Doing What Counts for Patient Safety:

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.

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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).

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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).

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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.

Return to Contents

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.

Return to Contents

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.

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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.

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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.

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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.

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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.

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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.

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