GUJHS. 2003 Oct; Vol. 1, No. 2
Melissa G. Bresnick, NHS ’05
The Institute of Medicine (IOM) issues policy reports on a wide variety of topics and thus supports a number of policy positions. In supporting universal access to healthcare, the Institute of Medicine has issued reports discussing population health, health disparity, and public disease prevention, simply to name a few. In 1999, the IOM issuedTo Err Is Human – Building A Safer Health System, a committee policy report discussing the health care quality agenda supported by the IOM (Kohn, Corrigan, Donaldson; 1999). The report lays out a comprehensive strategy for health providers, consumers, industry, and the government to reduce medical errors and improve the safety of health care. As part of a mission to improve the quality of health care in all organizations, the report calls on Congress to create a national patient safety center to develop new tools and systems needed to address persistent health care quality problems.
The severity of harm done to patients due to medical errors is dangerously under-recognized. The medical liability system, by its very nature, poses a serious impediment to any efforts made to expose errors so that future health providers may learn from them. Many errors that may occur are often silenced and hidden because the current system upholds a low tolerance for individual error. This cycle can lead to a false sense of security. Consumers believe that they are well protected under the standards of the liability system, when in fact inadequate attention has been focused on the issue of patient safety.
The media has a tendency to only concentrate on the catastrophic medical error cases, but these rare cases hardly do the issue justice. Two large studies were conducted to provide data concerning the incidence of adverse events. An adverse event is defined within the report as an injury resulting from a medical intervention, or in other words, it is not due to the underlying condition of the patient (Kohn et al., 1999). In the study conducted in Colorado and Utah it was found that adverse effects occurred in 2.9 percent of hospitalizations. In the second study conducted in New York, the number was 3.7 percent. Further, in Colorado and Utah, of the adverse events noted, 6.6 percent resulted in death. This was compared with 13.6 percent of adverse events that led to death in New York. In both these studies, the report states that over half of these adverse events resulted from medical errors and could have been prevented. Additional analysis done by the committee found that there could be as many as 98,000 Americans that die each year as a result of medical errors (Kohn et al., 1999).
The sphere of medical errors includes medication-related errors as well. Errors in prescribing and providing medications occur frequently in the hospital setting, although they do not all result in harm to the patient. Regardless of whether or not harm is a result of every medication-related error, these type of errors are still commonplace and carry with them the potential to cause serious harm to consumers. The report states that one out of every 100 admissions to the hospital experienced a preventable adverse drug event. For the nation as a whole, this results in approximately $2 billion in increased hospital costs due to events that were preventable (Kohn et al., 1999).
While these figures are compelling evidence for a need to increase patient safety, it is important to realize that the figures represent only hospital patients. Hospital patients alone account for only a small proportion of the total population at risk. Health care is provided in ambulatory settings, outpatient’s surgical centers, physician offices, and clinics as well. In addition, human error can also be found in retail pharmacies. It is certainly possible that any of these health care settings could put consumers at risk by not controlling the occurrence of medical errors.
With these statistics reporting that medical errors is a leading cause of death among Americans, the evidence initiated a congressional request that the IOM conduct a study to issue a policy report in a national effort to reduce medical errors. In response to this request, the IOM assembled a committee of diverse professionals to consider the issues surrounding patient safety. Specifically, the committee was assembled to analyze the role that medical error plays in the nation’s health care system. If this role was found to be detrimental to the nation’s health, then it was the committee’s responsibility to propose a mechanism by which medical error could be reduced. The end result was To Err Is Human, Building A Safer Health System (Kohn et al., 1999).
. The committee recognized that medical error is a serious problem, and they collectively engaged in an endeavor to redesign health systems so that they are safer in delivering care. Only then will the current health systems be capable of supporting efforts made to prevent medical errors.
Significant courses of action need to be redirected to result in efficient change. The committee hoped to break the silence, and awaken the public to the severity of this issue. At the forefront of any healthcare system is the mission to help, heal, and comfort its patients, and it is unacceptable that this same system be the source of such great harm. Before America’s health care system progresses further into the new century with increasing medical advances, the system must first prove that all consumers are safe within its care.
To Err Is Human offers a multifaceted approach to correcting this national problem (Kohn et al., 1999). In making its recommendations, the committee sought to strengthen the external environment that it may create pressure on health care organizations to reduce errors. The committee recognized that such a driving force was necessary to compel health providers to enhance safety measures for patients. In addition, the report also identified legal and cultural barriers that needed to be overcome by increasing public knowledge about enhancing safety. The committee expected nothing less than a 50 percent reduction in health care errors over five years.
The Committee’s Recommendations
The following discussion of the committee’s recommendations lays out a national agenda for reducing errors in health care and thereby improving patient safety. There is no single action that will alleviate this serious concern, but instead a collective effort must be made to reduce the barriers in place due to human habit. The committee chose to strengthen the external environment in hopes that doing so would construct new (safer) habits among health care professionals. The report determined factors in the external environment to include availability of knowledge and tools to improve safety, strong and visible professional leadership, legislative and regulatory initiatives, and actions of purchasers and consumers to demand safety improvements (Kohn et al., 1999). By creating the means by which to achieve improvements in the above areas, the committee expected to observe strong leadership for safety and an organized culture within health care organizations that encouraged recognition and learning from errors.
The recommendations contained within this report lay out a four-tiered approach to reducing medical error and improving patient safety (Kohn et al., 1999):
• establishing a national focus to create leadership, research, tools and protocols to enhance the knowledge base about safety;
• identifying and learning from errors through immediate and strong mandatory reporting efforts, as well as the encouragement of voluntary efforts, both with the aim of making sure the system continues to be made safer for patients;
• raising standards and expectations for improvements in safety through the actions of oversight organizations, group purchasers, and professional groups; and
• creating safety systems inside health care organizations through the implementation of safe practices at the delivery level. This level is the ultimate target of all the recommendations.
Thus, the following recommendations were made by the committee and published in To Err Is Human:
RECOMMENDATION 4.1 Congress should create a Center for Patient Safety within the Agency for Healthcare Research and Quality. This center should
• set the national goals for patient safety, track progress in meeting these goals, and issue an annual report to the President and Congress on patient safety; and
• develop knowledge and understanding of errors in health care by developing a research agenda, funding Centers of Excellence, evaluating methods for identifying and preventing errors, and funding dissemination and communication activities to improve patient safety.
The committee determined that there were areas of health care that required additional research for identifying knowledge that will allow care to be safer for patients. If funds are donated to this cause, the knowledge necessary to adequately prevent error will be known and health professionals can begin to provide care more appropriately.
RECOMMENDATION 5.1 A nationwide mandatory reporting system should be established that provides for the collection of standardized information by state governments about adverse events that result in death or serious harm. Reporting should initially be required of hospitals and eventually be required of other institutional and ambulatory care delivery settings. Congress should
• designate the National Forum for Health Care Quality Measurement and Reporting as the entity responsible for promulgating and maintaining a core set of reporting standards to be used by states, including a nomenclature and taxonomy for reporting;
• require all health care organizations to report standardized information on a defined list of adverse events;
• provide funds and technical expertise for state governments to establish or adapt their current error reporting systems to collect the standardized information, analyze it and conduct follow-up action as needed with health care organizations. Should a state choose not to implement the mandatory reporting system, the Department of Health and Human Services should be designated as the responsible entity; and
• designate the Center for Patient Safety to:
(1) convene states to share information and expertise, and to evaluate alternative approaches taken for implementing reporting programs, identify best practices for implementation, and assess the impact of state programs; and
(2) receive and analyze aggregate reports from states to identify persistent safety issues that require more intensive analysis and/or a broader-based response (e.g., designing prototype systems or requesting a response by agencies, manufacturers or others).
In designing this recommendation, the committee recognized that there was no mechanism in place by which to analyze reported adverse events. The mass reporting of such events is useless unless the data can be analyzed and thus conclusions can be made regarding how to prevent such errors in the future.
RECOMMENDATION 5.2 The development of voluntary reporting efforts should be encouraged. The Center for Patient Safety should
• describe and disseminate information on external voluntary reporting programs to encourage greater participation in them and track the development of new reporting systems as they form;
• convene sponsors and users of external reporting systems to evaluate what works and what does not work well in the programs, and ways to make them more effective;
• periodically assess whether additional efforts are needed to address gaps in information to improve patient safety and to encourage health care organizations to participate in voluntary reporting programs; and
• fund and evaluate pilot projects for reporting systems, both within individual health care organizations and collaborative efforts among health care organizations.
RECOMMENDATION 6.1 Congress should pass legislation to extend peer review protections to data related to patient safety and quality improvement that are collected and analyzed-by health care organizations for internal use or shared with others solely for purposes of improving safety and quality.
The committee composed this recommendation in an effort to break the silence surrounding medical errors. They believe that individuals should be held responsible for their actions, but if their actions are never made public knowledge, then holding only specific individuals responsible will never progress the safety of the overall health care system. If reported data regarding adverse events is not assured confidentiality, this information will continue to be hidden and progress will be hindered.
RECOMMENDATION 7.1 Performance standards and expectations for health care organizations should focus greater attention on patient safety.
• 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.
RECOMMENDATION 7.2 Performance standards and expectations for health professionals should focus greater attention on patient safety.
Health professional licensing bodies should
(1) implement periodic re-examinations and re-licensing of doctors, nurses, and other key providers, based on both competence and knowledge of safety practices; and
(2) work with certifying and credentialing organizations to develop more effective methods to identify unsafe providers and take action.
• Professional societies should make a visible commitment to patient safety by establishing a permanent committee dedicated to safety improvement. This committee should
(1) develop a curriculum on patient safety and encourage its adoption into training and certification requirements;
(2) disseminate information on patient safety to members through special sessions at annual conferences, journal articles and editorials, newsletters, publications and websites on a regular basis;
(3) recognize patient safety considerations in practice guidelines and in standards related to the introduction and diffusion of new technologies, therapies and drugs;
(4) work with the Center for Patient Safety to develop community-based, collaborative initiatives for error reporting and analysis and implementation of patient safety improvements; and
(5) collaborate with other professional societies and disciplines in a national summit on the professional’s role in patient safety.
RECOMMENDATION 7.3 The Food and Drug Administration (FDA) should increase attention to the safe use of drugs in both pre and post-marketing processes through the following actions:
• develop and enforce standards for the design of drug packaging and labeling that will maximize safety in use;
• require pharmaceutical companies to test (using FDA-approved methods) proposed drug names to identify and remedy potential sound-alike and look-alike confusion with existing drug names; and
• work with physicians, pharmacists, consumers, and others to establish appropriate responses to problems identified through post marketing surveillance, especially for concerns that are perceived to require immediate response to protect the safety of patients.
Recommendations 7.1, 7.2, and 7.3 are all seeking to create a culture within healthcare that promotes patient safety. Healthcare professionals should take the initiative to encourage improvements in patient safety. Leadership positions are particularly influential, and the committee recommends that health care leaders set specific standards regarding patient safety and see that they are efficiently implemented through employer/employee communication. In addition, the FDA plays an interesting role in reducing medication-related errors. Once the drug is approved by the FDA, it is still possible that the drug could be correlated with safety risks in practice. If the FDA takes this likelihood into consideration, steps can be made to reduce medication-related error at the level of the FDA.
RECOMMENDATION 8.1 Health care organizations and the professionals affiliated with them should make continually improved patient safety a declared and serious aim by establishing patient safety programs with defined executive responsibility. Patient safety programs should
• provide strong, clear and visible attention to safety;
• implement non-punitive systems for reporting and analyzing errors within their organizations;
• incorporate well-understood safety principles, such as standardizing and simplifying equipment, supplies, and processes; and
• establish interdisciplinary team training programs for providers that incorporate proven methods of team training, such as simulation.
RECOMMENDATION 8.2 Health care organizations should implement proven medication safety practices.
At the very least, the committee feels that previous research should be used to identify practices that are known to reduce medication-related errors. These practices should be implemented in a widespread fashion, and education regarding these practices should be available to all appropriate health care professionals.
This list of recommendations provides a framework within which to accomplish the national goal to improve safety within America’s health care system. It is true that significant barriers must be overcome, but the committee is confident that it is possible to improve awareness of the problem, to develop agencies to encourage safety improvements, to develop programs to increase knowledge of the importance of safety for the leaders in health care, and to create an overarching national standard that demands and demonstrates healthcare safety in all health settings.
The Impact of the Report
After its publication, To Err Is Human was found to be the motivating factor for many national changes that occurred in an effort to reduce medical errors. The media became interested in the report, and closely followed the progress of these changes. According to the Kaiser Family Foundation, one-half of the national population closely followed the media coverage for this report (Detmer, 2001). In part because the issue received so much attention from the media, Congress followed up the report by appropriating $15 million for The Agency for Research and Healthcare Quality (AHRQ) to develop a patient safety center. AHRQ is the health services research arm of the U.S. Department of Health and Human Services (HHS), complementing the biomedical research mission of its sister agency, the National Institutes of Health. AHRQ houses research centers that specialize in major areas of health care research such as quality improvement of patient safety, outcomes and effectiveness of care, clinical practice and technology assessment, health care organization and delivery systems, primary care (including preventive services), and health care costs and sources of payment (AHRQ Press Release, 2000). Health services research examines how people get access to health care, how much care costs, and what happens to patients as a result of this care. The main goals of health services research are to identify the most effective ways to organize, manage, finance, and deliver high-quality care; reduce medical errors; and improve patient safety.
After the publication of To Err Is Human, AHRQ developed a Comprehensive Patient Safety Program. This program was developed to organize and administer projects to test the effectiveness and cost of diverse reporting strategies and information technology innovation on the identification, management, and reduction of medical errors. “AHRQ’s new patient safety research program is an investment in building the knowledge base for improving patient safety,” said John M. Eisenberg, M.D., AHRQ’s director. “The integrated activities funded under this program will take the health care system from knowing that medical errors are a problem to doing something to prevent them.” (AHRQ Press Release, 2000).
Projects funded under the Centers of Excellence for Patient Safety Research will address a number of specific issues including,
Learning the most effective lessons from medical errors in order to improve patient safety, developing a more complete understanding of the types and causes of medical error in a variety of settings, understanding the impact of systems and professional and organizational cultures on reducing medical errors and improving patient safety, and describing and testing the role of informatics in improving clinical decision making, reducing errors, and advancing patient safety (AHRQ Press Release, 2001).
In 2001, the secretary of the United States Department of Health and Human Services Tommy G. Thompson announced that $50 million would be used to fund new research grants and other projects in place to reduce medical errors and improve patient safety (AHRQ Press Release, 2001). Because of the IOM report released in 1999, ninety-four new projects will be administrated to decrease the apparent harm to patients in the healthcare setting. These projects will, “address key unanswered questions about how errors occur and provide science-based information on what patients, clinicians, hospital leaders, policymakers and others can do to make the health care system safer. The results of this research will identify improvement strategies that work in hospitals, doctors’ offices, nursing homes, and other health care settings across the nation.” (AHRQ Press Release, 2001). In addition, Secretary Thompson created the HHS Patient Safety Task Force in April 2001 to coordinate and strengthen the department’s existing systems for collecting data on patient safety in concert with the states and the private sector (HHS).
Also in response to the IOM report, a coalition of more than 130 public and private organizations that provide health care benefits convened as The Leapfrog Group (Leapfrog Group for Patient Safety). This group was established to emphasize preventable medical mistakes by mobilizing employer purchasing power to initiate breakthrough improvements in the safety of healthcare. The Leapfrog Group also provides health care consumers with information about hospitals so as to make the most informed choice in choosing a health care institution. The group is a voluntary effort with its main goal to mobilize large purchasers and thus recognize and reward leaps in patient safety (Leapfrog Group, Inc.) As the IOM recommended, the Leapfrog group is hoping to strengthen external environmental factors so as to compel healthcare institutions to treat patient safety issues with the seriousness they deserve.
The nation has taken the information reported in To Err Is Human very seriously. Because of this, it can be seen that significant efforts have been made to correct this national problem. While no official evaluation of national efforts has been analyzed, the country is sure to see a dramatic decline of medical errors over the course of five years. The IOM report discussed here maintained that its ultimate goal was to improve health care quality. The nation has responded to the report, and health care will continue to advance until optimal consumer safety is obtained.