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Providing Strong Leadership and Clear Aims for Improvement
Variation in the quality of American health care results in excess morbidity and mortality and billions of dollars in wasted spending. Improving the quality of health care in the U.S. has the potential to save lives, reduce disability, improve productivity, and reduce health care spending. For those reasons, health care quality improvement merits national priority. Such improvement requires committed leadership, the establishment of clear aims for improvement, and an ongoing, coordinated effort to nurture and sustain quality improvement activities.
While many current quality improvement efforts are commendable and show great promise, they often have been fragmented and lacking in shared goals. A broader national effort can assure progress and further stimulate local commitment to improving health care. Such action must begin with national leadership by the President and the Congress and extend to all levels of the health care industry.
The Commission recommends the articulation of a unifying statement of national purpose; creation of a short list of national aims for improvement of health care quality accompanied by specific objectives for improvement; and the creation of an annual award for excellence in health care quality. Chapter Five discusses the creation of an ongoing public/private partnership to move these efforts forward.
The President should provide strong, continuous leadership to develop a broad national consensus on improving the quality of health care in the United States. The President should begin this effort by articulating and continuing to emphasize a unifying statement of purpose for the health care system. The President should then work with the Congress and leaders of the public and private sectors to embrace this statement of purpose and to initiate collaborative efforts for improving health care.
The Commission suggests the following statement: "The purpose of the health care system must be to continuously reduce the impact and burden of illness, injury, and disability, and to improve the health and functional status of the people of the United States."
National aims for improvement of health care quality should be established accompanied by appropriate, specific objectives for improvement. The first step toward improving the quality of health care is the creation of a concise set of national aims for improvement. To encourage the greatest possible gains in the health of the American people, these aims should be based on criteria that include focusing on common and/or costly conditions, areas where wide variability in practices exists, and improvements that have the greatest impact on reducing morbidity and mortality and improving functional capacity. Setting national improvement aims, accompanied by a commitment by all participants to support and practice evidence-based care, can enhance Americans' access to appropriate, affordable health care.
The Commission suggests that an initial set of national aims should include, but not be limited to, the following:
Measurable objectives within each of these aims should be specified and developed, including objectives that focus on the unique needs of local areas, individuals with chronic illness and disability, and other vulnerable populations. These aims and objectives should be revised over time as improvements occur and new concerns arise.
An annual award for excellence in health care quality should be established. The Malcolm Baldrige National Quality Award has served as a tremendous incentive for organizational quality improvement. It should be expanded to include an annual award program for health care quality to increase public awareness of health care excellence, motivate organizations to improve quality, encourage dissemination of best practices, and recognize achievement in areas established as national aims for improvement.
PRESIDENTIAL LEADERSHIP IS NEEDED
Despite extensive research documenting health care quality concerns (see Chapter 1), public attention generally has not focused on the need for quality improvement in health care. Instead, Americans have been more focused on the cost of care than on the quality of the care (Brook, 1997). Increasing public attention to issues related to the quality of health care and raising the public's will for improvement requires a more concerted national effort to develop a broad consensus on specific, priority aims for improvement in health care.
Creation of the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry is an important first step in raising the profile of quality concerns. Continued Presidential leadership is needed to highlight the need for quality improvement on the national agenda and to raise the public's interest in better health care. The President's "bully pulpit" can serve as a powerful catalyst for the disparate participants in the health care system to begin more collaborative efforts for improving American health care. This effort should begin with the President articulating a unifying purpose for health care as follows:
The purpose of the health care system must be to continuously reduce the impact and burden of illness, injury, and disability, and to improve the health and functional status of the people of the United States.
This statement affirms that the primary purpose of all health care activities should be to maximize the health and functional status of the population, and this unifying purpose is intended to serve as a goal for all participants in the health care system. The President should work closely with Congress and health care leaders in the private and public sectors, and at national, state, and local levels to embrace this goal and actively seek health care quality improvement. In this way, national leadership can serve to stimulate local leaders' commitment to improvement and achieve synergy through collaborative efforts that will be essential to increasing the availability of affordable, quality health care.
NATIONAL AIMS FOR IMPROVEMENT
A critical next step in working toward making health care quality improvement a national priority is identifying clear aims for improvement that will provide a direction for strategic resource allocation and decision-making. Several benefits would result from establishing an ongoing approach to develop national aims for improvement. While many individual organizations have identified improvement priorities, there is little coordination among these efforts. Ideally, a process for developing national aims would have better coordination and economies of scale than individual organizations' efforts to identify priorities and could help guide health organizations' quality improvement efforts. This may be of particular benefit to smaller health plans, geographically isolated health providers, and financially-strapped health organizations that may not have the resources to identify independently improvement goals and make extensive investments in original innovations. In addition, national aims for improvement would create synergy resulting from many entities working toward common improvement goals, sharing best practices, and raising public recognition of the need for improvement.
The success of setting such national aims can be best demonstrated by the nation's experience with Healthy People 2000. This cooperative effort among government, voluntary, and professional organizations established national goals for improvement in public health, identified measures to track progress toward these goals, and engaged the cooperative efforts of private practitioners, health care delivery organizations, and public health organizations in achieving improvements. Many quality measurement and quality improvement efforts in the public and private sectors, such as the National Committee for Quality Assurance's Healthplan and Employer Data Information Set (HEDIS), have relied on Healthy People 2000 to identify valid areas for attention. To date, progress has been made in about two-thirds of the measurable Healthy People 2000 objectives (NCHS, 1996).(1)
Chapter Five discusses a public/private partnership that would provide an ongoing structure for developing national aims and tracking progress in meeting these aims. Key steps that need to be undertaken include establishing criteria for identifying aims; conducting syntheses of clinical research literature to identify where the greatest improvements can occur; convening panels of experts to select priorities among potential aims for improvement and revise these aims over time; and developing ongoing tracking to measure progress toward improvement.
Establishing criteria for identifying aims. Several principles should be applied to ensure that the identified aims for improvement will encourage the greatest possible gains in the quality of health care and the health of the population. To achieve these goals, targets for improvement should be based on:
Identifying improvements that meet the last of these criteria requires information on the prevalence of specific conditions. Such information currently is available from existing national health surveys (such as the National Health Interview Survey or the Medical Expenditure Panel Survey), public health reporting systems (such as the Centers for Disease Control and Prevention's surveillance systems), and private data sources. However, information for addressing the first and second criteria are likely to require additional efforts in synthesizing existing clinical literature.
Aims for improvement should draw on lessons from other industries as well as health care, and should widely address the multiple dimensions of quality of care. These include reducing defects, reducing costs while maintaining or improving the experience of the people served (i.e., reducing waste), and developing and offering new products or services (i.e., innovation) (Kano, 1994; Langley, 1996). In addition, health care service characteristics are appropriate areas for improvement objectives, such as reducing waiting times and improving cultural competence.
Synthesizing clinical literature to identify areas where improvement can occur. To identify where typical health care practices vary from knowledge about effective care -- an important step in identifying aims for improvement in health care -- the massive literature of existing knowledge needs to be synthesized. The voluminous nature of clinical literature poses problems for decision-makers attempting to identify improvement goals and for health professionals committed to practicing state-of-the-art health care, and the continued rapid growth in clinical knowledge requires that synthesizing this literature must be an ongoing process. One systematic approach for synthesizing the diverse literature is meta-analysis, defined as "a structured review that incorporates statistical methods to combine the results of individual primary studies" (OTA, 1994). Meta-analyses have been increasingly useful in developing practice guidelines, but conducting these broad-based syntheses can be costly and ultimately are only as valid as the individual studies upon which they are based (Lelorier, 1997).
Convening a panel of experts to select aims for improvement. Once criteria for identifying aims are identified and syntheses of information on where improvement can occur are available, a group of experts needs to be responsible for identifying priority aims for improvement. Developing a broad-based consensus on these aims is important for gaining widespread acceptance and community involvement in improvement efforts. For example, the Healthy People 2000 objectives were developed through an association of Federal agencies responsible for relevant public health programs and a "Healthy People Consortium." This consortium currently includes 345 organizations representing health professions, non-profit public health organizations, community groups, and state and local public health agencies. The involvement of this broad consortium has led to broader buy-in to the objectives, promoted continuity in the objectives over time, and engaged private organizations and public health groups in adopting many of the objectives as goals for their own independent efforts (Maiese, 1997).
Similarly, the U.S. Preventive Services Task Force, a panel of experts appointed by the Federal government from medicine and related fields, developed recommendations on the effectiveness of clinical preventive services. The task force systematically has identified target conditions by examining (1) the burden of suffering from the condition and (2) the potential effectiveness of the preventive intervention. Evidence of effectiveness was based on a broad synthesis of published clinical research. The evidence was then translated into clinical practice recommendations for the use of effective preventive services and nonuse of preventive services evaluated as ineffective (US Preventive Services Task Force, 1996).
Developing ongoing tracking of progress toward improvement. Once aims for improvement are identified, there needs to be ongoing monitoring to track progress in achieving the goals established. This requires identifying key standard measures to assess quality of care in targeted areas and collecting data on these measures. In some areas, existing data systems may be available for tracking quality of care, whereas in many other areas data collection and reporting systems will need to be developed. The resulting data on these measures will allow monitoring to track improvements and provide benchmarks for health organizations to assess their performance relative to national standards.
For example, an important component of Healthy People 2000 has been that most of the established objectives are measurable. When the year 2000 objectives were initially established, more than 200 of the 300 specific objectives had baseline data. Setting specific objectives propelled development of data systems in many areas where data were lacking, so that baseline data have been developed for all but a few of the objectives. In addition, "using their health objectives as a catalyst, a number of States have been able to improve their data systems and surveillance capabilities" (NCHS, 1996).
A feasible approach for tracking aims for improvement is to establish a collaborative effort of key organizations involved in quality measurement and monitoring. Many aims for improvement may be measurable by using existing data sources, including Federal health surveys, Medicare and Medicaid data bases, and private quality measurement systems, such as the National Committee for Quality Assurance's measurement data base (Quality Compass), the Joint Commission on Accreditation of Healthcare Organizations' proposed data base (ORYX), and the American Medical Association's physician credentialing data base. Tracking progress in achieving aims for improvement should also incorporate community-level public health data collected by the Centers for Disease Control and Prevention. Seeking collaboration among these public and private entities to provide publicly-available data, therefore, will be essential not only in reaching a national consensus on priority aims for improvement but also for effectively measuring quality indicators and tracking improvements.
Where data are lacking, targeted surveys or additional data reporting may be necessary for developing measures. Thus, an important step will be assessing existing data from federal, state, and private organizations and identifying key gaps in data. Once recognized, strategies for filling gaps in data may include augmenting existing health surveys with supplemental questions, conducting targeted surveys, or requiring additional data reporting. Over the longer term, progress toward a more comprehensive monitoring system will require increased standardization of clinical data,(2) coordination among disparate data systems, and increased investment in automated health information networks (see Chapter 14).
PROPOSED NATIONAL AIMS
While there are many worthy possible aims for improvement, it is important to focus efforts on a few priorities where most improvements can occur. The Commission recommends the following aims as well-supported starting points for focusing health improvement efforts. National aims for improvement should include, but not be limited to:
Within each of these broad aims, specific measurable objectives should be established to allow tracking of progress in achieving these aims, and aims should be revised as improvements occur and new concerns arise. In addition to these aims focused on improving the clinical components of health care, improvements in the service characteristics of health care -- such as waiting times, access, and cost -- are important to consumers and establishing aims in these areas would improve the overall quality of their care.
Finally, the aims for improvement, while national in focus, should be sufficiently robust to reflect the needs of specific vulnerable populations and localities. This can be achieved through establishing specific objectives within the broader aims that reflect the unique needs of vulnerable populations, including individuals with chronic illness or disability, and ensuring that the tracking of national aims can support efforts to identify particular areas of concern to local areas and vulnerable populations. (Chapter 8 further discusses the need to focus on vulnerable populations in improving quality of care.)
Reducing Underlying Causes of Illness, Injury, and Disability
While much of the focus of health care is on treating existing health conditions, a major aim for improving health care should be to prevent the onset of illness, injury, and disability by reducing their underlying causes. Ensuring that correct clinical preventive services are used is an important objective in reducing the underlying causes of illness, injury, and disability. The shift in paradigm from treatment to prevention has perhaps been most complete in the dental professions, and prevention should be stressed in other health care professions as well. The U.S. Preventive Services Task Force has recommended appropriate preventive services for patients depending on their age and health status, yet many of these preventive services either are not sufficiently offered to appropriate patients (for example, screening for colorectal cancer) or are widely provided despite lack of evidence of their effectiveness (for example, routine screening electrocardiograms) (US Preventive Services Task Force, 1996). Improving the functional capacity of individuals with existing chronic conditions or disability is also important to avoid unnecessary complications, dependency, and use of health care services. In addition, sustaining the nation's vigorous health and disease research effort is central to finding, treating, and eliminating the causes -- and therefore the burden -- of illness and disability (see Chapter 11).
While health care is important, many other factors contribute to the health status of the population, and thus continuously reducing the impact and burden of illness, injury, and disability will require the efforts of health care professionals extending beyond clinical health care services. For example, the excessive use of alcohol and tobacco have been identified as among the most prominent contributors to mortality in the United States -- leading to an estimated 500,000 deaths in 1990 (McGinnis, 1993). Reducing their consumption would be an important objective in meeting the aim of reducing the underlying causes of illness. Injuries are the single greatest cause of potential years of life lost, and preventable injury is the single largest cause of death in children, making injury prevention efforts essential to preventing avoidable disability and death (Emergency Medical Services for Children, 1997). Finally, major gaps in health status exist among racial, socioeconomic, and underserved populations that should be targeted in setting objectives for reducing the underlying causes of illness, injury, and disability. For example, individuals living in poverty or who are uninsured are more likely to be prone to delays in receiving appropriate treatment, live in environmental conditions that contribute to injury or illness, and lack health care and other supports that support good health.
Expanding Research on New Treatments
Innovations in health care treatments can result in improved health care through developing health care interventions that reduce morbidity and mortality, improve functional capacity and quality of life, avoid undesired side effects, or achieve similar outcomes at a lower cost. Innovations in clinical therapies have been cited as one reason -- along with improvements in public health and preventive practices -- for the decline in chronic disability among elderly Americans (Manton, 1997).
The National Institutes of Health cites examples of how improved treatments have resulted in health care improvements:
The continuous improvement of health care treatments through innovation and the application of evidence-based practices should be a major aim for improving the health and functional status of Americans. For example, additional investment is needed to develop innovative, effective approaches to improve the health and functional capacity of individuals with chronic illness and disability (see Chapter 8). Additional efforts are also needed to improve the ability to prevent, diagnose, and treat conditions that are common, costly, or significantly reduce health or functional capacity.
Since most current health care practices are lacking in scientific evidence to demonstrate their effectiveness, a commitment to evidence-based health care will require a long-term effort to evaluate new and existing health care practices to develop an evidence base. As such evidence is developed, health care practitioners, organizations, and plans will be better able to determine and provide appropriate care. The recent initiative of the Agency for Health Care Policy and Research to establish evidence-based practice centers to synthesize evidence of effective practices for targeted conditions is an example of a constructive effort toward the goal of evidence-based care (see Chapter 11 for additional examples).
Assuring Appropriate Use of Services
A major aim for improving the quality of U.S. health care should be to seek more appropriate use of health services through the practice of evidence-based health care where scientific research has demonstrated the effectiveness or ineffectiveness of care. The inappropriate use of many health care services has been well documented and has deleterious effects on the quality of care in the United States (see Chapter 1). Inappropriate care can result from either underuse (the failure to provide a service whose benefit is greater than its risk) or overuse (when a health service is provided although its risk outweighs its benefit).
Specific objectives within the broader aim of assuring appropriate use of health services could include increasing the use of appropriate medications and other effective therapies. For example, one study found that only 21 percent of eligible elderly patients were treated with a class of medications known as "beta blockers" following a heart attack despite evidence that mortality rates are 75 percent higher for those not receiving this treatment (Soumerai, 1997). Based on these findings, Chassin estimates that nearly 18,000 deaths from heart attacks could have been averted if known, effective therapies were more widely used (Chassin, 1997).
Other objectives should target areas of overuse to reduce waste and undue risk associated with health care interventions. Extensive evidence demonstrates overuse of a variety of health care services, including a study of Medicare beneficiaries that identified 17 percent of coronary angiographies, 32 percent of carotid endarterectomies, and 17 percent of upper gastrointestinal endoscopies as inappropriate (Chassin, 1987). While cesarean sections are appropriate for many deliveries, experts contend that cesarean section rates could be significantly reduced in many practice settings without harming maternal or fetal outcomes (Clarke, 1996, 1995).
Other important objectives include ensuring that best-known care is provided at the end of life and for individuals with chronic illness or disability. Because care for these individuals consumes a large share of total health care resources, assuring appropriate care is important both for quality of care and for health care costs. A recent study found that about 5 percent of Medicare patients hospitalized in intensive care units in California received potentially ineffective care. The study concluded that these costly, intensive health care interventions -- which were less likely to be provided to Medicare patients enrolled in HMOs than in the traditional fee-for-service plans -- were ultimately impotent in aiding their patients and, in some cases, may have prolonged patients' and families' suffering (Cher, 1997). In other areas, more intense levels of services may be appropriate for improving the functional capacity of people with disabilities. For example, a randomized evaluation found that stroke patients admitted to rehabilitative hospitals showed greater improvement in their ability to perform activities of daily living than similar patients admitted to skilled nursing facilities or traditional nursing homes. However, the same study found that outcomes did not vary across different rehabilitative settings for hip replacement patients (Kramer et al., 1997).
Reducing Errors in Health Care
Another major aim to improve health care and health status would be to improve patient safety by reducing the level of error in health care delivery and designing systems that mitigate the consequences of errors when they do occur. Research has indicated that significant levels of error occur with health care that often result in injury to patients, in large part due to the complex nature of health care delivery (Leape, 1997). For example, the Harvard Medical Practice Study found that adverse events occurred in nearly 4 percent of hospitalizations, and 16 percent of these led to permanently disabling injuries or death (Leape, 1991). Health care professional associations are increasingly drawing upon the expanding research in human factors analysis and successful models in other technically complex, high stress fields (such as aviation and nuclear power) that recognize that, while some errors will inevitably occur, systems should be designed and health care professionals trained in methods that can improve patient safety by reducing hazards in health care (Cook, 1995). The development of the National Patient Safety Foundation at the American Medical Association is an example of a collaborative effort undertaken by a professional association to target error reduction. These efforts could be further stimulated through identifying reducing error as a national aim for improvement, specifying objectives focused on reducing the level of health care errors, developing a non-punitive error-reporting system to better identify needed improvement (see Chapter 10), and engaging in national collaborative efforts to design approaches to improve patient safety and reduce hazards.
Addressing Health Care Resources
Improving health care, and ensuring that health care services are provided in a manner that will most effectively improve Americans' health status, requires matching health care capacity to the health needs of the population. This includes reducing excess capacity to avoid waste and reduce costs while increasing capacity to ensure access for underserved populations. Efforts to profile the wide variations in health care provided and resources available across states and localities can provide valuable tools for evaluating areas of oversupply and undersupply as well as the appropriateness of care (Dartmouth, 1997; Wennberg, 1997).
One objective in matching capacity to needs is to recognize that often there is a strong relationship between the volume of health services provided and the quality of patient care. For many procedures, research has indicated that patient outcomes are better among facilities and practitioners that perform a higher volume of specific procedures than those that perform relatively few of the same procedures. For example, Hannan has found that mortality rates in New York are significantly higher among hospitals that perform fewer than 600 coronary angioplasties per year and among cardiologists who perform fewer than 75 coronary angioplasties per year (Hannan, 1997). It has also been shown that access to knowledgeable, experienced health care professionals can make a difference in survival rates for persons with HIV/AIDS (Kitahata, 1996; Stephenson, 1996). Thus, for some procedures, better coordination of health care capacity, such as directing patients to regional centers of excellence, could help to maximize the benefits of the positive relationship between volume and quality.
Another important objective is to recognize that increased health care capacity can drive health care use. Since the 1960s, health care economists have cited the maxim that "a built bed is a filled bed" because an increased supply of health care services can induce demand for those services (Roemer, 1961). This trend continues. The Dartmouth Atlas of Health Care finds that "both the sick and the less sick, if they live in regions with higher supplies of hospital beds, use more hospital care." For example, a Medicare enrollee reporting good health in a locality in the bottom half of per capita hospital bed supply would spend on average a full day less in the hospital each year than a similar enrollee in an area in the top half of per capita hospital bed supply (Dartmouth, 1997).
In other locations, particularly urban centers and rural areas, health care capacity is inadequate. In these areas, the health care capacity may need to be supplemented by targeted development efforts and new methods of delivering quality health care, such as telemedicine. Health care information systems may be another area where current capacity is underdeveloped and additional investment is needed (see Chapter 14).
Increasing Patient Participation
The active participation of patients in their care has the potential to improve both the effectiveness of care as well as patients' satisfaction with their care. Patients who are well informed and participate in treatment decisions are more likely to assume responsibility for complying with their treatment plans. A study of patients with early breast cancer found that those who believed they were more responsible for treatment decisions and had more choice of treatment reported higher quality of life than those who perceived themselves as less in control of the treatment decisions (Street and Voigt, 1997). However, a 1988 study of hospitalized patients found that physicians discussed test or treatment rationale in only 43 percent of cases; alternative treatments in 12 percent of cases; benefits in 34 percent of cases; and risks in 14 percent of cases (Wu and Pearlman, 1988). Thus, increasing patient participation in their care by better informing patients regarding health care options is an important aim for improving health care.
In addition, consumers should be better enabled to practice appropriate self-care. Empowering individuals with the skills and tools necessary for caring for themselves is especially important for individuals with chronic illness or disability. For example, the treatment paradigm for children with asthma has shifted from emphasizing inpatient hospitalization for acute episodes to providing patients and their families with equipment and medication to monitor, prevent, and care for their condition at home (Sheffer, 1993). As a result, research has found that these self- management approaches reduce incidences caused by asthma, result in fewer visits to physicians, and improve quality of life (Lahdensuo, 1996). Studies have demonstrated that self-help groups improve health and reduce unnecessary physician visits as well as reduce secondary conditions associated with chronic conditions such as arthritis (Lorig, 1993). In general, better enabling consumers to assess their health, practice preventive health care, and practice self-care will enhance their health outcomes and functional capacity while reducing unnecessary health care services and costs.
ESTABLISHING AN AWARD FOR EXCELLENCE
Another way in which a focus on improvement can be encouraged in the health care industry is to recognize excellence in quality. Selectively recognizing achievements among organizations dedicated to health care improvement can increase public awareness of health care excellence, motivate collaboration and constructive competition among health organizations with the goal of improvement, and encourage best practices to be shared as public goods rather than as proprietary knowledge.
The Malcolm Baldrige National Quality Award, administered by the Department of Commerce's National Institute of Standards and Technology (NIST) with private-sector financial support, has set a strong precedent for recognizing quality achievement of U.S. companies in general. Since 1988, the award has recognized the excellence of 31 U.S. companies based on the criteria of leadership; strategic planning; customer and market focus; information and analysis; human resource development and management; process management; and business results. Companies are selected through written applications focusing on quantitative data and on-site visits by a panel of peer examiners for applicants reaching the last stage of Award review. All applicants receive feedback summarizing their strengths and areas for improvement. Thus, the benefits of the process of applying for the Baldrige Award -- conducting extensive self-examination and receiving outside review by quality experts -- extend beyond the handful of companies actually receiving recognition to all Award applicants. Finally, annual conferences showcasing the achievements of selected companies provide a forum for disseminating information on quality performance. These conferences and other information sharing activities using the Baldrige framework as a common language have demonstrated new approaches to organizational learning and demonstrated the benefits and potential for cross-industry learning.
While the Baldrige Award is well established among U.S. businesses in general, its current structure does not meet the needs of the health care industry. For example, the Baldrige Award is available only to for-profit companies, whereas a significant share of health care organizations are non-profit. To tailor the Baldrige Award process to the health care sector, a pilot program for a health care award was initiated in 1995, but Federal funding was discontinued in 1996. NIST currently is working with the Malcolm Baldrige National Quality Award Foundation to establish a long-term, private-sector funding base to complement proposed funding by the Federal government to support an award program (Heinz, 1998; NIST, 1997).
The Commission recommends that a Baldrige Award in health care be established to recognize organizations that excel in health care quality. In addition, the Commission recommends that the health care award be conferred on a noncompetitive basis so that any organization meeting the rigorous criteria established by the Baldrige Award receive recognition and that the public exchange of lessons learned by applicants as well as recipients can be encouraged. Furthermore, organizations receiving recognition through the award should demonstrate measurable achievement within the categories of the national aims for improvement.
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(1)Measurement was unavailable for about one-quarter of the objectives because of the lack of either baseline data or changes in tracking since the baseline.
(2)The development of data standards for key administrative transactions are mandated by the Health Insurance Portability and Accountability Act of 1996.
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