The IOM calculated the cost of medical errors, in terms of lost income, disability, and health care costs, at about $29 billion per year. Other costs, such as pain, loss of loved ones, and human suffering are incalculable. However, they are important because unlike errors in other industries, medical errors often do more than merely inconvenience consumers—they may cause disability and death. According to the CDC, adverse events (bad outcomes) affecting medical care occur in about 3 to 4% of all patients. The IOM report found that most medical errors occurred as a result of system problems rather than mistakes made by individual health care providers.
In 2004 HealthGrades, Inc., an independent healthcare quality research organization that grades hospitals based on a range of criteria and provides hospital ratings to health plans and other payers, updated the 1999 IOM study. The study, Patient Safety in American Hospitals (Lakewood, CO: HealthGrades, July 2004), revealed that the IOM report may have underestimated the number of deaths attributable to medical errors and also concluded that little progress to reduce the frequency of medical error has been made in the five years since the IOM report was issued.
The HealthGrades hospital patient safety study looked at thirty-seven million Medicare patient records to assess the mortality and economic impact of medical errors and injuries that occurred during hospital admissions nationwide from 2000 to 2002. The study found that an average of 195,000 people in the United States died as a result of potentially preventable, in-hospital medical errors in each of the years 2000, 2001, and 2002—nearly twice the number of deaths from medical errors found by the 1999 IOM report.
Some of the most significant patient safety findings were:
- From 2000 to 2002 approximately 1.14 million patient-safety incidents occurred in the Medicare population considered by the study.
- One in every four Medicare patients hospitalized from 2000 to 2002 who experienced a patient-safety incident died.
- The selected patient-safety incidents studies accounted for $8.54 billion in excess inpatient costs to the Medicare system over three years. Applying these results to the entire United States, an extra $19 billion was spent and more than 575,000 preventable deaths occurred from 2000 to 2002.
- Patient-safety incidents with the highest rates per one thousand hospitalizations were failure to rescue, decubitus ulcer (bedsores), and postoperative sepsis (infection following surgical procedures), which accounted for nearly 60% of all documented patient-safety incidents.
- The best performing hospitals (hospitals that had the lowest overall patient safety incident rates of all hospitals studied, defined as the top 7.5% of all hospitals studied) had five fewer deaths per one thousand hospitalizations. This significant mortality difference is attributable to fewer patient-safety incidents at the best performing hospitals.
- Fewer patient safety incidents in the best performing hospitals resulted in a lower cost of $740,337 per one thousand hospitalizations.
Strengthening Safety Measures
In response to a request from the U.S. Department of Health and Human Services (HHS), the Committee on Data Standards for Patient Safety of the IOM created a detailed plan to develop standards for the collection, coding, and classification of patient safety information. The 550-page plan, Patient Safety: Achieving a New Standard for Care (Washington, DC: Academy Press, 2004), called upon the HHS to assume the lead in establishing a national health information infrastructure that would provide immediate access to complete patient information and decision support tools, such as clinical practice guidelines, and capture patient safety data for use in designing ever-improving and safer health care delivery systems.
The IOM plan exhorted all health care settings to develop and implement comprehensive patient safety programs and recommended that the federal government launch patient safety research initiatives aimed at increasing knowledge, developing tools, and disseminating results to maximize the effectiveness of patient safety systems. The plan also advised the designation of a standardized format and terminology for identifying and reporting data related to medical errors.
Who Is Responsible for Patient Safety?
Many federal, state, and private sector organizations work together to reduce medical errors and improve patient safety. The CDC and Food and Drug Administration (FDA) are the leading federal agencies that conduct surveillance and collect information about adverse events resulting from treatment or the use of medical devices, drugs, or other products. The CDC directs the National Nosocomial Infections Surveillance (NNIS) system to track the hospital-acquired infections estimated to affect about two million patients and claim more than ninety thousand lives per year. (Nosocomial infections are defined as infections that are not present or incubating at the time of admission to the hospital and as such are considered hospital-acquired.) The sixth-leading cause of death in the United States, hospital-acquired infections
TABLE 8.1
| Decrease in hospital-acquired infection rates in National Nosocomial Infections Surveillance (NNIS) hospitals, 1990–99 | ||||
| Type of ICU | Bloodstream infection rate1 (%) | Ventilator-associated pneumonia rate (%) | Urinary tract infection rate2 (%) | |
| 1Central line associated. | ||||
| 2Catheter associated. | ||||
| SOURCE: Robert Gaynes, et al, "Table 2. Decrease in Hospital-Acquired Infection Rates, NNIS, 1990–1999," in "Feeding Back Surveillance Data To Prevent Hospital-Acquired Infections," in Emerging Infectious Diseases, Centers for Disease Control and Prevention, vol. 7, no. 2, March–April 2001, http://www.cdc.gov/ncidod/eid/vol7no2/gaynes.htm (accessed September 13, 2004) | ||||
| Coronary | 43 | 42 | 40 | |
| Medical | 44 | 56 | 46 | |
| Surgical | 31 | 38 | 30 | |
| Pediatric | 32 | 26 | 59 | |
were estimated by the CDC during 2003 to have added $5 billion annually to direct patient care costs.
Table 8.1 shows the decline in hospital-acquired infection rates in hospitals participating in the NNIS system. In the March 3, 2001, issue of Morbidity and Mortality Weekly Report (MMWR), the CDC reported that the voluntary infection monitoring performed by NNIS hospitals produced significant reductions in hospital-acquired infections, including a 31–43% drop in bloodstream infections in the intensive care units (ICUs). The CDC collaborates with state and local health departments, private sector groups, academic medical centers, and health care providers to develop and implement other programs to reduce errors and adverse (bad) outcomes of care.
The Centers for Medicare and Medicaid Services (CMS; formerly known as the Health Care Financing Administration) acts to reduce medical errors for the approximately seventy-five million Medicare, Medicaid, and State Children's Health Insurance Program (SCHIP) beneficiaries through its peer review organizations (PROs). The PROs concentrate on preventing delays in diagnosis and treatment that have adverse effects on health.
The Department of Defense (DoD) and Department of Veterans Affairs (VA), responsible for health care services for U.S. military personnel, their families, and veterans, have instituted computerized systems that have demonstrably reduced medical errors. The VA established Centers of Inquiry for Patient Safety, and its hospitals also use barcode technology and computerized medical records to prevent medical errors.
Safe medical care is also a top priority of the states and the private sector. In 2000 some of the nation's largest corporations, including General Motors and General Electric, joined together to address health care safety and efficacy and to help direct their workers to health care providers—hospitals and physicians—with the best performance records. Called "The Leapfrog Group," this business coalition was founded by the Business Roundtable, a national association of Fortune 500 CEOs, to leverage employer purchasing power to initiate innovation to improve the safety of health care.
The Leapfrog Group publishes hospital quality and safety data to assist consumers in making informed hospital choices. Hospitals provide information to The Leapfrog Group through a voluntary survey that requests information about hospital performance across four quality and safety practices with the potential to reduce preventable medical mistakes and improve health care quality. As of 2004 The Leapfrog Group was composed of more than 150 Fortune 500 companies and other large private and public sector purchasers of health care benefits. Its mission was to promote health care safety programs and advocate innovative solutions to existing problems, such as equipping physicians with handheld devices to record patient information and perform electronic prescribing.
HEALTH CARE PROVIDERS SEEK TO PREVENT MEDICAL ERRORS AND IMPROVE PATIENT SAFETY. Because medical errors occur with alarming frequency, it is not surprising that nearly all physicians (95%) and the overwhelming majority of nurses (89%) and health care executives (82%) surveyed reported having seen serious medical errors ("Proportion of Medical Professionals Who Have Witnessed Serious Medical Errors, 2001," in Trends and Indicators in the Changing Health Care Marketplace, Menlo Park, CA: Henry J. Kaiser Family Foundation, 2002). Furthermore, another poll of physicians found that more than one third said they had been in a situation where a preventable error was made in their own care or that of a family member. (See Table 8.2.) ("Medical Errors Survey," conducted by Henry J. Kaiser Foundation, Harvard School of Public Health, April 24–July 22, 2002, in Kaiser Health Poll Report, Menlo Park, CA: Henry J. Kaiser Family Foundation, July/August 2003.)
Professional societies also are concerned with patient safety. More than 50% of all Joint Commission on Accreditation of Healthcare Organizations (JCAHO) hospital standards pertain to patient safety. As of July 1, 2002, hospitals seeking accreditation from the JCAHO were required to adhere to stringent patient safety standards to prevent medical errors. The JCAHO standards also require hospitals and individual health care providers to inform patients when they have been harmed in the course of treatment. The aim of these standards is to prevent medical errors by identifying actions and systems likely to produce problems before they occur. An example of this type of preventive measure, which is called "prospective review," is close scrutiny of hospital pharmacies to be certain that ordering, preparation, and dispensing of medications is accurate. Similar standards have been developed for JCAHO-accredited nursing homes, outpatient clinics, laboratories, and managed care organizations.
On January 1, 2004, the JCAHO began surveying and evaluating health care organizations using new medication management standards. The new standards revise and consolidate existing standards and place even greater emphasis on medication safety. The revised standards increase the role of pharmacists in managing appropriate and safe medication use and strengthen their authority to implement organization-wide improvements in medication safety.
Chief among the safety measures that concern professional societies are programs to prevent and report medication errors. Researchers estimate that about half of all medication errors are preventable. They suggest that when a medication error occurs, it is not the result of a single mistake, but rather a series of breakdowns in the health care delivery system. Research also supports the idea that the underreporting of medication errors stems from practitioners' concern that individuals will be punished rather than health system failures corrected. These researchers and many professional societies such as the Oncology (cancer) Nursing Society take the position that confidential voluntary reporting of medical errors will increase the frequency with which errors are reported and fully described and thereby will better identify health system deficiencies that lead to errors.
Professional organizations for nurses have also expressed concern about the effects of understaffed health care facilities on patient safety. On July 9, 2001, the CDC Division of Healthcare Quality Promotion and National Center for Infectious Diseases held a meeting to discuss the impact of the nation's nursing shortage on quality of care and patient safety with particular emphasis on health care-associated infections. Studies cited at the meeting showed a relationship between nursing staffing patterns and adverse patient outcomes such as infection rates. The participants observed, however, that staffing problems were not problems with nurses that could be solved by actions targeting nurses, but rather system problems that could only be resolved by actions to change the system.
WORKING OVERTIME INCREASES THE LIKELIHOOD OF MEDICAL ERRORS. The chance of a hospital nurse making a mistake was three times higher once a shift exceeded 12.5 hours, according to researchers from the University of Pennsylvania. Ann Rogers and her colleagues published the findings of their study of 393 hospital nurses ("The Working Hours of Hospital Staff Nurses and Patient Safety," Health Affairs, vol. 23, issue 4, July 2004), which revealed that about 40% of the nurses' shifts exceeded 12.5 hours over a four-week period. The risks of making an error were significantly increased when work shifts were longer than twelve hours, when nurses worked overtime, or when they worked more than forty hours per week.
During the 5,317 shifts the researchers scrutinized, there were 199 medical errors. Most were medication errors such as administering the wrong drug or the wrong dose, or delays—giving medication later than scheduled. The IOM, along with professional associations and patient advocacy groups has recommended limiting nurses' workdays to twelve hours.
Additional Actions to Improve Safety
The landmark 1999 IOM report called for aggressive national action to reduce the number of medical errors by 50% over five years. Representatives from eleven federal departments and agencies (the departments of Commerce, Defense, Health and Human Services, Labor, Veterans Affairs, the Federal Bureau of Prisons, Federal Trade Commission, National Highway Transportation and Safety Administration, Office of Personnel Management, Office of Management and Budget, and United States Coast Guard) formed the Quality Interagency Coordination Taskforce (QuIC). In February 2000 QuIC issued recommendations to the president for improving patient safety and a blueprint for implementing them.
The recommendations focused on education and technology and included:
- Enhancing public awareness of medical errors—A survey conducted during 2002 found that despite a wave of news media reports about the frequency and prevalence of medical errors, health care consumers are more likely to believe that medical errors are a frequent occurrence in general than they are to believe that errors occur frequently in their own medical care. Although nearly half of survey respondents believed that medical errors occurred "very often" (10%) or "somewhat often" (39%), when it comes to their own health care, just a third feel mistakes are made "often" (8%) or "sometimes" (26%) and nearly two-thirds feel mistakes occur "rarely" (42%) or "never" (22%). (See Table 8.3.) The QuIC taskforce asserted that alert, well-informed consumers could act to avert at least some medical errors by questioning providers, rather than assuming their actions are always correct. Improving the public's understanding of patient safety and the risks involved in obtaining medical care would also enable consumers to be more vigilant about the care they receive.
- Building purchasers' awareness of medical errors—To assist employers in offering quality health care plans and providers to their workers, it is vital that they be informed about quality, as well as cost, of competing plans and practitioners. In December 1998 the U.S. Department of Labor launched a Health Benefits Education Campaign to teach employers how to make informed choices about health care plans and benefits.
- Intensifying provider education—QuIC agencies resolved to work with professional societies and credentialing and accrediting organizations as well as with health care facilities to upgrade their overall safety knowledge with special emphasis on how to prevent medical errors.
- Applying information technology to health care delivery systems—Computerized medical records, computer reminder systems for laboratory testing, electronic prescribing, and test ordering should be widely adopted to reduce errors and enhance quality. Electronic patient records give health care providers immediate access to patient data such as recent diagnostic test results. Interactive decision-support tools can alert providers to allergies and potential drug interactions, thereby preventing medication errors. An example of a decision support system's capacity to improve care is its ability to recommend the most appropriate antibiotic for a patient's diagnosed infection. Barcodes on medications and mechanical or robotic dispensing can help to ensure that the right patient receives the right prescription at the right time.
- Incorporating standardized procedures and checklists in medical devices—QuIC called for the FDA to intensify its premarket analyses of medical devices since some have been found to be substandard or defective after they have gone to market. This analysis also applied to human factors associated with misuse of medical devices—stringent testing of operating, maintenance, and user instructions, and labels with instructions intended to prevent errors.
The member agencies of QuIC resolved to seek documentation from independent accrediting organizations to find out how they are working to strengthen patient safety standards. QuIC also identified its ability to gather data from various member agencies to improve research and practice related to patient safety. For example, the FDA could use hospital and pharmaceutical company databases to identify the frequency of specific medication or prescribing errors.
PROPOSED LEGISLATION TO IMPROVE SAFETY. On June 5, 2002, the "Patient Safety and Quality Improvement Act (S. 2590)," a legislative response to the IOM report, was introduced by U.S. Senators Jim Jeffords of Vermont, Bill Frist of Tennessee, John Breaux of Louisiana, and Judd Gregg of New Hampshire. The following day a comparable bill, H.R. 4889, sponsored by Nancy Johnson of Connecticut, was introduced in the U.S. House of Representatives. In addition to bipartisan support in the Senate, the legislation was widely hailed by hospital and health care practitioners' professional societies.
The legislation promotes the reporting, analysis, and prevention of medical errors by giving legal protection to health care providers who report patient safety data. The act protects this confidential information from being subpoenaed, disclosed under the Freedom of Information Act, or admitted as evidence in civil, criminal, or administrative proceedings. It also ensures that information reported may not be used to enforce personnel actions such as denying practitioners certain privileges (such as the ability to admit patients to the hospital) or credentials, such as licensure or recertification. Unlawful disclosure of patient safety data would be punishable by fines as high as $10,000 per violation.
The Act does not change existing remedies available to injured patients or limit patient access to medical records. It does stipulate that medical errors will be reported to "patient safety organizations," which may voluntarily submit the data they obtain to a national, non-identifiable patient safety database linked to the Agency for Healthcare Research and Quality. "Patient safety data" is an inclusive term and covers all reports, statements, and quality improvement information that are collected, developed, or reported by providers to patient safety organizations.
The Act was read twice during June 2002 and was referred to the Senate Committee on Health, Education, Labor, and Pensions. In March 2003 it was reintroduced in the 108th Congress as S. 720 with a related bill, H.R. 663, which passed by more than four hundred votes in the House of Representatives on March 12, 2003. On November 17, 2003, S. 720 was placed on the Senate legislative calendar. In June 2004 the American Medical Association (AMA), Medical Group Management Association (MGMA), and JCAHO along with other professional societies called upon the Senate to act on this legislation.
On July 23, 2004, the bill was easily approved by the Senate. It may be signed into law once it is reconciled with similar legislation passed by the House of Representatives in 2003.
User Comments Add a comment…