pharmacy benefit managers program under an expanded Medicare drug benefit.

Introduction. Errors: Part of a Broader Quality Agenda

"Mistakes are a fact of life. It's the response to the error that counts."

—Nikki Giovanni (American poet, 1943- )

For years, experts have recognized that medical errors exist and compromise health care quality, but the response to the November 30, 1999, release of the Institute of Medicine’s (IOM) report, To Err is Human: Building a Safer Health System, brought medical errors to the forefront of public attention. The report’s estimate that 44,000 to 98,000 Americans die each year as a result of adverse events has captured the public’s concern and resulted in a sense of urgency about increased attention to safety in the health care system. On December 7, 1999, one week after the IOM report’s release, the President directed the Quality Interagency Coordination Task Force (QuIC) to evaluate the recommendations in To Err is Human and report to him through the Vice President within 60 days "with recommendations to improve health care through the prevention of medical errors and enhancements of patient safety."

The QuIC was established by the President in the spring of 1998. Its goals are to ensure that all Federal agencies involved in purchasing, providing, studying, or regulating health care services are working in a coordinated way toward the common goal of improving the quality of care; to provide beneficiaries with information to assist them in making choices about their care; and to develop the infrastructure needed to improve the health care system, including knowledgeable and empowered workers, well-designed systems of care, and useful information systems.

The participating Federal agencies include the Departments of Health and Human Services, Labor, Defense, Veterans Affairs, and Commerce; the Office of Personnel Management, the Office of Management and Budget, the U.S. Coast Guard, the Federal Bureau of Prisons, the National Highway Transportation and Safety Administration, and the Federal Trade Commission. The QuIC is co-chaired by Secretary of Health and Human Services Donna Shalala and Secretary of Labor Alexis Herman. John Eisenberg, Director of the Agency for Healthcare Research and Quality, serves as Operating Chair of the QuIC.

The QuIC believes that the IOM report has performed an important service in drawing national attention to the problems of patient safety, showing how preventable errors cause an immense burden for patients and the Nation’s health care system. The Federal agencies that are members of the QuIC are working actively to reduce this burden through their roles as purchasers (i.e., buyers of health care services through private insurers or health maintenance organizations), program funders, research agencies, regulators, patient advocates, and providers of care. Some of the QuIC participants are already recognized as leaders in error recognition and prevention, and all are committed to improving the health care that Americans receive.

The QuIC agencies are aware of several challenges, many of which were dealt with in the IOM report, that must be addressed if there is to be a substantial increase in patient safety. This report addresses those issues, recognizing that the improvement of patient safety will require coordinated actions from a wide array of individuals and organizations involved in health care, including public and private-sector purchasers, providers, and oversight bodies, as well as patients. This report discusses ways the Federal Government, in collaboration with its partners in the private sector and in State and local government, can uncover the root causes of errors, identify best practices to avoid them, accelerate the widespread adoption of these best practices, and ensure that the public can be assured that the health care delivery systems on which their lives depend are operating safely.

The IOM emphasized that errors should not be studied in isolation from other health care issues. Rather, the IOM report To Err is Human is part of a larger project on quality in health care that is investigating ways to redesign the delivery system, realign financial incentives to reward high quality care, and use information technology as a tool for measuring and understanding quality. Because the QuIC also has a broad quality mandate, member agencies are already working in these areas and believe that progress in the broad domain of health care quality is essential to the more specific but compelling need to reduce errors.

The IOM Report

In addition to documenting the need for attention to the issue of patient safety, the IOM report makes specific recommendations for actions to galvanize the health care industry into action to improve safety. In brief, the key recommendations of the IOM report include:

• Establish a Center for Patient Safety at the Agency for Healthcare Research and Quality (AHRQ). The IOM recommends that a center be established within AHRQ with responsibility for promoting the development of knowledge about errors and to encourage the sharing of strategies for reducing errors. The IOM committee recommends substantial budget increases over the next several years.
• Promote voluntary and mandatory reporting of errors. First, the IOM recommends that voluntary reporting systems should focus on errors that result in little or no harm to patients, and should be encouraged by AHRQ. Second, a mandatory reporting system should be established to allow State governments to collect standardized information on adverse events resulting in death or serious harm.
• Protect reporting systems from being used in litigation. The IOM urges Congress to pass legislation extending peer review protections to data related to patient safety and quality improvement that are collected and analyzed by health care organizations for purposes of improving safety and quality.
• Make patient safety the focus of performance standards for health care organizations and professionals. Regulators and accreditors should require health care organizations to have meaningful patient safety programs. Purchasers are also encouraged to provide incentives for patient safety programs. The IOM suggests that professional licensing organizations periodically reexamine and relicense professionals based, in part, on their knowledge of patient safety. Licensing organizations also need to develop more effective means of identifying unsafe practitioners and taking actions against them. It also suggests that professional societies should promote patient safety education.
• Increase FDA attention to safety in pre- and postmarket reviews of drugs. The IOM specifically suggests developing standards for safe packaging and labeling; testing of drug names to prevent sound-alike and look-alike errors; and working with doctors, pharmacists, and patients to identify and rectify problems in the post-marketing phase.
• Encourage health care organizations to make a commitment to improving patient safety and to implement safe medication practices. Health care organizations should develop a culture of safety and implement nonpunitive systems for reporting and analyzing errors. These organizations should also follow recommendations for safe medication practices as published by professional and collaborative organizations interested in patient safety.

The President’s Directive

In response to the IOM report, the President directed the QuIC to prepare a set of recommendations for specific actions to improve health care outcomes and prevent medical errors. These recommendations were to include specific actions in both the public and private sectors, and be consistent with the strong privacy protections proposed by the Administration. Specifically, the President requested that the QuIC report:

• Identify prevalent threats to patient safety and medical errors that can be prevented through the use of decision-support systems, such as patient monitoring and reminder systems.
• Evaluate the feasibility and advisability of the recommendations provided by the Institute of Medicine's Quality of Health Care in America Committee on Patient Safety.
• Identify additional strategies to reduce medical errors and ensure patient safety in Federal health care programs.
• Evaluate the extent to which medical errors are caused by misuse of medications and medical devices, and consider steps to strengthen the Food and Drug Administration's surveillance and response system to reduce their incidence.
• Identify opportunities for the Federal Government to take specific action to improve patient safety and health care quality nationwide through collaboration with the private sector, including through the National Forum for Health Care Quality Measurement and Reporting (the Quality Forum).

The President requested that the recommended actions serve as a foundation for a national system that prevents adverse medical events.

The QuIC has prepared this response to the President’s directive with several principles in mind. First, it agrees with the IOM and with private-sector experts that medical errors are generally due to systemic flaws in health care rather than individual incompetence or neglect. Bad care givers are sometimes a problem, but most errors are the result of weaknesses in the organization of the health care system and its component services. Thus, the QuIC agrees with the IOM emphasis on systemic solutions and avoidance of the assignment of blame.

Second, the QuIC agrees with the IOM and other experts that errors are one of a number of problems in the health care system that compromise patient safety and quality and endanger large numbers of patients in ways that can be avoided. These include under-treatment, excessive treatment, and widespread deviations in practice that cannot be explained scientifically.

Third, the QuIC shares the belief of many experts that errors can be reduced and safety enhanced in health care by applying lessons from successful efforts in other American industries to improve quality. Now is the time to use these lessons in health care.

Fourth, the QuIC recognizes that errors occur in all sectors of health care, not just hospitals, and in all types of care, including prevention, diagnosis, drug therapy, anesthesia, surgery, and others.

Fifth, the Nation’s response to errors should emphasize opportunities to learn from errors in order to avoid future errors. The QuIC believes that Government can assist health care institutions to develop appropriate systems for capturing such knowledge, which will require some degree of confidentiality to operate effectively.

Sixth, Federal and State governments have the responsibility to ensure, through mandatory public reporting, that the Nation can determine whether health care institutions have met an adequate standard of patient safety. Public reporting of both certain types of errors and the use of proven error-reduction techniques would provide the Nation with information that is needed to make choices about where to seek health care.

Finally, the QuIC agrees with the IOM on the importance of launching patient safety initiatives within the context of the roles of the Federal Government in health care quality, as purchasers, program funders, research agencies, regulators, patient advocates, and providers of care.

This report to the President focuses on the roles that the Federal Government can and should play in the development and implementation of systemic solutions for avoiding medical errors. The Federal Government, in partnership with State and local governments and the private sector, can lead the way toward reaching this goal.

The following chapters describe the steps that QuIC’s member agencies are taking to assure patient safety. These steps can serve as a framework for developing a national strategy to reduce errors and variations in health care practices so that Americans not only get the best health care in the world, but the best health care possible.

Chapter 1. Understanding Medical Errors

Growing Concerns About Medical Errors

The IOM’s release of To Err is Human brought medical errors and patient safety the attention it has long needed but never had. The information presented in the report is not new. Indeed, many studies, some as early as the 1960s, showed that patients were frequently injured by the same medical care that was intended to help them (Schimmel, 1964). While evidence of medical error has existed for some time, the report succeeded in capturing the public’s attention by revealing the magnitude of this pervasive problem and presenting it in a uniquely compelling fashion. The IOM estimates that medical errors cause between 44,000 and 98,000 deaths annually in the United States. Using the more conservative figure, medical errors rank as the eighth leading cause of death, killing more Americans than motor vehicle accidents, breast cancer, or AIDS. In addition to this extraordinary human toll, medical errors result in annual costs of $17 to $29 billion in the United States (Institute of Medicine, 1999). Additionally, fear of becoming a victim of medical error may lead patients to delay obtaining potentially beneficial medical care, which may allow their illnesses to worsen.

Experiencing harm as a result of receiving health care is a growing concern for the American public. Front-page articles in newspapers, television exposes, and cover stories in magazine have provided the stark details of the latest and most dramatic examples of medical errors. Until recently, the perception of medical errors among health care providers and the public has been shaped by these anecdotes, and remedies have focused on fixing blame on individual providers, including health plans, hospitals, doctors, pharmacists, nurses, and other caregivers. That approach, however, has proven ineffective in addressing patient safety, as documented by the ongoing problems noted in the IOM report. The IOM’s recommended alternative approaches and other ways in which the Federal agencies can work to reduce medical errors are described in this report.

Definitions and Context

The lack of standardized nomenclature and a universal taxonomy for medical errors complicates the development of a response to the issues outlined in the IOM report. A number of definitions have been applied to medical errors and patient safety. In To Err is Human, the IOM adopted the following definition:

An error is defined as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim.

In an effort to thoroughly consider all of the relevant issues related to medical errors, the QuIC expanded of the IOM definition, as follows:

An error is defined as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures, and systems.

The explicit acknowledgment of the broad scope of errors reflected in this definition respects the responsibilities and capabilities of the Government agencies and departments contributing to this report. The term "patient safety" as used here applies to initiatives designed to prevent adverse outcomes from medical errors. The enhancement of patient safety encompasses three complementary activities: preventing errors, making errors visible, and mitigating the effects of errors.

It is critical to recognize that not all bad outcomes for patients are due to medical errors. Patients may not be cured of their disease or disability despite the fact that they are provided the very best of care. Additionally, not all adverse events that are the result of medical care are, in fact, errors. An adverse event is defined broadly as an injury that was caused by medical management and that resulted in measurable disability (Leape, 1991). Some adverse events, termed "unpreventable adverse events," result from a complication that cannot be prevented given the current state of knowledge. Many drugs, even when used appropriately, have a chance of side effects, such as nausea from an antibiotic. The occurrence of nausea would be an adverse event, but it would not be considered a medical error to have given the antibiotic if the patient had an infection that was expected to respond to the chosen antibiotic. Medical errors are adverse events that ar