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Patient Safety: Achieving a New Standard for Care Part I Building the National Health Information Infrastructure Americans should be able to count on receiving health care that is safe. To this end, a new health care delivery system is needed—one that both prevents errors and incorporates lessons learned from those errors that do occur. Achieving such a health care system requires, first, a commitment by all stakeholders to a culture of safety and, second, improved information systems. Recommendation 1. Americans expect and deserve safe care. Improved information and data systems are needed to support efforts to make patient safety a standard of care in hospitals, in doctors’ offices, in nursing homes, and in every other health care setting. All health care organizations should establish comprehensive patient safety systems that: Provide immediate access to complete patient information and decision support tools (e.g., alerts, reminders) for clinicians and their patients. Capture information on patient safety—including both adverse events and near misses—as a by-product of care and use this information to design even safer care delivery systems.
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Patient Safety: Achieving a New Standard for Care COMPONENTS OF A NATIONAL HEALTH INFORMATION INFRASTRUCTURE Achieving the goal set forth in Recommendation 1 can be accomplished in the United States only by building a national health information infrastructure (NHII). As defined by the National Committee on Vital and Health Statistics and discussed in Chapter 2 of this report, the NHII consists of a set of values, practices and relationships, laws and regulations, health data standards, technologies, and systems and applications that support all facets of individual health, health care delivery, and public health (National Committee on Vital and Health Statistics, 2001). Building the NHII requires actions on the part of health care providers, as well as public- and private-sector leadership at the national level. Of primary importance, it is necessary for health care providers to invest in electronic health record (EHR) systems that can capture patient and other clinical data and interact with decision support applications that improve safety and quality of care. In August 2003, this committee released a letter report entitled Key Capabilities of an Electronic Health Record System (Institute of Medicine, 2003) (see Appendix E) which provides guidance on the functional capabilities such systems should possess. Actions by individual health care providers, however, will not be enough to create a safe health care delivery environment. Patients receive services from many different health care providers. A nationwide infrastructure is required to support the exchange of patient information and to facilitate communication among the members of the patient’s care team and between clinicians and the patient. At the national level, the federal government, working collaboratively with the private sector, will need to provide financial resources and establish national standards for the NHII. Other IOM committees have recommended that the federal government provide both capital resources for the development of key aspects of the NHII and financial incentives to health care providers to invest in EHRs (Institute of Medicine, 2001, 2002a, b). It is essential that the federal government act on these recommendations. Also critically important to the development of the NHII is the need for the federal government to enhance its leadership role in the establishment of national data standards. In fact, the federal government has already taken the initiative to assume this leadership role in some key areas. The Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191) led to the establishment of standards to protect the privacy and confidentiality of personally identifiable data, and the Department of Health and Human Services recently endorsed the use of certain messaging standards to
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Patient Safety: Achieving a New Standard for Care facilitate the exchange of data and information among health care providers, vendors, and others. However, much more remains to be done, and that is the focus of this committee’s work. Recommendation 2. A national health information infrastructure—a foundation of systems, technology, applications, standards, and policies—is required to make patient safety a standard of care. The federal government should facilitate deployment of the national health information infrastructure through the provision of targeted financial support and the ongoing promulgation and maintenance of standards for data that support patient safety. Health care providers should invest in electronic health record systems that possess the key capabilities necessary to provide safe and effective care and to enable the continuous redesign of care processes to improve patient safety. A PUBLIC AND PRIVATE PARTNERSHIP TO SET STANDARDS The development of standards for health care data in the United States often occurs as a series of independent, voluntary processes. Many of the important standards are developed by standards development organizations using a consensus process. Despite efforts toward harmonization and cooperation among the various standards development organizations, the development of health data standards in the United States is essentially an entrepreneurial activity. As a result, standards development organizations sometimes create competing standards, and there is no guarantee that all the necessary standards will be developed. Indeed, the full range of needs for health care data standards have not yet been fulfilled. Currently, there is no oversight body in the United States tasked with reviewing the full portfolio of existing health care data standards, identifying gaps, and fostering efforts to fill those gaps. The committee believes that, as the largest purchaser of health care services and the most influential regulator, it is critical that the federal government assume a more active role in the establishment of the data standards necessary to protect patient safety (see Chapter 3). Recommendation 3. Congress should provide clear direction, enabling authority, and financial support for the establishment of national standards for data that support patient safety. Various govern-
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Patient Safety: Achieving a New Standard for Care ment agencies will need to assume major new responsibilities, and additional support will be required. Specifically: The Department of Health and Human Services (DHHS) should be given the lead role in establishing and maintaining a public–private partnership for the promulgation of standards for data that support patient safety. The Consolidated Health Informatics (CHI) initiative, in collaboration with the National Committee on Vital and Health Statistics (NCVHS), should identify data standards appropriate for national adoption and gaps in existing standards that need to be addressed. The membership of NCVHS should continue to be broad and diverse, with adequate representation of all stakeholders, including consumers, state governments, professional groups, and standards-setting bodies. The Agency for Healthcare Research and Quality (AHRQ), in collaboration with the National Library of Medicine and others, should (1) provide administrative and technical support for the CHI and NCVHS efforts; (2) ensure the development of implementation guides, certification procedures, and conformance testing for all data standards; (3) provide financial support and oversight for developmental activities to fill gaps in data standards; and (4) coordinate activities and maintain a clearinghouse of information in support of national data standards and their implementation to improve patient safety. The National Library of Medicine should be designated as the responsible entity for distributing all national clinical terminologies that relate to patient safety and for ensuring the quality of terminology mappings. AN AGENDA FOR DATA STANDARDS The committee’s recommendations address data standards that support patient safety. Data standards are formally accepted or endorsed definitions and rules regarding the format, meaning, and transmission of data elements. Data elements are individual pieces of data, such as age, medication, or diagnosis. This report is concerned specifically with standards for the following: Data interchange formats—standard formats for electronically encoding the data elements (including sequencing and error handling). Interchange standards can also include document architectures for structuring
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Patient Safety: Achieving a New Standard for Care data elements as they are exchanged and information models that define the relationships among data elements in a message. Terminologies—the medical terms and concepts used to describe, classify, and code the data elements, and data expression languages and syntax that describe the relationships among the terms/concepts. Knowledge representation—standard methods for electronically representing medical literature, clinical guidelines, and the like for decision support (Hammond, 2002). Chapter 4 details the committee’s recommendations on data interchange, terminology, and knowledge representation standards. Recommendation 4. The lack of comprehensive standards for data to support patient safety impedes private-sector investment in information technology and other efforts to improve patient safety. The federal government should accelerate the adoption of standards for such data by pursuing the following efforts: Clinical data interchange standards. The federal government should set an aggressive agenda for the establishment of standards for the interchange of clinical data to support patient safety. Federal financial support should be provided to accomplish this agenda. After ample time for provider compliance, government health care programs should incorporate into their contractual and regulatory requirements standards already approved by the secretaries of DHHS, the Veterans Administration, and the Department of Defense (i.e., the HL7 version 2.x series for clinical data messaging, DICOM for medical imaging, IEEE 1073 for medical devices, LOINC for laboratory test results, and NCPDP Script for prescription data).1 AHRQ should provide support for (1) accelerated completion (within 2 years) of HL7 version 3.0; (2) specifications for the HL7 Clinical Document Architecture and implementation guides; and (3) analysis of alternative methods for addressing the need to support patient safety by instituting a unique health identifier for individuals, such as implementation of a voluntary unique health identifier program. 1 HL7—Health Level Seven; DICOM—Digital Imaging and Communications in Medicine; IEEE—Institute of Electrical and Electronics Engineers; LOINC—Logical Observation Identifiers, Names, and Codes; NCPDP—National Council for Prescription Drug Programs.
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Patient Safety: Achieving a New Standard for Care Clinical terminologies. The federal government should move expeditiously to identify a core set of well-integrated, nonredundant clinical terminologies for clinical care, quality improvement, and patient safety reporting. Revisions, extensions, and additions to the codes should be compatible with, yet go beyond, the federal government’s initiative to integrate all federal reporting systems. AHRQ should undertake a study of the core terminologies, supplemental terminologies, and standards mandated by the Health Insurance Portability and Accountability Act to identify areas of overlap and gaps in the terminologies to address patient safety data requirements. The study should begin by convening domain experts to develop a process for ensuring comprehensive coverage of the terminologies for the 20 IOM priority areas. The National Library of Medicine should provide support for the accelerated completion of RxNORM2 for clinical drugs. The National Library of Medicine also should develop high-quality mappings among the core terminologies and supplemental terminologies identified by the CHI and NCVHS. Knowledge representation. The federal government should provide support for the accelerated development of knowledge representation standards to facilitate effective use of decision support in clinical information systems. The National Library of Medicine should provide support for the development of standards for evidence-based knowledge representation. AHRQ, in collaboration with the National Institutes of Health, the Food and Drug Administration, and other agencies, should provide support for the development of a generic guideline representation model for use in representing clinical guidelines in a computer-executable format that can be employed in decision support tools. 2 RxNORM is a normalized (standard) form for representing clinical drugs and their components.
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Patient Safety: Achieving a New Standard for Care REFERENCES Hammond, W. E. 2002. Patient Safety Data Standards: View from a Standards Perspective. PowerPoint Presentation to IOM Committee on Data Standards for Patient Safety on May 6, 2002. Online. Available: http://www.iom.edu/file.asp?id=9915 [accessed December 16, 2003]. Institute of Medicine. 2001. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press. ———. 2002a. Fostering Rapid Advances in Health Care: Learning from System Demonstrations. Washington, DC: The National Academies Press. ———. 2002b. Leadership by Example: Coordinating Government Roles in Improving Health Care Quality. Washington, DC: The National Academies Press. ———. 2003. Committee on Data Standards for Patient Safety. Key Capabilities of an Electronic Health Record System: Letter Report. Washington, DC: The National Academies Press. National Committee on Vital and Health Statistics. 2001. Information for Health: A Strategy for Building the National Health Information Infrastructure. Online. Available: http://ncvhs.hhs.gov/nhiilayo.pdf [accessed April 18, 2002].
Representative terms from entire chapter: