1. ACGME Duty Hours: Where are we and where are we going? George Sarosi Jr. MD Robert H Hux MD Professor of Surgery Residency Program Director

2. Disclosures I have no financial conflicts of interest to disclose.

3. Disclosure II However, those who dislike major change are likely to find this talk highly unpleasant I did not make these rules No amount of complaining about this will cause it to change

4. A Brief History of Duty Hours Limits 1984 Libby Zion case – Concerns raised about resident fatigue and supervision 1989 New York State sets 80 hour limit – Applies to 15% of nations residents 2003 ACGME Imposes national duty hour limits

5. The Current Duty Hours Were established in 2003 and represented a substantial change for surgery training programs Were initially to be reevaluated in 5 years Have largely been complied with in most programs

6. The Current Duty Hours No more than 80 hours per week averaged over a 4 week rotation In house call no more Frequent than 1 in 3 averaged over a 4 week period Continuous Duty hours must not exceed 24 hours – 6 hours after provided for hand-off and didactics or clinics. NO NEW PATIENTS

7. Current Duty Hours Cont. 10 hours off between duty periods should be provided. 1 day off in 7, averaged over 4 weeks, free from formal educational and duty assignments Internal Moonlighting (but not external) counts as duty hours

8. What Have Duty Hour Limits Accomplished? In 1999 in a self reported survey residents in the US reported average duty hours of – PGY-1 83 hours/week – PGY-2 76.2 hours /week – 49% worked more than 80 hours/ week Surgery residents reported working more hours – PGY-1 103 – PGY-2 105.7 – 89% of PGY-1 and 93% of PGY-2 residents reported working more than 80 hours/ week Baldwin Acad Med 2003 78(11)

9. Effect of Initial Duty Hours Reform PGY-1 residents surveyed reported working fewer hours: – 2002 70.7 hours/week – 2003 66.6 hours/ week – Only 43% of residents nationally reported more that 80 hours/ week – 67.2% in General Surgery worked more than 80 hours /week Landrigan JAMA 96(9) 2006

10. Other Effects of Duty Hours Reform Surgical case volume has shown a small but statistically significant drop in case numbers of graduating residents – 938.9 total and 249.2 chief cases in 2002-3 – 914.2 total and 238.3 chief cases in 2007-8 – No increase in residents failing to meet defined categories – Declines in case numbers in areas outside classic general surgery such as Vascular, Thoracic and Plastics Simien Ann Surg 252(2) 2010

11. Other Effects of Duty Hours Reform The majority of Studies show an increase in resident job satisfaction and personal time. The majority of studies show an increase in resident test performance. The majority of studies show a decrease in attending job satisfaction, satisfaction with education and quality of life. Jamal Acad Med 86(1) 2011

12. Inconclusive Evidence that Duty Hours Reform has Effected Hospital Mortality 2007 JAMA study showed no change in Medicare hospital mortality in 2004 or 2005 compared to 2000-2003 A second study showed decrease in mortality in VA hospitals for medical but not surgical patients in high intensity teaching VA hospitals over the same time period Volpp JAMA 298(9) 2007

13. 2009 IOM Report 2007 Congress commissioned the IOM to examine the relationship between resident duty hours and patient safety. 2009 the IOM released it report Resident Duty Hours: Enhancing Sleep, Supervision and Safety – At least 5 hours sleep after 16 hours of continuous duty – Increased frequency of days off – Greater supervision especially for PGY-1 – Improved hand offs

14. Effect of the IOM Report Significant Discussion about legislation to govern resident Duty hours Significant criticism of 2003 Duty hours rules Raised issues beyond just duty hours such as supervision ACGME commissioned a 16 member task force to review evidence and draft new standards.

15. August 2010: New ACGME Common Program Requirements Announced in NEJM (vol. 363 (2) pp. e3. 2010) Have undergone some slight modification since initial announcement – Relaxation of strict q3 call to on average Focus on three broad areas – Duty Hours – Mitigation of Fatigue – Supervision of residents and transitions of care Have level of training specific rules

16. Total Duty Hours 2003 Rules Duty hours must be limited to 80 hours per week, averaged over a fourweek period, inclusive of all inhouse call activities. 2011 Rules VI.G.1. Duty hours must be limited to 80 hours per week, averaged over a fourweek period, inclusive of all inhouse call activities and all moonlighting.

17. Maximum Duty Period Length 2003 Rules Continuous onsite duty, including inhouse call, must not exceed 24 consecutive hours. Residents may remain on duty for up to six additional hours to participate in didactic activities, transfer care of patients, conduct outpatient clinics, and maintain continuity of medical and surgical care. 2011 Rules VI.G.4.a) Duty periods of PGY1 residents must not exceed 16 hours in duration. VI.G.4.b) Duty periods of PGY2 residents and above may be scheduled to a maximum of 24 hours of continuous duty in the hospital. VI.G.4.b).(1) It is essential for patient safety and resident education that effective transitions in care occur. Residents may be allowed to remain onsite in order to accomplish these tasks; however, this period of time must be no longer than an additional four hours

18. Some New Flexibility in Duty Hour Length VI.G.4.b).(3) In unusual circumstances, residents, on their own initiative, may remain beyond their scheduled period of duty to continue to provide care to a single patient. Justifications for such extensions of duty are limited – to reasons of required continuity for a severely ill or unstable patient – academic importance of the events transpiring – humanistic attention to the needs of a patient or family. VI.G.4.b).(3).(a) Under those circumstances, the resident must: – appropriately hand over the care of all other patients to the team responsible for their continuing care – document the reasons for remaining to care for the patient in question and submit that documentation in every circumstance to the program director.

19. Minimum Time off Between Scheduled Duty Periods 2003 Rules Adequate time for rest and personal activities must be provided. This should consist of a 10hour time period provided between all daily duty periods and after inhouse call. 2011 Rules VI.G.5.a) PGY1 residents should have 10 hours, and must have eight hours, free of duty between scheduled duty periods. VI.G.5.b) Intermediatelevel residents (PGY 2&3) should have 10 hours free of duty, and must have eight hours between scheduled duty periods. They must have at least 14 hours free of duty after 24 hours of inhouse duty.

20. Minimum Time off Between Scheduled Duty Periods (Chiefs) 2003 Rules Adequate time for rest and personal activities must be provided. This should consist of a 10hour time period provided between all daily duty periods and after inhouse call. 2011 Rules VI.G.5.c) Residents in the final years of education (PGY 4&5) must be prepared to enter the unsupervised practice of medicine and care for patients over irregular or extended periods. VI.G.5.c).(1) This preparation must occur within the context of the 80 hour, maximum duty period length, and onedayoffinseven standards. While it is desirable to have eight hours free of duty between scheduled duty periods, there may be circumstances when these residents must stay on duty to care for their patients or return to the hospital with fewer than eight hours free of duty. These circumstances must be monitored by the program director

21. Minimum Time Between Shifts Simplified Switch from should be 10 hours to must be 8 and should be 10 for all levels For 24 hour shifts residents must have 14 hours between shifts Chiefs (PGY-4 & 5) can have less time between shifts for compelling clinical reasons related to continuity of care: – A patient on whom a resident operated/intervened that day who needs return to the operating room (OR). – A patient on whom a resident operated/intervened that day who requires transfer to the Intensive Care Unit (ICU) from a lower level of care. – A patient on whom a resident operated/intervened that day who is in the ICU and is critically unstable. – A patient who returns to OR for a complication during the same admission Reasons for return must be documented for PD

22. Maximum Frequency of In House Call is Unchanged 2003 Rules Inhouse call must occur no more frequently than every third night, averaged over a fourweek period. 2011 Rules VI.G.7. PGY2 residents and above must be scheduled for inhouse call no more frequently than everythirdnight (when averaged over a four week period).

23. Home Call Rules are Largely Unchanged 2003 Rules The frequency of athome call is not subject to the every thirdnight, or 24+6 limitation. However athome call must not be so frequent as to preclude rest and reasonable personal time for each resident. Residents taking athome call must be provided with one day in seven completely free from all educational and clinical responsibilities, averaged over a fourweek period. When residents are called into the hospital from home, the hours residents spend inhouse are counted toward the 80 hour limit. 2011 Rules VI.G.8.a) Time spent in the hospital by residents on athome call must count towards the 80hour maximum weekly hour limit. The frequency of athome call is not subject to the everythirdnight limitation, but must satisfy the requirement for onedayinseven free of duty, when averaged over four weeks. VI.G.8.a).(1) Athome call must not be so frequent or taxing as to preclude rest or reasonable personal time for each resident. VI.G.8.b) Residents are permitted to return to the hospital while on at home call to care for new or established patients. Each episode of this type of care, while it must be included in the 80hour weekly maximum, will not initiate a new offduty period.

24. Rules Have Been Added Governing Night Float Rotations 2003 Rules2011 Rules VI.G.6. Residents must not be scheduled for more than six consecutive nights of night float. Night float rotations must not exceed two months in duration, and there can be no more than three months (14 Weeks) of night float per year. There must be at least two months between each night float rotation. (Surgery RRC)

25. Strong Language on Fatigue Mitigation Added 2003 Rules Faculty and residents must be educated to recognize the signs of fatigue and sleep deprivation and must adopt and apply policies to prevent and counteract its potential negative effects on patient care and learning. 2011 Rules VI.C.1. The program must: VI.C.1.a) educate all faculty members and residents to recognize the signs of fatigue and sleep deprivation VI.C.1.b) educate all faculty members and residents in alertness management and fatigue mitigation processes VI.C.1.c) adopt fatigue mitigation processes to manage the potential negative effects of fatigue on patient care and learning, such as naps or backup call schedules. Strategic napping, especially after 16 hours of continuous duty and between the hours of 10:00 p.m. and 8:00 a.m. is strongly suggested. VI.C.2. Each program must have a process to ensure continuity of patient care in the event that a resident may be unable to perform his/her patient care duties. VI.C.3. The sponsoring institution must provide adequate sleep facilities and/or safe transportation options for residents who may be too fatigued to safely return home.

26. Significant Changes to Statements Regarding Resident Supervision In 2003 resident supervision: The program must ensure that qualified faculty provide appropriate supervision of residents in patient care activities

27. Significant Changes to Statements Regarding Resident Supervision In 2011: VI.D.1. In the clinical learning environment, each patient must have an identifiable, appropriatelycredentialed and privileged attending who is ultimately responsible for that patients care. – VI.D.1.a) This information should be available to residents, faculty members, and patients. – VI.D.1.b) Residents and faculty members should inform patients of their respective roles in each patients care. VI.D.2. The program must demonstrate that the appropriate level of supervision is in place for all residents who care for patients. Supervision may be exercised through a variety of methods. Some activities require the physical presence of the supervising faculty member. For many aspects of patient care, the supervising physician may be a more advanced resident or fellow. Other portions of care provided by the resident can be adequately supervised by the immediate availability of the supervising faculty member or resident physician, either in the institution, or by means of telephonic and/or electronic modalities. In some circumstances, supervision may include posthoc review of residentdelivered care with feedback as to the appropriateness of that care.

28. Levels of Supervision Defined VI.D.3. Levels of Supervision To ensure oversight of resident supervision and graded authority and responsibility, the program must use the following classification of supervision: Direct Supervision – the supervising physician is physically present with the resident and patient. Indirect Supervision: – (1) with direct supervision immediately available – the supervising physician is physically within the hospital or other site of patient care, and is immediately available to provide Direct Supervision. – (2) with direct supervision available – the supervising physician is not physically present within the hospital or other site of patient care, but is immediately available by means of telephonic and/or electronic modalities, and is available to provide Direct Supervision. Oversight – The supervising physician is available to provide review of procedures/encounters with feedback provided after care is delivered.

29. Deliberate Assignment of Independence with Certification will Be Required VI.D.4. The privilege of progressive authority and responsibility, conditional independence, and a supervisory role in patient care delegated to each resident must be assigned by the program director and faculty members. VI.D.4.a) The program director must evaluate each residents abilities based on specific criteria. When available, evaluation should be guided by specific national standardsbased criteria. VI.D.4.b) Faculty members functioning as supervising physicians should delegate portions of care to residents, based on the needs of the patient and the skills of the residents. VI.D.4.c) Senior residents or fellows should serve in a supervisory role of junior residents in recognition of their progress toward independence, based on the needs of each patient and the skills of the individual resident or fellow. VI.D.5. Programs must set guidelines for circumstances and events in which residents must communicate with appropriate supervising faculty members, such as the transfer of a patient to an intensive care unit, or endoflife decisions. VI.D.5.a) Each resident must know the limits of his/her scope of authority, and the circumstances under which he/she is permitted to act with conditional independence.

30. Strong Focus on PGY-1 Supervision Direct Supervision Direct supervision is required until competency is demonstrated for: Patient Management Competencies – 1. initial evaluation and management of patients in the urgent or emergent situation, including urgent consultations, trauma, and emergency department consultations (ATLS required) – 2. evaluation and management of post-operative complications, including hypotension, hypertension, oliguria, anuria, cardiac arrythmias, hypoxemia, change in respiratory rate, change in neurologic status, and compartment syndromes – 3. evaluation and management of critcially-ill patients, either immediately post-operatively or in the intensive care unit, including the conduct of monitoring, and orders for medications, testing, and other treatments – 4. management of patients in cardiac or respiratory arrest (ACLS required)

31. Strong Focus on PGY-1 Supervision Direct Supervision Procedural Competencies – 1. Performance of advanced vascular access procedures, including central venous catheterization, temporary dialysis access, and arterial cannulation – 2. repair of surgical incisions of the skin and soft tissues – 3. repair of skin and soft tissue lacerations – 4. excision of lesions of the skin and subcutaneous tissues – 5. tube thoracostomy – 6. paracentesis – 7. endotracheal intubation – 8. bedside debridement

32. Strong Focus on PGY-1 Supervision Indirect Supervision Indirect Supervision allowed for: Patient Management Competencies – 1. evaluation and management of a patient admitted to hospital, including initial history and physical examination, formulation of a plan of therapy, and necessary orders for therapy and tests – 2. pre-operative evaluation and management, including history and physical examination, formulation of a plan of therapy, and specification of necessary tests – 3. evaluation and management of post-operative patients, including the conduct of monitoring, and orders for medications, testing, and other treatments – 4. transfer of patients between hospital units or hospitals – 5. discharge of patients from the hospital – 6. interpretation of laboratory results Procedural Competencies – 1. performance of basic venous access procedures, including establishing intravenous access – 2. placement and removal of nasogastric tubes and Foley catheters – 3. arterial puncture for blood gases

33. New Statements on Transitions of Care VI.B.1. Programs must design clinical assignments to minimize the number of transitions in patient care. VI.B.2. Sponsoring institutions and programs must ensure and monitor effective, structured handover processes to facilitate both continuity of care and patient safety. VI.B.3. Programs must ensure that residents are competent in communicating with team members in the handover process. VI.B.4. The sponsoring institution must ensure the availability of schedules that inform all members of the health care team of attending physicians and residents currently responsible for each patients care.

34. What does all this mean? Fundamental changes in the intern year – No more call – Strong incentive to move PGY-1 residents to shift work – Limits on the amount of night work by interns – Delayed maturation of residents? More work and more flexibility for upper level residents – Likely more in house call for intermediate level residents – Much more flexibility for senior residents

35. What does all this mean II? New Focus on supervision and certification of competence (or at least experience) – Interns will need to have much more direct supervision by senior residents and attendings – A new focus on documentation of competence on the part of programs and faculty (to allow for expanded intern independence) The changes in supervision are the most radical changes and likely the hardest to predict This may be a very good (but painful) thing

36. It's a good idea to obey all the rules when you're young just so you'll have the strength to break them when you're old. -Mark Twain