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2 Current Duty Hours and Monitoring Adherence In 00, the Accreditation Council for Graduate Medical Education (ACGME) established a maximum but not required 0-hour workweek for residents, averaged over 4 weeks. The best available national data show that first-year residents across various specialties reported working . hours a week on average during 00-004. Hours of work tend to be higher for residents in their first year of training, during rotations with overnight call responsibilities, and for certain specialty programs (e.g., general surgery). Lack of adherence to the ACGME limits remains an is- sue in some programs, particularly with respect to the limitations on the number of consecutive hours a resident can work and requirements for adequate time off for recovery sleep and personal activities. As a result, residents remain susceptible to acute and chronic sleep deprivation, despite the intent of the 00 duty hour limits to prevent fatigue. The commit- tee found the need to enhance monitoring of and adherence to duty hour rules. These changes should include () unannounced audits of duty hours by ACGME and strengthened whistle-blower protections at the local and national levels for better detection and resolution of violations; () over- sight by the Centers for Medicare and Medicaid Services (CMS) and the Joint Commission of duty hours in relation to patient safety and quality improvement; and () evaluation of the hours worked and the frequency of violations, including documentation of their causes (such as patient needs or unnecessary workload) by specialty. Residency is a unique career stage, a time to focus exclusively on train- ing and professional development. Residents experience a sense of growing every day as they become more competent while performing important, 4

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4 RESIDENT DUTY HOURS meaningful work. The design of this training ideally maximizes rich edu- cational experiences and has traditionally meant working long hours. In settings where camaraderie with faculty and fellow residents is strong, trainees experience a healthy learning environment and exponential growth as physicians, not just the fatigue associated with working long hours. However, concerns have been raised about the quality of care delivered by fatigued residents and the humane treatment of residents themselves. These concerns have led to duty hour reforms. The committee’s task has been to consider whether the current Ac- creditation Council for Graduate Medical Education (ACGME) duty hour limits are optimal for resident safety, patient safety, and education. Before determining this, it was important to understand how the current limits came to be, whether implementation of any of the limits has been problem- atic, how the limits have been monitored, and whether data on adherence to these limits are reliable. Additionally, the committee reviewed duty hour limits in safety-sensitive transportation industries, including the processes for establishing regulations in these industries. Based on this appraisal, the committee makes recommendations in this chapter for future duty hour monitoring practices at the local and national levels. SETTING DUTY HOUR LIMITS Resident work schedules first received widespread public attention in 1984 after the death of Libby Zion, an 18-year-old woman treated in the emergency department of a New York hospital for fever and earache. Her family charged that she died due to the poor care by overworked and un- dersupervised medical residents (no attending physician saw her, although one was consulted by phone). Upon investigation of her death, a grand jury in 1986 exonerated the doctors involved in the case (Ludmerer, 1999) and, instead, faulted the broader system of graduate medical education (New York Supreme Court, 1986): the underlying causes of the medical deficient care and treatment in this case might be prevalent in other Level One hospitals . . . the most serious deficiencies can be traced to the practice of permitting inexperienced physi- cians to staff emergency rooms and allowing interns and junior residents to practice medicine without supervision. . . . Moreover, those patients who are admitted into these hospitals for treatment are often cared for by interns and residents who are not required to have contemporaneous, in person consultations with senior physicians before they initiate a course of treatment. As a consequence, the most seriously ill patients may be cared for by the most inexperienced physicians. The grand jury concluded that the long duty hours of residents at that time were counterproductive to patient care and to resident learning, and

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4 CURRENT DUTY HOURS AND MONITORING ADHERENCE it recommended limitations on resident duty hours and enhanced super- vision (Bell, 2003). During further court proceedings in 1995 related to Libby Zion’s death, questions continued to be raised about whether duty hours and supervision were the only contributing factors (Andrews, 1995; Douglas, 1995). Regardless of the cause, concerns about the circumstances surrounding her death led to changes in resident scheduling in New York State and ultimately throughout the country. Table 2-1 outlines changes in duty hour limits over the past 25 years. The New York State Commissioner of Health appointed the New York State Ad Hoc Advisory Committee on Emergency Services, commonly re- TABLE 2-1 Evolution of Duty Hour Limits 1981 ACGME begins to require “time for rest” 1984 Patient (Libby Zion) dies in a New York teaching hospital, her father claiming she died due to poor care delivered by overworked, fatigued, and inadequately supervised residents 1986 Responding to Zion’s death, a grand jury recommends patient care improvements including limits on resident duty hours in New York State 1987 The Bell Commission recommends specific limits on resident duty hours and increased supervision of their work New York State sets duty hour requirementsa 1989 1989-1990 ACGME sets an 80-hour limit in several specialties (internal medicine, dermatology, ophthalmology, and preventive medicine) and limits in-house call to every third night with 1 day off in 7 in all specialties, on average 1998 Surprise inspections in 12 New York hospitals find extensive violations of New York duty hour limits 2001 Public Citizen, Committee of Interns and Residents of the SEIU, and American Medical Student Association petition OSHA; Representative Conyers introduces the Patient and Physician Safety and Protection Act of 2001 (not enacted) 2001-2002 ACGME Work Group on Resident Duty Hours and the Learning Environment develops common duty hour limits for all specialties 2003 ACGME requires current common duty hour limits; Representative Conyers and Senator Corzine introduce the Patient and Physician Safety and Protection Act of 2003 (not enacted) 2005 Representative Conyers and Senator Corzine introduce the Patient and Physician Safety and Protection Act of 2005 (not enacted) NOTE: OSHA = Occupational Safety and Health Administration; SEIU = Service Employees International Union. aNew York State Laws and Regulations: Title 10 NYCRR, § 405.4 (1998). SOURCES: ACGME, 2007b; GovTrack.us, 2005a,b; IPRO, 2007a; Steinbrook, 2002.

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0 RESIDENT DUTY HOURS ferred to as the Bell Commission, to investigate the conditions of residency. The Bell Commission, named after its chair Bertrand Bell, recommended changes in graduate medical education, including limiting duty hours and improving supervision of residents. In 1989, as a result of the recommenda- tions, New York State implemented rules limiting total resident duty hours per week and the length of extended duty periods, as well as providing for time off from work to address resident fatigue (Table 2-2).1 Table 2-2 compares New York State rules with subsequent proposals (Public Citizen petition and legislative proposals) and the 2003 ACGME limits established for all residencies nationwide. Attempts to limit resident duty hours through regulatory or legisla- tive bodies separate from the medical establishment have repeatedly been stopped both in the U.S. Congress and in state legislatures other than New York and Puerto Rico (IPRO, 2007a). The ACGME acknowledges that its “initiative to institute common minimum standards for duty hours unfolded against a political backdrop in which groups pursued federal intervention to regulate resident hours” (ACGME, 2003, p. 1; Steinbrook, 2002). Previ- ously in 2001, Public Citizen petitioned the U.S. Occupational Safety and Health Administration (OSHA) to establish national duty hour limits for residents by arguing that long duty hours are physically and mentally harm- ful to medical residents (Table 2-2) (Public Citizen, 2001). OSHA turned down the group’s petition in 2002 saying, “Because the issues involved with medical resident hours go well beyond job safety and affect hospital patient safety, because other knowledgeable groups are taking action to work on this problem . . . , the Agency has decided to deny your petition” (Depart- ment of Labor, 2002). Several bills to legislate duty hour limits have come before the U.S. Congress since 2001—all have been referred to committee, and none has ever been called up for a vote. The most recent bills, introduced by Rep- resentative Conyers and Senator Corzine, are the Patient and Physician Safety and Protection Act of 2005 (H.R. 1228 and S. 1297, respectively). This legislation would have amended title XVIII (Medicare) of the Social Security Act and authorized the U.S. Secretary of Health and Human Services to establish regulations on resident duty hours, supervision, and whistle-blower protections (Table 2-2). The bills would have authorized funding for training facilities to help meet regulations and required fines for nonadherence (GovTrack.us, 2005a,b). 1 New York State Laws and Regulations: Title 10 NYCRR, § 405.4 (1998).

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 CURRENT DUTY HOURS AND MONITORING ADHERENCE ACGME 2003 Duty Hour Rules Beginning July 1, 2003, the ACGME required that duty hours for resi- dents “must” meet the following provisions: • An 80-hour workweek averaged over a period of 4 weeks, includ- ing all in-house calls; • 1 day in 7 off without any educational or clinical duties or call, averaged over 4 weeks; • In-house overnight call frequency of no more than every third night, averaged over 4 weeks; • A maximum onsite duty period of 24 hours with up to 6 additional hours available for didactic education as well as transfer of patients (residents may not take any new patient after 24 hours on duty); and • Although at-home or pager calls do not count toward the every third night or 24 + 6 hour limit, they “must” not be utilized so frequently that the resident is unable to rest or to have a reasonable amount of personal time (ACGME, 2007b). Additionally, residents “should” have 10 hours off between shifts for ad- equate rest (ACGME, 2003). The ACGME used “must” to designate man- datory requirements (ACGME, 2008a). These duty hour limits apply to trainees in their fellowship years as well. The 80-hour workweek specified in the New York and ACGME rules was not empirically determined. The Bell Commission put forth the 80-hour week using the following heuristic: “There are 168 hours in a week. It is rea- sonable for residents to work a 10-hour day for 5 days a week. It is humane for people to work every fourth night. If you subtract the 50-hour week . . . from 168 hours, you end up with 118 hours. If you then divide 118 by 4 (every fourth night), it equals 30. If you then add 50 to 30, that equals an 80-hour week” (Bell, 2003, p. 40). Similarly, Dr. Paul Friedmann, co-chair of the later ACGME’s duty hours working group said that 80 hours is “a num- ber with some general acceptance, without much scientific underpinning” (Steinbrook, 2002, p. 1298). The ACGME adopted the 80-hour limit to help protect against the sleep loss associated with working long hours (ACGME, 2003). ACGME indicated that the +6 hours was added to the extended duty period to prevent residents from driving home at their circadian nadir and to provide time for learning activities and handover of patient information (ACGME, 2003).

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 RESIDENT DUTY HOURS TABLE 2-2 Comparison of Duty Hour Provisions New York Code 405 Rules (1989, updated in 1998)a Duty Hour Provisions Maximum hours per week 80 hours, averaged over 4 weeks Maximum shift length 24 hours + 3 hours for transitional activities Maximum in-hospital on-call Every third night, with averaging frequency Minimum time off between 8 hours scheduled shifts Mandatory time off duty 24 hours off per week, no averaging Emergency room limits 12-hour limits in hospitals with more than 15,000 unscheduled visits Whistle-blower protections Enforcement Civil penalties issued by the state; originally $2,000 per violation; in 2000 raised to $6,000 per item, plan of correction within 30 days; $25,000 penalty for noncompliance with correction plan; additional $50,000 penalty for subsequent noncompliance with correction plane Funding (for additional staff Initially, yes; to make up for loss of resident also funding for compliance monitoring duty time) SOURCES: aNew York State Laws and Regulations: Title 10 NYCRR, § 405.4 (1998). bPublic Citizen, 2001. cACGME, 2003. dGovTrack.us, 2005a,b. eNew York State Department of Health, 2002.

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 CURRENT DUTY HOURS AND MONITORING ADHERENCE Public Citizen Petition to OSHA ACGME Accreditation H.R. 1228 and S. 1297 (2001)b Standards (2003)c (2005)d 80 hours, no 80 hours, averaged over 4 80 hours, no averaging averaging weeks; 88 hours for select programs for a sound educational rationale 24 hours 24 hours + 6 hours for 24 hours + 3 hours for transitional activities transitional activities (exception for patient emergencies) Every third night, Every third night, with Every third night, no averaging averaging no averaging 10 hours 10 hours 10 hours 24 hours off per 24 hours off per week, averaged 24 hours off per week, one full week, no averaging over 4 weeks weekend off per month; no averaging 12-hour shift limit, at least 12 hours an equivalent period of time off between shifts; 60-hour workweek with additional 12 hours for education Yes Some confidentiality protection Yes in complaint procedure Civil penalties Potential loss of accreditation; Civil penalties, not to exceed sufficiently large plan of correction $100,000 per training to deter violations; program in a hospital, with unannounced corrective action plans to the inspections Secretary of Health and Human Services; public disclosure on a hospital and residency training program-specific basis No No Yes, to cover hospital incremental costs to comply with regulations

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4 RESIDENT DUTY HOURS Definition of Terms ACGME’s definition of graduate medical trainee duty hours includes all time spent in “clinical and academic activities related to the program, that is: patient care (both inpatient and outpatient), administrative duties relative to patient care, provision for transfer of patient care, time spent in-house during call activities, and scheduled activities, such as conferences. Duty hours do not include reading and preparation time spent away from the duty site” (ACGME, 2008a). The term extended duty period (also known as “long call”) is used in this report to refer to the 30-hour (24 + 6) maximum continuous duty period allowed under the 2003 limits (ACGME, 2008a). The term shift is applied to any other scheduled period of work, whether during the day, evening, or night. Residents may or may not have any time to sleep during extended duty periods, depending on how busy their service is and the presence or absence of mechanisms for distributing responsibilities to other residents in a “night float” system or to a hospital- ist service who will admit new patients or respond to the needs of patients already in the hospital. On a day or night float schedule, residents are not assigned to a single service but float across services or teams to help with admissions and follow-up (PAIRO, 2008). Cross-coverage means being available to care for patients admitted by other residents when the resident who has had primary care responsibility for these patients is not at the hospital or is otherwise unavailable. Other definitions of terms are available in a glossary in Appendix D. Suggested Refinements to Duty Hours The committee heard testimony from organizations representing the graduate medical education community, which favored continuation of the current rules over any further reductions in duty hours (AAMC, 2008; ABNS, 2008; ACGME, 2007b, 2008c; ACS, 2008; AMA Resident/Fellow Section, 2007). Other speakers, however, pointed out that resident train- ing in different countries used much shorter workweeks and suggested that the committee consider shortening the total number of hours allowed (Landrigan, 2007; Public Citizen, 2007). Speakers from the surgical com- munity described implementation problems encountered in the United Kingdom as it has reduced hours substantially. Their perception was that fewer hours did not ensure sufficient operative experience to attain the level of competence required for independent practice (ABMS, 2008; ACS, 2008; Royal College of Surgeons of England, 2008). Appendix C contains an expanded discussion of the lessons from the international experience. The main objection to the 2003 rules raised in testimony concerned the extended duty period of 24 + 6 hours. Public Citizen, the Committee

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 CURRENT DUTY HOURS AND MONITORING ADHERENCE of Interns and Residents (CIR) of Service Employees International Union (SEIU) Healthcare, and Drs. Landrigan and Czeisler advocated that resi- dents work no more than 16 hours straight, including time for transfer of patient care and resident education (American Medical Student Association, 2007; CIR/SEIU, 2007; Czeisler, 2007; Landrigan, 2007). The CIR/SEIU Healthcare also recommended that averaging of duty hours no longer be allowed in order to prevent large variations in the number of duty hours from week to week (CIR/SEIU, 2007). ADAPTING TO 2003 DUTY HOURS Have duty hours changed in response to 2003 duty hour limits? The best available evidence shows that mean hours have been reduced over time (Baldwin et al., 2003; Landrigan et al., 2006). Despite progress in reducing overall hours, residents and their residency programs do not always adhere to every aspect of the 2003 ACGME limits (ACGME, 2004; IPRO, 2007b; Landrigan et al., 2006). Certain elements of the rules are more problematic than others, and certain specialties have more problems with adherence than others. Change in Mean Duty Hours Mean hours are useful information but they alone do not capture the variation within and across institutions or specialties. Mean duty hours for first-year residents (interns) appear to have declined nationwide in response to duty hour reforms from approximately 83 hours per week in 1998-1999 to 66.6 hours after the 2003 limits. Table 2-3 shows the results from a national survey of a randomly drawn sample of residents (n = 3,493) in the 1998-1999 academic year, with interns from two-thirds of special- ties working more than 80 hours (83.3 hours) on average (Baldwin et al., 2003). Second-year residents averaged 76.2 hours per week, with one-third of specialties (all but one a surgical specialty) over 80 hours (Baldwin et al., 2003). Landrigan and colleagues (2006) looked at the duty hours of a national self-selected sample of first-year residents (n = 1,278) from at least 13 different specialties (e.g., internal medicine, pediatrics, psychiatry, general surgery, obstetrics-gynecology [OB/GYN]) using a monthly web- based survey to track duty hours. They found a decline from a mean of 70.7 hours before duty hour reform (2002-2003) to 66.6 hours in the first year of implementation (2003-2004) (Landrigan et al., 2006). The difference in pre-duty hour levels between Baldwin’s 83 and Landrigan’s 70.7 hours may be due to many programs starting to transition to expected limits even before the ACGME limits became official, although it may also reflect

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 RESIDENT DUTY HOURS TABLE 2-3 Average Reported Weekly Work Hours and Percentage of PGY-1 and PGY-2 Residents Working Over Proposed 80-Hour Limit by Specialty, 1998-1999 National Survey PGY-1 PGY-2 Percent of Percent of Residents Residents Working Working Over 80- Over 80- Specialty Mean (SD) Hour Limit Mean (SD) Hour Limit Anesthesiology 78.1 (18.1) 44.1 77.7 (16.2) 42.3 Dermatology 59.9 (16.7) 6.9 Emergency medicine 80.1 (17.5) 41.2 71.0 (15.2) 14.3 Family practice 78.1 (16.1) 39.1 67.6 (17.1) 17.9 Internal medicine 83.7 (15.5) 52.4 77.1 (17.3) 35.6 Internal medicine/pediatrics 81.6 (13.9) 46.7 77.5 (16.5) 37.3 Neurological surgery 110.6 (14.4) 100.0 Neurology 82.4 (17.5) 41.0 Obstetrics/gynecology 90.5 (13.7) 69.5 90.8 (17.1) 71.1 Ophthalmology 72.4 (18.9) 23.1 Orthopedic surgery 94.5 (19.1) 75.9 93.8 (16.3) 70.7 Otolaryngology 88.6 (16.5) 57.7 Pathology 60.8 (16.2) 9.4 56.7 (11.2) 5.1 Pediatrics 81.3 (14.9) 43.6 78.1 (14.9) 36.2 Physical 64.2 (18.6) 27.3 medicine/rehabilitation Preventive medicine 58.7 (18.9) 0.0 Psychiatry 69.7 (16.5) 20.4 59.2 (14.9) 7.1 Radiation oncology 67.4 (10.8) 9.1 Radiology 66.5 (14.7) 20.4 Surgery (general) 102.0 (16.1) 89.0 105.7 (13.6) 93.3 Transitional year 80.1 (17.2) 38.2 Urology 98.5 (19.3) 66.7 Overall 83.0 (17.7) 49.7 76.2 (19.9) 35.1 NOTE: PGY-1 = postgraduate year 1; PGY-2 = postgraduate year 2. Reprinted with permission by Academic Medicine. Baldwin, D. C., Jr., S. R. Daugherty, R. Tsai, and M. J. Scotti, Jr. 2003. A national survey of residents’ self-reported work hours: Thinking beyond specialty. Academic Medicine 78(11):1154-1163. methodological differences in sampling and recall period for hours worked. No other national study is available since the 2003 reforms on mean duty hours across such a spectrum of specialties; studies tend to be specialty or institution specific. Landrigan et al. (2006) also noted a significant decline in the mean length of extended duty periods from 32.1 to 29.9 hours for interns in multiple specialties. In a subsequent analysis of the change of pediatric residents’ extended duty hours in three institutions, Landrigan et al. (2008)

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 CURRENT DUTY HOURS AND MONITORING ADHERENCE found a significant decline in the mean from 29.3 ± 3.2 hours before the 2003 rules were implemented to 28.5 ± 2.4 hours afterward. Degree of Compliance with Current Limits The responsibility for ensuring that residents and institutions adhere to the 2003 duty hour standards falls to institutions themselves and the ACGME as part of its announced accreditation visits. The ACGME ac- creditation review occurs once every 1-5 years, or once every 3.7 years on average (ACGME, 2008b). After 10 years of experience with the 80-hour workweek, New York State mandated yearly, unannounced audits of its training institutions because surprise inspections in 1998 found widespread violations: 94 percent of residents in New York City and 37 percent of those throughout the rest of the state worked more than 85 hours per week, and 77 percent of surgical residents in New York City and 60 percent in the rest of the state worked more than 95 hours per week. Further 38 percent of all residents and 67 percent of surgical residents worked more than 24 consecutive hours. Emergency room residents were in compliance with their 12-consecutive-hour limits (DeBuono and Osten, 1998; Kennedy, 1998). To achieve annual review, the New York Department of Health has contracted with IPRO since 2001 to focus solely on monitoring duty hour compliance (IPRO, 2008). IPRO, an independent, not-for-profit healthcare and quality improvement organization, is the New York Medicare Quality Improvement Organization and its Medicaid Utilization Review/Quality Assurance Agent. All 124 New York teaching hospitals have monitoring by both IPRO and ACGME. Substantial Compliance Versus Counting Each Violation ACGME and IPRO both use what they term a “substantial compli- ance model” for monitoring duty hours. Using this model, a program will not receive a citation for single or isolated violations of duty hour rules. The violations need to be more systemic. ACGME examines programs more closely if 15 percent or more residents report violations on three or more standards through ACGME’s yearly resident survey. IPRO also uses a threshold of 15 percent for resident nonadherence to a single duty hour rule before giving a citation. IPRO does not trigger a violation at precisely the hour limit. Instead 15 percent of residents would have to be over an 85- hour week average, for example, to trigger a violation or 15 percent would have to be over 28 hours on an extended duty period (New York limit is 24 + 3 hours).2 Various accreditation bodies (e.g., The Hague Accreditation 2 Personal communication, V. Wilbur, IPRO, June 9, 2008.

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 RESIDENT DUTY HOURS appropriately, and a clean slate with no perceptions of bias. The main dis- advantages to doing this are similar to those mentioned for a new organiza- tion to conduct monitoring: delays in getting authority and funds to create such an organization and the need to establish public credibility. It would also need to design and establish a mechanism and procedures for providing oversight. The committee concluded that the delays and expense involved with creating a new oversight organization were not justified. Alternative : A Government Agency for Oversight Some of the advantages of using a public federal agency are that it is less likely to be co-opted by the profession than are private bodies, it can be tough and authoritative, and may already enjoy a measure of public trust. The most obvious government agencies that might conduct oversight of duty hour monitoring are the Centers for Medicare and Medicaid Services (CMS) or the Agency for Healthcare Research and Quality (AHRQ). The specific pros and cons of using CMS and AHRQ are discussed below. The role envisioned for CMS would be to help ensure the accuracy and reliability of ACGME procedures, data, and reports by supporting periodic evaluations of duty hours that would look not only at compliance but also examine the reasons behind violations and to suggest when exceptions to rules might be necessary to promote patient safety and under what circum- stances (e.g., direct supervision) a resident might be able to stay beyond his or her hour limit to participate in an unusual learning opportunity. This overview of the exceptions process as well as duty hour adherence is important in light of the committee’s recommendations on adjustments to duty hours and provisions for exceptions in Chapter 7. CMS has an Office of Clinical Standards and Quality (OCSQ) that serves as a focal point for all quality and safety issues and it has direct access to funds from the Medicare Trust Fund that support contracts for research and evaluation related to quality and safety. A very small percent- age of those funds could support periodic contracted evaluations of duty hours and their monitoring and their relationship to quality of care, patient safety, resident safety, and educational outcomes. CMS could either con- tract for studies of duty hour compliance and manage the contracts directly or it could support research managed by another federal agency, such as AHRQ. Alternatively, OCSQ also has ongoing contracts with private qual- ity improvement organizations in each state, such as IPRO in New York, and could support one or more of them to conduct an evaluation of the outcomes of ACGME monitoring on adherence to rules. There are several reasons why CMS would be the most appropriate agency to take on some of the necessary evaluative responsibilities, but also reasons why that might not be desirable. On the positive side, CMS

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 CURRENT DUTY HOURS AND MONITORING ADHERENCE has had an intimate relationship with teaching hospitals since 1965 con- cerning graduate medical education (GME) funding and resident educa- tion. It expends more than $8 billion in funds annually related to GME and associated patient care. CMS is the main federal agency responsible for assuring healthcare quality, paying for the care of millions of patients in teaching hospitals, as well as auditing the facilities. In addition, CMS has had ongoing relations with the VA and DOD health systems over the years concerning Medicare-eligible veterans and retirees, which might facilitate cooperative oversight of resident hours in those systems. CMS has the resources to conduct the evaluative studies envisioned for their oversight role. Having CMS involved in the oversight of duty hours monitoring pro- vides additional possibilities for increasing adherence to the rules. If the changes in ACGME monitoring practices and whistle-blower protections do not prove sufficient to have institutions comply, financial levers should be considered in addition to the threat of ACGME accreditation withdrawal or placing a residency program on probationary status. For example, in New York State, fines for duty hour violations are levied on institutions. The committee suggests that ACGME and CMS explore this and other options related to Medicare’s program rules for institutions receiving direct or in- direct GME funds. CMS would want to have confidence in the monitoring process before leveling such fines and having conducted an evaluation of the process would be critical. Additionally, ACGME through its Committee on Innovations may discover that certain carrot-and-stick approaches will foster adherence and these should also be considered (Volpp and Landrigan, 2008). On the negative side, CMS is a large bureaucracy that has not done such oversight of the GME program in the past and that function may not be a top priority for funding and attention in the organization. Since it is a federal agency, its policies and staff could potentially change significantly from one administration to another. Some people might object to giving a government agency oversight over a private organization’s monitoring of duty hours as has been evidenced in opposition to previous attempts to regulate duty hours in HHS through legislation. While AHRQ might also be an appropriate option for the evaluative studies, it would likely have more difficulty obtaining needed funds than would CMS, and it does not have the leverage over training institutions that CMS has. The committee expects that AHRQ would play a significant role in implementing the recommendation concerning future research and evaluation, discussed in Chapter 9, and AHRQ would benefit from having a neutral role when working with other research-oriented parties planning a research agenda rather than direct oversight responsibilities. Addition- ally, the newly initiated AHRQ program on Patient Safety Organization

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0 RESIDENT DUTY HOURS reporting could yield complementary information on whether residents and/or fatigue contribute to reported events if resident status and fatigue are included in those reporting requirements (AHRQ, 2008). The committee recommends that CMS should provide evaluative over- sight of ACGME’s monitoring of duty hours and the possible effects of violations on quality of care and patient safety. That oversight function would be enhanced by complementary oversight by an existing private organization as well. Alternative : An Existing Private Organization for Oversight An existing private organization conducting related functions could have certain advantages over both a new organization and a public one. It could move quickly and readily update its procedures, have stature and recognition among the profession and the public, and a focus on quality and safety. The Joint Commission, which currently accredits hospitals, could play a complementary role to CMS’s oversight of the duty hours monitoring. The oversight role for the Joint Commission would differ from that of CMS and should fit consistently with its own accreditation process, which focuses on patient safety and quality during periodic, unannounced visits to institutions by a team of surveyors. Testimony by the Joint Commission on its approach to monitoring quality of care and safety indicated that rather than monitoring whether resident duty hours meet ACGME limits within an institution, the Joint Commission’s approach could be to deter- mine whether residents or other staff were involved in patient safety events examined through patient-centered tracer cases and whether fatigue was a contributing cause (Joint Commission, 2008). For the Joint Commission to take on this systematic oversight function, it would likely need to adjust its policies and procedures to include a stronger focus and guidance on fatigue, safety, and work hours, although it already has raised the issue through its publications. Since their tracer case process as well as preliminary data analysis related to each hospital’s accreditation visit include a wide variety of data and record checks, the marginal increase in work and costs based on cases with fatigued residents to assure proper monitoring policies and pro- cedures would likely not be great. The surveyors would not have to check adherence documentation for all the residency programs in an institution, just those related to programs in a tracer case. There are advantages to including the Joint Commission in the over- sight process. The Joint Commission currently accredits 97.5 percent of major teaching hospitals and 93.6 percent of minor teaching hospitals (Joint Commission, 2008). An oversight role would place adherence to duty

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 CURRENT DUTY HOURS AND MONITORING ADHERENCE hours and prevention of fatigue within institution-specific quality and safety efforts and highlight the role of residents and their importance to patient safety. Joint Commission accreditation affects the entire hospital not just the educational programs and, through its recommendations for systems improvements, receives the attention of institutional administrators. The accreditation process is used to identify areas for correction and improve- ment in a hospital (i.e., Requirements for Improvement that facilities must address specified by surveyors based on findings of deficiencies), and if a problem concerning adherence to duty hours is uncovered, it should be treated as other similar violations by the Joint Commission. The loss of accreditation is rare and occurs because of large, serious, and persistent problems. Disadvantages associated with the inclusion of the Joint Commission in the oversight process include the need for the Joint Commission to expand its survey process to include some specific attention to resident fatigue and to adjust its working relationship with other organizations to recognize the duty hour limits set by ACGME. The Joint Commission’s priorities are on patient safety and quality issues. Their complaint process, which receives approximately 12,000 complaints per year, gets only 5-8 related to resident work hours and their voluntary sentinel events reporting system rarely finds resident fatigue mentioned in the root cause analyses, indicating that currently the resident fatigue issue does not demand much attention (Joint Commission, 2008). It could happen that the Joint Commission’s use of its tracer case method will reveal very few patient events related to resident fatigue and duty hours, but that would not necessarily negate the value of its oversight role. The committee concludes that the advantages of a strengthened ACGME monitoring process along with external oversight by both CMS and the Joint Commission would help assure the public that programs would be more likely to adhere to the rules, problems with duty hours com- pliance would be uncovered and dealt with properly, and there would be more rapid implementation of the committee’s recommended adjustments to duty hours. CMS, the Joint Commission, and ACGME should discuss how their functions could complement each other and what information can be shared. The recommended oversight functions discussed for CMS and the Joint Commission are designed to be practical, derive from existing functions, and not be overly burdensome. Also, residents are more likely to report problems when they arise if probation of their educational program was not the only lever. The stature of existing relationships of both CMS and Joint Commission with teaching institutions would significantly add weight at the institutional level to ACGME processes.

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 RESIDENT DUTY HOURS Recommendation 2-1: 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, pro- tected reporting of duty hour violations by residents through their compliance 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 viola- tions 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 ac- creditation actions. Service demands on residents and educational expectations can create pressures for longer hours of service than are necessary for achieving edu- cational competence alone. In instituting the 2003 duty hour reforms, the ACGME indicated that training programs needed to “decouple notions of professionalism from the number of hours worked” (AAMC, 2003). Going forward, professionalism should not just mean staying long hours. Edu- cational leaders, hospital administrators, and residents themselves should recognize that ensuring adequate sleep for residents is part of responsible behavior to promote safe conditions for both residents and patients. This chapter has focused on the need for increased monitoring of resident duty hours and increasing transparency of why rules are violated. The commit- tee’s ultimate intent is not to establish a burdensome and costly monitoring

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