Discussion of Draft Duty Hour Standards Clinical Chairs-July 15, 2010

1. E. Stephen Amis, Jr., MD Co-chair, Duty Hour Task Force Discussion of Draft Duty Hour StandardsClinical Chairs-July 15, 2010

2. History & Background • 1987—Bell Commission and NY State 405 regulations • 1999—Institute of Medicine Report: “To Err is Human” • 2003—ACGME Duty Hours standards go into effect • 2007—Congress asked AHRQ to investigate resident work hours (legislative oversight threatened) • 2008—IOM Report: “Resident Duty Hours” • 2009—ACGME Duty Hour Task Force formed

3. Duty Hours Task Force E. Stephen Amis Jr., MD - RRC Chair, Radiology, CRC Chair – Co-Chair Susan Day, MD - Ophthalmology. Board Chair, ACGME – Co-Chair Thomas J. Nasca, MD, MACP - Nephrology. CEO, ACGME – Vice Chair Paige Amidon – ACGME Board Director, Public Director Jaime Bohl, MD – CRCR Resident Member, Colon and Rectal Surgery Lois Bready, MD – former RRC Chair, Anesthesiology Ralph Dacey, Jr., MD – RRC Chair, Neurosurgery Rosemarie Fisher, MD – RRC Chair, Medicine. CRC Vice Chair Timothy Flynn, MD – Vascular Surgery. ACGME Board Chair-Elect Stephen Ludwig, MD – RRC Chair, Pediatrics Robert Muelleman, MD – RRC Chair, Emergency Medicine Janice Nevin, MD, MPH – former RRC Chair, Family Medicine Meredith Riebschleger, MD – CRCR Resident Member, Pediatrics William Walsh, MD, MPH – ACGME Board Director, Pulmonary & Critical Care George Wendel, Jr., MD – RRC Chair, Obstetrics and Gynecology Thomas V. Whalen, MD – RRC Chair, Surgery

4. Where the Task Force has been • International Duty Hours Symposium, ACGME Annual Educational Conference, Dallas, TX, March 2009 • ACGME Duty Hours Congress, Chicago, IL, June 2009 • 11 meetings of TF, both face-to-face and virtual

5. Testimony Heard by TF Alone • Expert Testimony in the following areas: • History and impact of 2003 duty hours standards • Report of ACGME Monitoring Committee on duty hours • Sleep research & physiology • Historical/political framework of IOM Report & duty hours • Patient safety, quality, and the teaching hospital • Effect of duty hours on Safety Net hospitals • New York hospitals’ experience with duty hour regulations • Duty hours and the legal perspective • Fatigue management strategies • Three (3) commissioned literature reviews

6. Commissioned Literature Reviews • Conceptual frameworks in the study of duty hour changes in graduate medical education: an integrative review • University of Illinois at Chicago • Systematic review of the literature: resident duty hours and related topics • Medical College of Wisconsin, Mayo Clinic College of Medicine, Univ. of Chicago • Systematic review of the literature on the impact of variation in residents’ duty hour schedules on patient safety • Jefferson Medical College

7. Testimony from the Profession • Duty Hours Congress, June 2009 (two days) • Testimony from over 65 groups representing the GME community • Need for flexibility: “one size doesn’t fit all” • Reduction in medical errors is related to much more than just duty hours • Focus on all components of the learning environment—not just hours • Personal responsibility (professionalism) is essential and must be fostered in fatigue management • Patient safety is more than the alertness of the resident taking care of patients at 3AM…senior residents must be practice-ready

8. Further Concerns • Work intensity/workload have greatest impact on least experienced residents • No evidence to support value of a maximum of only four consecutive nights on night float • Evidence from other vocations (airline pilots, truck drivers) do not necessarily apply in MD work environment • Valid methods of detecting fitness for duty are under development • Concept of fatigue management is very important

9. Fiscal Concerns • IOM predicts $1.7 billion price tag • ACGME concurs there will be a cost, but study commissioned to determine amount • Safety net hospitals are a major concern: services must compete for available dollars (medical care, education, public services) • Cost for additional regulatory oversight (annual site visits to institutions) • All are compounded by current recession

10. Keep in Mind…. • Patient safety, yes, but also…. • Resident well-being and • Preparing the resident for independent practice We must remember that this is not just about duty hours!!!

11. New Draft RequirementsResident Duty Hours in the Learning and Working Environment(Currently posted on ACGME web site for comment)

12. Professionalism, Personal Responsibility, and Patient Safety The program must be committed to and be responsible for promoting patient safety and resident well-being in a supportive educational environment. The program director must ensure that the residents are integrated into and actively participate in interdisciplinary clinical quality improvement and patient safety programs

13. Professionalism, Personal Responsibility, and Patient Safety The program director and institution must ensure a culture of professionalism that supports patient safety and personal responsibility. Residents and faculty must demonstrate: assurance of the safety and welfare of patients entrusted to their care; provision of patient and family-centered care; assurance of their fitness for duty;

14. Professionalism, Personal Responsibility, and Patient Safety management of their time before, during, and after clinical assignments; recognition of impairment, including illness and fatigue, in themselves and in their peers; attention to lifelong learning; monitoring their patient care performance improvement indicators; and, honest and accurate reporting of duty hours, patient outcomes, and clinical experience data.

15. Transitions of Care Programs must design clinical assignments to minimize the number of transitions in patient care. Institutions and programs must ensure and monitor effective, structured hand-over processes to facilitate both continuity of care and patient safety.

16. Transitions of Care Programs must ensure that residents are competent in communicating with team members in the hand-over process. Institutions must ensure the availability of schedules that inform all members of the health care team of faculty and residents currently responsible for each patient’s care.

17. Alertness Management The program must: educate all faculty and residents to recognize the signs of fatigue and sleep deprivation; educate all faculty and residents in fatigue mitigation processes; and, adopt fatigue mitigation processes to manage the potential negative effects of fatigue on patient care and learning, including naps and back-up Call schedules.

18. Alertness Management Each program must have a process to ensure continued patient care in the event that a resident may be unable to perform his/her patient care duties. The Sponsoring Institution must provide adequate sleep facilities and/or safe transportation options for residents who may be too fatigued to safely return home.

19. Supervision of Residents Introduction: Supervision may be exercised in a variety of methods. Some activities require the physical presence of the supervising faculty. The supervising physician for many aspects of patient care may be a more advanced resident. Other portions of care provided by the resident can be adequately supervised by the immediate availability of the supervising faculty or resident physician either in the institution or by means of telephonic and/or electronic modalities. In some circumstances, supervision may include post hoc review of resident-delivered care with feedback as to the appropriateness of that care.

20. Supervision of Residents In the clinical learning environment, each patient must have an identifiable, appropriately-credentialed and privileged supervising faculty who is ultimately responsible for that patient’s care. This information should be available to residents, faculty, and patients. Residents and faculty should inform patients of their roles in each patient’s care.

21. Supervision of Residents The program must demonstrate that the appropriate level of supervision is in place for all patients cared for by all residents.

22. Supervision of Residents 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.

23. Supervision of Residents Indirect Supervision: With direct supervision immediately available – the supervising physician is physically within the confines of the site of patient care, and is immediately available to provide Direct Supervision. With direct supervision available – the supervising physician is not physically present within the confines of the site of patient care, but is immediately available via phone, and is available to provide Direct Supervision.

24. Supervision of Residents Oversight – The supervising physician is available to provide review of procedures/encounters with feedback provided after care is delivered.

25. Supervision of Residents The privilege of progressive responsibility, authority and a supervisory role in patient care delegated to each resident must be assigned by the program director and faculty.

26. Supervision of Residents The program director must evaluate each resident’s abilities based on specific criteria. When available, evaluation should be guided by specific national standards-based criteria Faculty functioning as supervising physicians should delegate portions of care to residents, based on the needs of the patient and the skills of the residents. This refers to “MILESTONES”

27. Supervision of Residents 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 the patient and the skills of the resident/fellow.

28. Supervision of Residents Programs must set guidelines for circumstances and events in which residents must communicate with appropriate supervising faculty, e.g., transfer to an intensive care unit, end-of-life decisions.

29. Supervision of Residents The resident is responsible for knowing the limits of his/her scope of authority, and the circumstances under which they are permitted to act with conditional independence. In particular, during the PGY1, residents must be supervised either directly or indirectly, with direct supervision immediately available. This means that interns can never be in house without faculty or more senior residents also in house supervising them

30. Supervision of Residents Faculty supervision assignments should be of sufficient duration to assess the knowledge and skills of the resident and delegate to them the appropriate level of patient care authority and responsibility.

31. Clinical Responsibilities The clinical responsibilities for each resident must be based on the PGY-level, patient safety, resident education, severity and complexity of patient illness/condition and available support services. (As further specified by the Review Committee) Note need for RRC to specify what these clinical responsibilities are for residents at each level of training

32. Teamwork Residents must care for patients in an environment that maximizes effective communication. This must include the opportunity to work as a member of effective interdisciplinary teams that are appropriate to the delivery of care in the specialty.

33. Resident Duty Hours Maximum Hours of Work per Week Duty hours must be limited to 80 hours per week, averaged over a four-week period, inclusive of all in-house call activities and moonlighting.

34. Resident Duty Hours Duty Hour Exceptions A Review Committee may grant exceptions for up to 10% or a maximum of 88 hours to individual programs based on a sound educational rationale. In preparing a request for an exception the program director must follow the duty hour exception policy from the ACGME Manual on Policies and Procedures.

35. Resident Duty Hours Moonlighting Time spent by residents in Internal and External Moonlighting (as defined in the ACGME Glossary) must be counted towards the 80-hour Maximum Weekly Hour Limit. PGY1 residents are not permitted to moonlight. Inclusion of external moonlighting in 80 hours max is a major change. This was an IOM recommendation.

36. Resident Duty Hours Mandatory Time Free of Duty Residents must be scheduled for a minimum of one day free of duty every week (when averaged over four weeks). At-home call cannot be assigned on these free days. NO CHANGE

37. Resident Duty Hours Maximum Duty Period Length Duty periods of PGY1residents must not exceed 16 hours in duration. Duty periods of PGY2 residents and above may be scheduled to a maximum of 24 hours of continuous duty in the hospital. Programs must encourage residents to use alertness management strategies in the context of patient care responsibilities. 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. Note absence of 5 hour nap The PGY1 residents are expected to go home at the end of the 16 hr shift

38. Resident Duty Hours Maximum Duty Period Length It is essential for patient safety and resident education that effective transitions in care occur. Residents may be allowed to remain on-site in order to accomplish these tasks; however, this period of time must be no longer than an additional four hours. Residents must not attend continuity clinics after 24 hours of continuous in-house duty. CHANGE FROM 6 HOURS TO 4 HOURS; NO MORE CONTINUITY CLINICS

39. Resident Duty Hours Maximum Duty Period Length 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, or humanistic attention to the needs of a patient or family. Adds flexibility

40. Resident Duty Hours Maximum Duty Period Length Under those circumstances, the resident must: appropriately hand over the care of all other patients to the team responsible for their continuing care; and, document the reasons for remaining to care for the patient in question and submit that documentation in every circumstance to the program director.

41. Resident Duty Hours Maximum Duty Period Length The program director must review each submission of additional service, and track both individual resident and program-wide episodes of additional duty. But having flexibility has a price; will this be only occasional, or become a real problem for PDs? Must be included in the 80 hours/week maximum.

42. Resident Duty Hours Minimum Time Off between Scheduled Duty Periods PGY1 residents should have 10 hours, and must have eight hours, free of duty between scheduled duty periods. Intermediate-level residents[as defined by the Review Committee] 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 in-house duty. The RRCs will need to provide specialty-specific definitions

43. Resident Duty Hours Minimum Time Off between Scheduled Duty Periods Residents in the final years of education (as defined by the Review Committee) should have eight hours between scheduledduty periods. However, these residents must be prepared to enter into the unsupervised practice of medicine and care for patients over irregular or extended periods. Therefore, under circumstances defined by the Review Committee and approved by the ACGME, these residents may be permitted to return to duty with fewer than eight hours between in-hospital activities. This must occur only within the context of the 80 hour and one day off in seven standards. Again, more flexibility, this time for senior residents!

44. Resident Duty Hours Minimum Time Off between Scheduled Duty Periods Circumstances of return to hospital activities with fewer than eight hours away from the hospital by residents in the final years of training must be monitored by the program director. And again, the PD is on the hook to make sure this is all documented

45. Resident Duty Hours Maximum Frequency of In-House Night Float Residents must not be scheduled for more than six consecutive nights of night float. (The maximum number of consecutive weeks of night float, and maximum number of months of night float per year may be further specified by the Review Committee) RRCs may address this issue if they wish. Limitation on night float is NEW…

46. Resident Duty Hours Maximum In-House On-Call Frequency PGY2 residents and above must be scheduled for in-house call no more frequently than every-third-night (no averaging). This is a change….averaging allowed before. No more “every other night” in house call. Upsetting to residents….precludes the “golden week-end”

47. Resident Duty Hours At-Home Call Time spent in the hospital by residents on at-home call must count towards the 80-hour maximum weekly hour limit. The frequency of at-home call is not subject to the every-third-night limitation. At-home call must not be so frequent or taxing to preclude rest or reasonable personal time for each resident.

48. Resident Duty Hours At-Home Call 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 80-hour weekly maximum, will not initiate a new “off-duty period.” In other words, returning to the hospital while on At-Home Call does not restart the “time off between scheduled duty periods” clock

49. * as defined by the individual RRCs

50. Monitoring Compliance • IOM has a negative view on the current ACGME monitoring of compliance with duty hour standards • ACGME has beefed up monitoring and sanctions in past couple of years • New standards will be monitored by ANNUAL visits to sponsoring institutions • Beginning July 2011 • Results will be available to the public • Cost may be around $12-15K/visit (rough estimate)