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4—
Building Leadership and Knowledge for Patient Safety

Errors in the health care industry are at an unacceptably high level. A national commitment to achieve a threshold improvement in patient safety is needed. This will require strong leadership, specification of goals and mechanisms for tracking progress, and an adequate knowledge base. This chapter proposes the development of the Center for Patient Safety within the Agency for Healthcare Research and Quality (AHRQ) to serve as a focal point for these activities. Experience from other industries suggests that unless a Center is created or designated to keep attention focused on patient safety and enhance the base of knowledge and tools, meaningful progress is not likely. Although existing efforts to improve patient safety are valuable, they are inadequate. There is no way of knowing if these efforts are attending to the most critical issues or if they are actually reducing errors. There must be greater attention placed on evaluating current approaches for reducing errors and building new systems to improve patient safety.

Recommendations

RECOMMENDATION 4.1 Congress should create a Center for Patient Safety with the Agency for Healthcare Research and Quality. This Center should



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4 Building Leadership and Knowledge for Patient Safety E rrors in the health care industry are at an unacceptably high level. A national commitment to achieve a threshold improvement in patient safety is needed. This will require strong leadership, specification of goals and mechanisms for tracking progress, and an adequate knowledge base. This chapter proposes the development of the Center for Patient Safety within the Agency for Healthcare Research and Quality (AHRQ) to serve as a focal point for these activities. Experience from other industries suggests that unless a Center is created or designated to keep attention focused on patient safety and enhance the base of knowledge and tools, meaningful progress is not likely. Although existing efforts to improve patient safety are valuable, they are inadequate. There is no way of knowing if these efforts are attending to the most critical issues or if they are actually reducing errors. There must be greater attention placed on evaluating current approaches for reducing errors and building new systems to improve patient safety. RECOMMENDATIONS RECOMMENDATION 4.1 Congress should create a Center for Patient Safety with the Agency for Healthcare Research and Quality. This Center should 69

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70 TO ERR IS HUMAN • set the national goals for patient safety, track progress in meet- ing these goals, and issue an annual report to the President and Con- gress on patient safety; and • develop knowledge and understanding of errors in health care by developing a research agenda, funding Centers of Excellence, evalu- ating methods for identifying and preventing errors and funding dis- semination and communication activities to improve patient safety. National goals for safety should be established through a process in- volving consumers, providers, health care organizations, purchasers, re- searchers, and others. The goals should also reflect areas that represent opportunities for significant improvement. In carrying out its activities in the areas of research and dissemination, the Center for Patient Safety should collaborate with universities, research centers, and various groups involved in education and dissemination, such as the National Patient Safety Foundation. The committee believes that initial annual funding of $30 to 35 million for a Center for Patient Safety would be appropriate. This initial funding would permit a center to conduct activities in goal setting, tracking, research and dissemination. Funding should grow over time to at least $100 million, or approximately 1% of the $8.8 billion in health care costs attributable to preventable adverse events (see Chapter 2). This level is modest compared to the resources devoted to other major health issues. The committee be- lieves a 50% reduction in errors over five years is imperative. WHY A CENTER FOR PATIENT SAFETY IS NEEDED As discussed in Chapter 2, errors in health care are a leading cause of death and injury. Yet, the American public is seemingly unaware of the prob- lem, and the issue is not getting the attention it should from leaders in the health care industry and the professions. Additionally, the knowledge that has been used in other industries to improve safety is rarely applied in health care. Although more needs to be learned, there are actions that can be taken today to improve safety in health care. Medical products can be designed to be safer in use, jobs can be designed to minimize the likelihood of errors, and much can be done to reduce the complexity of care processes. Although multiple agencies are concerned with selected issues that in- fluence patient safety, there is no focal point for patient safety in health care today. Public- and private-sector oversight organizations, such as state licen-

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71 BUILDING LEADERSHIP AND KNOWLEDGE FOR PATIENT SAFETY sure units, accrediting bodies, and federal certification programs devote some attention to patient safety, but patient safety is not their sole focus. The National Patient Safety Foundation conducts educational programs, work- shops, and various convening activities but its programs and resources are limited. The Food and Drug Administration (FDA) focuses only on drugs and devices through the regulation of manufacturers. The Joint Commission on Accreditation of Healthcare Organizations’ (JCAHO) mission is to im- prove quality of care through accreditation. This may include issues relevant to patient safety, but patient safety is not its sole focus. Many states operate reporting programs or other oversight programs for patient safety but they take a variety of approaches and focus. Although anesthesiology applied some of the techniques of system analy- sis and human factors during the 1980s, the concepts are just beginning to diffuse through the health care industry. The advantage of this lag is that we can learn about building safe systems from the experiences of others. The problem is that there has to be a substantially greater commitment to getting more and better information to advance the science and apply the tech- niques to health care. The next section describes how attention to safety issues has been ap- plied in two areas: aviation and occupational health. Both of these examples illustrate how broad-based safety improvements can be accomplished. HOW OTHER INDUSTRIES HAVE BECOME SAFER The risk of dying in a domestic jet flight between 1967 and 1976 was 1 in 2 million. By the 1990s, the risk had declined to 1 in 8 million.1 Between 1970 (when the Occupational Health and Safety Administration was cre- ated) and 1996, the workplace death rate was cut in half.2 Health care has much to learn from other industries about improving safety. Aviation Health care is decades behind other industries in terms of creating safer systems. Much of modern safety thinking grew out of military aviation.3 Until World War II, accidents were viewed primarily as individually caused and safety meant motivating people to “be safe.” During the war, generals lost aircraft and pilots in stateside operations and came to realize that plan- ning for safety was as important to the success of a mission as combat plan- ning. System safety continued after the war when several military aviation

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72 TO ERR IS HUMAN safety centers were formed in the early 1950s. Human factors started to enter the picture at around the same time. In 1954, the Flight Safety Foun- dation was formed to design aircraft cockpits using better human engineer- ing. In the mid-1960s, the University of Southern California began its first advanced safety management programs and included a heavy emphasis on human factors. By the 1970s, principles of system safety began to spread to other industries, including rapid rail and the oil industry. Building on the successful experience and knowledge of military avia- tion, civilian aviation takes a comprehensive approach to safety, with pro- grams aimed at setting and enforcing standards, accident investigation, inci- dent reporting, and research for continuous improvement. The Federal Aviation Administration (FAA), housed in the Department of Transportation, has regulatory oversight of the industry and an explicit charge for ensuring safety. Accident investigations are conducted by the National Transportation Safety Board (NTSB), an independent federal agency, which has no regulatory or enforcement power but can issue recom- mendations to the FAA for regulatory action. Confidential incident report- ing (defined as an occurrence associated with the operation of an aircraft that affects or could affect the safety of operations) is conducted through the National Aeronautics and Space Administration Aviation Safety Reporting System (ASRS), which is discussed in Chapter 5. Research into safety is an integral component of the aviation industry strategy. The national research agenda is set through several mechanisms. First, a formal process determined how to allocate approximately $60 mil- lion committed to the Aviation Safety Program for FY 2000 (Cynthia Null, Ames Research Center, personal communication, May 24, 1999). Workshops and meetings were held with multiple agencies and organizations to define the work in the specific program area; participants included NASA, FAA, Department of Defense, all levels of airline employees (pilots, maintenance workers, flight attendants, air traffic controllers), airlines, manufacturers, and others. Existing resources are being redirected consistent with the pri- orities. Other research that supports safety is funded through “base re- search” in which in-house researchers propose and carry out research projects for development. Research into human factors is part of the base research program. The Aviation Safety Reporting System may also conduct “topical re- search,” which could include structured callback studies on a certain topic or basic research. This area of work is funded within ASRS’s main program, but funding is not often available (Linda Connell, Director of ASRS,

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73 BUILDING LEADERSHIP AND KNOWLEDGE FOR PATIENT SAFETY personal communication, May 20, 1999). Human factors researchers at Ames may also tap into the ASRS database to generate hypotheses which can then be tested through other research. Finally, the FAA itself maintains several databases that aggregate a vari- ety of statistics (e.g., airline operations such as departures, hours and miles flown, history of safety recommendations to different parts of the industry and responses to them). FAA and NASA coordinate their research efforts to minimize duplication. For example, both agencies may jointly contribute to a single effort, or they may fund different, but complementary, aspects of an issue. Charles Billings, M.D., designer and founder of the Aviation Safety Re- porting System, has stated his belief that aviation would not be as safe as it is today without the FAA.4 By setting standards, maintaining multiple data- bases to monitor trends, and supporting research to constantly improve sys- tems, the FAA (in collaboration with other agencies such as NASA and NTSB) has made flying safer. Occupational Health The Occupational Safety and Health Act of 1970 created both the Oc- cupational Safety and Health Administration (OSHA), housed in the De- partment of Labor, and its research arm, the National Institute for Occupa- tional Safety and Health (NIOSH), housed in the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services. OSHA’s purpose is to encourage employers and employees to re- duce workplace hazards and to implement new, or improve existing, safety and health programs. It provides for research in occupational health and safety, maintains reporting and record-keeping systems, establishes training programs, and develops and enforces mandatory standards for job safety and health.5 OSHA is administered through a combined federal–state ap- proach. States that develop their own programs and have an approved plan receive up to 50 percent of the plan’s approved operating costs. OSHA requires employers with 11 or more employees to routinely main- tain records of occupational injury and illness as they occur. These records are not submitted to OSHA, but must be made available during inspection and shared with OSHA if the company is selected for an annual tracking survey. OSHA and the Bureau of Labor and Statistics both conduct sample surveys to collect the routine data maintained by companies. These surveys

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74 TO ERR IS HUMAN are used to construct population rates or to examine particular issues of concern. A related incentive for employers to create a safe environment is the worker’s compensation program. Under state law, employers must pay the premium for insuring workers against the medical costs of injuries sustained while on the job. Responsibility for the costs associated with workers com- pensation further encourages employers to improve the safety systems in their companies. Responsibility for research and for identifying new safety improvements is housed in a separate agency. The National Institute for Occupational Safety and Health (NIOSH) has the responsibility for conducting research and making recommendations for the prevention of work-related illnesses and injuries.6 It conducts and funds research on safety and health problems, provides technical assistance to OSHA, and recommends standards for OSHA adoption. Although OSHA provides input into the NIOSH research agenda, it is set mainly through input from other stakeholders, including company requests. Information gathered by NIOSH from these companies for research purposes is not shared with OSHA for regulatory purposes. A major agenda for research was established in 1996 through the Na- tional Occupational Research Agenda (NORA). Input was obtained from 500 public and private organizations to provide a framework for safety re- search during the next decade and to guide intramural and extramural fund- ing decisions. Twenty-one research priorities were selected and are now be- ing implemented, mostly by shifting existing resources so that over time, more monies are directed to the priority areas. For example, in 1998, NIOSH and three institutes at the National Institutes of Health (NIH) committed $24 million over three years to certain priority areas.7 For 1999, NIOSH’s operating budget is $200 million, of which $156 million is for intramural and extramural research projects (Janice Klink, Associate Director for Policy, Planning, and Legislation, NIOSH, personal communication, May 19, 1999). Lessons Learned There are several key points to be taken from the experiences in aviation and occupational health. In each of these areas, there was a growing aware- ness of safety concerns and the need to improve performance. This led to comprehensive strategies, which included the creation of a national focal point for leadership, development of a knowledge base, and dissemination of information throughout the industry.

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75 BUILDING LEADERSHIP AND KNOWLEDGE FOR PATIENT SAFETY In both areas, there is a designated government agency with regulatory responsibility for safety, which is separate from the agency responsible for research. Although the entity responsible for research may generate reports that are useful to the regulatory authority in setting standards, data and in- formation collected from organizations are not available for use in enforcing standards on a particular organization. Both areas recognized the need to rapidly expand the knowledge base on safety and to establish ongoing processes for the diffusion of this knowl- edge. The creation of a carefully constructed research agenda was devel- oped with broad-based input from the industry and is implemented through both public- and private-sector programs to draw upon the best expertise in the academic and scientific communities. Finally, substantial resources were devoted to these initiatives. Achiev- ing steady improvement requires that adequate resources be sustained over a sufficient period of time. The safety improvements did not occur because of a one-time effort. The results were achieved through an ongoing commit- ment of resources and leadership. Although some of these components can be found in health care to- day—regulatory oversight, research and dissemination—there is no cohe- sive effort to improve safety in health care, and the resources devoted to enhancing and disseminating the knowledge base are wholly inadequate. Given the experience of other industries, health care is not likely to make significant safety improvements without a more comprehensive, coordinated approach. OPTIONS FOR ESTABLISHING A CENTER FOR PATIENT SAFETY Objectives The objectives of a Center for Patient Safety are to provide leadership for safety improvements throughout the industry, to establish goals and track progress in achieving results, and to expand the knowledge base for improv- ing safety in health care. A central objective of the Center for Patient Safety is to provide visibil- ity to safety concerns. The leadership of the Center must possess the requi- site expertise and stature to communicate with a broad audience to raise awareness of safety concerns and convene stakeholders to identify strategies for improving safety.

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76 TO ERR IS HUMAN Expanding the knowledge base requires the formulation and implemen- tation of a research agenda. Such an agenda should include short-term, fo- cused studies as well as long-term, population studies. Expanding the knowl- edge base also requires effective methods for diffusing the new knowledge to a variety of audiences, including those in the industry and the general public. The Center should develop a limited number of high-priority goals based on careful analysis of areas in which improvements will result in the greatest gains in terms of reduced morbidity and mortality and reduced costs. Specific goals identify priority areas for the industry so the industry can respond supportively. Specific goals also provide a basis for tracking change. Safety efforts must be evaluated to determine whether actual improvements are being achieved and to ensure that resources are allocated to high-prior- ity areas that will have the most impact on patients. Implementation Options The committee believes that an organization designated as the focal point for patient safety should have the following characteristics. First, it should be involved in a broader agenda for improving quality. Patient safety is part of general quality improvement, even if certain safety problems may utilize distinct knowledge and expertise. It would not be desirable to have one agency focused on quality issues and a separate agency focused on pa- tient safety. Second, the agency should possess the core competencies required to undertake the broad array of tasks identified. Although some may be carried out through partnership arrangements, the agency should have adequate expertise and funding to engage in strategic planning, convening, tracking, research and evaluation, and information dissemination activities. Finally, the designated agency should be able to work collaboratively with other health- and non-health-related safety agencies. For example, it should consult with NTSB and ASRS to understand how an entire industry sets safety as a priority and becomes safer over time. Experts from OSHA may also offer guidance on their experience in encouraging companies to build safety systems within their own organizations. Collaboration with the National Patient Safety Foundation might be desirable in carrying out vari- ous agenda-setting and education activities. The committee discussed three alternative organizational arrangements for a Center for Patient Safety. One option considered was the creation of a

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77 BUILDING LEADERSHIP AND KNOWLEDGE FOR PATIENT SAFETY new, free-standing agency whose sole purpose is to focus on patient safety issues. A second alternative was to place such a center within NIH, as a defined division or institute. A third option was to place the proposed Cen- ter for Patient Safety within the AHRQ. The committee decided that placing the Center within AHRQ was the best option for several reasons. Although a dedicated agency might be most able to maintain a focus on patient safety, this option should be pursued as a last resort, given the resources and time required to establish a new agency. NIH has the expertise and industry respect to drive a basic research agenda and has built partnerships with other agencies, but its agenda is already very broad and does not routinely involve analyses of systems of care or quality measurement or improvement. AHRQ is already involved with a broad range of quality-of-care issues, including quality measurement, quality improvement, and identification of best practices. The Consumer Assessment of Health Plans (CAHPS) is a standardized measurement and reporting tool in which consumers report their experience with specific aspects of their health plans to assess the fea- tures that form the basis of overall satisfaction. The goal is to provide con- sumers and purchasers with objective information for choosing among health plans. Another initiative is the support of evidence-based practice centers. These are five-year contracts awarded to 12 institutions to review scientific literature on assigned clinical care topics and to produce evidence reports and technology assessments, conduct research on methodologies and the effectiveness of their implementation, and participate in technical assistance activities. AHRQ also is engaged in activities specifically related to patient safety, and these activities constitute a good base of experience upon which to ex- pand. AHRQ has sponsored research in the area of patient safety, specifi- cally in the areas of medication errors, diagnostic inaccuracies, inaccurate information recall by patients, and system failures in adverse drug events.8 A recent Memorandum of Understanding was executed with the National Institutes on Aging to cofund a grant to examine adverse drug events among a geriatric population in an ambulatory setting. Technologies tested in AHRQ-sponsored research that would improve patient safety include com- puterized monitoring of adverse drug events, computer-generated remind- ers for follow-up testing, standardized protocols, and computer-assisted de- cision making. A new AHRQ endeavor initiated in 1998 is the establishment of Centers for Education and Research in Therapeutics (CERTs). CERTs will conduct

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78 TO ERR IS HUMAN research to increase understanding of ways to improve the appropriate and effective use of pharmaceuticals and other interventions to avoid adverse drug events. CERTs will also increase knowledge of the possible risks of new drugs and combinations of drugs, as they are prescribed in everyday prac- tice. CERTs are being implemented in collaboration with FDA.9 AHRQ also has experience in collaborating with other relevant organi- zations. It has provided support for meetings on patient safety and is a mem- ber of the National Patient Safety Partnership, a public–private group dedi- cated to reducing preventable adverse medical events. AHRQ participates in the Quality Interagency Coordinating Committee (QuIC), which is devel- oping an initiative on reducing medical errors. AHRQ also sponsors the User Liaison Program (ULP) as a vehicle to link states, local health policy makers and researchers to disseminate research to states, conduct work- shops, and provide technical assistance.10 Finally, the agency’s reauthorization legislation for FY 2000 is expected to include explicit language defining a focus on reducing medical errors and improving patient safety. FUNCTIONS OF THE CENTER FOR PATIENT SAFETY Creating an information infrastructure and building a better evidence base for patient safety are critical to taking a more strategic approach to reducing medical errors and improving patient safety. The goal is to improve decision making by policy makers, regulators, health care organizations, and others, so that decisions are based on evidence rather than anecdote. Good information can and should be used to guide the development and continu- ous improvement of standards and to support communication and outreach efforts. The Center for Patient Safety should build an information infrastruc- ture and resource for patient safety. It should have a broad agenda com- prised of multiple programs. In its first five full years of existence, it should deliver the following products: 1. Establish a limited set of high-priority goals for improving patient safety based on expert opinion and review of the evidence on errors. 2. Assess progress toward national goals by compiling aggregate infor- mation from state adverse event reporting systems, voluntary reporting sys- tems, health care organizations, and other sources; and periodically con- ducting a representative survey of health care organizations. 3. Develop a research agenda, conduct and fund intramural and extra-

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79 BUILDING LEADERSHIP AND KNOWLEDGE FOR PATIENT SAFETY mural research to assess the magnitude of errors, and the role of human factors, and test and evaluate approaches for preventing errors. 4. Define feasible prototype systems (best practices) and tools for safety in key processes, including both clinical and managerial support systems for: • medication systems (from prescribing to administering), • operating rooms and surgery processes, • emergency departments, • management of diagnostic tests, screening, and information, • intensive care units, • neonatal intensive care units, • care of frail elderly (e.g., falls, decubitus, etc.), • the use of simulation and simulators in health care, and • team training and crew resource management applications in health care. 5. Develop instructional methods, demonstration projects, and techni- cal support to ensure widespread implementation of the prototype systems and tools identified above. 6. Conduct periodic evaluations of error reporting systems for two pur- poses: assessing the impact of mandatory reporting systems in various states and identifying best practices in program design and implementation; and assessing the usefulness of voluntary reporting systems in identifying impor- tant safety improvements and determining whether current levels of partici- pation by health care organizations are adequate or additional incentives are needed. 7. Provide support to health care organizations for internal quality im- provement demonstration projects to prevent and reduce errors. 8. Develop tools and methods for educating consumers about patient safety. 9. Issue an annual report on progress made to improve patient safety, and recommend changes for continuously improving patient safety to ap- propriate parties, such as FDA, states, accrediting agencies, professional as- sociations, group purchasers, and health care organizations. In setting the research agenda, the Center for Patient Safety should establish a formal process to gather input on priorities, methodologies and approaches for research. Advice should be obtained from a wide range of people and organizations who will use and can benefit from the availability of information. It should look at the experiences of other industries and the

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80 TO ERR IS HUMAN processes they employed, such as aviation and occupational health, as al- ready described. Initial areas for attention might include the following: • enhance understanding of the impact of various management prac- tices (e.g., maximum work hours and overtime) on the likelihood of errors; • apply safety methods and technologies from other industries to health care, especially human factors and engineering principles; • increase understanding of errors in different settings (e.g., ambula- tory or home care) and for vulnerable populations (e.g., children, elderly); • establish baseline rates of specific types of errors and monitor trends; • monitor error rates that accompany the introduction of new tech- nologies; and • increase understanding of the use of information technology to im- prove patient safety (e.g., automated drug order or entry systems, reminder systems). In conducting research and developing prototype systems, the Center should consider providing support for the establishment of several Centers of Excellence in academic or applied research settings and which can gather expertise from diverse settings as needed. Centers of Excellence might focus on particular types of errors (e.g., medication-related errors), errors in par- ticular settings or clinical specialties (e.g., intensive care), or types of inter- ventions or strategies that might be applied across many areas and settings (e.g., interdisciplinary teams). In establishing Centers of Excellence, the Center for Patient Safety will want to learn from and coordinate with the Veterans Health Administration (VHA), which has pursued a similar strategy on a much smaller scale. As part of its comprehensive program in improving patient safety throughout their delivery system, the Veterans Health Administration has committed $6 million to establish four Patient Safety Centers of Inquiry, focused on re- searching new knowledge in patient safety, with special emphasis on trans- ferring safety technologies from other high-risk industries to health care, and on disseminating existing knowledge.11 It is also imperative that the Center for Patient Safety focus adequate attention on the communication of information on and knowledge of pa- tient safety. The support and production of more and better information on medical errors and patient safety will be of little use without explicit mecha- nisms identified for dissemination of the information and recommended ac- tions. Although dissemination of information is sometimes an afterthought, there are attributes that can improve outreach. Important factors that have

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81 BUILDING LEADERSHIP AND KNOWLEDGE FOR PATIENT SAFETY been identified are translating raw data into summary measures and infor- mation that can be used; presenting information in formats that are tailored to different audiences; and providing multiple ways to access the informa- tion, such as print, television, radio, videotaped presentations, online ser- vices, and face-to-face presentations. The information also needs to be timely and to come from a credible source.12 At the present time, there are few objective sources for the latest infor- mation on patient safety. Improvements may be made in practice within health care organizations, but there is no way to disseminate such informa- tion to a broader audience. An important responsibility of the Center for Patient Safety should be to work to increase the frequency of communica- tion about patient safety to multiple audiences. In carrying out its responsi- bilities to communicate information and knowledge on safety, the Center should work closely with existing organizations that have related objectives, including public and private organizations; policy, educational and accredit- ing entities; and quality oversight organizations. The National Patient Safety Foundation (NPSF) is an existing organiza- tion that may be able to serve this resource and dissemination role. The National Patient Safety Foundation was formed by the American Medical Association in 1997 as an independent, nonprofit research and education organization, whose mission is to improve patient safety in the delivery of care. The AMA’s goal was to establish linkages with other health care organi- zations dedicated to improving patient safety. NPSF is well positioned to “translate” concerns and findings about pa- tient safety between many different parties because of the broad base of representation on its board that can communicate with various constituen- cies and its proven ability to convene a mix of stakeholders. NPSF’s core strategies include activities to raise awareness and foster communication and dialogue to enhance patient safety and to develop information, collaborative relationships, and educational approaches that advance patient safety.13 It supports an annual grant program for innovative research to prevent patient injuries; has conducted a benchmark survey to capture consumer attitudes, experience and expectations about health care safety; conducts regional fo- rums to bring together community and health leaders in local communities and convenes national conferences that brings together leaders in patient safety from around the world.14 NPSF has also begun developing a clearing- house function to collect patient safety information that can be accessed by both health professionals and consumers. The National Patient Safety Partnership is a voluntary public–private partnership, comprised of the American Hospital Association, American

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82 TO ERR IS HUMAN Medical Association (AMA), American Nurses Association, Association of American Medical Colleges, JCAHO, National Patient Safety Foundation of the AMA, and Department of Veterans Affairs as charter members. Addi- tional members include AHRQ, FDA, HCFA, NIOSH, and the Depart- ment of Defense, Health Affairs. Its primary concerns have focused on year 2000 (Y2K) issues and adverse drug events.15 The deliverables previously identified for the Center for Patient Safety include the development of tools and methods for educating consumers about patient safety. Although consumers are an important audience, there are many other constituencies that must be reached, including health pro- fessionals and managers, health care organizations, state and national policy makers, regulators, pharmaceutical companies and medical device manufac- turers, professional groups and associations, medical and health care train- ing centers, and various forms of media. Although AHRQ and the Center for Patient Safety will disseminate their work on patient safety through cur- rent mechanisms (e.g., reports, newsletters, Internet), the NPSF and the National Patient Safety Partnership are existing organizations that can sup- port a broad approach for dissemination activities. RESOURCES REQUIRED FOR A CENTER FOR PATIENT SAFETY In determining what would be an adequate level of funding for a Center for Patient Safety, the committee considered three things: (1) research in- vestments made to address health care issues of a similar magnitude; (2) investments in safety research in other industries; and (3) operating budgets for research initiatives with similar programs. The United States invests significant resources in research to reduce the morbidity and mortality associated with various diseases and health con- cerns. As noted in Chapter 2, medical errors among hospitalized patients ranks as a leading cause of death, exceeding the number of deaths in 1997 due to motor vehicle accidents, breast cancer, or AIDS. NIH funding in 1998 for AIDS was estimated at $1.6 billion and for breast cancer, $433 million.16 Another funding comparison in health care is to examine research centers that have a more focused agenda. The National Institute for Deaf- ness and Other Communication Disorders has funding of approximately $230 million in FY99.17 The National Institute of Nursing Research received funding of approximately $63 million in FY99.18 These are examples of “smaller” institutes at NIH. The success of other industries in improving safety is undoubtedly at-

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83 BUILDING LEADERSHIP AND KNOWLEDGE FOR PATIENT SAFETY tributable in part to the commitment made to enhancing the knowledge base. As noted previously, the NIOSH operating budget for 1999 is $200 million, of which $156 million is for intramural and extramural research projects. The Aviation Safety Program at NASA Ames Research Center allo- cated approximately $60 million for FY 2000. Another funding comparison is the resources devoted by AHRQ to dif- ferent programs. In FY 1999, $2 million was appropriated for the CERTs, newly established research centers; twice that amount is expected for FY 2000 to continue funding.19 The Evidence-Based Practice Centers at AHRQ are funded at more than $3 million per year (Nancy Foster, AHRQ, personal communication, July 22, 1999). AHRQ also conducts a Medical Expendi- ture Panel Survey for which almost $35 million was appropriated in FY 1999.20 Finally, the Veterans Health Administration created several centers within its own system devoted to research and improved understanding about medical errors. It committed $6 million over 4 years. Initial annual funding of $30 to 35 million for the Center for Patient Safety would be reasonable. This estimate is based on the functions that the center is to perform. Goal setting would involve convening a broad set of audiences for input into goals and a research agenda. Regional meetings and other mechanisms may be employed to gather input. It is estimated that approximately $2 million would be needed for goal setting activities. Track- ing progress on meeting goals would require periodic data collection from health care organizations. The Harvard Medical Practice Study reviewed over 31,000 hospital records and cost approximately $3 million. The devel- opment and implementation of a national survey is estimated at $5 million. To implement a research agenda, it is estimated that five Centers of Excel- lence would be formed, each with a specific focus of attention. Each Center of Excellence should be initially funded at $5 million, growing over time to $15 million each. Dissemination of information to the industry, general pub- lic, policy makers and others is estimated initially at $5 million. The estimate of initial funding seems modest in light of the investments made to address health concerns of similar magnitude. The committee believes that the growth in the funding level is necessary to communicate to researchers, states, professional groups and health care organizations that this will be a sustained effort. In the absence of a signifi- cant long term commitment to funding, researchers are unlikely to re-orient their focus to patient safety. The patient safety initiatives of other groups, such as states, professional associations and health care organizations are likely to be far more successful if accompanied by a steady flow of new

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84 TO ERR IS HUMAN knowledge, tools, and prototype systems. It can take several years to create awareness about safety and build interest. The growth in funding recognizes that initial funding should be at a lower, but sufficient, level to begin work in the area, but should grow over time as the efforts evolve and expand. REFERENCES 1. “The Aviation Safety System,” Aviation Safety Information From The Federal Aviation Administration, http:www.faa.gov/publicinfo.htm 2. “Common Sense at Work,” OSHA Vital Facts 1997, Occupational Safety and Health Administration, Department of Labor, http://www.osha-slc.gov/OshDoc/ OSHFacts/OSHAFacts.html, last modified May 4, 1999. 3. Miller, C.O., “System Safety,” in Human Factors in Aviation, eds., Earl L. Wiener, David C. Nagel, San Diego, CA: Academic Press, Inc., 1988. 4. Comments to Subcommittee on Creating an External Environment for Quality, IOM Quality of Health Care in America project, January 28, 1999. 5. “All About OSHA,” OSHA 2056, 1995 (Revised), http://www.osha.gov 6. “About NIOSH,” National Institute for Occupational Safety and Health, Cen- ters for Disease Control, http://www.cdc.gov/niosh/about.html 7. “NIOSH/NORA Fact Sheet, July 1999,” www.cdc.gov/niosh/99-130.html, July 29, 1999. 8. Reducing Errors in Health Care. Research in Action, September, 1998. Agency for Healthcare Research and Quality, Rockville, MD. http://www.AHRQ.gov/research/ errors.htm. 9. Therapeutics Research Centers to be Established Through Federal Cooperative Agreement Funding: Applications Sought. Press Release. February 1, 1999. Agency for Healthcare Research and Quality, Rockville, MD. http://www.AHRQ.gov/news/press/ pre1999/certspr.htm. 10. “Research Findings, User Liaison Program,” http://www.AHRQ.gov/research. 11. NPSF News Brief, No. 6, March 22, 1999, The National Patient Safety Founda- tion at the AMA. http://www.ama-assn.org/med-sci/npsf/news/03_22_99.htm. 12. Quality First: Better Health Care for All Americans, The President’s Advisory Com- mission on Consumer Protection and Quality in the Health Care Industry. Final Report, Washington, D.C., March 1998. 13. Request for Proposals for Research in Patient Safety, The National Patient Safety Foundation at the AMA. http://www.ama-assn.org/med-sci/npsf/focus.htm, January 1999. 14. “Leading the Way,” National Patient Safety Foundation at the AMA, http:// www.ama-assn.org/med-sci/npsf/broc.htm. 15. Kenneth W. Kizer, presentation at National Health Policy Forum, May 14, 1999, Washington, D.C. 16. Institute of Medicine, Scientific Opportunities and Public Needs. Improving Pri- ority Setting and Public Input at the National Institutes of Health. Washington, D.C.: National Academy Press, 1998. 17. “Fiscal Year 2000 President’s Budget request for the National Institute on Deaf-

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85 BUILDING LEADERSHIP AND KNOWLEDGE FOR PATIENT SAFETY ness and Other Communication Disorders,” Statement by Dr. James F. Battey, Jr., Direc- tor, National Institute of Deafness and Other Communication Disorders, www.nih.nidcd/ about/director/openstate00.htm 18. Fiscal Year 2000 President’s Budget request for the National Institute of Nursing Research,” Statement by Dr. Patricia A. Grady, Director, National Institute on Nursing Research, www.nih.gov/ninr/openingstatement99.htm. 19. Margaret Keyes, AHRQ Center for Quality Measurement and Improvement, pre- sentation to Subcommittee on Creating an External Environment for Quality of the IOM Quality of Care in America Study, June 15, 1999. 20. Justification for Budget Estimates for Appropriations Committees, Fiscal Year 2000. Agency for Healthcare Research and Quality, Rockville, MD. http://www.AHRQ.gov/ news/cj2000/cjweb00.htm.