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Summary STUDY SCOPE AND OVERVIEW The Institute of Medicine (IOM), at the request of Congress, and under a contract with the Agency for Healthcare Research and Quality (AHRQ), formed a consensus committee to “1) synthesize current evidence on medi- cal resident schedules and healthcare safety, and 2) develop strategies to enable optimization of work schedules to improve safety in the healthcare work environment. The strategies recommended will take into account the learning and experience that residents must achieve during their training. The recommendations will be structured to optimize both the quality of care and the educational objectives.” (See Appendix A.) AHRQ expressed interest in total resident duty hours and how they were scheduled, and included both in the selection of the committee name: Committee on Opti- mizing Graduate Medical Trainee (Resident) Hours and Work Schedules to Improve Patient Safety. Given the charge outlined in its statement of task, the committee additionally focused on limited aspects of graduate medical education and the resident work environment related to hours, schedules, and patient safety. The committee first reviewed graduate medical training in the United States and the views of various stakeholders toward the current Accredita- tion Council for Graduate Medical Education (ACGME) duty hour limits (Chapter 1), data on resident adherence to the limits and ACGME monitor- ing practices (Chapter 2), and resident duty hour limits in other countries (Appendix C). The committee then reviewed evidence on sleep, fatigue, work, and performance, relative to errors and safety, and came to the fol- 

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 RESIDENT DUTY HOURS lowing conclusion: There is considerable scientific evidence that 30 hours of continuous time awake, as is permitted and common in current resident work schedules, can result in fatigue. There is also extensive research that shows that fatigue is an unsafe condition that contributes to reduced well- being for residents and increased errors and accidents (Chapters 5, 6, and 7). A detailed examination of the scientific literature on fatigue and hours of work identified prevention of sleep deprivation as a fundamental way to optimize resident work schedules and prevent or minimize fatigue, while en- suring the learning and experience that residents must achieve during their training (Chapter 7). Studies find that fatigued residents can make more er- rors and have more accidents, but there are simply too few data to reliably estimate the extent to which errors in performance by fatigued residents affect patients and cause them harm (Chapter 6). Evidence also suggests additional ways to improve learning and safety in the healthcare work en- vironment, through adjustment of resident workload, increased supervision (Chapters 3 and 4), and other systems changes to enhance patient safety (Chapter 8). Additional resources will be required to achieve the commit- tee’s recommended adjustments to resident duty hours (Chapter 9). Human beings deprived of sleep exhibit decreased cognitive perfor- mance and alertness and increased likelihood of making errors. Although some people are more vulnerable than others to sleep loss, everyone is adversely affected by lack of adequate sleep. The committee evaluated the current ACGME duty hours from the perspective of how well they prevent acute and chronic sleep deprivation. It has concluded that greater attention should be focused on increasing the opportunities for sleep during resident training to prevent fatigue-related errors, rather than on simply reducing total duty hours. The recommended fatigue prevention and mitigation ap- proach preserves options to address individual training program needs to have residents available for patient care at night and to allow for continu- ity of patient care on admitting days through extended duty periods. The evidence concerning resident safety and the risk of causing errors when fatigued argues for strong and prompt action. The committee has also concluded that solely regulating resident duty hours and increasing adherence to them would be insufficient to improve conditions for resident and patient safety. The committee firmly believes that a number of additional interrelated changes are needed: more direct supervision of junior residents, adjustment of residents’ workload, provid- ing sufficient time for residents to reflect on their clinical experiences, and improved patient transfers. These necessary accompaniments to duty hour reform are worth implementing even under existing duty hour limits. A stronger culture of safety in hospitals and enhanced teamwork in patient care can also contribute to safety. The committee noted that 8 years after the publication of the 2000 IOM report To Err Is Human (IOM, 2000),

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 SUMMARY patient safety in hospitals remains a very serious problem that goes well beyond the subset of hospitals that train residents. Adequate and reliable national data necessary to identify the scope of the problem and track progress are not available. BACKGROUND The principal aim of residency training in the United States is to pre- pare young doctors for the safe, independent practice of medicine once they are on their own. An important part of graduate medical training is that it exposes residents to the demands of real-life practice, including the long work hours of physicians (50 to 60 hours a week on average, with a certain percentage working more than 80 hours a week). In 2003 the ACGME adopted a set of duty hour regulations limiting resident workweeks to an average of 80 hours over 4 weeks, among other limits (ACGME, 2003). The 80-hour average was established as a maximum workweek, not a required workweek. Many medical educators believe that these extensive duty hours during training are essential to provide residents with the rich educational experience necessary to achieve professional competence in the complexities of diagnosis and treatment of patients. Residents play a significant role in the health system. They are fre- quently the frontline physician-level staff on duty 24/7 in teaching hospitals. Residency continues to consist largely of an apprenticeship approach to learning through service to hospital inpatients and outpatients under the guidance of their attending physician. It is during rotations on inpatient services that residents are more likely to have 80-hour workweeks. The academic health centers in which most residents train are known for their cutting-edge, quality care for many conditions. During training, residents care for a large number of patients. All current and potential consumers of health care benefit from their services as well as from the graduate medical system that trains future physicians. Doctors in train- ing, while paid an annual salary, cost the institution less than other fully trained clinicians (e.g., nurse practitioners, physician assistants, attending physicians) who could perform some or all of residents’ services, when their salary is calculated on an hourly basis because they work such long hours. As the committee examined alternative resident duty hours and sched- ules, it was aware of the tension between the educational objectives of medical residency and the economic incentives of training institutions. Both society at large and the training institutions benefit from residents’ service at relatively low cost. An institution’s decision about when to as- sign residents to perform service tasks and when to use other healthcare

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 RESIDENT DUTY HOURS professionals depends on both the costs and the availability of a workforce with appropriate skills. THE HISTORY OF RESIDENT DUTY HOUR REGULATION The work of the committee follows previous modifications in residents’ duty hours. Before 2003, the on-duty hours of first- and second-year resi- dents frequently exceeded a mean of 80 hours per week (e.g., neurosurgery residents reported averaging 110 hours per week) (Baldwin et al., 2003). The genesis of widespread public concern about resident duty hours was the death of 18-year-old Libby Zion in the emergency room of a New York City hospital in 1984. Her family charged that her death was due to inadequate care provided by overworked and undersupervised medical residents. A grand jury did not charge any of the residents but concluded that the long duty hours of residents are counterproductive to both patient care and resident learning. The Bell Commission was formed to review these issues and recommended that resident duty hours in New York be limited and supervision increased (Bell, 2003). Since then the focus of atten- tion has been on regulating duty hours, yet the Bell Commission’s greatest concern was actually with the supervision of residents by more experienced physicians. After the Bell Commission, resident unions, some residents’ organiza- tions, and public interest groups advocated for national duty hour limits common to all specialties. Public Citizen petitioned the U.S. Occupational Safety and Health Administration to regulate resident hours as a worker safety issue, and Congress introduced legislation that would have the U.S. Department of Health and Human Services regulate resident hours and impose fines for institutional violations. These legislative proposals would have provided incremental funding to help institutions adjust to the limits. These proposals were not adopted. In 2003 the ACGME promulgated nationwide requirements common to all specialties limiting the workweek to an 80-hour average. Although for a sound educational rationale some programs can obtain an exemption for up to 88 hours per week, relatively few programs (primarily neurosurgery programs) have received this exemp- tion (ACGME, 2003). IMPLEMENTATION OF 2003 DUTY HOUR RULES Residency programs changed in a variety of ways to accommodate the 2003 ACGME rules. Some residency programs redesigned their schedules or shifted tasks from interns to more senior residents or faculty; others hired substitutes for some of the residents’ workload (e.g., support staff, nurse practitioners, physician assistants, hospitalists, moonlighting residents

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 SUMMARY and fellows). Still others reconfigured their programs to eliminate nighttime coverage by residents, restricted which services would be part of resident training programs (e.g., retreating from some affiliations), or even con- sidered no longer having training programs. The committee has reviewed reports and heard testimony on particular programs’ adaptations, but no one has conducted a national data-driven assessment across specialties of how adoption of the 2003 ACGME duty hour requirements has changed residency programs. In assessing the influence of the 2003 duty hour limits to date, the fol- lowing are five key questions: 1. Have resident duty hours actually been reduced? Yes, it appears so from a single national study and from individual program reports. The best available national data across multiple specialties from the first year of implementation (2003-2004) show that the workweek of interns, who typically had the longest duty hours, was reduced from an average of 70.7 to 66.6 hours per week. However, 43 per- cent of interns reported having violated the 80-hour rule when aver- aged over 4 weeks (Landrigan et al., 2006). No more recent, reliable, national data are available to determine average hours worked by training year or specialty or the reasons for violations when they occur. Reports from individual programs, ACGME surveys and ac- creditation visits, and annual reviews of compliance in the State of New York also indicate that violations persist, particularly of the 30-hour extended duty rule and the required opportunities for rest and recovery from fatigue. Reasons given by residents for violating the duty hour limits include workload pressures, individual patient circumstances, or the desire of residents to stay in order to partici- pate in the continuing care of their patients. 2. Have patient outcomes improved? A few large-scale nationwide studies show slight improvements in mortality for some medical, but not surgical, patients in teaching-intensive hospitals and no worsening of mortality in teaching hospitals after the introduction of the 2003 limits (Shetty and Bhattacharya, 2007; Volpp et al., 2007a,b). One cannot attribute these improvements to duty hour reduction per se because numerous quality improvement initia- tives were introduced in teaching hospitals over the same period; however, these studies show no evidence of harm as measured by mortality rates. Individual site-specific and specialty-specific studies focus on their success in restructuring programs to maintain previ- ous levels of patient outcomes; these studies tend to be too small to detect statistically significant changes in mortality or do not control for external trends in quality improvement.

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0 RESIDENT DUTY HOURS 3. Is resident fatigue from long duty hours among the most signifi- cant risks to patient safety? Residents report that fatigue decreases the quality of care they deliver and contributes to error, as does high workload. Patient safety is affected by many factors, and the research data available did not make it possible for the commit- tee to assess the current level of all risks to patients or the degree to which fatigued residents contribute to patient harm. Only one randomized controlled trial compared shifts of up to 16 hours and scheduled work of 60-63 hours per week to a schedule with extended duty periods up to 30 hours and scheduled work weeks averaging 77-81 hours. This study reported no statistically signifi- cant difference in patient safety as measured by preventable adverse events (Landrigan et al., 2004). However, in the more traditional schedule with longer duty hours, residents made more serious medical errors (Landrigan et al., 2004) and had a higher rate of attentional failure (Lockley et al., 2004). The committee believes there is enough evidence from studies of residents and additional scientific literature on human performance and the need for sleep to recommend changes to resident training and duty hours aimed at promoting safer working conditions for residents and patients by reducing resident fatigue. 4. Have educational outcomes been affected? Residency training takes 3 to 7 years, depending on the specialty being pursued; the first cohort of 3-year residents trained entirely under 2003 ACGME limits finished in June 2006. Data on board certification pass rates for this cohort are just beginning to emerge. Thus, it is impossible at this time to determine if there has been a consistent trend across specialties. 5. Has resident quality of life improved? In general, the perception of residents and faculty, as reported in the literature and testimony before the committee, is that resident quality of life and work-life balance have improved with the advent of the 2003 duty hour limits. Eighty hours a week is still a demanding schedule, and a number of single-institution and specialty-specific studies show that residents report high rates of stress, depression, and burnout. However, studies also suggest that factors beyond duty hours, such as work intensity, contribute to the resident’s emotional state. THE NExT ERA OF REFORM FOR BETTER EDUCATION AND PATIENT SAFETY ACGME and its constituent stakeholders adopted the 80-hour work- week in 2003 as a national standard for all graduate medical training in the

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 SUMMARY United States. Countries under the European Work Time Directive currently have fewer weekly hours for their training programs; the European goal is 48 hours per week by 2009. Elsewhere, New Zealand has a 72-hour limit, and Manitoba, Canada, an 89-hour limit. Foreign nations have had trouble implementing their significantly reduced duty hour targets, and some of their efforts appear to have had unintended consequences, such as exacer- bating workforce shortages and reducing the amount of time for residents to learn and for surgeons to gain operative experience (see Appendix C). The committee concludes from these international experiences that no single model from another country is directly and completely applicable to the U.S. system of care. The past 5 years since the ACGME duty hour rules were implemented have been a period of change and adjustment for training programs in the United States. Many programs have replaced scheduling and staffing models adopted in the initial year, and they continue to refine them in their efforts to improve educational value, quality of patient care, and service coverage. Research studies tend to report institution-specific adaptations, and there are few national data or rigorous analyses of different scheduling models across institutions or specialties. However, based on the collective field experiences of programs, the committee concluded that some degree of flexibility in duty hour scheduling would have to be retained. COMMITTEE FINDINGS AND RECOMMENDATIONS The evidence and rationale behind each recommendation can be found in the chapter cited prior to the recommendation. Preamble to Recommendations To promote conditions for safe medical care, improve the education of doctors in training, and increase the safety of residents and the general public, the committee offers the following recommendations, which should be implemented with all deliberate speed. While some recommendations should be implemented immediately, changes to duty hours, adjustments in workload, and the funding needed for these changes might require an integrated phase-in. The recommendations will require additional re- sources—both financial and human. Without the necessary restructuring in resource allocation, attempts to implement the recommendations will fail to have the desired benefits and could even reduce patient safety. The committee believes that the Accreditation Council for Graduate Medical Education and the other organizations charged to implement aspects of the recommendations should begin their work with urgency, and that action on all recommendations should be taken within 24 months.

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 RESIDENT DUTY HOURS Preventing and Mitigating Fatigue A robust evidence base linking fatigue with decreased performance in both research laboratory and clinical settings has convinced the committee to focus on how to prevent fatigue when possible and how to mitigate fa- tigue when residents must be on duty by allowing for sleep during extended duty periods and adequate time for recovery sleep while off duty. Reducing total duty hours from an 80-hour average is one way that might be expected to allow more sleep, but evidence suggests it is an indirect and inefficient approach given the moderate correlation that exists between resident duty hours and sleep time. Prolonged wakefulness in excess of 16 hours at work, reduced or disturbed periods of sleep, more consecutive days or nights of work, shift variability, and the volume of work all increase fatigue and thus can contribute to errors. Meeting daily and weekly sleep needs helps pre- vent fatigue and diminished performance and contributes to an enhanced ability to learn and remember. Residency programs should increase the opportunity for sleep each day, utilize strategic naps and longer sleep periods at work, increase the number and frequency of days free from work for “catch-up sleep” and recovery, and minimize cumulative sleep loss in a week based on rest and recovery factors. Published research from the sleep literature supports the specific actions contained in the committee’s adjustments to duty hours, including limiting the amount of time a resident is continuously working each day to no more than 16 hours unless a 5-hour protected period for sleep is pro- vided. This in-house sleep period during extended duty of 30 hours should count against total duty hours as sleep during night shifts or overnight call periods does now. Table S-1 compares the elements in the committee’s rec- ommendations to current ACGME rules. (See also Chapter 7.) The recommendations permit flexibility in several ways under the new duty hour parameters set out below. Although the scientific evidence base establishes that human performance begins to deteriorate after 16 hours of wakefulness, the committee does not believe that limiting all shifts to a maximum of 16 hours would address the educational needs of all spe- cialties. So extended duty periods of up to 30 hours (the current limit) are allowed with the inclusion of a sleep period to address acute sleep deprivation. Additionally, there is the possibility of nonroutine exemptions from individual limits for the safety of unstable patients and exceptional learning experiences with the expectation that residents will be closely supervised when these learning experiences extend beyond hour limits, and ACGME already sponsors research projects to test innovations for scheduling alternatives. Further, the committee has retained the maximum of an 80-hour-a-week average, rather than reduce it, to continue to allow each specialty and program site to have what they determine are sufficient

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 SUMMARY TABLE S-1 Comparison of IOM Committee Adjustments to Current ACGME Duty Hour Limits 2003 ACGME Duty Hour Limits IOM Recommendation Maximum hours of work 80 hours, averaged over 4 No change per week weeks Maximum shift length 30 hours (admitting • 30 hours (admitting patients patients up to 24 hours for up to 16 hours, plus then 6 additional hours 5-hour protected sleep for transitional and period between 10 p.m. and educational activities) 8 a.m. with the remaining hours for transition and educational activities) • 16 hours with no protected sleep period Maximum in-hospital on- Every third night, on Every third night, no call frequency average averaging Minimum time off between 10 hours after shift length • 10 hours after day shift scheduled shifts • 12 hours after night shift • 14 hours after any extended duty period of 30 hours and not return until 6 a.m. of next day Maximum frequency of Not addressed 4 night maximum; 48 hours in-hospital night shifts off after 3 or 4 nights of consecutive duty Mandatory time off duty • 4 days off per month • 5 days off per month • 1 day (24 hours) off per • 1 day (24 hours) off per week, averaged over 4 week, no averaging weeks • One 48-hour period off per month • nternal and external Moonlighting Internal moonlighting is I counted against 80-hour moonlighting is counted weekly limit against 80-hour weekly limit • ll other duty hour limits A apply to moonlighting in combination with scheduled work Limit on hours for 88 hours for select No change exceptions programs with a sound educational rationale Emergency room limits 12-hour shift limit, at least No change an equivalent period of time off between shifts; 60-hour workweek with additional 12 hours for education

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4 RESIDENT DUTY HOURS hours to achieve their learning goals. The committee does not believe that all specialties and rotations will require this lengthy workweek. Any Residency Review Committee that sets educational standards for its spe- cialty in conjunction with ACGME may choose to create more restrictive duty hour limits if it considers changes to be necessary for its particular circumstances (e.g., severity of patient cases, constancy of high-intensity work). For example, this has been done in emergency medicine, which limits shift length to 12 hours, totaling 60 hours per week, plus 12 hours for education; the committee does not recommend any change in the hours for emergency medicine. (See Chapter 7.) Residency programs will have to continue to redesign schedules and handover practices to promote patient safety. They may need to use night floats or other backup mechanisms, such as onsite attending-level supervi- sion, when residents are required to have a scheduled sleep period. The committee understands the challenges of changing individual and institu- tional behaviors and the importance of changing professional attitudes to promote personal responsibility for one’s own safety and that of others by obtaining necessary sleep. With implementation of the new duty hour adjustments, monitoring is necessary to identify and address unintended scheduling consequences that provide fewer educational experiences for residents (e.g., excessive nighttime work, expanded cross-coverage). (See Chapter 7.) Recommendation: ACGME should adopt and enforce requirements for residency training that adhere to the following principles: duty hour limits and schedules should promote the prevention of sleep loss and fatigue; additional measures should mitigate fatigue when it is unavoid- able (e.g., during night work and extended duty periods); and schedules should provide for predictable, protected, and sufficient uninterrupted recovery sleep to relieve acute and chronic sleep loss, promote resident well-being, and balance learning requirements. Programs should design resident schedules using the following parameters: • Duty hours must not exceed 80 per week, averaged over 4 weeks. • Scheduled continuous duty periods must not exceed 16 hours unless a 5-hour uninterrupted continuous sleep period is pro- vided between 10 p.m. and 8 a.m. This period must be free from all work and call, and used by the resident for sleep in a safe and sleep-conducive environment. The 5-hour period for sleep must count toward total weekly duty hour limits. Following the protected sleep period, a resident may continue the extended duty period up to a total of 30 hours, including any previous work time and the sleep period.

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 SUMMARY • Residents should not admit new patients after 16 hours during an extended duty period. • Extended duty periods (e.g., 30 hours that include a protected 5-hour sleep period) must not be more frequent than every third night with no averaging. • After completing duty periods, residents must be allowed a con- tinuous off-duty interval of o A minimum of 10 hours following a daytime duty period that is not part of an extended duty period, o A minimum of 12 hours following a night float or night shift work that is not part of an extended duty period, and o A minimum of 14 hours following an extended duty period, and residents should not return to service earlier than 6 a.m. the next day. • Night-float or night-shift duty must not exceed four consecutive nights and must be followed by a minimum of 48 continuous hours off duty after three or four consecutive nights. • At least one 24-hour off-duty period must be provided per 7-day period without averaging; one additional (consecutive) 24-hour period off duty must be provided to ensure at least one continu- ous 48-hour period off duty per month. • In exceptional circumstances requiring the resident’s physical presence to ensure patient safety or to engage in a critical learn- ing opportunity, program faculty may permit, but not require, residents to remain on duty beyond the scheduled time; programs must record for ACGME review the nature of each exception allowed. These exceptions are not to become routine practice. Residency Review Committees should determine at the time of program re-accreditation whether the documented exceptions to scheduled duty hours warrant citation. • The ACGME should develop criteria for granting individual programs waivers from one or more of the above scheduling parameters; such criteria should be formulated only to accom- modate rare, well-documented circumstances in which patient safety and/or educational requirements of specific programs outweigh the advantages of full compliance with the commit- tee’s recommendations and cannot be addressed by means other than the requested waiver(s); programs that are granted waiv- ers (if any) and the nature of those waivers should be posted on the public access portion of the ACGME website. Included in the application for waiver should be a long-term plan that articulates how the program will work to avoid a permanent need for the requested waiver. All waivers should be monitored

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 RESIDENT DUTY HOURS and reviewed on an annual basis to determine suitability for renewal. • Programs should provide annual formal education for residents and staff on the adverse effects of sleep loss and fatigue and on the importance of and means for their prevention and mitigation. • Sponsoring institutions and programs should ensure that their practices promote and ensure that residents take the required sleep during extended duty periods. Given the committee’s intent to reduce fatigue and improve learning during residency, it believes that moonlighting by residents, which can interfere with already limited opportunities for sleep, must be addressed. Moonlighting outside of residency training would cut into the strategically designed periods for rest and sleep and could reduce residents’ readiness for their primary duties. Limits on resident duty hours designed to protect patients and residents should extend to any additional paid healthcare work that residents undertake. This requirement, built into the residency contract, would emphasize that residents ultimately have a responsibility to exhibit professional commitment and to avoid additional obligations that increase their fatigue level and interfere with their capacity to learn and to provide safe patient care. (See Chapter 7.) Recommendation: The ACGME should immediately amend its current requirements on moonlighting by • Requiring that any internal and external moonlighting for pa- tient care adhere to the duty hour limits listed above (e.g., 80 hours and all other limits), even if the program has received an exception to schedule longer hours; and • Requiring that sponsoring institutions, if they choose to permit moonlighting, include provisions in resident contracts that (1) a resident must request prospective, written permission from the program director for moonlighting; and (2) resident perfor- mance will be monitored to ensure that there is no adverse effect of moonlighting on resident performance. Improving Adherence to Current Duty Hours ACGME is currently responsible for assessing adherence to duty hours rules along with the educational aspects of graduate medical training as part of its announced onsite accreditation review and via surveys of resi- dents. In 2006-2007, ACGME reported that 8.8 percent of programs were

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 SUMMARY substantially noncompliant with some aspect of duty hour limits. This is likely an underestimation of noncompliance—probably due to the current disincentive for residents to report violations because it puts their training program at risk of disaccreditation. The committee concludes that ACGME monitoring of duty hours needs to be strengthened by adding unannounced visits and increasing their frequency to deter violations. Additionally, the incentives need to be realigned, perhaps through fines for continued viola- tions and improved protections for residents who report pressure to violate limits. The committee sees benefits in continuing ACGME monitoring because of the value of maintaining the integration of duty hours with educational program monitoring and the need to expedite a stronger process. Rather than establish a new entity, ACGME could move more quickly to enhance its enforcement and whistle-blower processes, since it already has several years of experience and has the infrastructure in place. The committee noted that the experiences of other countries and other industries with government regulation does not ensure full adherence to duty hour limits. To further address concerns raised to the committee about ACGME as the sole duty hour monitoring agency and to tie duty hours to patient safety reviews, it considered the pros and cons of involving other organizations in monitoring responsibilities. The committee recommends a complementary oversight role for both the Centers for Medicare and Medicaid Services (CMS) and the Joint Commission. CMS could conduct or contract for pe- riodic evaluations of adherence to resident duty hours, the effectiveness of ACGME monitoring practices, and the acceptability of program rationales for exceptions to duty hour limits. Similarly, the Joint Commission could integrate duty hour oversight by monitoring the contribution of fatigue to patient safety events in the tracer cases that it reviews during hospital ac- creditation site visits. (See Chapter 2.) Recommendation: ACGME and residency programs should ensure adherence to the current limits now, and to any new limits when imple- mented, by strengthening their current monitoring practices. To provide additional support, the Centers for Medicare and Medicaid Services and the Joint Commission should take an active oversight role: • ACGME should maintain responsibility for duty hour moni- toring and should enhance its procedures by including unan- nounced visits for monitoring duty hours and regular collec- tion of sufficient data to understand when and why limits are violated. • Sponsoring institutions should provide for confidential, protected reporting of duty hour violations by residents through their com-

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 RESIDENT DUTY HOURS pliance office or by an entity above the program level that does not have direct responsibility over the residency programs. • ACGME should strengthen its complaint procedures to provide more confidentiality and protection to persons reporting violations of duty hours, as well as other violations of residency rules. • The Centers for Medicare and Medicaid Services should as- sess the reliability of ACGME procedures and data and should sponsor periodic independent reviews of ACGME’s duty hour monitoring to determine the characteristics of and reasons for violations. • The Joint Commission should seek to ensure that duty hour monitoring is linked to broader activities to improve patient safety in hospitals, including the use of ACGME’s adherence data as part of the Joint Commission’s hospital surveys and accredita- tion actions. Improving the Safety of Residents and the Public The degree of fatigue experienced by residents places them at risk for workplace and driving injuries. At work, physical injuries commonly oc- cur while caring for patients, such as accidental needlesticks or exposure to blood-borne pathogens. Driving home after an extended duty period or a night shift can be hazardous to both residents and the public because residents are more likely to be involved in a crash at those times. The com- mittee recognizes that steps to reduce fatigue such as the 5-hour protected sleep period may not be put in place immediately, making it particularly important to provide safe transportation options now to and from work for residents working extended duty periods. Education should also be provided for residents to understand the risks they pose to themselves and others if they choose to drive. The committee recognizes that there may be alternative solutions (e.g., providing space to allow residents to sleep before driving home after long shifts), but there should be monitoring and evaluation to ensure usage of alternatives and reduction in opportunities for unsafe driving. (See Chapter 5.) Recommendation: The committee recommends that sponsoring insti- tutions immediately begin to provide safe transportation options (e.g., taxi or public transportation vouchers) for any resident who for any reason is too fatigued to drive home safely. Optimizing Resident Education for Resident Learning and Patient Safety One of the unintended consequences of the 2003 duty hour limits has been work compression (i.e., residents have to care for the same number of

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 SUMMARY patients in less time), which is basically an increased workload. Economic pressures continue to tilt the balance between learning and service in many residency programs too far toward service delivery and away from educa- tion. To improve the quality of care delivered to current and future patients and to meet long-term educational objectives, the committee recommends improvements in the content of residents’ work, a patient workload and intensity appropriate to learning, and more frequent consultations between residents and their supervisors. The committee believes that better-educated residents will contribute to increased safety for future patients. Educational research demonstrates that a manageable workload contributes to effective learning because of human limits on cognitive capacity, the necessity for well-timed periods of reflection, and the need for sleep in order to consoli- date learning. There are more than 26 types of residency specialties (e.g., surgery, pe- diatrics, anesthesiology, emergency medicine), and each has a different mix of patient characteristics, flow of work, and types of interventions. Resi- dency Review Committees (RRCs) are in a better position than this com- mittee to determine proficiency requirements for the individual specialties and to set appropriate caseload limits that support learning for each year of residency. The committee notes that the ACGME’s internal medicine RRC is the only discipline thus far to set caseload caps for its residents. Other RRCs should gather and analyze the data needed to establish guidelines for caseload, as a start toward making the number of patients that resi- dents care for more transparent and reducing unjustified variability within a specialty across the country while permitting necessary adjustments for individual program circumstances. Reducing resident duty hours and workload within those hours should not mean that residency training must be lengthened, although some dis- ciplines may choose to do so. Having better ways to identify and assess mastery of a specialty (e.g., use of simulators) and maximizing the learning content of each resident’s clinical experiences, rather than relying on “time in service” as a proxy for determining true competence, would be a major advance in medical education. Also, the committee emphasizes that the re- duction of work with little or no educational value (e.g., making follow-up appointments) opens time for education, caring for additional patients, and compliance with duty hours. (See Chapter 3.) Recommendation: To ensure that residency programs fulfill their core educational mission, ACGME should require that institutions sponsor- ing residency programs appropriately adjust resident workload by • Providing support services and redesigning healthcare delivery systems to minimize the current level of residents’ work that is of limited or no educational value, is extraneous to their graduate

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0 RESIDENT DUTY HOURS medical education program’s educational goals and objectives, and can be done well by others; and • Providing residents with adequate time to conduct thorough evaluations of patients and for reflective learning based on their clinical experiences. ACGME should require each Residency Review Committee to define and then require appropriate limits on the caseload (e.g., patient cen- sus, number of admissions, number of surgical cases to assist per day, cross-coverage) that can be assigned to a resident at a given time, taking into consideration the severity and complexity of patient illness and the level of residents’ competency. In the Libby Zion case, the grand jury said, “A hospital is . . . a place where the learning process should continue under strict supervision. Thus, medical decisions, whether in an emergency room or on a hospital floor should not be made by inexperienced interns and junior residents without in-person consultations with more senior physicians . . .” (Bell, 2003). Bet- ter supervision not only provides educational benefits, but also increases the likelihood of intercepting potential errors, better patient outcomes, less test ordering, more resident comfort with performing procedures, fewer delays in diagnosis and test ordering, more widespread use of care guidelines, and potentially lower costs. Although reimbursement policies require residents to consult with their supervising attending physicians on their assessment of a patient and the proposed treatment plan, residents too often lack adequate communication with them except in the operating room where they are more likely to be directly supervised. Protocols should be developed and implemented to have the supervisor reach out and periodically check with the resident on duty, thus increasing the willingness of residents, especially first-year residents, to contact their supervisors. (See Chapter 4.) Recommendation: To increase patient safety and enhance education for residents, the ACGME should ensure that programs provide adequate, direct, onsite supervision for residents. The ACGME should require • The Residency Review Committees, in conjunction with teach- ing institutions and program directors, to establish measurable standards of supervision for each level of doctor in training, as appropriate to their specialty; and • First-year residents not to be on duty without having immediate access to a residency program-approved supervisory physician in-house.

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 SUMMARY Deploying Learning Systems for Handovers and Error Detection, Correction, and Reporting A handover is the transfer of patients’ information and responsibil- ity for their care from one healthcare provider or team of caregivers to another. Handovers are considered critical moments in the continuity of patient care and have been identified as a significant source of hospital errors, often related to poor communication. Learning how to conduct better handovers and intercept errors before they reach patients would enhance the performance of all staff, not only residents. Yet because handover frequency increased with the reduction of duty hours in 2003 (and likely with protected sleep periods as well), the committee con- cludes that it will be vital for residents to learn how to perform them most effectively. Residents will need to be trained in practicing struc- tured handover procedures, with their attending physicians helping them learn to anticipate the key information that needs to be passed from one shift to another. It will be important to schedule shift changes so that there is an adequate overlap of time to conduct effective handovers. (See Chapter 8.) Recommendation: Teaching hospitals should design, implement, and institutionalize structured handover processes to ensure continuity of care and patient safety. • Programs should train residents and teams in how to hand over their patients using effective communications. • Programs should schedule an overlap in time when teams transi- tion on and off duty to allow for handovers. • The process should include a system that quickly provides staff and patients with the name of the resident currently responsible in addition to the name of the attending physician. Residents also need to be taught error detection, correction, report- ing, and monitoring in order to participate fully in the hospital’s quality improvement efforts. Although residents admit to making errors, the reason for the error is often not traceable to individual negligence, fatigue, or lack of knowledge, but rather to shortcomings in the system in which the resident works (e.g., unsafe medication labeling, excessive work- load leading to rushing). Residents (and others) are also reluctant to report errors if the environment is punitive. Residency programs could become leaders by helping their institution develop a culture of safety and inte- grating residents into its quality improvement efforts. (See Chapter 8.)

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 RESIDENT DUTY HOURS Recommendation: Graduate medical education-sponsoring institutions should fully involve residents in their safety reporting, learning, and quality improvement systems, and this should become an important part of the residents’ educational experience. Obtaining Additional Resources for Implementation Sponsoring institutions incurred substantial costs when adapting to the 2003 ACGME duty hour rules; some major teaching hospitals report an additional $1 million to $7 million each in annual costs. No specific national funds were allocated for implementation, but many hospitals were able to offset the costs through enhanced revenues or reduced expenditures elsewhere. To meet the committee’s recommended duty hour changes, ad- ditional financial and human resources would have to be obtained and existing ones applied differently. Some resident work could be transferred to other clinicians and support staff, but programs in some areas might be constrained by shortages of nurses, physician assistants, and nurse prac- titioners or by lack of funds to hire additional personnel. The committee estimated that annual national costs of personnel to substitute for the re- duced resident work could be approximately $1.7 billion, according to an economic model of selected scenarios. This range represents approximately 0.4 percent of the Medicare budget (CBO, 2008). While some institutions would be able to find some or all of the necessary financial and human re- sources, other institutions would need outside assistance to help implement the recommendations. To avoid having residents bear the burden of implementing the duty hour recommendations by increasing their workload again, and increasing the risk to patient safety, additional funds for graduate medical education (GME) are needed from all existing as well as new sources. The commit- tee strongly urges Congress and all potential GME funding sources to consider various mechanisms to support the recommended changes. For example, some possible considerations include increasing the pool of feder- ally supported residency positions (perhaps through changes to the current Medicare cap on positions), enhancing Medicare’s direct medical education payments, and greater support for residency training through private insur- ers. (See Chapter 9.) Recommendation: All financial stakeholders in graduate medical educa- tion, such as the Centers for Medicare and Medicaid Services, Depart- ment of Veterans Affairs, Department of Defense, Health Resources and Services Administration, states and local governments, private insurers, and sponsoring institutions, should financially support the changes necessitated by the committee’s recommendations to promote

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 SUMMARY patient safety and resident safety and education, with special attention to safety net hospitals. • An independent convening body should bring together all the major funders of graduate medical education to examine current financing methodologies and develop a coordinated approach to generate needed resources. Closing the Gap in Knowledge Gaps in the available evidence base hampered the committee’s work. Given concerns that the medical community has expressed about the 2003 changes in duty hours, the committee was disappointed with the lack of any comprehensive attempt to document changes in residency programs and their impact, if any, on educational outcomes and patient safety. The committee believes that its recommendations can be implemented now without years of additional research because the adjustments for duty hours are rooted in a solid evidence base. Going forward, there should be a plan to evaluate key indicators and a process to document future changes by specialty. Monitoring is important for early detection of any unintended consequences that might indicate a need to fine tune the recommendations over time. Prospective studies that have attempted to evaluate the effects of duty hours on patient safety generally have had sample sizes that lacked suf- ficient power to determine whether significant changes in errors (especially preventable adverse events), mortality, or other measures of patient harm occurred. Prospective studies of the implementation of the committee’s rec- ommendations should be planned, conducted, and funded; consideration of any future adjustments to duty hours would then have a more comprehen- sive database as a foundation for recommendations. (See Chapter 9.) Recommendation: To gather the data necessary to monitor implemen- tation of these recommendations and to prepare for future adjustments as needed to achieve the desired objectives, ACGME should convene a meeting of stakeholders and potential funders to set priorities for re- search and evaluation projects. The Centers for Medicare and Medicaid Services, Agency for Healthcare Research and Quality, National Insti- tutes of Health, Department of Defense, Department of Veterans Af- fairs, and other funders should support this work as a high priority. CONCLUSION Educating resident physicians is an exceedingly important function of the health system; it is essential for ensuring safe, high-quality health care to patients in the future. A fundamental requirement of resident education is

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4 RESIDENT DUTY HOURS in-depth, firsthand experience caring for actual patients. Ensuring the safety and well-being of patients who participate in the education of residents is of the utmost importance. During acquisition of the competencies required for independent practice, residents are going to make errors but they should not result in harm to patients. One must look beyond hours of work alone as a risk factor during training and put in place practices (e.g., time for sufficient sleep, enhanced supervision, appropriate workload, unambiguous handovers) that will minimize other contributors to error (fatigue, insuf- ficient knowledge to arrive at a diagnosis, excessive workload that leads to rushing, failure to communicate key clinical data). Fortunately, these fac- tors can be addressed, and in doing so, the patient care environment can be made safer. The committee recognizes that full implementation of all its recommendations will take some time to be phased in. The aim in adjusting duty hours and recommending other improve- ments is to develop training institutions that provide the best health care in safe environments for patients and the optimal learning environment for residents. The issues surrounding residency education and duty hours should be revisited in a few years to assess the changes put in place and their impact. The committee hopes that by spurring more rigorous moni- toring and evaluation there will be further identification of best practices that result in improved patient and resident safety. Duty hour requirements should evolve to incorporate new scientific evidence as well as changing circumstances in the U.S. healthcare system. REFERENCES ACGME (Accreditation Council for Graduate Medical Education). 2003. Common program requirements for duty hours. Chicago, IL: ACGME. Baldwin, D. C. J., S. R. Daugherty, R. Tsai, and M. J. J. Scotti. 2003. A national survey of residents’ self-reported work hours: Thinking beyond specialty. Academic Medicine 78(11):1154-1163. Bell, B. M. 2003. Reconsideration of the New York State laws rationalizing the supervi- sion and the working conditions of residents. Einstein Journal of Biological Medicine 20(1):36-40. CBO (Congressional Budget Office). 2008. The budget and economic outlook: An update. Washington, DC: Congressional Budget Office. Supplemental data of mandatory out- lays. http://www.cbo.gov/budget/factsheets/2008b/medicare.pdf (accessed September 23, 2008). IOM (Institute of Medicine). 2000. To err is human: Building a safer health system. Washing- ton, DC: National Academy Press. Landrigan, C. P., J. M. Rothschild, J. W. Cronin, R. Kaushal, E. Burdick, J. T. Katz, C. M. Lilly, P. H. Stone, S. W. Lockley, D. W. Bates, and C. A. Czeisler. 2004. Effect of reduc- ing interns’ work hours on serious medical errors in intensive care units. New England Journal of Medicine 351(18):1838-1848.

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 SUMMARY Landrigan, C. P., L. K. Barger, B. E. Cade, N. T. Ayas, and C. A. Czeisler. 2006. Interns’ com- pliance with Accreditation Council for Graduate Medical Education work-hour limits. JAMA 296(9):1063-1070. Lockley, S. W., J. W. Cronin, E. E. Evans, B. E. Cade, C. J. Lee, C. P. Landrigan, J. M. Rothschild, J. T. Katz, C. M. Lilly, P. H. Stone, D. Aeschbach, C. A. Czeisler, and Harvard Work Hours-Health and Safety Group. 2004. Effect of reducing interns’ weekly work hours on sleep and attentional failures. New England Journal of Medicine 351(18):1829-1837. Shetty, K. D., and J. Bhattacharya. 2007. Changes in hospital mortality associated with resi- dency work-hour regulations. Annals of Internal Medicine 147(2):73-80. Volpp, K. G., A. K. Rosen, P. R. Rosenbaum, P. S. Romano, O. Even-Shoshan, A. Canamucio, L. Bellini, T. Behringer, and J. H. Silber. 2007a. Mortality among patients in VA hospitals in the first 2 years following ACGME resident duty hour reform. JAMA 298(9):984-992. Volpp, K. G., A. K. Rosen, P. R. Rosenbaum, P. S. Romano, O. Even-Shoshan, Y. Wang, L. Bellini, T. Behringer, and J. H. Silber. 2007b. Mortality among hospitalized Medicare beneficiaries in the first 2 years following ACGME resident duty hour reform. JAMA 298(9):975-983.

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