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Duty Hours in Emergency Medicine: Balancing Patient Safety, Resident Wellness, and the Resident Training Experience: A Consensus Response to the 2008 Institute of Medicine Resident Duty Hours Recommendations Mary Jo Wagner, MD, Stephen Wolf, MD, Susan Promes, MD, Doug McGee, DO, Cheri Hobgood, MD, Christopher Doty, MD, Mara Ann McErlean, MD, Alan Janssen, DO, Rebecca Smith-Coggins, MD, Louis Ling, MD, Amal Mattu, MD, Stephen Tantama, MD, Michael Beeson, MD, Thomas Brabson, DO, Greg Christiansen, DO, Brent King, MD, MMM, Emily Luerssen, MD, and Robert Muelleman, MD

Abstract Representatives of emergency medicine (EM) were asked to develop a consensus report that provided a review of the past and potential future effects of duty hour requirements for EM residency training. In addition to the restrictions made in 2003 by the Accreditation Council for Graduate Medical Education (ACGME), the potential effects of the 2008 Institute of Medicine (IOM) report on resident duty hours were postulated. The elements highlighted include patient safety, resident wellness, and the resident training experience. Many of the changes and recommendations did not affect EM as significantly as other specialties. Current training standards in EM have already emphasized patient safety by requiring continuous on-site supervision of residents. Resident fatigue has been addressed with restrictions of shift lengths and limitation of consecutive days worked. One recommendation from the IOM was a required 5-hour rest period for residents on call. Emergency department (ED) patient safety becomes an important concern with the decrease in the availability and in the patient load of a resident consultant that may result from this recommendation. Of greater concern is the already observed slower throughput time for admitted patients waiting for resident care, which will increase ED crowding and decrease patient safety in academic institutions. A balance between being overly prescriptive with duty hour restrictions and trying to improve resident wellness was recommended. Discussion is included regarding the appropriate length of EM training programs if clinical experiences were limited by new duty hour regulations. Finally, this report presents a review of the financing issues associated with any changes. ACADEMIC EMERGENCY MEDICINE 2010; 17:1004–1011 ª 2010 by the Society for Academic Emergency Medicine

From Michigan State University (MJW), East Lansing, MI; University of Colorado (SW), Denver, CO; University of California at San Francisco (SP), San Francisco, CA; Albert Einstein Medical Center (DM), Philadelphia, PA; University of North Carolina (CH), Chapel Hill, NC; State University of New York, Downstate Medical Center (CD), Brooklyn, NY; Albany Medical Center (MAM), Albany, NY; Genesys Regional Medical Center (AJ), Grand Blanc, MI; Stanford University (RSC), Palo Alto, CA; University of Minnesota (LL), Minneapolis, MN; University of Maryland (AM), Baltimore, MD; Naval Medical Center–San Diego (ST), San Diego, CA; Akron General Medical Center (MB), Akron, OH; Atlanticare Regional Medical Center (TB), Atlantic City, NJ; Virginia Commonwealth University Health System (GC), Richmond, VA; University of Texas (BK), Medical School at Houston, Houston, TX; Madigan Army Medical Center (EL), Tacoma, WA; and University of Nebraska (RM), Omaha, NE. Received April 1, 2010; accepted April 5, 2010. Presented at the ACGME Duty Hours Congress, Chicago, IL, June 12, 2009. Supervising Editor: David C. Cone, MD. Address for correspondence and reprints: Mary Jo Wagner, MD; e-mail: [email protected]. Representative organizations: American Academy of Emergency Medicine (AAEM), Association of Academic Chairs of Emergency Medicine (AACEM), American College of Emergency Physicians (ACEP), American College of Osteopathic Emergency Physicians (ACOEP), Council of Emergency Medicine Residency Directors (CORD), Emergency Medicine Residents Association (EMRA), Residency Review Committee of Emergency Medicine (RRC-EM), Society for Academic Emergency Medicine (SAEM). This paper will be co-published in the Journal of Emergency Medicine.

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ISSN 1069-6563 PII ISSN 1069-6563583

ª 2010 by the Society for Academic Emergency Medicine doi: 10.1111/j.1553-2712.2010.00789.x

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Keywords: education, medical, graduate, internship and residency

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mergency medicine (EM) was invited by the Accreditation Council for Graduate Medical Education (ACGME) to review resident work hour standards and key dimensions of the EM learning environment as they relate to the current ACGME duty hour requirements and the 2008 Institute of Medicine (IOM) report ‘‘Resident Duty Hours: Enhancing Sleep, Supervision and Safety.’’1 EM graduate medical education (GME) experts from eight major EM professional organizations were invited to participate in a task force to discuss the IOM report and its implications on EM. Following review and approval of the task force’s consensus document by each organization, it was submitted to the ACGME. This publication represents an abridged version of that document.

recent 2008 IOM resident duty hour recommendations. We addressed these recommendations through the lens of EM with respect to key elements of GME: patient safety, resident wellness, and the resident training experience. Finally, we included a brief discussion of the perceived financial impact of the 2008 IOM duty hour recommendations.

HISTORICAL PERSPECTIVE

Resident Supervision: IOM 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 teaching institutions and program directors (PDs), to establish measurable standards of supervision for each level of doctor in training, as appropriate to their specialty….

As one of the youngest medical specialties, EM has been a progressive leader in providing innovative GME. To achieve balance between patient safety, resident wellness, and training, EM focuses on supervision and resident duty hours as integral to all three of these important elements. For more than 20 years, EM has been proactive in improving patient care and the GME experience by addressing faculty supervision and resident duty hours in its ACGME program requirements. In the late 1980s, EM became the first specialty to modify the program requirements to require full-time, in-hospital faculty supervision. Today all residents in the emergency department (ED) are supervised by board-certified or board-eligible emergency physicians at all times. In 1990, the Residency Review Committee in EM (RRC-EM) mandated that residents rotating in the ED have an average of one day in seven free of all clinical and educational requirements. At the same time, a consensus of EM GME leaders proposed limiting resident shift lengths to no more than 12 continuous scheduled hours with an equivalent time off between shifts. In 1995, additional EM-specific duty hour requirements were implemented instituting a 60-hour clinical week while the residents are in the ED. In 2003, the RRC-EM subsequently limited EM residents’ overall duty hours to a maximum of 72 hours per week including all didactics and other educational activities. Finally, the specialty of EM has recognized that off-service rotations have different expectations and requirements, in addition to varying intensities of their clinical workload. Because of this, the RRC-EM has stated that duty hours and supervision requirements for EM residents on nonEM rotations are subject to the requirements of the RRCs in those other specialties. CONSENSUS RESPONSE TO THE 2008 IOM REPORT Given this historical perspective and with input from representatives of all major EM organizations, we provided the ACGME with consensus responses to the

Patient Safety The ACGME and recent IOM report place considerable and appropriate emphasis on preserving patient safety. The report makes recommendations for changes to GME in areas of resident supervision, patient handovers, error ⁄ safety reporting, and resident sleep and workload.

EM Response: All residents should have adequate, direct, and on-site supervision, regardless if working in the ED or training on another service. Currently, EM meets this recommendation with faculty supervision when residents are training in an ED. Other specialties should seek ways to meet the spirit of the IOM recommendation regarding resident supervision on non-EM rotations. Research has suggested that increased supervision may improve patient safety. Specific to the ED, one study showed direct supervision of residents in the ED is significantly associated with better compliance with guidelines, regardless of level of training, but was unable to show an association with patient satisfaction.2 Another study identified direct supervision of non-EM residents rotating in the ED as resulting in ‘‘frequent and clinically important changes in patient care.’’3 Improving Handovers and Safety Reporting: IOM 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 transition 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. EM Response: As indicated by the IOM, resident training should include training for structured

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handovers. Effective communication and handovers has always been a priority in EM GME training. EDs use boards or electronic tracking systems to identify patients and their providers. This information is updated when handovers occur. However, EM is concerned that with more restrictions on duty hours based on other recommendations, the number of hand-offs will increase with a resultant increase in the opportunity for errors. Significant concerns exist that current ACGME duty hour restrictions have had the unintended consequence of fragmenting the educational and patient care milieu. At both the student and the resident levels, multiple studies demonstrate that more hand-offs of patient care occur, resulting in less continuity of care.4 These transitions in care are recognized to be a particularly dangerous time, placing patients at risk for medical error.5 In fact, a cohort of internal medicine residents report that failure to identify important information during signout is one of the top five suboptimal patient care practices.6 In their 2008 ‘‘National Patient Safety Goals’’ report, the Joint Commission reported that nearly 70% of sentinel events arose from communication errors, and of these, 50% occurred during hand-offs of patient care.7 This prompted the specific Joint Commission recommendations to address the sign-out process in an attempt to set a standard for improvement and prevention of medical error.8 Resident Sleep and Workload: IOM Recommendation: Programs should design resident schedules using the following parameters: Scheduled continuous duty periods must not exceed 16 hours unless a 5-hour uninterrupted continuous sleep period is provided 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. Residents should not admit new patients after 16 hours during an extended duty period. EM Response: If the current system for resident overnight coverage of inpatient services is maintained, the recommendations of a 5-hour ‘‘nap gap’’ may lead to a backlog of patients waiting to be admitted and hence increased patient crowding in the ED. Increased patient boarding has been shown to decrease patient safety.9–13 Requiring a 5-hour sleep period would necessitate additional patient care handovers, which has patient safety issues. Finally, implementation of a nap policy would be contrary to the recommendations from another IOM report on emergency care in America.14 Most academic teaching hospitals are configured in such a way that inpatient resident teams are called to the ED to perform examinations and write admission orders. Unless additional personnel are added or attending physicians see patients primarily during this

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nap gap (the term coined by EM), a mandated 5-hour sleep period will create a considerable shortfall of the resident workforce required to complete the admission process. Patient care cannot always wait for a consultant from a specialty service to complete the recommended 5-hour protected period. EDs already experience delays in the admission process and high levels of ED boarding. As a consequence of the 2003 ACGME common duty hour requirements, there was an increase in ED crowding due to decreased resident workload (unpublished data, Council of Emergency Medicine Residency Directors survey, 2009). There is concern that the new IOM recommendations will lead to additional crowding and compromise patient safety. IOM Recommendation: ACGME should require each residency review committee to define and then require appropriate limits on the caseload (for example, patient census, 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. EM Response: Similar to the suggested decrease in duty hours by requiring a sleep period, significant concern exists that decreasing patient caseloads for residents will increase the ED crowding and patient boarding in the ED, compromising not improving patient safety. Existing duty hour limitations and workload caps negatively affect ED workflow and patient safety. ED crowding is due, in part, to holding inpatients for considerable times, while waiting for available beds (a practice called boarding). Multiple studies confirm that boarding inpatients is perhaps the greatest patient safety issue in the ED.9–13,15–18 ED boarding is the cause of more than 15% of all hospital sentinel adverse events (and 31% of those occurring in the ED).19 In June 2006, the IOM issued a report with recommendations centering on decreasing ED crowding and improving ED workflow.13 Paradoxically, the current IOM duty hours’ recommendation may well exacerbate these very problems. Unlike the limited data suggesting errors are exacerbated by fatigue, significant data show that ED crowding negatively affects hospital length of stay, utilization of extended care facilities of boarded patients following hospital discharge, and patient outcomes.13 Despite this, the practice of ED boarding is still common. At a national meeting in March 2009, EM PDs discussed the potential effects of the IOM recommendations on EM training. PDs expressed concern that there would be further effects on patient care, with increased ED boarding, if further duty hour restrictions were implemented. A subsequent on-line survey of all EM PDs (>50% response rate) found that 76% of responding programs experienced ED boarding on a daily basis, and 60% of responding programs boarded patients when inpatient beds were available. Pertinent to the recent national discussion, 24% of all programs boarded because house staff from the admitting service had reached their workload caps (unpublished data,

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Council of Emergency Medicine Residency Directors survey, 2009). PDs anticipate that if these new duty hour restrictions are instituted, ED boarding would worsen and patient safety would be compromised. The 2003 ACGME common duty hour requirements had minimum effect on resident ED rotations. However, they did result in considerable changes on off-service rotations as other specialties struggled to meet the new requirements. Many specialties decreased the time their residents spent rotating in and learning EM. The loss of this emergency care education occurred because these services needed to reallocate their workforce to cover their inpatient care needs. This unintended consequence of decreasing the ED workforce is also felt to have impaired ED workflow. Furthermore, the 2003 duty hour restrictions resulted in increased difficulty in identifying the proper consulting physicians due to the greater turnover of on-call specialty residents. Some surgical specialties have shifted from in-house call to at-home call. As a result, these consultants are relying more heavily on telephone assessments, placing patients at risk for diagnostic and management errors, as admissions too often either get shifted to other less appropriate services or just occur with telephone orders without a contemporaneous direct patient assessment. Resident Wellness Assuming that a link between wellness, performance, and patient safety does exist, the profession must also assume that it exists in a balance and that this balance is one society should strive to preserve both in the short-term setting of a resident’s training and, more importantly, in the long-term setting of a physician’s career since it effects professional performance throughout a physician’s working lifetime. Short-term resident wellness is in part related to the quality of the work environment, length of duty hours, avoidance of fatigue and sleep deprivation through appropriate sleep cycles, and adequate time for relaxation. The current ACGME requirements focus heavily on these components, with the belief that improving resident wellness ultimately leads to improved physician performance and patient safety. While this is surely true on one level, great concern exists among many medical educators that overemphasis on duty hours and shortterm wellness marginalizes GME programs’ more substantial long-term responsibility to both trainees and society. These responsibilities include, but are not limited to, assuring overall quality of training, ensuring professionalism and competence in clinical knowledge and skills, acquiring the personal management strategies required to minimize career stress and maximize career happiness, and vocational ownership. Almost all of the IOM-proposed duty hour restrictions would not change the scheduling of resident shifts in the ED. The RRC-EM requirements currently meet or exceed the limitations described by the IOM for maximum hours per week, maximum shift length, minimum time off between scheduled shifts, and mandatory time off duty. Only the specific IOM recommendation suggesting that residents must be scheduled off for a continuous 48 hour period after working three or four

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consecutive night shifts would have negative consequences for scheduling EM clinical shifts at many training programs. IOM Recommendation: Programs should design resident schedules using the following parameters: 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. EM Response: Studies from EM and sleep experts show that limiting the number of night shifts to a maximum of three to four may not be provide the most beneficial sleep schedule. Flexibility is the most important consideration for PDs and resident sleep schedules. Some EM programs schedule residents for a month or block of night shifts to limit circadian disturbances, while other programs have residents work a string of six night shifts at a time. Limiting nights to just three or four in a row does not seem to be supported by EM sleep studies. Much has been studied about work hours and circadian rhythms. It is generally agreed that it is healthiest for a person to have a routine diurnal circadian rhythm. In medicine, however, this regular schedule is not possible given that health care needs are continuous. It is known from the literature that night shift work is associated with health and safety risks.20,21 Phase-shifting the circadian clock such that it is more aligned with night work and day sleep is one way to lessen these risks. However, it generally takes 2 weeks to change one’s circadian rhythms to a nocturnal existence. Circadian entrainment to night shift work can be done more quickly with the strategic use of bright light, scheduled dark environments, sunglasses, and melatonin.22,23 This means that the benefit of the phase advancement is only available if a person works for longer blocks of night shifts, which has been shown to be beneficial in EM.24 Placing a cap on the number of night shifts is not beneficial in EM because it does not allow individuals to phase delay their sleep in a gradual manner or take advantage of the reversal of their diurnal sleep ⁄ wake schedule once they have achieved it. Moonlighting An aspect of wellness defined by some residents is their participation in moonlighting. EM residents choose to moonlight as emergency practitioners for a variety of reasons including to allay their financial debt and further their clinical experience. IOM Recommendation: The ACGME should immediately amend its current requirements on moonlighting by requiring that any internal and external moonlighting for patient care adhere to the duty hour limits listed above (80 hours and all other limits), … [and] resident performance will be monitored to ensure that there is no adverse effect of moonlighting on resident performance. EM Response: The current standards for monitoring and including internal moonlighting in the resident

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duty hours are appropriate. Monitoring outside moonlighting should be based on the PD’s assessment of an individual resident’s fatigue and educational progress.

must be evaluated in a scientific manner. This type of research is underfunded and often limited in scope secondary to funding issues.

Moonlighting currently is given a broad definition by the ACGME and IOM as ‘‘patient care activities external to the educational program that residents ⁄ fellows engage in ….’’ EM organizations generally agree that residents should practice clinical care in an ED only under appropriate supervision. As with all employment, activities outside the residency program are not and should not be controlled by the program if they do not affect the professional behavior or clinical performance of the resident at work. Residents should have autonomy during their nonwork hours. Attempts to monitor outside moonlighting would not only be difficult but would infringe on residents’ personal freedom. Examples include the resident who wishes to volunteer at a free clinic or one with an EMT license who wishes to staff a rural ambulance squad. These are not just financial opportunities but often provide personal satisfaction that increases resident wellness.

IOM Recommendation: To gather the data necessary to monitor implementation 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 financers to set priorities for research and evaluation projects.

THE RESIDENT TRAINING EXPERIENCE Resident Length of Training EM residency training programs are designed to produce competent clinicians for clinical practice in the specialty of EM. These programs must meet training goals of the prescribed regulatory accrediting body sanctioned by the American Board of Medical Specialties, or the Bureau of Professional Education of the American Osteopathic Association, to gain admittance to formal board examinations.25,26 These regulatory bodies offer core competency measures as well as procedural and resuscitation guidelines as standards for residency programs to meet as part of the residency program approval process.27,28 Although core competency measures have recently been introduced as a benchmark for proficiency and ultimately board eligibility, the process of determining milestone attainment is largely predicated on a time unit of measure, either 3 or 4 years for EM training. In other disciplines such as surgery, there are limited data that demonstrate an improvement in patient outcomes after duty hours decreased. However, there is also concern that significant reduction in case volume may lead to inadequate operative experience. Surgical educators speculate that although outcomes are improved in teaching centers where there is 1:1 attending physician oversight, this improvement may not be sustained in independent practice.29,30 Similarly, in the EM residency director’s survey, approximately 40% of the participants believed that they might have to extend their residents’ training if all of the IOM recommendations were implemented and this resulted in a decrease in experience by the EM residents (unpublished data, Council of Emergency Medicine Residency Directors survey, 2009). Monitoring and Evaluation The possible change from any current duty hour requirements and any future anticipated restrictions

EM Response Summary: As with other specialties, in EM there have been few studies that have been completed to assess the effects of the past duty hour changes. There is a demonstrated need for a more complete understanding of the issues with regard to the length of training, patient contact, and duty hour restrictions. FINANCIAL ANALYSIS Additional Resources for Implementation The EM educators are strongly supportive of the IOM recommendation suggesting an understanding of all stakeholders, including the American public and our patients, that these recommendations will require a large financial investment in the already underfunded health care educational system. IOM Recommendation: All financial stakeholders in GME, such as the Centers for Medicare and Medicaid Services (CMS), Department 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 patient safety and resident safety and education, with special attention to safety net hospitals. An independent convening body should bring together all the major financers of GME to examine current financing methodologies and develop a coordinated approach to generate needed resources. EM Response Summary: We agree with a societal discussion regarding the approach to these financial issues. Funding is the critical component needed to make recommended changes in resident supervision, support decreased patient loads, and allow for the possible increase in the length of EM residency training. Current regulations for residency funding by CMS allow for financing of residency programs only to a specified number of slots. With institutions ‘‘capped’’ or limited to these slots only, the cost of increasing the number of residents or the length of training for residents will fall to the academic medical centers. This cost shifting is not likely to result in meaningful reform of program curricula focusing on the educational needs of the learner, nor will substantial increases in the resident complement occur. Systemwide reform mandates a sizeable financial investment in the already underfunded health care system.

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Improving the Safety of Residents and the Public The recommendation for providing safe transportation for residents is an example of the nonmedical costs that will be added to the health care system. IOM Recommendation: The committee recommends that sponsoring institutions immediately begin to provide safe transportation options (for example, taxi or public transportation vouchers) for any resident who for any reason is too fatigued to drive home safely. EM Response Summary: The current ACGME requirements of maintaining a safe method for the fatigued resident to travel home should be continued. Mandating specific solutions may be cost-prohibitive and may not be as effective as local flexibility to address this issue. Improving Adherence to Duty Hours The IOM report includes many other recommendations that will increase the cost of medical education. Society must address the cost ⁄ benefit ratios of these suggestions before any organization mandates further change. IOM Recommendation: ACGME and residency programs should ensure adherence to the current limits now, and to any new limits when implemented, 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. Sponsoring institutions should provide for confidential, protected 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. EM Response Summary: The institutions should be responsible for the monitoring of their residency programs and the ACGME should maintain the oversight for the academic medical institutions. Further oversight by organizations with less understanding of the medical education system is unlikely to add to this process. Unintended Workforce Issues The last change in duty hours resulted in less resident staffing of teaching hospital EDs when non-EM residency programs abandoned their EM experience to increase their own specialty staffing needs. Although the costs to society would be high to replace the work done by residents, it is not the only or perhaps the most substantial concern. With implementation of new, more restrictive duty hours, the ability to staff EDs with appropriately trained clinicians is a substantial concern. Workforce studies with data from 1999, 2005, and 2008 all found significant gaps in the supply of emergency physicians being trained compared to the staffing needs to provide residency-trained emergency physicians in all U.S. EDs.31–33 With the possible increased length of training and increased need for staffing in teaching hospitals, the supply of emergency physicians will not

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meet the anticipated demand for more than the 30 years currently estimated.

CONCLUSIONS In the field of EM, residents are supervised at all times by expert attending staff who are immediately available for consultation and at the bedside providing care. This strategy is the best method for the prevention of medical mistakes of any cause, including from resident fatigue. We believe that continuous supervision by engaged faculty should be the first line of defense for patient safety in all medical disciplines. These IOM recommendations are designed for the more typical medical practice pattern of other specialties. Emergency physicians staff the ED in a fundamentally different manner than many other specialties. Practice variability among disciples must be considered when crafting such recommendations and an understanding of the complex consequences that result from such measures must be an important component of the design. It is clear that for duty hours regulations, one size does not fit all as disciplines such as EM have long considered the issues of fatigue, shift cycle variability, and direct faculty oversight in their training programs. In today’s health care marketplace, without a concomitant increase in funding, decreasing resident work hours will dramatically change the workforce at the front line of patient care. If, as predicted, these IOM recommendations result in a decrease in the number of residents working at any given time, hospitals will either cut services or simply be passive. The net result of this passivity will be to increase the workload on the remaining residents and faculty and threaten patient safety by unsafe increases in the number of patient contacts, substantial delays in treatment, and a very real limitation of access to care. Both of these options put the patients and the public at substantially more risk than the current duty hour configuration. We as a profession and as a public cannot allow further strain on already overburdened EDs and teaching hospitals. To guarantee competent graduates under such large financial and time restrictions may lead to substantially lengthening residency training and ⁄ or increasing the number of resident slots will be mandated. We believe that this may be the only solution that allows trainees to see a critical number of patients and obtain the clinical skills and cognitive abilities required for a lifelong safe practice. Failure to address these issues and enacting the IOM recommendations without consideration of these substantial concerns amounts to an unfunded mandate. This unfunded mandate would burden the already tenuous GME system and result in disastrous outcomes for patient safety and physician competence. The authors acknowledge the efforts of and express our gratitude to Marjorie Geist who provided the coordination of the consensus group and editorial assistance for this project. The authors also express our appreciation to Nissi George for her assistance with the references and other clerical efforts. The authors thank Lynne Meyer and Barb Mulder for their assistance in providing data and background for this project. Others who assisted with reviewing the project include Nick Jouriles and Philip Shayne.

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