On April 30, 2001, a petition filed with the Occupational Safety and Health Administration (OSHA) requested that OSHA adopt federal regulations limiting "work hours" for resident physicians. It was filed by Public Citizen, the American Medical Student Association and the Committee of Interns and Residents (CIR). CIR is the labor organization that was the petitioner in the Boston Medical Center case before the National Labor Relations Board.
OSHA was established in 1970 by Congress. As defined in its enabling legislation, OSHA's mission is to "Assure so far as possible every working man and woman in the Nation safe and healthful working conditions." According to a press release issued by the petitioners, the rationale for the requested federal regulation is that "The federal government should limit the number of hours worked by medical residents and fellows because sleep-deprived students are at increased risk of being in auto crashes, suffering depression and giving birth to premature infants…"
The petition identifies the accreditation standards of the Accreditation Council for Graduate Medical Education (ACGME or "Council") as voluntary guidelines, and alleges that "a significant proportion of hospitals across the U.S. have failed to meet them." The ACGME believes there is benefit in highlighting its standards and their role in facilitating educational quality and patient and resident safety in residency education programs, specifically focusing on resident duty hours.
Role of the ACGME
The ACGME is responsible for evaluating and accrediting more than 7,700 accredited residency education programs in 110 medical specialties and subspecialties. The Council establishes and updates educational standards for residency programs. It periodically measures residency programs against these standards through a peer review process involving 28 committees. The standards specify educational content, teaching activities, patient care responsibilities, supervision, duty hours (as opposed to "work hours"), and program resources and facilities. Compliance is measured through on-site inspections, including interviews with residents, with every program being visited approximately every 3.7 years. The interval between inspections ranges from one to five years, with a longer period indicating that the ACGME is confident about the program's ability to provide high-quality education and safe resident participation in patient care. Stakeholders of the ACGME's accreditation process are programs, sponsoring institutions, residents, medical students, patients, government and the general public.
Addressing the Key Points of the Petition
The petition calls for federal regulations enforced by OSHA limiting resident work hours to 80 hours per week, with at least one 24-hour off-duty period per week, and limiting shifts to a maximum of 24 consecutive hours. Also, under the proposed regulations, on-call shifts would be no more frequent than every third night, and residents would have a minimum of 10 hours off between shifts. Finally, under the proposed regulations, emergency room residents who work in hospitals with more than 15,000 unscheduled patient visits a year would have shifts limited to 12 consecutive hours.
The ACGME Institutional Requirements, which are applicable to all residency programs, contain general standards relating to duty hours. 1 The Program Requirements contain standards relating to duty hours for each accredited specialty. In several subject matter areas, the ACGME Program Requirements are identical to what is proposed in the petition, including stipulating call no more frequently than every third night, requiring one day off in seven and limiting shifts for emergency medicine residents to a maximum of 12-hours. In the remaining areas, the ACGME standards vary by discipline, reflecting the needs of education and safe patient care in that specialty.
Residency education has multiple goals - high-quality education, safe and effective patient care, and resident safety. This provides the rationale for the ACGME's standards and the system that facilitates compliance. It would not be appropriate to single out one component - resident safety - and vest it with a separate entity. This risks separating inter-related standards. The petition recognizes this by noting that the New York State regulations for residencies treat duty hours and supervision as related matters. For a residency program to ensure that residents do not become exhausted while learning and providing patient care involves more than limiting hours. Supervision and back-up systems are equally important. The ACGME has well-defined supervision standards and its requirements also stipulate that "programs must ensure that residents are provided appropriate backup support when patient care responsibilities are especially difficult or prolonged."
By statute or regulation, virtually all state medical licensing agencies maintain as a condition of physician licensure the completion of one or more years in a residency program that is accredited by the ACGME. Some states approve or license residency programs. Of these states, most, if not all, by statute or regulation, designate residency programs that are accredited by the ACGME as approved or licensed. 2 One state, Illinois, specifically compels hospitals by statute to comply with the resident physician duty hour requirements of the ACGME.3
Citing a March 6, 2000 article in American Medical News, the petition quotes Marvin Dunn, M.D. of the ACGME as stating, "The number of work hour citations has increased every year for surgery and several other specialties." Here is the actual quotation, as it appeared in American Medical News:
"The number of work-hour citations has increased every year for surgery and several other specialties," said Dr. Dunn, who said the causes may include simply greater enforcement by the committees and not necessarily longer hours.
The petition cites 1999 duty hour data from a study that ACGME published in early 2000. 1999 was the first year for which the ACGME published information on duty hour citations, as part of an increased effort to focus attention on this area and to enhance compliance. The petition invites particular attention to the 1999 finding that 17 of 87 institutions reviewed ("nearly 1 in 5") failed to comply substantially with the ACGME duty hour requirements. In the corresponding data for year 2000, 10 of 127 institutions reviewed (8%) failed to so comply.
The petition cites selected 1999 specialty duty hour data from the study. The percentage of programs in internal medicine cited for duty hour compliance fell from 30% in 1999 to 10% in 2000. Similarly, the orthopaedic surgery programs fell from 29% in 1999 to 10% in 2000. On the other hand, general surgery programs remained at 36% in 1999 and 35% in 2000. Pediatric surgery programs reduced from 53% in 1999 to 44% in 2000. 4
Several of the specialty Residency Review Committees have "beta-tested" an enhanced system for compliance with the standards for duty hours, i.e., requesting an immediate progress report from all programs cited for failure to adhere to the duty hour requirements. The report must detail the steps the program is taking to come into compliance and the time frame for implementation.
The petition mentions that no residency program has had its accreditation withdrawn because of failure to comply with work hour standards, citing this as evidence of lax enforcement. The Council's standards broadly address education, resident safety and safe patient care, and it is rare that a program's accreditation is withdrawn because of failure to comply with any single standard. Moreover, violations of duty hour requirements generally occur in places that also fail to comply with other standards. They are evidence of programs' broader failure to attend to the educational needs of their residents and the demands of safe patient care. Some of these programs are ultimately withdrawn for their failure to comply, after a system of due process. In many cases the ACGME is able to foster improvement and compliance with the standards. The Council does this by citing the program and monitoring compliance. Programs may be placed on probation for failure to comply with the standards. The fact that residency applicants must be notified that the program is on probationary accreditation negatively impacts the ability to attract good residents, and is a powerful incentive for compliance.
Experience with Regulation
The petition proposes federal regulatory intervention based upon the proposition that the private accreditation process is not robust. New York is the only state that since the late 1980's has adopted its own duty hour standards through state regulation. New York State's enforcement provisions provide for fining institutions, the same enforcement mechanism proposed in the petition to OSHA. Several other states (California and Iowa, for example) have considered and rejected adopting similar regulation, presumably because the New York regulatory system has not improved upon the national experience. As a relevant aside, ACGME understands that New York State is currently seeking an external contractor for enforcing its regulations through a request for proposals.
Further evidence of the negative aspects of focusing on a single issue - duty hours - emerges from the European Community, where limits have been imposed on work hours for all physicians (including those in practice). The experience has demonstrated that it is impossible to clearly separate educational and non-educational activities, and to focus the reduction in hours solely on the "non-educational work." Unanticipated consequences of the European Community limitation in hours include concern by residents' over whether the new system offers them sufficient opportunities for learning, and lower resident satisfaction with their educational program. This could occur in the United States, if a hospital's sole intent becomes compliance with an external standard that governs work hours, but does not address education.
The Need for a Comprehensive Approach
The issue of resident duty hours is complex and cannot be separated from the goal of advancing educational and patient care quality, together with patient and resident safety in residency programs. The ACGME's ongoing efforts to address this matter are much broader in scope than those proposed in the petition to OSHA. The need for this broader approach is apparent from the information emerging from the European Community after it implemented regulations limiting work hours for all physicians. It is also evident from the impact of New York State's regulations on residents, which demonstrates that the regulations themselves can create moral and ethical dilemmas for residents. One study found "an open-ended workday and competing considerations confronting residents when deciding to leave the hospital - including concerns about leaving patients at critical junctures in their care, regard for the workload of their colleagues, and uneasiness about the educational consequences." 5
This finding highlights the need for the ACGME's comprehensive approach. In addition to resident safety, the Council's approach considers education issues and the safety and effectiveness of patient care. The latter has been identified as a critical issue by the two recent reports of the Institute of Medicine on health care errors and on the design of the health care system for the 21st Century. Clearly, resident duty hours are an important issue for the safety of residents and patients, and for a high quality educational environment. The ACGME standards broadly define programs' and institutions' obligations, including their obligations in this area. The ACGME believes that it is ill advised to "carve out" a section of this environment - resident duty hours - in a way that does not consider the other elements essential to the quality of the educational process. There is a significant potential for an unanticipated impact that may be detrimental to high quality education and safe and effective patient care.
1 Resident Supervision, Duty Hours, and Work Environment
Institutions must ensure that their GME programs provide appropriate supervision for all residents, as well as a duty hour schedule and a work environment, that is consistent with proper patient care, the educational needs of residents, and the applicable Program Requirements.
Supervision: There must be sufficient institutional oversight to assure that residents are appropriately supervised. Residents must be supervised by teaching staff in such a way that the residents assume progressively increasing responsibility according to their level of education, ability, and experience. On-call schedules for teaching staff must be structured to ensure that supervision is readily available to residents on duty. The level of responsibility accorded to each resident must be determined by the teaching staff.
Duty Hours: The sponsoring institution must ensure that each residency program establishes formal written policies governing resident duty hours that foster resident education and facilitate the care of patients. Duty hours must be consistent with the Institutional and Program Requirements of the specialties and subspecialties that apply to each program. These formal policies must apply to all institutions to which a resident rotates.
The educational goals of the program and learning objectives of residents must not be compromised by excessive reliance on residents to fulfill institutional service obligations. Duty hours, however, must reflect the fact that responsibilities for continuing patient care are not automatically discharged at specific times. Programs must ensure that residents are provided appropriate backup support when patient care responsibilities are especially difficult or prolonged.
Resident duty hours and on-call time periods must not be excessive. The structuring of duty hours and on-call schedules must focus on the needs of the patient, continuity of care, and the educational needs of the resident.
Work Environment: Sponsoring institutions must provide services and develop systems to minimize the work of residents that is extraneous to their educational programs, ensuring that the following conditions are met:
Residents on duty in the hospital must be provided adequate and appropriate food services and sleeping quarters.
Patient support services, such as intravenous services, phlebotomy services, and laboratory services, as well as messenger and transporter services, must be provided in a manner appropriate to and consistent with educational objectives and patient care.
An effective laboratory and radiologic information retrieval system must be in place to provide for appropriate conduct of the educational programs and quality and timely patient care.
A medical records system that documents the course of each patient's illness and care must be available at all times and must be adequate to support the education of residents, quality-assurance activities, and provide a resource for scholarly activity.
Appropriate security and personal safety measures must be provided to residents in all locations including but not limited to parking facilities, on-call quarters, hospital and institutional grounds, and related clinical facilities (e.g., medical office building).
2 The nature and importance of such reliance and adoption was discussed by the Supreme Court of Pennsylvania in addressing the state medical board's interrelationship with ACGME process in the context of the board's having relied upon ACGME standards and decisions for the purpose of licensure of residency programs.
The benefits of using private accrediting organizations are well recognized, and we have held that the determination of factual matters by them is permissible. (Citation omitted) Here, the legislature expressly provided that the board could use private accrediting bodies to determine the qualifications of medical training facilities. Had it intended that those determinations would be subject to the board's review, it surely would have so provided. The obvious intent of the legislature was to make the task of the board a manageable one by relieving it of the need to delve, on its own and without expert assistance, into the merits of each institution's medical training programs. The use of accrediting bodies was authorized in recognition of the fact that such bodies are better equipped to study the quality of medical training programs.
MCKeesport Hospital v. Pennsylvania State Board of Medicine, 539 Pa. 384, 389, 652 A.2d 827 (1995).
3 "Hospitals licensed under this Act shall comply with the duty hour requirements for residents and interns established by the Accreditation Council for Graduate Medical Education." 210 ILCS 85/6.14.
4 ACGME Accreditation Data for 1999 and 2000, ACGME, 2001.
5 Yedidia MJ, Lipkin M Jr, Schwartz MD, Hirschkorn C. Doctors as workers: work-hour regulations and interns' perceptions of responsibility, quality of care, and training. Journal of General Internal Medicine Aug 8(8):429-435, 1993.