2
Components of a National Health Information Infrastructure

CHAPTER SUMMARY

A comprehensive approach to patient safety requires the ability to anticipate and protect against circumstances that might lead to adverse events and implement corrective actions. Both adverse events and near misses require standard collection/reporting processes, datasets, definitions, and analytic approaches that can be achieved only by integrating patient safety reporting systems into the context of health information systems in both large institutions and office practices. These systems employ multiple detection methods and multiple reporting channels and involve a broad array of data elements. Establishing a national health information infrastructure is necessary to provide the backbone for such systems.

This chapter is divided into three sections: the first provides a general overview of the national health information infrastructure and a conceptual model of standards-based integrated data systems to support patient safety in institutional and office practice settings for all audiences; the second presents a technical review of the informatics components that support an information infrastructure for the technical reader; and the third provides a discussion of how standards-based clinical systems can be and have been implemented to support this endeavor for both audiences.



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Patient Safety: Achieving a New Standard for Care 2 Components of a National Health Information Infrastructure CHAPTER SUMMARY A comprehensive approach to patient safety requires the ability to anticipate and protect against circumstances that might lead to adverse events and implement corrective actions. Both adverse events and near misses require standard collection/reporting processes, datasets, definitions, and analytic approaches that can be achieved only by integrating patient safety reporting systems into the context of health information systems in both large institutions and office practices. These systems employ multiple detection methods and multiple reporting channels and involve a broad array of data elements. Establishing a national health information infrastructure is necessary to provide the backbone for such systems. This chapter is divided into three sections: the first provides a general overview of the national health information infrastructure and a conceptual model of standards-based integrated data systems to support patient safety in institutional and office practice settings for all audiences; the second presents a technical review of the informatics components that support an information infrastructure for the technical reader; and the third provides a discussion of how standards-based clinical systems can be and have been implemented to support this endeavor for both audiences.

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Patient Safety: Achieving a New Standard for Care GENERAL OVERVIEW Improving patient safety requires much more than systems for reporting and analyzing events; errors must be prevented from occurring in the first place. Several effective tools are available that can assist in the prevention of adverse events. Clinical decision support systems (CDSSs), such as those for medication order entry, can prevent many errors from occurring (Bates et al., 1997, 1998, 1999). Computer-based reminder systems can facilitate adherence to care protocols (Balas et al., 2000); computer-assisted diagnosis and management programs can improve clinical decision making at the point of care (Durieux et al., 2000; Evans et al., 1998); and immediate access to clinical information, such as results of laboratory and radiology tests, can reduce redundancy, allowing for more efficient decision making. Incorporation of new research findings into clinical practice is also important for improving patient safety. Balas and Boren found that it takes an average of 17 years for research to reach clinical practice, whereas newer technological innovations take an average of 4 to 6 years. Actionable knowledge representation through the use of information systems holds promise for better connecting clinical research and patient care practices (Balas and Boren, 2000). In addition, the Internet can be used for customized health education for patients, thereby promoting more effective self-management of chronic and other medical conditions (Cain et al., 2000; Goldsmith, 2002). The Internet can be used as well for communication among all authorized members of the care team (e.g., primary care providers, specialists, nurses, pharmacists, home health aides, the patient, and lay caregivers), a capability that is especially important for the chronically ill. The capabilities provided by these clinical information systems cannot be achieved, however, without standards-based interoperability founded on the national health information infrastructure (NHII). The NHII is defined as a set of technologies, standards, applications, systems, values, and laws that support all facets of individual health, health care, and public health (National Committee on Vital and Health Statistics, 2001). It encompasses an information network based on Internet protocols, common standards, timely knowledge transfer, and transparent government processes with the capability for information flows across three dimensions: (1) personal health, to support individuals in their own wellness and health care decision making; (2) health care providers, to ensure access to complete and accurate patient data around the clock and to clinical decision support systems; and (3) public health, to address and track public health concerns and health education campaigns (National Committee on Vital and Health

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Patient Safety: Achieving a New Standard for Care Statistics, 2001). As shown in Figure 2-1, there are significant areas of overlap among these three dimensions in terms of functionality and applications. With the NHII, information systems will be able to provide the right information, at the right time, and to the right individuals, enabling safe care and supporting robust safety reporting systems for cases in which adverse events and near misses do occur. The NHII also will yield many other benefits in terms of new opportunities for care access, efficiency, and effectiveness; public health; homeland security; and clinical and health services research. For example, electronic health records (EHRs), in conjunction with secure data exchange, may allow for early detection of and rapid response to infectious diseases. The NHII will also facilitate the organization and execution of large-scale inoculation programs, as well as the dissemination to clinicians and patients of up-to-date information and practice guidelines on the presentation and treatment of morbidity due to chemical and biological threats. Standards-based information systems built on the foundation of the NHII will permit cross-organizational data sharing. Several promising FIGURE 2-1 Examples of content for the three NHII dimensions and their overlap. SOURCE: National Committee on Vital and Health Statistics, 2001.

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Patient Safety: Achieving a New Standard for Care public–private information technology demonstrations currently under way nationwide are exchanging data outside traditional organizational boundaries. One such project is the New England Healthcare Electronic Data Interchange (EDI) Network (NEHEN)—a consortium initiated in 1998 and led by Computer Science Corporation (New England Healthcare EDI Network, 2002). Membership is open to providers, health plans, and payers in Massachusetts and Rhode Island; there are currently 14 members, including most of the region’s largest insurers and health plans. NEHEN provides its members, who pay a flat monthly fee, with access to a secure high-speed network for sending and receiving transactions. Members can either integrate NEHEN functions directly into their own management systems or access the NEHEN network using NEHENLite, a Web-based application. A second promising project is the Indiana Network for Patient Care (INPC), initiated 10 years ago in Indianapolis by the Regenstrief Institute for Health Care. Currently, all 13 acute care hospitals in the city and approximately 20 percent of the metropolitan area’s outpatient physician practices are participating (Overhage, 2003). Participating institutions pay a monthly fee for access to selected electronic information that forms the basis for an “operational community-wide electronic medical record” that includes reports from emergency room visits, laboratory results, admission notes/discharge summaries, operative reports, radiology reports, surgical pathology reports, inpatient medications, immunizations, and a tumor registry (Overhage, 2003). Each health care provider retains its patients’ information in its organization’s database; however, selected information in those datasets can be shared among organizations through use of a Global Patient Index (Overhage, 2003). INPC not only allows for the secure storage and exchange of clinical information but also provides clinical decision support and public health surveillance and reporting. A third example of a regional data sharing network is the Santa Barbara County Care Data Exchange, initiated in 1998 through a partnership between CareScience and the California Healthcare Foundation (CareScience, 2003). More than 75 percent of the health care providers in Santa Barbara County are participating, including medical groups, hospitals, clinics, laboratories, pharmacies, and payers. The Care Data Exchange allows for rapid and secure delivery of patient data to authorized users who have informed consent. While the above projects are all extremely promising, they remain isolated examples. Such efforts are unlikely to be replicated on a larger scale until the major technical, organizational, and financial impediments to the development of the NHII are addressed.

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Patient Safety: Achieving a New Standard for Care From a technical perspective, the NHII will require the construction of an information and communications infrastructure in much the same way as one builds an electrical power grid. The “materials” for constructing the infrastructure are the core informatics components required to generate data flows: data acquisition methods and user interfaces, health care data standards, data repositories and clinical event monitors, data mining techniques, digital sources of evidence or knowledge, communication technologies, and clinical information systems (each discussed in detail later in this chapter). To facilitate the development of the NHII, the Institute of Medicine (IOM) recently proposed several demonstration projects aimed at establishing state-of-the-art health care information and communications infrastructure at the community, state, and regional levels (Institute of Medicine, 2002a). That report suggests that information and communications infrastructure can contribute to improvements in four areas of relevance to patient safety: communication, access to patient information, knowledge management, and decision support. At the organizational level, moving forward with a health information infrastructure requires the development of comprehensive, standards-based systems necessary for delivering clinical information at the point of care, facilitating communication for care coordination, and supporting patient safety systems for detection and prevention of adverse events and for detection and recovery from near misses. The first section of this chapter presents a conceptual model of a standards-based data system that draws on the above core informatics components of a national health information infrastructure; the second section provides a brief overview of each of those components. The results of a demonstration project to assess the current state of vendor information systems in attaining the conceptual model are then summarized. The next section presents several practical approaches to moving forward with integrated health data systems. Finally, we discuss how challenges to overcoming the implementation of information technology in the national health information infrastructure can be overcome. CONCEPTUAL MODEL OF STANDARDS-BASED, INTEGRATED DATA SYSTEMS TO SUPPORT PATIENT SAFETY A conceptual model for standards-based, integrated data systems to support patient safety is presented in Figure 2-2. This conceptual model encompasses several key principles of such systems:

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Patient Safety: Achieving a New Standard for Care FIGURE 2-2 Conceptual model of standards-based, integrated data systems to support patient safety. NOTE: aEHR = electronic health record; bCPOE = computerized physician order entry.

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Patient Safety: Achieving a New Standard for Care Reuse of data Aggregation of data for learning and accountability Feedback from learning that results in improvement and system changes Interoperability standards as essential glue Parallel reporting pathway outside patient care systems Usable by both providers and patients Integrated Systems and Large Institutions Under this model, patient data are captured in a variety of clinical applications, such as EHRs and computerized physician order entry systems, in a variety of inpatient and outpatient settings as part of the health care delivery process. Patients may also enter such data as symptoms and self-care behaviors directly into clinical systems and review aspects of their record, such as laboratory results. In some organizations, patient data from different clinical applications are integrated in a clinical data repository; in other organizations, the EHR can be utilized for data integration. For patient safety purposes, data about adverse events and near misses also can be integrated and fed into the repository through CDSSs. Evidence-based care is enhanced over time with a constant infusion of new medical knowledge from the biomedical literature into decision support systems so that significant aspects of care are supported for such purposes as delivering preventive care reminders to clinicians. Patient care data, along with other useful data sources, are aggregated for analysis in registries, analytic databases, and data warehouses. They can be used for analysis and reporting to support learning and accountability both within and outside individual health care organizations. These aggregated data resources can be used to generate insights into patient care processes and to monitor performance. Finally, while the majority of data for learning and accountability are reused from clinical care, it is essential that voluntary reports from patients and clinicians also feed into these systems—represented in Figure 2-2 as the “voluntary reporting” pathway. While Figure 2-2 is the overall objective for integrated systems in the NHII, technology is currently at varying degrees of implementation across different health care settings. Thus, a strategy is needed to progressively increase the informatics capabilities, interoperability, and utilization of clinical systems and decision support applications. To begin the integration and data sharing process, local systems can establish interoperability by incorpo-

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Patient Safety: Achieving a New Standard for Care rating common standards for messaging formats, a generic information model, and terminology standards where appropriate. The primary systems that support most decision support applications—pharmacy, laboratory, radiology, and administrative databases—can also be linked so that computerized physician order entry, alert/reminder, and other such systems can be implemented. For patient safety, triggers can be implemented to identify potential adverse events or patient contraindications in laboratory and pharmacy systems, integrated with systems that can accept narrative patient safety reports. Integrated Systems and Office Practice A key result of the NHII will be to permit information exchange across institutional boundaries, providing more complete patient information and enabling better coordination of care. Traditionally, most data exchange has occurred within the boundaries of larger institutions or health systems. However, since most providers practice, at least in part, outside of large institutions, much of the anticipated benefit of the NHII may result from improved data linkages with and among smaller, office-based practices. While large institutions and office practices require somewhat different information technology architectures, the informatics requirements to support systems integration and clinical decision support tools are the same. Instead of linking with internal departmental systems within larger organizations that account for the majority of patient data (e.g., pharmacy, laboratory, radiology), office practices will be able to use data exchange standards to send and receive important patient data (e.g., results of a laboratory test, a discharge summary) to/from external systems and retrieve information from knowledge sources (e.g., a medical literature database, disease registries). Instead of the information technology architecture of distributed systems connected through a central data repository that would characterize a large institution, small office practices will use a simpler architecture, with the EHR and/or practice management system as the principal repository for information on their patients and general office operations. These systems will still link to external systems using common message and data standards. Patient safety systems will be connected to office practices by one of several means: (1) direct integration with the internal database of a practice as part of a quality improvement program, (2) linkage to an external patient safety organization, or (3) voluntary or mandatory participation in external public repositories. Common standards will allow the systems to exchange data that can be integrated into patient records and support tools in a manner

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Patient Safety: Achieving a New Standard for Care that retains data comparability. Additionally, integrated systems and common data standards in clinical practice will yield the benefits of data reuse, lessening the burden of clinicians’ regulatory obligations for reporting on quality measures, patient safety, accreditation, and the like. Under this model, office practices will utilize the wide range of clinical information systems that make up the totality of the EHR. Information technology systems may include computers, personal digital assistants (PDAs), and/or voice recognition devices. These systems will be available in every examining room and clinician’s office, offering the promise of greater convenience, accessibility, integration, and accuracy in information about patients and their health conditions (Bodenheimer and Grumbach, 2003). Electronic communications will enhance efficiency in patient–physician and physician–physician communications. For example, it will be possible to handle many interactions—such as reporting test results, arranging specialty referrals, receiving data on home glucose levels, and adjusting medication doses—by e-mail (Bodenheimer and Grumbach, 2003). Using electronic devices or computers, physicians will be able to store or electronically access vital knowledge bases, such as directories of pharmacies and specialists, descriptions of medications and drug interactions, reference texts, practice guidelines, and evidence-based abstracts (Bodenheimer and Grumbach, 2003). To date, much discussion related to the use of technology in office practices has focused on administrative and financial transactions defined under the Health Insurance Portability and Accountability Act (HIPAA) and on the incorporation of the EHR. By 2002, however, only 17 percent of U.S. primary care physicians were using an EHR system, compared with 58 percent in the United Kingdom and 90 percent in Sweden. The lag in U.S. adoption of the EHR has been the result of several factors that are now being addressed: the cost of investing in health information technologies, inertia and a lack of incentives for change, the quality of medical information available on the Web, incompatibility of software programs, privacy concerns, lack of reimbursement, and concern about compromising the personal interaction between physician and patient (Bodenheimer and Grumbach, 2003). To move forward with the implementation of clinical information technology systems, a central focus of initiatives to implement the NHII must be on providing small practices with support comparable to that extended to large health care institutions. Public–private partnerships will be required that provide opportunities for financial incentives, technical assistance, and the development of a migration strategy that addresses the special needs of small practice physicians.

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Patient Safety: Achieving a New Standard for Care The process for creating integrated systems requires consideration and incorporation of the functionalities associated with the primary informatics components that support an information infrastructure. A more technical discussion of these components is provided in the next section. TECHNICAL CONSIDERATIONS: INFORMATICS COMPONENTS OF THE INFORMATION INFRASTRUCTURE The informatics components of the NHII provide a foundation for a comprehensive standards-based system and a migration strategy for its implementation. This section briefly describes the key components of a health information infrastructure that supports patient safety. Data Acquisition Methods and User Interfaces Data become available to learning or accountability systems by various means, including abstraction from paper records; direct entry into a computer system (keyboard entry, voice, touch screen, pen); and reuse of data collected by other systems, such as those used for clinical care or administrative purposes. Information capture per se takes many forms, including speech, free text, document imaging, clinical imaging (e.g., x-rays), motion video, binary electronic data representation (e.g., laboratory values, device settings, operational status, measurements), waveforms (e.g., electrocardiograms), graphical codes (e.g., digital ink), and indexing/clinical encoding (e.g., extensible markup language [XML], International Classification of Diseases [ICD]) (Waegemann et al., 2002). Regardless of entry mode, data that are captured in standardized terminologies are more accessible for reuse than narrative text. As discussed later in this chapter, however, significant advances have been made in the use of natural language processing of narrative text for the detection and prevention of adverse events. Methods of acquiring data may also vary by domain. For example, speech input works well in radiology, where the reporting is structured. On the other hand, pen-based data entry using a wireless tablet computer suits the task of documentation associated with home health care nursing. Laboratory and pharmacy data that are essential to the detection and prevention of adverse events and near misses are typically available from department-level information systems and can be reused for patient safety and quality management purposes. Given variations in levels of technology adoption and the needs of different clinical domains, organizations should maintain

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Patient Safety: Achieving a New Standard for Care the ability to accommodate various methods of data acquisition and styles of documentation in progressing toward fully automated learning and accountability systems. Waegemann et al. (2002) have developed a set of essential overall principles for optimal information capture and report generation with information technologies. According to these principles, such technologies should provide for unique identification of the patient, accuracy of information capture through the use of standards-based terminologies, completeness of information and minimization of duplication, timeliness such that data can be captured at the point of care, interoperability with any clinical information system, retrievability so that information can be found efficiently, authentication and accountability so that all data can be attributed to its source, auditability for ongoing assessments of quality, and confidentiality and security features to protect the data. An intuitive and efficient user interface, that part of the computer system that communicates with the user, is utilized for interactive data entry, and controls the execution and flow of data (van Bemmel and Musen, 1997); it is another key component of clinical information systems (Shortliffe et al., 2001). User interface tools to facilitate data acquisition are still in the early stages of development, and a number of research projects are now under way to resolve associated impediments to the widespread implementation of clinical information systems. Much is being learned from the ubiquity of Web interfaces (Shortliffe et al., 2001). Current research integrates a number of methodologies from both engineering and cognitive science to evaluate and design systems from the perspective of terminology use (e.g., coded data entry) and navigation (Cimino et al., 2001); customization for the intended users and their unique requirements related to data structure, collection, and display (e.g., physician, nurse, patient) (Kinzie et al., 2002); and integration with emerging advanced technologies, such as speech recognition, multimedia, hypermedia (documents that contain links to various media), and virtual reality (van Bemmel and Musen, 1997). Core guidelines for the successful design of user interfaces identify several approaches to facilitate usability, including grouping of information, minimization of information overload, consistent and standards-based information display, information highlighting relative to importance, use of graphics, optimal text presentation, and use of icons (van Bemmel and Musen, 1997). Additional information on standards for user interfaces is provided in Chapter 4.

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Patient Safety: Achieving a New Standard for Care BOX 2-6 Perspective Online: Data Management Procedures Data verification—As data are received from each hospital, operations staff check for correct file formats and record counts. Staff calculate total discharges, charges, and costs from the records and compare them with the totals submitted by the hospital. Should there be any discrepancy at this point, the entire file is returned to the hospital for correction and resubmission. Initial reconciliation—At this point, the totals on the discharge data file are compared with financial data submitted separately by the hospital. This comparison allows for a limited variance between the totals; for example, discharges from both sources cannot vary by more than 0.5 percent. If the variance exceeds the threshold, the entire file is returned to the hospital for correction and resubmission. Data validation—Data in each record are compared with acceptable values and ranges. Codes are compared with code master tables. Records that appear to be in error are returned to the facility for correction. Final reconciliation—Once data have been corrected, the reconciliation process is repeated to ensure that there is no further discrepancy between the discharge records and the financial data. Clinical resource consumption quality assurance—Data are reviewed to determine whether the values are consistent with what would be expected from a clinical perspective; for example, anesthesia time and operating room time must be within a certain range of each other. Records failing this review are returned to the facility for correction. Manual data audit—A final review of the data is performed manually. This review checks for errors that cannot be found through automated processes, for example, whether the outlier percentage is consistent with other values. Warehouse audit—Once data are in the warehouse, one more check is performed. The current data file is compared with historical patterns to see whether the number of cases with specific characteristics differs from the hospital’s historical experience. De-identification methods—Full compliance with all privacy and security requirements of the Health Insurance Portability and Accountability Act (HIPAA) is essential. De-identification policies and practices are reviewed, documented, and modified as necessary to ensure that the vendor meets or exceeds all such requirements. pendent on data from departmental systems, they necessitate upgrading of legacy systems for interoperability and the use of common data standards to allow sharing of data. VHA has implemented a bar-code medication administration system for inpatient care, in which all products in the pharmacy are bar coded in single dosage units. The patient also is provided with a bar-coded wristband upon admission to the hospital. The VHA system links such data as demographic data, medical history, medication history, drug terminology, drug reference

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Patient Safety: Achieving a New Standard for Care data, drug interaction data, and drug–laboratory correlations. The system is used at the point of care to validate that the medication ordered, timing of administration, and dosage are correct and to maintain a medication administration history (Department of Veterans Affairs, 2001). For patient safety and quality research, reports can be generated for medication log, missed medications by patient or ward, missing dose request, follow-up and report, medication due list, medication administration history, drug inquiry, and other information (Department of Veterans Affairs, 2001). OVERCOMING CHALLENGES TO IMPLEMENTATION OF INFORMATION TECHNOLOGY FOR THE NATIONAL HEALTH INFORMATION INFRASTRUCTURE Organizational Leadership Traditionally, a lack of organizational commitment to information technology and organizational culture have been significant barriers to the development of an informatics infrastructure within health care organizations. Leaders of health care organizations struggle with their organizations’ use of and commitment to information technology (Glaser, 2002), and the health sector as a whole continues to lag significantly behind other industries in this regard. Achieving the vision described in this chapter requires commitment, leadership, and strategy. Aligning information technology strategy with business strategy requires adjustment of the organizational structure to provide strong leadership and strategic support at the highest levels of management, adequate resources and incentives to support the required cultural change, and front-line decision making and feedback regarding the development and maintenance of patient safety and quality improvement systems. While structures, strategies, and approaches vary among organizations, certain fundamental principles correlate directly with successful integration of information technology and business strategies: A high-level, long-term commitment to information technology that starts at the level of the board of directors and senior management An integrated vision for the building of an information technology infrastructure Direct linkage between the information technology division and users, creating a feedback loop that provides for input and adjustment of the system to ensure that its functionality meets user needs

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Patient Safety: Achieving a New Standard for Care Implementation of an adoption strategy for information technology systems and active support by senior medical staff for the cultural change necessary for effective adoption Systematic implementation (within an integrated vision) to build experience and confidence, to uncover unexpected problems, and to spread the cost out over time Continual adaptation and modification of systems and processes to reflect current medical science and technological advancements The cultural change that is inherent in the deployment of information technology is dependent on organizational drivers from both the top down and the bottom up. An example to illustrate this point is offered by the success of the Latter Day Saints (LDS) Hospital in Salt Lake City, Utah, in creating a culture for both innovative clinical systems automation and quality improvement. Top management made its support known through planning, providing the necessary resources, and encouraging an attitude of willingness to change and experiment. Simultaneously, clinical department leadership undertook with zeal the effort to achieve continuous improvement. When the clinical information system and clinical improvement processes were transferred from LDS Hospital to other institutions, one of the greatest challenges was to transfer the continuous improvement mind-set (e.g., emerging deficiencies in information technology systems were often viewed as “works in progress” rather than failures). Careful attention to both the product being developed, whether information technology systems or patient safety reporting, and the culture in which they reside is essential to success. Comprehensive systems such as the NHII develop over time. Because of the dynamic nature of medical practice and information systems, one of the most important principles for organizational leadership to embrace is the need for constant adaptation and modifications to reflect science and technological innovation and advancement. Strategic planning with fore-thought to incorporate this need for continued evolution can assist organizations in achieving greater business value for their information technology investments as the horizon continually shifts (Glaser, 2002). The organization’s culture and leadership should also encourage innovation through creativity and experimentation in addressing business problems, crises, and opportunities for better meeting the needs of those interacting with the systems (Glaser, 2002). For example, an area of expected high-growth opportunity that would require system expansion could include personal health records for consumers. The personal health record includes a subset of the

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Patient Safety: Achieving a New Standard for Care data in the individual’s EHR and information recorded by them to support their care, disease management, and clinical communication (Markle Foundation, 2003). The personal health record could be made available to consumers through a link to a health care organization’s secure Web-based portal that utilized HIPAA standards for authentication. Another area for organizational expansion is the establishment of global health networks of population-based information. Organizational leadership should also pursue a more global perspective in aligning the organization’s evolutionary adaptations and modifications with accepted international standards and technologies that can support the development of and linkage to a global health network. Global health networks based on common data standards can facilitate information access for health care providers on important concerns related to public health, such as infectious disease surveillance and the effects of bioterrorism that may directly affect their patients. The recent emergence of severe acute respiratory syndrome–SARS–is a prime example of this critical need. At the time the disease presented, each country was utilizing different standards to define and store salient information. It was not possible to share electronically vital information that could have eased the burden of tracking and monitoring the spread of the disease or facilitated a global research database. Financial Incentives The committee recognizes that building the NHII is an enormous undertaking with sizable costs in terms of human, organizational, financial, and governmental resources. The committee also understands that the majority of the effort for developing and implementing the information systems and data standards of the NHII will fall to the private sector. Estimating the costs to build the NHII is a major endeavor and one that was outside the scope of this study. However, the primary areas where costs are expected to arise include those related to the NHII (e.g., architecture, consumer health, homeland security, research, and population health), data standards (e.g., data interchange, terminologies, and knowledge representation), and patient safety reporting systems (e.g., organizational, state, national). These areas of significant cost can best be evaluated by those organizations that are directly involved in their respective areas. Those organizations should initiate large-scale studies of the costs and resources required to fulfill the goal of building the NHII. To date, there has also been some broader-scale progress in addressing the challenges to the development of the NHII. In particular, the NHII

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Patient Safety: Achieving a New Standard for Care Conference, convened in July 2003 by the Department of Health and Human Services, brought stakeholders together to develop a consensus on a national action agenda to guide the development of the NHII (Department of Health and Human Services, 2003). The conference focused on several key topics, including data standards and vocabulary, as well as financial incentives. Private-sector investments, such as those discussed earlier, will likely account for a good deal of the capital required to build the NHII, but the federal government also has an important role in providing financial support. To achieve the greatest gains, federal financial support should be targeted toward three areas. First, federal resources should support the development of critical building blocks of the NHII that are unlikely to receive adequate support through the combined investments of individual private-sector stakeholders. On the regional level, this support should come in the form of start-up funds to public–private partnership organizations to develop secure platforms for exchanging patient and other data and for carrying out transactions, along with the necessary technical assistance to enable providers to begin using the platform. Nationally, the federal government should provide the financial support and leadership needed for the establishment and ongoing maintenance of national data standards. Second, the federal government should provide financial incentives to stimulate private-sector investments in the necessary information technology. Multiple approaches should be taken to this end and then evaluated to identify those that are most effective. These approaches might include revolving loans, differential payments to providers with certain information technology capabilities (e.g., inclusion of fees in the Medicare fee schedule for the provision of information technology services to patients, such as e-mail communications), or one-time-only payments to small physician offices to offset the costs and loss of productivity associated with the transition from paper to computer-based records. Third, in the absence of considerable help from the federal government, safety net providers will likely fall behind in the transition to a safer health care delivery system. The federal government should provide grants, in-kind contributions, and technical assistance to such providers. This support might include offering one-time-only grants through the Health Resources and Services Administration to federally qualified health centers or VHA making its Veterans Health Integration System and Technology Architecture—VISTA available in the public domain and facilitating its use by safety net providers. The federal government should thoroughly evaluate the various possibilities for providing incentives and investment support to facilitate the

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Patient Safety: Achieving a New Standard for Care adoption of information technology in health care, with a special focus on office practice providers. Specific criteria for participation in each incentive and/or investment support program should be determined, along with parameters for analysis of program effectiveness. Technical Assistance A significant amount of technical assistance will be needed to support those implementing the clinical systems and EHRs associated with the NHII. Because the United States has a private-sector–based health care delivery system, many companies have already been established specifically for the purpose of providing technical assistance and support for the implementation of information technology systems in health care organizations. These companies will play an important role in bringing the conceptual model presented earlier to fruition. Likewise, there is an important role for the Agency for Healthcare Research and Quality (AHRQ) in providing assistance to safety net providers and in leveraging and/or expanding existing educational programs for small group providers in office practice settings. Enforcement of Privacy and Security Enforcement of privacy provisions and security protocols will be essential to build the confidence of providers and patients utilizing the networks and information systems of the NHII. Consequently, the federal government will play a particularly important leadership role in the enforcement of HIPAA standards for privacy and security. Penalties for violations must be strongly enforced. Likewise, from a technology perspective, the federal government, through AHRQ, should develop strong application certification requirements for health-sector technologies to minimize potential threats to information systems that compose the NHII. For example, a requirement could be established that all application programs used in health care be certified as defect-free such that all known “holes” in software programming that could be exploited have been appropriately corrected. Given recent events and the current climate, moreover, the federal government may have an interest in extending its scope as a resource in handling sensitive situations and Internet-related problems that may affect health information systems.

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Patient Safety: Achieving a New Standard for Care CONCLUSIONS Because patient safety is an integral part of delivering quality health care, the committee believes that ensuring patient safety requires multiple measures throughout the continuum of care that can be accomplished through the establishment of an NHII. The key to the development of the NHII is threefold: (1) the implementation of a strategic plan for progressive migration from the current state to the comprehensive integrated network incorporating the principal informatics components outlined earlier in this chapter, (2) the provision of financial incentives by the federal government to support investments in information technologies, and (3) the implementation of common data standards for interoperability and comparability of health information. Although a health information infrastructure that supports learning and accountability systems for patient safety has not been implemented in most organizations to date, the barriers involved are not primarily technological. The technologies needed for building the integrated systems described in this chapter exist today. Rather, the lack of technology implementation and the failure to use common data standards have been the principal barriers. This chapter has explicitly highlighted the need for standards for (1) a concept-oriented terminology that supports nonambiguous definitions of concepts and data reuse for safety and quality purposes; (2) a CDA that will improve the utility of using NLP techniques for extracting the data required for learning and accountability systems from textual documents, such as clinical notes and voluntary reporting systems; (3) messaging standards that enable data integration across disparate computer-based systems, including those that cut cross organizations; and (4) knowledge representation standards that support the development of computable guidelines for evidence-based practice and decision support rules that are shared among organizations. The accelerated adoption of such standards in turn requires public–private partnerships and sufficient incentives, rather than technical innovation, as discussed in the next chapter. REFERENCES Abidi, S. S. R., and C. Yu-N. 2000. A Convergence of Knowledge Management and Data Mining: Towards ‘Knowledge-Driven’ Strategic Services. Proceedings from the Third International Conference on the Practical Applications of Knowledge Management, Manchester. Aha, D. W., L. A. Breslow, and H. Munoz-Avila. 2001. Conversational case-based reasoning. Appl Intel 14 (1):9–32.

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