In 2000, the Institute of Medicine (IOM) released the report To Err Is Human: Building a Safer Health System, focusing national attention on the issue of patient safety (Institute of Medicine, 2000). Since that time, the evidence base substantiating the magnitude of the safety concerns addressed in that report has continued to grow, but so, too, has our knowledge of ways to make the health system safer. It has also become clear that the use of information technology must be a core component of any comprehensive strategy to improve patient safety (Institute of Medicine, 2001).
This report is one of a series of reports following from the IOM’s Crossing the Quality Chasm: A New Health System for the 21st Century (Institute of Medicine, 2001). Its focus is on the role of information technology in improving patient safety, in particular the need for national standards for safety-related data. This introductory chapter provides a brief description of the magnitude of the safety problem, with emphasis on recently released literature; an overview of the response to To Err Is Human; a discussion of the vital role of information technology in designing a safer health care system; an overview of the IOM Quality Chasm Series, intended to place this report within a broader context of health system change initiatives; a brief review of the charge to this IOM committee; and an overview of the report, including a discussion of essential concepts. The chapter also introduces definitions for key terms used throughout the report, which are summarized in Appendix B.
MAGNITUDE OF THE PROBLEM
It has long been recognized that medical care has the potential to cause harm. However, general acknowledgment that much iatrogenic injury may be due to human error or system failures has been slower to emerge.
Every day, tens if not hundreds of thousands of errors occur in the U.S. health care system. Fortunately, most of these errors result not in serious harm but in near misses. A near miss is defined as an act of commission or omission that could have harmed the patient but did not do so as a result of chance (e.g., the patient received a contraindicated drug but did not experience an adverse drug reaction), prevention (e.g., a potentially lethal overdose was prescribed, but a nurse identified the error before administering the medication), or mitigation (e.g., a lethal drug overdose was administered but discovered early and countered with an antidote). Sadly, however, a small proportion of errors do result in adverse events—that is, they cause harm to patients—exacting a sizable toll in terms of injury, disability, and death.
To Err Is Human estimates that 44,000 to 98,000 hospitalized patients die annually in the United States and that more than 1 million patients are injured as a result of error. These estimates were based on the findings of studies conducted in Colorado and Utah (Thomas et al., 1999, 2000) and on the Harvard Medical Practice Study conducted in New York State (Leape et al., 1991), extrapolated to hospital admissions throughout the nation. These epidemiological studies helped jump-start a process to define the overall scope of the safety problem. Elsewhere, the Quality in Australian Health Care Study (Wilson et al., 1995) generated similar findings for hospital-based care, as did a preliminary study in the United Kingdom (Vincent et al., 2001).
An error is the failure of a planned action to be completed as intended (i.e., error of execution) or the use of a wrong plan to achieve an aim (i.e., error of planning). An error may be act of commission or an act of omission.
It is not possible to quantify the full magnitude of the safety challenge with certainty. The health care sector does not routinely identify and collect information on errors. Experts have challenged the estimates of patient harm attributable to errors as well as the methodologies used to derive them (Brennan, 2000; Hayward and Hofer, 2001; Sox and Woloshin, 2000; McDonald et al., 2000). As substantial evidence about adverse events continues to accumulate in the United States and other countries, however, there
is no doubt that their occurrence is a serious matter warranting attention. The risks to public safety—and the opportunities for large-scale improvements—are sizable.
To Err Is Human focuses primarily on inpatient injuries arising as a direct consequence of treatment (errors of commission, such as prescribing a medication that has a potentially fatal interaction with another drug the patient is taking). Since the release of that report, major studies have been published substantiating serious shortcomings in other care settings and involving errors of omission (such as failing to prescribe a medication from which the patient would likely have benefited; see Table 1-1). For example, many adverse drug events occur in ambulatory care settings and in nursing homes, as well as in hospitals. A large cohort study of all Medicare enrollees cared for by a major multispecialty group practice during a 12-month period (1999–2000) identified 1,523 adverse drug events during 30,397 person-years of observation (i.e., 50.1 adverse drug events per 1,000 person-years) (Gurwitz et al., 2003). And a study of 18 Massachusetts nursing homes identified 546 adverse drug events during 2,403 nursing home resident-years of observation (i.e., 227 adverse drug events per 1,000 resident-years) (Gurwitz et al., 2000).
Similarly, a major recent study found high levels of errors of omission in U.S. health care (McGlynn et al., 2003). More than 6,700 adults in 12 metropolitan areas were interviewed during the period 1998–2000 about selected health care experiences. In addition, those interviewed gave written consent for researchers to review their medical records and use the information to evaluate performance on 439 detailed clinical indicators of care for 30 acute and chronic conditions, as well as preventive care. The study focused on identifying instances in which proven, noncontroversial, poten-
TABLE 1-1 Health Care Errors in the United States
Type of Error
Other Care Settings
An estimated 44,000 to 98,000 hospitalized patients die annually in the United States (Institute of Medicine, 2000).
In outpatient care, 50 adverse drug events per 1,000 person-years were found (Gurwitz et al., 2003).
In nursing home care, 227 adverse drug events per 1,000 resident-years were found (Gurwitz et al., 2000).
Patients receive 55 percent of recommended care (McGlynn et al., 2003).
tially life-saving treatment was not used when it should have been. Overall, participants in the study had received only 55 percent of recommended care. There was little difference in the proportion of recommended preventive care provided (55 percent), the proportion of recommended acute care provided (54 percent), and the proportion of recommended care for chronic conditions provided (56 percent).
An adverse event results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient.1
A cause for additional concern is that errors resulting in adverse events are likely underreported, perhaps by as much as a factor of 20 (Cullen et al., 1995); that is, for every event reported, 20 are not. Such underreporting likely reflects care providers’ fear of blame and retribution through litigation and of losing professional respect, their failure to appreciate the extent of iatrogenic injury, and the burden of reporting.
RESPONSE TO TO ERR IS HUMAN
In response to To Err Is Human and to the ensuing report of the U.S. Department of Health and Human Services’ (DHHS) Quality Interagency Coordination Task Force (Quality Interagency Coordination Task Force, 2000), a major federal initiative was launched to reduce medical errors and improve patient safety. Congress appropriated $50 million in fiscal year 2001 to carry out this initiative and directed the Agency for Healthcare Research and Quality (AHRQ) to establish a Center for Quality Improvement and Patient Safety.
To date, AHRQ has funded more than 90 new grants, contracts, and other activities. These efforts are organized into several areas, including clinical informatics, centers of excellence, developmental centers, dissemination and education, reporting demonstrations, working conditions, and integrated delivery systems research networks. Nearly half of the AHRQ funding, $22.9 million, supports 16 patient safety reporting demonstration projects. These projects were initiated in September 2001 and are all sched-
uled to be completed in August or September 2004. Most are hospital based, but a small number are being carried out in ambulatory and other settings. Additionally, several are focusing on specific clinical areas or conditions, such as end of life, medication usage, diabetes, asthma, chronic obstructive pulmonary disease, congestive heart failure, lipid management, intensive care, and nosocomial infections. In general, the purposes of these demonstrations fall into two categories: (1) evaluation of a new or existing patient safety reporting system and (2) examination of surveillance methods and other patient safety or quality improvement systems to detect injuries or errors and determine the frequency and patterns of errors.
To Err Is Human, along with federal support for patient safety reporting and surveillance activities, boosted existing reporting systems and stimulated new ones. Today in the United States, there are many types of patient safety reporting systems in operation or under development in the public and private sectors (Appendix C provides an overview of selected examples of these reporting systems). Overseas, Australia (Australian Council for Safety and Quality in Health Care, 2001; Runciman and Moller, 2001) and the United Kingdom (National Patient Safety Agency, 2001) are implementing nationwide patient safety reporting systems.
In the United States, the federal government operates many reporting systems in carrying out its public health responsibilities (e.g., the National Nosocomial Infections Surveillance System operated by the Centers for Disease Control and Prevention), its regulatory responsibilities (e.g., the Adverse Event Reporting System of the Food and Drug Administration), and its caregiver role (e.g., the Patient Safety Reporting System of the Veterans Administration). Twenty-one states also have mandatory reporting requirements as part of their oversight processes for hospitals and other institutional settings (Rosenthal, 2003a). One example, the New York Patient Occurrence Reporting and Tracking System, is described in Appendix C. In addition, many health care institutions operate patient safety reporting systems for internal quality improvement purposes, and a few private-sector organizations operate such systems on a national basis.
Of the patient safety reporting systems currently operational in the United States, most focus on adverse events; only a small proportion collect and analyze information on near misses (see Appendix C). None of the federal regulatory oversight reporting systems includes near misses as reportable events. Of the 21 states mandating patient safety reporting systems, only Pennsylvania and Kansas collect information on near misses (Rosenthal, 2003b). Private-sector reporting systems are more likely to collect such information.
A near miss is an act of commission or omission that could have harmed the patient but did not cause harm as a result of chance, prevention, or mitigation.
As the number of patient safety reporting systems has grown, it has become apparent that a more consistent, standardized approach is needed to reduce the burden of multiple reporting requirements; to make the systems easier to use; and to allow for the pooling of data, which is especially useful for the early identification of the types of errors that occur infrequently. DHHS has responded to this need in two ways. First, AHRQ contracted for the development of technical specifications to integrate the many reporting systems that are operated by federal agencies (as discussed in Chapter 9). Second, AHRQ asked this IOM committee to provide guidance on whether certain aspects of reporting (e.g., types of events, information provided on those events, reporting formats, and definitions of data elements) should be standardized (as discussed below).
THE IMPORTANCE OF INFORMATION TECHNOLOGY IN DESIGNING A SAFER HEALTH CARE SYSTEM
The overarching objective of all patient safety reporting systems is to obtain information that can be used to design a safer health care delivery system. As more and more has been learned about the factors that contribute to the occurrence of errors, the focus of the patient safety movement has moved upstream from detecting and analyzing errors to redesigning the care delivery environment to prevent errors. Indeed, patient safety is the prevention of errors.
In recent years, it has become increasingly apparent that major improvements in safety will be achieved only if a stronger information infrastructure is built. For example, the reporting and analysis of adverse drug events in hospitals have led to the identification of the following common factors associated with errors: a decline in renal or hepatic function requiring alteration of drug therapy (13.9 percent); patient history of allergy to the same medication class (12.1 percent); use of the wrong drug name, dosage form, or abbreviation (11.4 percent); incorrect dosage calculations (11.1 percent); and atypical or unusual and critical dosage frequency considerations (10.8 percent) (Lesar et al., 1997). The factors most commonly associated with errors were found to be those related to knowledge and the application of knowledge regarding drug therapy (30 percent); knowledge and the use of
knowledge regarding patient factors that affect drug therapy (29.2 percent); use of calculations, decimal points, or unit and rate expression factors (17.5 percent); and nomenclature, such as incorrect drug name, dosage form, or abbreviation (13.4 percent).
Many if not most errors might be prevented with better use of information technology to support care delivery. Many errors occur because clinicians do not have ready access to complete, accurate, and legible patient data; paper medical records are poorly organized, are dispersed in many different settings, contain illegible handwriting, and are difficult to locate (Institute of Medicine, 2001). Other errors occur because the health system relies on humans to remember large amounts of knowledge (e.g., contraindications and drug–drug interactions for numerous medications) and to make complex decisions that routinely exceed the bounds of the human mind (Masys, 2002). Finally, some errors occur because the health system relies on clinicians, who are often busy and sometimes tired, to perform simple calculations (e.g., determination of the proper drug dose for a small child) that can be performed more reliably by a computer (Lepage et al., 1992; Mekhjian et al., 2002; Sittig and Stead, 1994). Redesigning care processes to reduce the likelihood of most types of errors requires changes in the way health care workers perform their jobs, in particular greater use of information technology.
In 1991, the IOM created a new concept—computer-based patient record systems (CPRS)—to differentiate such systems from those that simply put the then-standard medical record into an electronic format (Institute of Medicine, 1997). CPRS included functions such as decision support and enabled other improvements that took advantage of computer capabilities not possible with paper-based systems. In particular, CPRS involved a more active focus on and involvement with the patient’s care rather than being simply a record that held medical information.
More recently, these systems have been called electronic health record (EHR) systems to emphasize the point that health care not only involves care of people with illnesses but also includes activities that promote health and prevent illness. Because of the committee’s focus on patient safety as the prevention of harm, we have adopted this newer term.
In the health care sector, a great deal of attention and resources are now being directed at the establishment of EHR systems. An EHR system encompasses (1) longitudinal collection of electronic health information, defined as information pertaining to the health of an individual or health care provided to an individual; (2) immediate electronic access to person- and population-level information by authorized, and only authorized, users;
(3) provision of knowledge and decision support that enhance the quality, safety, and efficiency of patient care; and (4) support for efficient processes of health care delivery (Institute of Medicine, 2003a). Investments in EHR systems will produce far greater gains in patient safety if such systems in all health care settings adhere to national data standards for the collection, coding, and sharing of patient data and possess the decision support capabilities (e.g., the ability to detect drug–drug interactions) necessary to provide safe and effective care. Accordingly, this committee was asked to provide guidance to DHHS on data standards; the committee was also asked to identify key capabilities of EHR systems that will promote patient safety.
The work of this committee was undertaken within a broader context of health system change initiatives. For over a decade, the IOM and other expert bodies have issued reports addressing the need to build a communications and information technology infrastructure to support health care delivery and other national priorities, such as public health and homeland security. The work of this committee is in part an outgrowth of and where possible builds upon this earlier work.
As noted above, in 1991 the IOM issued a report concluding that CPRS is an essential technology for all health care and that electronic records should be the standard for medical and all other records related to health care. In 1997 the IOM issued a revised edition of this report noting the strides that had been made in the power and capacity of personal computers and other computer-based technologies, the growth in use of the Internet for research and some health applications, the increasing level of computer literacy among health professionals and the public, and the linkage of organizations and individuals through local and regional networks that were beginning to tackle the development of population databases (Institute of Medicine, 1997). Despite these advances, however, progress had been slow. The revised report also outlines the continuing challenges to the development and implementation of computer-based patient records, including resistance to change by the organizational culture, the lack of interoperability and data standards, security and privacy concerns, and financing and policy issues.
In March 2001, the IOM released Crossing the Quality Chasm: A New Health System for the 21st Century, which calls for fundamental change in the health care system to achieve improvement in six national quality aims: safety, effectiveness, patient centeredness, timeliness, efficiency, and equity
(Institute of Medicine, 2001). The report stresses the enormous potential of information technology to improve the quality of health care with regard to all of these aims and recommends a renewed national commitment to building an information infrastructure to support health care delivery, public accountability, clinical and health services research, and clinical education, leading ultimately to the elimination of most handwritten clinical data by the end of the decade (Institute of Medicine, 2001).
The Quality Chasm report also recommends that initial efforts to redesign the health care delivery system focus on a limited set of priority areas, mainly chronic conditions that account for the majority of health encounters and expenditures. In 2002, the IOM released Priority Areas for National Action: Transforming Health Care Quality, identifying 20 such priority areas (see Box 1-1) (Institute of Medicine, 2003b). Efforts are now under way to synthesize the evidence base pertaining to practice in each of these areas and to ensure that practice guidelines are available. The IOM has also recommended that sets of standardized performance measures be developed for each of these priority areas. As discussed below, the IOM committee that conducted the present study was asked to consider the types of standardized clinical data that will be needed by health care providers as they strive to redesign the care processes associated with one or more of the priority areas.
In recent years, numerous expert panels have called for the development of a national health information infrastructure (NHII) (National Committee on Vital and Health Statistics, 2001; President’s Information Technology Advisory Committee, 2001). To this end, summits and workshops have been held by the DHHS (Department of Health and Human Services, 2003a), the National Quality Forum (National Quality Forum, 2003), and the Kaiser Permanente Institute for Health Policy (Raymond and Dold, 2002).
Components of an NHII include national data standards for the collection, coding, and exchange of patient and other information; computer-based patient records with decision support; and a secure platform for the exchange of patient health information. It will not be enough for individual providers making independent decisions to invest in information technology because patients often receive services from many different providers and in a variety of settings. In addition to supporting the delivery of high-quality and efficient patient care, the NHII must meet the nation’s needs for public health, homeland security, and research. Several IOM reports have recommended that the federal government provide financial support for the NHII, including financial incentives to providers to encourage investment in EHRs (Institute of Medicine, 2001, 2002a, b). The IOM has also recom-
SOURCE: Institute of Medicine (2003b).
mended that the federal government, working in partnership with the private sector, establish national data standards (Institute of Medicine, 2002a).
In recent years, important progress has been made toward establishing national data standards in the health care domain. In 1996, Congress passed the Health Insurance Portability and Accountability Act (Public Law 104-191), which mandated standardization of administrative and financial transactions. In 2001, the Consolidated Health Informatics (CHI) initiative, an interagency effort, was established as part of the Office of Management and Budget’s eGOV initiative to streamline and consolidate government programs among like sectors (Office of Management and Budget, 2003). The CHI initiative played an important role in the recent decision by the federal government that programs of DHHS, the Veterans Administration, and the Department of Defense would incorporate certain data standards and terminologies (Department of Health and Human Services, 2003b). The ef-
forts of the Markle Foundation’s Connecting for Health initiative have also helped focus national attention on the data standards issue and forge public and private collaboration in this regard.
Efforts are now under way to establish standards for EHRs. In response to a request from DHHS, this IOM committee released a letter report in July 2003 identifying key capabilities of an EHR (Institute of Medicine, 2003a) (see Appendix E). That report identifies EHR capabilities in eight areas important for patient safety: health information and data, results management, order entry/management, decision support, electronic communication and connectivity, patient support, administrative processes, and reporting and population health management. Many of these capabilities relate to the availability of certain patient information and the provision of key decision support functions (e.g., the ability to alert providers to potential drug–drug interactions). Health Level 7, a leading private-sector standards-setting body, is now building on this work to develop a functional model of an EHR. A common set of expectations will assist providers in acquiring and vendors in developing the necessary software. A functional model will also assist public- and private-sector stakeholders in their efforts to encourage investment in EHRs through regulatory and purchasing policies.
Although progress has been made in setting national standards for health data, migration from paper to electronic records has been slow. Many hospitals have computerized the reporting of results in laboratory, imaging, and other ancillary areas, but only a fraction have comprehensive EHR systems (Brailer, 2003). Rates of adoption of EHRs in ambulatory settings are estimated to range between 5 and 10 percent.
Furthermore, only a handful of communities have established secure platforms for the exchange of data, so access to patient data by authorized users is limited (CareScience, 2003; Kolodner and Douglas, 1997; Markle Foundation, 2003; New England Healthcare EDI Network, 2002; Overhage, 2003). In a recently released report, Fostering Rapid Advances in Health Care: Learning from System Demonstrations, a bottom-up approach to establishing the NHII is recommended (Institute of Medicine, 2002a). Although data standards are set at the national level, the report recommends demonstration projects to establish state-of-the-art health care information technology infrastructure in a limited number of states, communities, or multistate regions by 2005. Steps would then be taken to replicate successful efforts or expand the geographic reach of these nodes to cover the entire United States. This infrastructure would include a secure platform for data exchange, computer-based patient records, and decision support systems. The IOM report was produced in response to a request from the Secretary of Health
and Human Services that the National Academies identify bold ideas that might change conventional thinking about serious challenges facing the health care system.
CHARGE TO THE COMMITTEE
In this context, DHHS, through AHRQ, requested that the IOM conduct a study:
To produce a detailed plan to facilitate the development of data standards applicable to the collection, coding, and classification of patient safety information.
To identify key standardization issues pertaining to the “priority areas” recommended by the Priority Areas for Quality Improvement Project (Institute of Medicine, 2003b) and develop an action plan for addressing them.
To provide guidance to DHHS on a set of “basic functionalities” that computer-based clinical records (i.e., EHRs) should possess to promote patient safety. The IOM committee will consider functions such as the types of data that should be available to providers when making clinical decisions (e.g., diagnoses, allergies, laboratory results) and the types of decision support capabilities that should be present (e.g., the capability to alert providers to potential drug-to-drug interactions).
As discussed above, the committee responded to the third part of this charge in July 2003 when it released its letter report on key capabilities of an EHR (see Appendix E). The present report addresses the first and second parts of the committee’s charge. Its focus is on data standards for patient safety, i.e., standardized representations of clinical data important to systems that promote patient safety. In general, these standards fall into two categories:
Patient safety data standards—formally accepted or endorsed definitions and rules regarding the format (e.g., structure), meaning (e.g., terminology), and encoding (e.g., interchange specifications) for transmission of patient data and scientific knowledge.
Patient safety reporting standards—formally accepted or endorsed definitions and rules regarding the types of events reported to patient safety reporting systems, the data and information collected on these events, and the reporting formats used.
Patient safety data standards are critical to the development of the NHII, but they are not the only standards needed. For example, the continued development and application of standards to protect the privacy and security of personally identifiable data are also critical but are outside the scope of the present study. It is also important to note that data standards are not the only barrier to the implementation of an NHII. Other barriers include the lack of incentives to invest in information technology systems, the lack of a culture of safety in many health care organizations, unwillingness to share patient data for business reasons, and uncertainties about legal liability and privacy issues. As noted, the primary focus of this report is patient safety data standards. Other barriers are acknowledged and discussed briefly, but detailed analysis in those areas is beyond the scope of this report.
OVERVIEW OF THE REPORT
The remainder of this report is divided into three main parts:
Part I: Building the National Health Information Infrastructure
Part II: Establishing Comprehensive Patient Safety Programs
Part III: Streamlining Patient Safety Reporting
Part I focuses on the NHII that is needed to make patient safety a standard of care. Chapter 2 provides an overview of the components of an NHII. Chapter 3 addresses the need for strong federal leadership to establish a public–private partnership for the ongoing promulgation of national data standards. Chapter 4 reviews the types of data standards that are needed and provides an action plan for their establishment.
Part II focuses on patient safety programs in health care organizations. Chapter 5 presents a general discussion of patient safety programs from the perspective of a health care provider organization and is intended to place reporting activities within a broader context. This is followed by detailed discussion of the functional requirements and data standards applicable to the prevention, detection, and reporting of adverse events (Chapter 6) and near misses (Chapter 7).
Part III of the report is devoted to patient safety reporting programs. Chapter 8 provides an overview of the various types of reporting systems, from reporting for accountability purposes to reporting for system redesign. Finally, Chapter 9 reviews the types of patient safety reporting standards that are needed to enable aggregation of data and reduce the reporting bur-
den and to support the establishment of the national patient safety database first called for in To Err Is Human.
In addition, seven appendixes are provided. Appendix A contains biographical sketches of the committee members; Appendix B is a list of terms and acronyms used in the report; Appendix C presents examples of federal, state, and private-sector patient safety reporting systems; Appendix D provides a listing of those clinical domains important for patient safety and for which appropriate terminology should be developed; Appendix E is the committee’s letter report on the key capabilities of an EHR system; Appendix F is a paper commissioned for this study on quality improvement and proactive hazard analysis models; and Appendix G outlines the Health Incident Type event taxonomy of the Australian Incident Monitoring System.
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