Perspectives on Safety
ACGME's 2017 Revision of Common Program Requirements
The Accreditation Council for Graduate Medical Education (ACGME) is committed to supporting the safety and quality of patient care provided by residents in training while assuring that the educational experience prepares young physicians to safely and effectively provide care for their patients after graduation. Therefore, it is essential that residents participate in a clinical and educational environment that includes programs in which faculty role model participation in patient safety and quality activities, and in which trainees can gain the experience they need to become independent practitioners.
These commitments and expectations are reflected in the major revision of Section VI of the ACGME Common Program Requirements (1), which establishes or strengthens standards related to the learning and working environment. This environment includes patient safety, supervision, well-being of residents and faculty, and clinical and educational work hours. The changes are significant and include new requirements that elevate expectations in the domains of quality and safety programs, as well as resident and faculty well-being.
Initiated in late 2015 with the appointment of a multidisciplinary Task Force that included residents and a member of the public, this revision was a major undertaking. The Task Force invited more than 100 organizations, including certifying boards, specialty societies, resident groups and unions, medical student groups, and patient safety organizations, to submit position papers related to the learning and working environment; 64 organizations responded.(2) The ACGME also invited input from the community, and 61 individuals and organizations provided recommendations.(3) In March 2016, the ACGME sponsored a Congress on the Learning and Working Environment and received testimony from 53 organizations. The Task Force also extensively reviewed research from the past 5 years, including relevant multicenter research trials.(4-7) The Task Force spent more than 4200 hours formulating the new requirements, including systematically reviewing more than 1000 published articles, such as references (8-12), and the extensive input from stakeholders. Following a public comment period, the requirements were finalized and approved by the ACGME Board of Directors in February 2017, with an effective date of July 1, 2017.
The 2017 requirements place greater emphasis on patient safety and quality improvement; more comprehensively address physician well-being; strengthen expectations around team-based care; and create flexibility for programs to schedule clinical and educational work hours within the maximums currently utilized in the United States.
The changes reinforce the patient safety framework already in place in the Common Program Requirements as it pertains to total hours in clinical care and education, required levels of supervision, and the graduated level of responsibility given to residents and fellows as they gain experience. They include emphasis on the culture of safety, requiring residents and faculty to actively participate in patient safety and quality improvement systems. Residents are required to participate as team members in real and/or simulated interprofessional clinical patient safety activities, such as root cause analyses or other activities that include analysis, formulation, and implementation of actions.
The requirements related to clinical and educational work hours are also designed to support patient safety and provide safeguards. They allow work at home as part of the 80-hour weekly maximum; optimize the quality of care transitions and handoffs; ensure that residents and fellows can be relieved of responsibilities when needed; define the need for direct oversight of first-year residents; and ensure that patients and the entire health care team know who is responsible and accountable for each patient's care.
In an attempt to enhance patient safety, in 2011 the clinical work and educational hour requirements were modified to limit (only) postgraduate year (PGY) 1 residents to a maximum of 16 hours of continuous duty. The Task Force's revision of clinical experience and education hours reflects the ACGME's commitment to developing evidence-based requirements, and thus included an assessment of the evidence regarding the 2011 changes.(13)
The evidence drawn from a number of studies conducted after implementation of the 16-hour cap fails to demonstrate a benefit to patient safety. Moreover, the evidence raises the possibility of significant negative impacts to the quality of physician education and professional development.(10,14,15)
To further investigate these issues, the ACGME provided support for (but had no role in the conduct or interpretation of) two national, large, independent multicenter trials.(16) The iCOMPARE trial for internal medicine and the FIRST trial for general surgery are randomized controlled trials examining the PGY-1 16-hour cap. In them, the test groups were allowed to follow more flexible work hour schedules. The findings from the FIRST trial demonstrated that allowing for some flexibility in the 16-hour limit did not adversely affect patient outcomes among general surgical patients or overall resident well-being. Rather, residents in the flexible arm noted "numerous benefits with respect to nearly all aspects of patient safety, continuity of care, surgical training, and professionalism."(7) A follow-up survey of residents participating in the FIRST trial found that they strongly prefer flexible work hour policies that allow them to work longer when needed to provide patient care over standard, more restrictive schedules.(17) In light of this evidence and the consensus of the graduate medical education community that the 16-hour rule had a negative impact on education, the requirement was eliminated.
The 2017 Common Program Requirements establish standards for institutional programs and support for the well-being of residents, faculty, and all members of the health care team. While not based on controlled clinical trials, these standards represent professional consensus based on information gathered from the literature and the experience of educators and clinicians across the country.(18)
It is anticipated that the iCOMPARE trial will release its results beginning in the 2018–2019 academic year, and the FIRST trial will continue to follow its currently enrolled cohorts. The National Academy of Medicine Collaborative on Physician Well-Being and Resilience (19) will potentially yield recommendations for evolution of the clinical learning environment. The ACGME has pledged to host at least two more annual Physician Well-Being Symposia (2017, 2018), and cosponsor (with the Association of American Medical Colleges) the efforts of the National Academy. These efforts, and other studies, may hold implications for further development or modification of these standards. The ACGME remains committed to ongoing review of all of its requirements as new evidence becomes available.
Kathy Malloy Vice President for Accreditation Services Accreditation Council for Graduate Medical Education
Timothy P. Brigham, PhD Senior Vice President for Education and Chief of Staff Accreditation Council for Graduate Medical Education Associate Professor of Medicine Sidney Kimmel Medical College Thomas Jefferson University
Thomas J. Nasca, MD Chief Executive Officer Accreditation Council for Graduate Medical Education ACGME International Professor of Medicine and Molecular Physiology Sidney Kimmel Medical College Thomas Jefferson University Senior Scholar, Department of Medical Education University of Illinois at Chicago College of Medicine
4. Ahmed N, Devitt KS, Keshet I, et al. A systematic review of the effects of resident duty hour restrictions in surgery: impact on resident wellness, training, and patient outcomes. Ann Surg. 2014;259:1041-1053. [go to PubMed]
5. Rajaram R, Chung JW, Jones AT, et al. Association of the 2011 ACGME resident duty hour reform with general surgery patient outcomes and with resident examination performance. JAMA. 2014;312:2374-2384. [go to PubMed]
6. Desai SV, Feldman L, Brown L, et al. Effect of the 2011 vs 2003 duty hour regulation-compliant models on sleep duration, trainee education, and continuity of patient care among internal medicine house staff: a randomized trial. JAMA Intern Med. 2013;173:649-655. [go to PubMed]
9. Rajaram R, Chung JW, Cohen ME, et al. Association of the 2011 ACGME resident duty hour reform with postoperative patient outcomes in surgical specialties. J Am Coll Surg. 2015;221:748-757. [go to PubMed]
10. Patel MS, Volpp KG, Small DS, et al. Association of the 2011 ACGME resident duty hour reforms with mortality and readmissions among hospitalized Medicare patients. JAMA. 2014;312:2364-2373. [go to PubMed]
11. Parshuram CS, Amaral ACKB, Ferguson ND, et al; Canadian Critical Care Trials Group. Patient safety, resident well-being and continuity of care with different resident duty schedules in the intensive care unit: a randomized trial. CMAJ. 2015;187:321-329. [go to PubMed]
14. Sen S, Kranzler HR, Didwania AK, et al. Effects of the 2011 duty hour reforms on interns and their patients: a prospective longitudinal cohort study. JAMA Intern Med. 2013;173:657-662. [go to PubMed]
15. Choma NN, Vasilevskis EE, Sponsler KC, Hathaway J, Kripalani S. Effect of the ACGME 16-hour rule on efficiency and quality of care: duty hours 2.0. JAMA Intern Med. 2013;173:819-821. [go to PubMed]
17. Yang AD, Chung JW, Dahlke AR, et al. Differences in resident perceptions by postgraduate year of duty hour policies: an analysis from the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial. J Am Coll Surg. 2017;224:103-112. [go to PubMed]