Patient Safety Achieving a New Standard for Care (2004) / Chapter Skim
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Executive Summary
Executive Summary
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to capture patient safety information as a by-product of care and use this information to design even safer delivery systems. Health data standards are both a critical and time-sensitive building block of the national health information infrastructure.
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To achieve an acceptable standard of patient safety, the committee recommends that all health care settings establish comprehensive pa tient safety programs operated by trained personnel within a culture of safety and involving adverse event and near-miss detection and analysis. In addition, the federal government should pursue a robust applied research agenda on patient safety, focused on enhancing knowledge, developing tools, and disseminating results to maximize the impact of patient safety systems.
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. As substantial evidence about adverse events continues to accumulate in the United States and other countries (Vincent et al., 2001; Wilson et al., 1995)
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In recent years, patient safety reporting systems have emerged in the health care arena. Many hospitals now routinely capture information on errors, both near misses and adverse events, as a part of their internal safety 1An EHR system encompasses (1)
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. The availability of complete patient health information at the point of care delivery, along with clinical decision support systems (e.g., for medication order entry)
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To support the objectives of care delivery that is free of errors and the implementation of robust safety reporting systems, a broad range of patient data will be needed, including demographic information, signs and symptoms, medications, test results, diagnoses, therapies, and outcomes. In addition, to learn from near misses and adverse events, the system must capture such data as the individuals involved, where and when the event occurred, what happened, the likely severity of avoided or actual outcomes, contributing factors, and recovery procedures, as well as reporters' narratives that will reveal the underlying system failure.
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To achieve the greatest gains, federal financial support should be targeted to three areas. First, federal financial investment should support the development of critical building blocks of the national health information infrastructure that are unlikely to receive adequate support through investment by private-sector stakeholders, including the establishment of a secure platform for the exchange of data across all providers and, as discussed below, maintenance of a process for the ongoing promulgation of national data standards.
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• The federal government should facilitate deployment of the na tional health information infrastructure through the provision of tar geted financial support and the ongoing promulgation and mainte nance 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 pro cesses to improve patient safety.
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, and computerized decision support systems must be modified to issue an alert to the clinician and patient if the patient's record does not include entries substantiating that beta-blockers were prescribed at the time of the heart attack, if appropriate. Unfortunately, the current health care delivery system lacks well-defined processes for translating new knowledge into practice.
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The data requirements for clinical guidelines and for safety and quality reporting must feed into the process used to develop data standards for EHR systems if those systems are to serve as the primary source of information and decision support for providers seeking to follow best-practice guidelines and respond to patient safety reporting requirements. The National Committee on Vital and Health Statistics (NCVHS)
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The CHI initiative played a pivotal 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)
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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 terminol ogy mappings.
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• Knowledge representation -- standard methods for electronically representing medical literature, clinical guidelines, and the like for decision support (Hammond, 2002)
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Use of standardized clinical terminologies facilitates electronic data collection at the point of care; retrieval of relevant 4The administrative simplification provisions of HIPAA set forth standards and regulatory requirements for the electronic transmission of data for administrative and financial transactions. The provisions also include standards for privacy and security to protect individually identifiable health information and standards to uniquely identify providers, employers, health plans, and patients.
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Knowledge Representation As noted above, to support patient safety, ongoing syntheses of the clinical literature should be conducted to determine best practices for clinical management in the 20 priority areas identified by the IOM. The National Institutes of Health and many private-sector academic and research centers play critical roles in the ongoing generation of clinical knowledge.
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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.
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As noted above, safe care settings are ones that have an adequate information infrastructure to provide clinicians and patients with immediate access to health information. But other organizational supports are needed as well, including trained professionals with expertise in safety and well-designed reporting systems for near misses and adverse events.
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However, none of these patient safety reporting systems for detecting and analyzing adverse events and near misses can function effectively in the absence of universally adopted standards for data to support patient safety. Perhaps the most important dimension of the evolution of patient safety programs among the three cited at the beginning of this section is an increased emphasis on prevention.
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Additional research is also needed to assist health care settings in establishing effective reporting systems for near misses. As noted above, the health care sector has far less experience with such systems than with those focusing on adverse events.
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At the other end of the spectrum are applications that focus on learning -- both organizational and professional. The feedback of performance data to clinicians for continuing education purposes falls into this category, as does the redesign of care processes by health care organizations based on analysis of data collected by reporting systems for near misses and adverse events.
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The development of a standardized format and terminology for the capture and reporting of data related to patient safety events (i.e., adverse events and near misses) would improve the usefulness of the data and ease the reporting burden considerably.
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The widely used Eindhoven Classification Model -- Medical Version should be used as a standard taxonomy to classify root causes identified through analysis of near misses and adverse events. All new terms should be incorporated into the key reference terminology (Systemized Nomenclature of Human and Veterinary Medicine Clinical Terms [SNOMED CT]
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At the heart of the agenda is the development of a national health information infrastructure, including EHR systems that adhere to national standards for data supporting patient safety in all health care settings. Although the committee recognizes that carrying out this agenda will require a sizable up-front capital investment, we believe its creation is essential not only to patient safety but also to the health of the American people more generally.
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Robust internal and external reporting systems for near misses and adverse events provide new knowledge that makes it possible to design even safer delivery systems. In building their EHR systems, health care organizations may want to target initial investments to the establishment of key capabilities for which a sizable knowledge base already exists with regard to the prevention of errors (e.g., medication order entry systems significantly reduce medication errors)
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DHHS -- Department of Health and Human Services DICOM -- Digital Imaging and Communications in Medicine EHR -- electronic health record HIPAA -- Health Insurance Portability and Accountability Act HL7 -- Health Level Seven ICD -- International Classification of Diseases IEEE -- Institute of Electrical and Electronics Engineers JCAHO -- Joint Commission on Accreditation of Healthcare Organizations NCPDP -- National Council on Prescription Drug Programs NCVHS -- National Committee on Vital and Health Statistics SNOMED CT -- Systemized Nomenclature of Human and Veterinary Medicine Clinical Terms UHI -- unique health identifier REFERENCES Agency for Healthcare Research and Quality.
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2003a. National Health Information Infrastructure 2003: Developing a National Action Agenda for NHII.
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2001. Information for Health: A Strategy for Building the National Health Information Infrastructure.
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28 PATIENT SAFETY Wilson, R
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