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Patient Safety: Achieving a New Standard for Care E Key Capabilities of an Electronic Health Record System Letter Report Committee on Data Standards for Patient Safety Board on Health Care Services INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu
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Patient Safety: Achieving a New Standard for Care THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. Support for this project was provided by the U.S. Department of Health and Human Services. The views presented in this report are those of the Institute of Medicine Committee on Data Standards for Patient Safety and are not necessarily those of the funding agencies. Additional copies of this report are available in limited quantities from the Committee on Data Standards for Patient Safety through the Board on Health Care Services, 500 Fifth Street, N.W., Washington, DC 20001. This report is also available online at www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2003 by the National Academy of Sciences. All rights reserved. Printed in the United States of America.
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Patient Safety: Achieving a New Standard for Care “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Shaping the Future for Health
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Patient Safety: Achieving a New Standard for Care THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org
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Patient Safety: Achieving a New Standard for Care KEY CAPABILITIES OF AN ELECTRONIC HEALTH RECORD SYSTEM Letter Report July 31, 2003 Dr. Carolyn Clancy Director, Agency for Healthcare Research and Quality John M. Eisenberg Building 540 Gaither Road Rockville, MD 20850 Dear Dr. Clancy: In May 2003, the Department of Health and Human Services (DHHS) asked the Institute of Medicine (IOM) to provide guidance on the key care delivery-related capabilities of an electronic health record (EHR) system. An EHR system includes (1) longitudinal collection of electronic health information for and about persons, where health information is 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 of efficient processes for health care delivery. Critical building blocks of an EHR system are the electronic health records (EHR) maintained by providers (e.g., hospitals, nursing homes, ambulatory settings) and by individuals (also called personal health records). There is a great deal of interest within both the public and private sectors in encouraging all health care providers to migrate from paper-based health records to a system that stores health information electronically and employs computer-aided decision support systems. In part, this interest is due to a growing recognition that a stronger information technology (IT) infrastructure is integral to addressing such national concerns as the need to improve the safety and quality of health care, rising health care costs, and matters of homeland security related to the health sector. The efforts of all parties—purchasers, regulators, providers, and vendors—to advance the deployment of EHR systems would benefit from a common set of expectations about EHR capabilities.
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Patient Safety: Achieving a New Standard for Care The IOM was asked to respond very rapidly to this request from DHHS. Fortunately, a sizable project focused on patient safety data standards was already under way at the IOM, and this new task proved to be an appropriate expansion of that ongoing work. Thus the charge to the IOM Committee on Data Standards for Patient Safety (the IOM Committee) was expanded to address this additional task, and the committee devoted a portion of its previously scheduled meeting of June 9–10, 2003, to the development of this letter report. The IOM Committee’s full report on data standards will be issued in fall 2003. BACKGROUND The development of an IT infrastructure has enormous potential to improve the safety, quality, and efficiency of health care in the United States (Institute of Medicine, 2001). Computer-assisted diagnosis and chronic care management programs can improve clinical decision making and adherence to clinical guidelines, and can provide focus on patients with those diseases (Durieux et al., 2000; Evans et al., 1998). Computer-based reminder systems for patients and clinicians can improve compliance with preventive service protocols (Balas et al., 2000). More immediate access to computer-based clinical information, such as laboratory and radiology results, can reduce redundancy and improve quality. Likewise, the availability of complete patient health information at the point of care delivery, together with clinical decision support systems such as those for medication order entry, can prevent many errors and adverse events (injuries caused by medical management rather than by the underlying disease or condition of the patient) from occurring (Bates et al., 1998, 1999; Evans et al., 1998). Via a secure IT infrastructure, patient health information can be shared amongst all authorized participants in the health care community (National Research Council, 2000). An IT infrastructure also has great potential to contribute to achieving other important national objectives, such as enhanced homeland security and improved and informed public health services (Institute of Medicine, 2002b; National Committee on Vital and Health Statistics, 2001; Wagner et al., 2001). EHRs, combined with Internet-based communication, may enable early detection of and rapid response to bioterrorism attacks, including the organization and execution of large-scale inoculation campaigns and ongoing monitoring, detection, and treatment of complications arising from exposure to biochemical agents or immunizations (Tang, 2002; Teich et al., 2002). A more advanced health information infrastructure is also crucial for
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Patient Safety: Achieving a New Standard for Care various forms of biomedical and health systems research, as well as educating patients, informal caregivers, and citizens about health (Detmer, 2003; National Committee on Vital and Health Statistics, 2001). EHR system implementation and its continuing development is a critical element of the establishment of an IT infrastructure for health care. In 1991, the IOM issued a report calling for the elimination of paper-based patient records within 10 years, but progress has been slow, and this goal has not yet been met (Institute of Medicine, 1991; Overhage et al., 2002). It should be noted that the motivation is not to have a paperless record per se, but to make important patient information and data readily available and useable. In addition, computerizing patient data enables the use of various computer-aided decision supports. There are some noteworthy examples of health care settings in both the private and public sectors in which EHRs have been deployed. A handful of communities and systems have established secure platforms for the exchange of data among providers; suppliers; patients; and other authorized users, such as the Veterans Health Administration, the New England Healthcare Electronic Data Interchange Network, the Indiana Network for Patient Care, the Santa Barbara County Care Data Exchange, the Patient Safety Institute’s National Benefit Trust Network, and the Markle Foundation’s Healthcare Collaborative Network (CareScience, 2003; Kolodner and Douglas, 1997; Markle Foundation, 2003b; New England Healthcare EDI Network, 2002; Overhage, 2003; Patient Safety Institute, 2002). But these examples are the exception, not the rule. In most of the nation’s hospitals, orders for medications, laboratory tests, and other services are still written on paper, and many hospitals lack even the capability to deliver laboratory and other results in an automated fashion. The situation is no different in most small practice settings, where there has been little if any migration to electronic records. In addition to the technical challenges, there are sizable policy, organizational, financial, and technological challenges that must be addressed to facilitate the adoption of EHR systems (Overhage et al., 2002). Some attempts to introduce order entry systems and other components of an EHR system have been unsuccessful (Auber and Hamel, 2001; Ornstein, 2003). Also, currently available personal health records, which allow patients to enter their own information, have demonstrated limited functionality to date (Kim and Johnson, 2002). Government health care programs, along with various private-sector stakeholders, are considering options for encouraging the implementation of EHR systems by providers. To achieve widespread implementation, some
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Patient Safety: Achieving a New Standard for Care external funding or incentive programs will be necessary (Institute of Medicine, 2001, 2002a). For example, the Centers for Medicare and Medicaid Services might provide some form of financial reward to providers participating in the Medicare program that have deployed EHR systems. On the private-sector side, various insurers, purchasers, and employer groups are instituting quality incentive programs for specific EHR system functionalities, such as computerized provider order entry for prescription drugs and electronic reporting of performance measures (National Health Care Purchasing Institute, 2003). In addition, a number of employers, health plans, and physicians have recently formed a coalition called Bridges to Excellence, which will provide financial bonuses to providers to encourage improved patient care management systems, including EHR systems (Bridges to Excellence, 2003). Another option is to provide grant funding or access to “low-cost” capital to enable providers, especially those with a safety net role, to invest in acquiring EHR systems (Health Technology Center and Manatt, Phelps and Phillips, LLP, 2003). Certain regulatory strategies might also be pursued, such as requiring providers to have an EHR system as a condition of participation in Medicare (Department of Health and Human Services, 2003). To implement any of the above strategies, one must first clearly define a functional model of key capabilities for an EHR system. There have been many different views of what constitutes an EHR system. Some EHR systems include virtually all patient data, while others are limited to certain types of data, such as medications and ancillary results. Some EHR systems provide decision support (e.g., preventive service reminders, alerts concerning possible drug interactions, clinical guideline-driven prompts), while others do not. Most current EHR systems are enterprise-specific (e.g., operate within a specific health system or multi-hospital organization), and only a few provide strong support for communication and interconnectivity across the providers in a community. The functionality of EHR systems also varies across multiple settings—from the perspective of both what is available from vendors and what has actually been implemented. Some EHR systems have been developed locally and others by commercial vendors. In summary, EHR systems are actively under development and will remain so for many years. A “functional model” of an EHR system will assist providers in acquiring and vendors in developing software. For most providers, the migration to an electronic environment will take place over a period of years. The development of a common set of requirements for the functional capabilities of various EHR system software components would allow providers to compare and contrast the systems that are available, and enable vendors to
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Patient Safety: Achieving a New Standard for Care build systems more in line with providers’ expectations. To be most useful, a functional model of an EHR system must also reflect a balance between what is desirable and what can feasibly be implemented immediately or within a short time frame. It will be important to update the functional model from time-to-time to reflect advancements in health care technology and care delivery. PROJECT OVERVIEW In response to the request from DHHS in May 2003, the charge to the IOM Committee on Data Standards for Patient Safety was expanded as follows: Provide guidance to DHHS on a set of “basic functionalities” that an electronic health record system 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-drug interactions). The IOM Committee was asked to focus on care delivery functions, and did not address infrastructure functions, such as database management and the use of health care data standards (e.g., terminology, messaging standards, network protocols). Although not within the scope of this project, the IOM Committee would like to emphasize the importance of two infrastructure functions—privacy and security (e.g., access control, encryption). It is absolutely critical that an EHR system be capable of safeguarding privacy and security. DHHS requested a rapid response because of its desire to implement various programs in 2004 that would benefit from the availability of a functional model for an EHR system. Specifically, the Center for Medicare and Medicaid Services (CMS) is considering offering financial and other incentives to providers to encourage the deployment of EHR systems. The Agency for Healthcare Research and Quality is implementing an applied research program that will provide funding for the implementation and evaluation of innovative IT-related programs. The federal government is also working collaboratively with private sector stakeholders to facilitate the development of a national health information infrastructure (Department of Health and Human Services, 2003). In addition, the IOM work is the first step of a two-step process. IOM is being asked to identify core care delivery–related functionalities of an EHR
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Patient Safety: Achieving a New Standard for Care system. Health Level Seven (HL7), a leading standards-setting organization working on the development of an EHR functional model, will incorporate these core functionalities into the model, and further specify each functionality along three dimensions: (1) develop a functional statement or definition (what), (2) establish a rationale for the functionality (why included), and (3) establish a compliance metric or test (Dickinson et al., 2003). Because of the quick turnaround required, the IOM Committee convened a small working group that met at the National Academies’ Jonsson Conference Center in Woods Hole, Massachusetts, on June 7–8, 2003. The work of this group served as a starting point for discussions of the full IOM Committee at its June 9–10, 2003, meeting. FRAMEWORK FOR IDENTIFYING CORE EHR FUNCTIONALITIES In recent years, several IOM reports have recommended that the U.S. health care system make a commitment to the development of a health information infrastructure by the year 2010 (Institute of Medicine, 2001, 2002a, 2002c). This IOM Committee concurs with those recommendations. It is recognized that the EHR system will be built incrementally utilizing clinical information systems and decision support tools as building blocks of the EHR, and the IOM Committee has strived to identify reasonable steps that can be taken by health care providers over the next 7 years to advance the accomplishment of this overall goal. It will be important for the Agency for Healthcare Research and Quality and others to pursue a robust research agenda if the EHR system is to reach full maturity in the years ahead. Key EHR functionalities have been identified for four settings—hospital, ambulatory care, nursing home, and care in the community (i.e., the personal health record). Additional settings will need to be addressed in the future, such as home health agencies, pharmacies, and dental care. In considering the core functionalities of EHR systems, it is important to recognize their many potential uses (see Box 1). EHR systems must support the delivery of personal health care services, including care delivery (e.g., care processes), care management, care support processes, and administrative processes (e.g., billing and reimbursement). As individuals engage more actively in management of their own health, they too become important users of electronic health information. There are also important secondary uses, including education, regulation (e.g., credentialing), clinical and health services research, public health and homeland security, and policy support. There are both individual users (e.g., patients, clinicians, manag-
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Patient Safety: Achieving a New Standard for Care BOX 1 Primary and Secondary Uses of an Electronic Health Record System Primary Uses Secondary Uses Patient Care Delivery Patient Care Management Patient Care Support Processes Financial and Other Administrative Processes Patient Self-Management Education Regulation Research Public Health and Homeland Security Policy Support SOURCE: Adapted from Institute of Medicine (1997). ers) and institutional users (e.g., hospitals, public health departments, accreditation organizations, educators, and research entities). To guide the process of identifying core EHR system functionalities, the IOM Committee formulated five criteria, which are listed below. Although each functionality independently may not fulfill all five criteria, when taken together as part of an EHR system, the core functionalities should address all criteria. Improve patient safety. Safety is the prevention of harm to patients. Each year in the United States, tens of thousands of people die as a result of preventable adverse events due to health care (Institute of Medicine, 2000). Support the delivery of effective patient care. Effectiveness is providing services based on scientific knowledge to those who could benefit and at the same time refraining from providing services to those not likely to benefit (Institute of Medicine, 2001). Only about one-half (55 percent) of Americans receive recommended medical care that is consistent with evidence-based practice guidelines (McGlynn et al., 2003). Facilitate management of chronic conditions. Chronic conditions are now the leading cause of illness, disability, and death in the United States (Hoffman et al., 1996). Persons with chronic conditions account for over 75 percent of all health care spending, and more than half of that spending is on behalf of people with multiple such conditions (Partnership for Solutions, 2002; U.S. Department of Health and Human Services, 2002). More than half of those with chronic conditions have three or more different providers and report that they often receive conflicting information from those
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Patient Safety: Achieving a New Standard for Care Appendix A Committee and Staff COMMITTEE ON DATA STANDARDS FOR PATIENT SAFETY PAUL C. TANG (Chair), Chief Medical Information Officer, Palo Alto Medical Foundation MOLLY JOEL COYE (Vice Chair), Chief Executive Officer, Health Technology Center SUZANNE BAKKEN, Alumni Professor of Nursing and Professor of Biomedical Informatics, Columbia University E. ANDREW BALAS, Dean, School of Public Health, Saint Louis University DAVID W. BATES, Chief, Division of General Medicine, Brigham and Women’s Hospital JOHN R. CLARKE, Professor of Surgery, Drexel University DAVID C. CLASSEN, Associate Professor of Medicine, Vice President, University of Utah, First Consulting Group SIMON P. COHN, National Director of Health Information Policy, Kaiser Permanente CAROL CRONIN, Consultant JONATHAN S. EINBINDER, Assistant Professor, Harvard Medical School and Corporate Manager, Partners Health Care Information Systems LARRY D. GRANDIA, Chief Technology Officer, Executive Vice President, Premier, Inc. W. ED HAMMOND, Professor, Division of Medical Informatics, Duke University BRENT C. JAMES, Executive Director, Intermountain Health Care Institute for Health Care Delivery Research, and Vice President for Medical Research, Intermountain Health Care KEVIN JOHNSON, Associate Professor and Vice Chair, Department of Biomedical Informatics and Associate Professor, Department of Pediatrics, Vanderbilt University JILL ROSENTHAL, Program Manager, National Academy for State Health Policy TJERK W. van der SCHAAF, Associate Professor of Human Factors in Risk Control, Eindhoven University of Technology, Eindhoven Safety Management Group, Department of Technology Management
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Patient Safety: Achieving a New Standard for Care Special Consultant J. MARC OVERHAGE, Associate Professor of Medicine and Investigator, Regenstrief Institute for Health Care, Indiana University School of Medicine Study Staff JANET M. CORRIGAN, Director, Board on Health Care Services PHILIP ASPDEN, Study Director JULIE WOLCOTT, Program Officer SHARI ERICKSON, Research Associate REBECCA LOEFFLER, Senior Project Assistant ANTHONY BURTON, Administrative Assistant The committee wishes to thank the co-chairs of the Health Level Seven (HL7) Special Interest Group (SIG), Linda Fischetti (U.S. Department of Veterans Affairs), Gary L. Dickinson (Misys Healthcare), and Sam Herd (Ocean Informatics, Australia), for the briefing and background materials they provided to the committee at its June 2003 meeting. The committee would also like to thank Gary Christopherson of the U.S. Department of Veterans Affairs, William C. Rollow of the Centers for Medicare and Medicaid Services, and Scott Young of the Agency for Healthcare Research and Quality for their helpful contributions to the report.
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Patient Safety: Achieving a New Standard for Care Appendix B Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: REED M. GARDNER, Professor, Medical Informatics, University of Utah BLACKFORD MIDDLETON, Director of Clinical Informatics Research and Development, Partners Healthcare System, Inc., Brigham and Women’s Hospital DAVID N. MOHR, Professor of Medicine, Area Medicine, Mayo Clinic JUDITH J. WARREN, Associate Professor, School of Nursing, University of Kansas Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the report before its release. The review of this report was overseen by Don E. Detmer, Dennis Gillings Professor of Health Management, The Judge Institute of Management Studies, University of Cambridge, and Professor Emeritus, Professor of Medical Education, University of Virginia. Appointed by the National Research Council and Institute of Medicine, he was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.
Representative terms from entire chapter: