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~ ~ ~ ~ of; Hi ~ Highlighted Reports To Err is Human: Bui/cling a Safer Hea/fh System Perhaps the best example of the Institute of Medicine's potential for shaping and guiding health care policy is To Err Is Human: Building a Safer Health System, a report on preventable errors in the health care delivery system. The lOM Quality of Health Care in . ~ . it would be irresponsible to America Committee was formed in June expect anything less than a 50 1998. Its charge: Develop a 10-year na- percent reduction in errors over tional strategy to effect a threshold im- 5 years. provement In quality. The committee's first report, To Err Is Human, was intended to break the cycle of inac- tion on medical errors. Given current knowledge -about the magnitude of the problem, it would be irresponsible to expect anything less than a 50 percent reduction in errors over 5 years. To Err Is Human argues for a comprehensive approach to im- prove patient safety. It does not focus on a single solution because there is no "magic bullet" that will reduce errors; and, indeed, no sin- gle recommendation in the report should be considered as the answer.

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Informing the Future: Critical Issues in Health ~ developing its recommendations, the committee sought to strike a balance between regulatory and market-based initiatives, and between the roles of professionals and organizations. The report offers a four- part plan to improve safety: expand the knowledge base about errors and safety, implement mechanisms to learn about and prevent errors, raise oversight standards related to safety and implement safe prac- tices at the local delivery level. The combination of activities proposed in the report offers a roadmap toward a safer health system. The committee recommended that the proposed program be evaluated after 5 years to assess prog- ress in making the health system safer. Despite the difficulty of its subject, To Err Is Human is positive and optimistic. Its Executive Summary concludes: "With adequate leadership, attention, and resources, improvements can be made. It may be part of human nature to err, "it may be part of human nature to but it is also part of human nature to err, but it is also part of human create solutions, find better alterna- nature to create solutions. . . ." fives, and meet the challenges ahead." The response to the report has been rapid arid far-reaching, with activities occurring at the national, state, and local levels to address dif- ferent aspects of the four-part plan. On December 7, 1999, President Clinton signed an executive order inaugurating a major federal ~n~tia- tive to improve patient safety in federally funded health care programs. The Agency for Health Care Research and Quality has developed a research agenda for patient safety and awarded several grants In FY 2000 to improve understanding about how to prevent errors. Numerous congressional hearings were held and bills that would provide up to $40 million for patient safety research have been introduced. At the state level, activities have focused on creating consistent ap- proaches for learning about errors rapidly to prevent their recurrence. Accrediting organizations and large purchasers are considering how they can strengthen their standards for patient safety. The Leapfrog Group, a consortium of Fortune 500 comparnes sponsored by the Busi- ness Roundtable, has made a commitment to use their purchasing 6

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Highlighted Reports power to put forth stronger safety standards, such as the use of com- puterized physician order entry for medications. Several professional societies have increased their attention to error prevention through con- ferences and journals and are developing strategies for continuing edu- cation. At the local level, health care organizations Took for new ways to improve safety within their own institutions, with hospitals particu- larly focused on improving medication safety as a starting point. Media coverage on television, radio, arid in newspapers and magazines has alerted consumers to the actions they can take to improve the safety of the care they receive by asking questions and staying informed. Ca//ing file Shots: /mmunization Finance Policies anc/ Practices In June 2000, TOM released Ca Ring the Shots: Immunization Finance Policies and Practices. This study, originally requested by the U.S. Senate Appropriations Committee, examines the finance requirements of the U.S. national immunization system and offers a comprehensive analysis of the public and private health care systems that support the purchase and delivery of vaccines for children and adults in the United States. The study corrunittee concluded that the infrastructure that sup- ports the U.S. immunization system is weakening, even though cov- erage rates for young children have reached record highs. The addi- lion of new vaccines; the shift in serv- ices between public and private health . . . the infrastructure that supports care systems; the increased needs for the U.S. immunization system is surveillance, education, and safety ef- weakening, even though coverage forts; and the data requirements of the rates for young children have immunization system have all placed reached record highs. extraordinary demands on state public health systems. As a result, states are unable to exercise new respon- sibilities in such areas as performance assessment and assurance, nor are they able to engage effectively in policy development with public and private health finance systems. 7

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Informing the Future: Critical Issues in Health The committee recommended Mat the federal government increase its investment in immunization infrastructure by $75 million per year which would increase annual state grant awards to a total of $200 mil- lion. State governments were also urged to increase their levels of ex- penditure for immunization infrastructure by $100 million per year. The committee further recommended that the federal government spend an additional $50 million per year on adult vaccines, focusing on the needs of high-nsk adults between IS and 65 years of age who are ineligible for other fonns of heath care assistance. Congress arid We Centers for Disease Control arid Prevention (CDC) have acted swirly in response to the report's recommendations. The CDC has indicated Mat the report provides art excellent bluepnnt to guide its state grant award system ir1 Me fixture. The FY 2001 appro- pna~cions bill for Me Department of The CDC has indicated that the report provides an excellent blueprint to guide its state grant award system in the future. Health arid Human Services (DHHS) includes half of the recommended in- crease for in~as~ucture ($37.5 m~- lion), with He remaining half sched- uled for support in FY 2002. State governments are now considering increasing Heir own investments. A series of regional briefings win state-level legislative, budgetary, arid heath officials wall be organized In 2001 to consider ways In which these recommendations could be Implemented. Organ Procurement and Transp/antation: Assessing Current Policies and the Pofenfia/ impact of the DHHS Fina/ Rule ~ He fall of 1998, Congress asked He TOM to review He potential im- pact that a DHHS regulation Known as the "Final Rule") would have on various aspects of organ procurement and transplantation. These areas included access for low-income and minority populations, organ donation rates, waiting times for transplants, patient survival rates, and costs. The area of most concern to DHHS, Congress, and He transplant community was liver transplantation. An implicit issue, underlying the 8

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Highlighted Reports tension between DHHS and its con- The thrust of the report was to tractor, the United Network for Bogart support through a rigorous Sharing, was He appropriate scope of statistical analysis that had not federal oversight. The Trust of the re- been clone previously the port was to supportthrough a rigor- conclusion that broacler sharing of ous statistical analysis that had not been organs would save anc! improve done previously" the conclusion that lives, and that there [is] a clear broader sharing of organs would save need for stronger federal and improve lives, and Hat Here was a oversight. clear need for stronger federal over- sight. The report's recommendations were integrated into the Final Rule and were instrumental In facilitating its enachnent. The Unequa/ Burden of Cancer: An Assessment of N/H Research anc/ Programs for Ethnic Minorities and the Mec/ica//y Unc/erserved This congressionally requested study examined the range of research and training programs supported by the NTH that address racial and ethnic dispanties in cancer incidence, morbidity, and mortality. The study committee notes that while NIH, and in particular the National Cancer Institute (NC0, has funded an impressive array of programs designed to increase knowledge of the impact of cancer in ethnic mi- Potty communities, no blueprint or strategic pearl appeared to guide this activity. In addition, funding for research and training programs to meet the specific needs of ethnic minority communities appeared insufficient to address the unequal burden of cancer. The report's recommendations included suggestions that NCT ex- pand surveillance programs to provide a more complete understanding of the burden of cancer among ethnic minority and medically ur~der- senred populations, provide greater authority and funding to the NCT Office of Special Populations Research, expand behavioral and social science research regarding cancer risk factors and population-based intervention strategies, and increase public participation in the NIH research pnonty-setting process. ~ response to these recommenda- 9

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Informing the Future: Critical Issues in Health lions, NTH has developed a comprehensive strategic plan to address minority health dispanties and is establishing a center to coordinate and focus minority health research efforts. A similar legislative pro- posal to establish a Center for Health Disparities is pending before Congress. In addition, NCI's National Cancer Advisory Board has re- viewed NCT funding of research and training programs relevant to mi- nonty and medically underserved populations and has recommended several changes in the institute's accounting procedures to provide more accurate infonnation regarding limping for these programs. Benefits Coverage: Extending Medicare Reimbursement in Clinical Trials The Balanced Budget Act of 1997 directed the Health Care Financing Administration (HCFA) to commission a study of payment of routine patient care costs for Medicare beneficiaries enrolled in approved cTini- cal tnal programs. A committee was established under the aegis of the National Cancer Policy Board to explore this subject. In December . . . clinical trials are integral to modern medical care and to the progress of medical science. 1999, the committee issued Extending Medicare Reimbursement in Clinical Trials. The TOM concluded that clini- cal teals are integral to modern medical care and to the progress of medical sci- ence. HCFA has issued little explicit policy on payment for care of pa- tients in teals, although Medicare law has been widely interpreted to exclude such payment. The TOM report noted, however, that bills for payment are usually submitted, arid paid, without disclosing or recog- nizing patient participation in trials. The report recommended that clinical trials should be encouraged, that patients should be reassured that costs will be covered as they would absent a trial, and that art ex- plicit decision should be issued by HCFA to implement such policies and eliminate any confusion. On June 7, 2000, President Clinton issued an executive memoran- dum directing the Secretary of Health aIld Human Services to "explic- itIv authorize (Medicare) payment for routine patient care costs . . . and ~0

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Highlighted Reports costs due to medical complications associated with participation in clinical teals," and his memorandum cited the TOM report as a promi- nent basis for this directive. By September 2000, HCFA issued a proposed National Coverage Decision which required cover- age of care costs of patients in clinical tri- als for "all items and services that are oth- . . President Clinton issued an executive memorandum . . . to "explicitly authorize (Medicare) payment for routine patient care erwise generally available to Medicare costs . . . and costs clue to beneficiaries...except the investigational mecli<:al complications associ- item or service, itself, items provided ateclwith participation in clinical solely to satisfy data collection needs, . . . trials," and his memorandum and items arid services provided by the cited the lOM report as a promi- ~al sponsor without charge." This deci- nent basis for this clirective. sion applies to both fee-for-service Medi- care and Medicare+Choice. In January 2001, the National Cancer Pol- icy Board will begin examining how HCFA is disseminating this cov- erage decision and ensuring that providers, trial sponsors, arid patients are filthy informed of Medicare's support of clinical teals. Leading Hea/fh indicators for Healthy People 2010 "Healthy People" is the nation's agenda for health promotion and dis- ease prevention. The report, prepared by the Office of the Surgeon General, has been revised on a regular basis since 1979 and is In its fourth iteration, as Healthy People 2010. Over the past 20 years, the Healthy People agenda has grown Tom 15 strategies supporting five primary health goals to approximately 1,000 health objectives. The DWIS, the agency responsible for implementing the agenda, asked the TOM to develop a set of leading indicators to engage the public's at- tention and motivate actions at the individual arid community levels in a small number of health objectives. In response to this request, TOM published two interim reports and a final report, Leading Health Indi- cators for Healthy People 2010. Through the series of reports, TOM recommended a framework for identifying a science-based framework around which sets of leading indicators could be organized. These ef- forts resulted in the development of three sets of leading health indica- tors in the areas of health determinants and health outcomes, life course 11

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Informing the Future: Critical Issues in Health determinants, and prevention-onented mbicators. TOM's framework for selecting indicators and proposed final set of Indicators was used by DELIS to prioritize the nation's Hearty People 2010 agenda. Scientific Oppoffunifies an c! Pub/ic Needs: improving Priority Setting and Pub/ic input at N/H This study, requested by Congress, charged the lOM with examining four issues related to setting priorities at NIH: allocation cntena, the decision-making process, mechanisms for public input, and the im- pact of congressional directives. The report's recommendations ad- dress each of these charges, but there is a single theme that runs through them. It was that NIH should re- vamp its approach to public input and outreach at every level without delay. The reposes recommendations have been process, including a realization acted upon by N]H and have helped. NIH that openness is as important ~0 to strengthen the pnority-setting process the process as such other including a realization that openness Is as valued qualities as expertise, innovation, and objectivity. The report's recommendations have helped NIH to strengthen the priority-setting important to the process as such other valued qualities as expertise, innovation, and objectivity. Enacting the recommen- dilations has also helped to enhance the public's understanding of the complexities of decision-making at NIH. Implementing the report's recommendations gave Congress confidence that it cart delegate panty setting to Ned leadership knowing that a broader range of views will be sought and welcomed before decisions are made. Ensuring Quality Cancer Care The National Cancer Policy Board reviewed evidence on He quality of cancer care, from early detection to end-of-life care, and concluded that many individuals with cancer do not receive care Imown to be effective for their condition. :~ the report, Ensuring Qualify Cancer Care, the Board outlined steps that could be taken to improve quality, highlight- ~ng the need for accountability systems to ensure the translation of re- 12

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Highlighted Reports search into practice. The federal response to He report has been heart- en~ng. A Quality of Cancer Care Committee has been established within He Detent of Heath and Human Services to provide inter- agency opportunities for collaborative action, and the National Cancer Institute has launched new research Initiatives In key areas outlined in the report. The report was featured in a congressional hearing of the Senate Coalition on Cancer, cochaired by Senators Diane Feinstein and Connie Mack In September 1999, with promise of more congressional attention ~ . . . the National Cancer Institute 2000 arid beyond. The American Society has launched new research of Clinical Oncology, concemed about the initiatives in key areas outlined reE'ort's findings, has initiated a large in the report. quality-of-care study to test the feasibility of building and implementing a national cancer quality mon~tonng system. ~ 2000, the Board issued Enhar~c- ing Data Systems to Improve the Quality of Cancer Care focusing on the important role of data systems to quality improvement. The Board win continue to follow up on unportant issues identified in the quality- of-care report. In 2001, the Board watt examine further the policy im- plications of the volume-outcome relationship in cancer care and re- v~ew He state of end-of-life care for m~ duals with cancer. Ensuring Safe Food: From Production to Consumplion At the request of Congress, He TOM was asked to identify ways in which the food safety system in He United States could be improved. The resulting report presented two major recommendations: change federal food statutes to foster and enhance science-based strategies for food safety; and invest In one individual, who should report to a cabi- net-level federal official or to the president, the statutory responsibility arid budgetary authority to coordinate federal food safety efforts arid speak on food safety issues. Immediately following the release of the report, the president appointed a federal Food Safety Council, com- posed of the Secretanes of Health arid Human Services and of Agn- culture, the Administrator of the Environmental Protection Agency, arid He Director of the Of floe of Science and Technology Policy of He White House. The president directed the Food Safety Council to pro- 13

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Informing the Future: Critical Issues in Health vice a report within 6 months regarding efforts to improve the coordi- nation of federal food safety activities, and to respond to Me findings arid recommendations of the NOM/NRC report. Veterans and Agent Orange response to the concerns voiced by Vietnam veterans and their families, Congress called upon the lOM to review the scientific evi- dence on the possible health effects of exposure to Agent Orange and other herbicides. Since 1993 the lOM has published several reports that synthesize the developing literature on dioxin, an unintentional con- tam~nant of one of the herbicides used in Vietnam, and a number of cancer arid non-cancer health outcomes: Veterans and Agent Orange: Health Elects of Herbicides Used in Vietnam (19949; Veterans and Agent Orange: Update 1996; and Veterans and Agent Orange: Update 1998. The IOM reports concluded that lOM assessments and conclu- there is sufficient evidence of an associa- sions have been user! by the lion between exposure to herbi- cides/dioxin arid four diseases: soft-tissue sarcoma, non-Hodgkin's lymphoma, compensation policy . . . Hodgkin's disease, and chioracne. The reports also concluded that there is lim- ited/suggestive evidence of an association for six classes of diseases, three cancers respiratory (larynx, lungbronchus, and trachea) car~- cer, prostrate cancer, and multiple myeloma and three other health out- comesspine bifida in children of veterans, acute and subacute pe- npheral neuropathy, and porphyria cutarlea tarda. lOM assessments and conclusions have been used by the Secretary of Veterans Affairs to make determinations about compensation policy for the Department of Veterans Affairs. As a result, veterans are now compensated for these conditions. The lOM is currently conducting a review to assess new research on the topic. The results of this work will be published in the upcoming Veterans and Agent Orange: Update 2000. Secretary of Veterans Affairs to make cteterminations about HIV/AIDS The lOM's long-standing interest and involvement in AIDS policy- making has spanned over a decade and is marked by significant con- ~4

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Highlighted Reports tubutions. Confronting AIDS: Directions for Public Health, Health Care, arid Research (1986) was one of the first published reports to provide a comprehensive scientific and policy analysis of efforts to address the epidemic. It also proposed strategies for meeting the sci- entific, public health, and social challenges that arise in developing rational AIDS policy. Confronting AIDS: Update 1988 was published as a supplement to the onginal report and provided an assessment of the nation's progress in the intervening years. Both reports are cred- ited with stimulating a number of federal legislative and public policy options to increase federal spending for AIDS research and other AIDS-related prevention, public health, and health care programs. Two subsequent reports HIV Screening of Pregnant Women and Newborns (1991) arid Reducing the Odds: Preventing Perinatal Transmission of HIV in the United States (1999were influential in fostering a dialogue and cntical examination of perinatal HIV- screening policies and have provided guidance to federal agencies, such as the Centers for Disease Control and Prevention and to states in developing policies for HIV counseling and testing of pregnant women. IOM's recent report No Time to Lose: Getting More from HIV Prevention (2000) challenges the na- tion to implement a new strategy to avert as Marty new HIV infections as possible. The strategy includes developing a more accurate surveillance system, allocating resources based on HIV incidence and cost-effectiveness pnnciples, directing prevention services to HIV-infected persons, improving the transla- tion of prevention research findings into action at the community level, investing in the development of new prevention tools and tech- nologies, arid striving to overcome social and policy barriers that im- pede HIV prevention. The report's recommendations are currently under consideration by the CDC as it develops its HIV Prevention Strategic Plan through 2005. No Time to Lose. . . challenges the nation to implement a new strategy to avert as many new HIV infections as possible. 15

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Selected Recommendations for Health Care Delivery. . . Reduce Medical Errors: Establish a Center for Patient Safely within the Agency for Healthcare Research and Quality. Encourage the de- velopment of voluntary reporting systems for errors that do not result in serious harm by extending peer-review protections to the data and information in these systems. Establish a nationwide mandatory re- porting system administered by the states to collect standardized information about adverse events that result in death or serious harm. (To Err is Human: Bui/cling a Safer Health System) . Improve End-of-Life Care: Revise payment systems so they en- courage rather than impede good end-of-tife care and sustain rather than frustrate coordinated systems of excellent care. For cancer care, fake steps to ensure quality of care at the end of life, in par- ticular, the management of cancer-related pain and timely referral to palliative and hospice care. (Approaching Death: Improving Care at the En c! of Life; Ensuring Quality Cancer Care) Improve the Quality of Long-Term Care: Congress should require a 24-hour presence of registered nurse coverage in nursing homes. Payment levels for Medicare and Medicaid should be adjusted to enable such staffing to be achieved, and the Health Care Financing Administration should develop minimum staffing levels (number and skill mix) for direct care based on case-mix adjusted standards. (Nursing Sfaffin Hospitals and Nursing Homes: is if Adequate?) . Reform Medicare Laboratory Payment: Medicare payments for outpatient clinical laboratory services should be based on a single, rational, national fee schedule. (Medicare Laboratory Payment Po/- icy: Now and in the Future) NOTE: Also see recommendations concerning health insurance and the health care safely net in the Demographic Trends section.