By KATHERINE MATOS

On September 2, Assistant Secretary David Michaels for Occupational Safety and Health received a petition requesting that OSHA regulate resident physician and subspecialty resident physicians.  “Depending on the type of residency, physicians-in-training can work anywhere from 60 to 100 or more hours a week, sometimes without a day off for two weeks or more.”  The petition requests that OSHA exercise the authority granted under §3(8) of the Occupational Safety and Health Act to implement the following federal work-hour standard:

(1)   A limit of 80 hours of work in each and every week, without averaging;

(2)   A limit of 16 consecutive hours worked in one shift for all resident physicians and subspecialty resident physicians;

(3)   At least one 24-hour period of time off work per week and one 48-hour period of time off work per month for a total of five days off work per month, without averaging;

(4)   In-hospital on-call frequency no more than once every three nights, no averaging;

(5)   A minimum of at least 10 hours off work after a day shift, and a minimum of 12 hours off after a night shift;

(6)   A maximum of four consecutive night shifts with a minimum of 48 hours off after a sequence of three or four night shifts.

More information about the petition can be found at the Public Citizen-run website, WakeUpDoctor.org.

Present Accreditation Standards

The Accreditation Council for Graduate Medical Education (ACGME), “[a]s the accrediting body for more than 8,800 medical residency programs,… is charged with setting and enforcing standards for supervision and resident duty hours for graduate medical education.”  In 2002, OSHA denied a petition by Public Citizen, the Committee of Internists and Residents (CIR), and American Medical Student Association, citing the voluntary adoption of standards by ACGME.  In 2003, the ACGME set standards that restricted resident work hours to 80 hours per week when averaged over four weeks and no more than 30 consecutive hours of work. (A breakdown of the differences between the OSHA petition and ACGME 2003 standards can be found here.)

In 2007, the Institute of Medicine (IOM) evaluated resident work standards pursuant to a request from Congress. The resulting report, “Resident DutyHours: Enhancing Sleep, Supervision, and Safety” found, among other things, that considerable scientific evidence demonstrates that “30 hours of continuous time awake, as is permitted and common in current resident work schedules, can result in fatigue, and that adjustments to the 2003 rules are needed.” In response, the ACGME proposed revised standards for resident work hoursand supervision. The comment period ended on August 9 and the changes will be implemented after July 2011.

The Substance of the Petition

According to petitioners, the ACGME revised standards are not sufficient.  A study by Landrigan et al. found that even after implementation of the ACGME’s 2003 standards:

• The average work week was 66.6 hours (95% confidence interval [CI] 66.3-66.9);
• The mean length of an extended shift was 29.9 hours (95% CI, 29.8-30);
• 29% of all work weeks were more than 80 hours in duration, 12.1% were 90 or more, and 3.9% were 100 hours or more;
• 83.6% of all interns reported hours of work in violation of the professional self-regulations that were established and are being monitored by the ACGME. This number far exceeds the rates of violations reported by resident physicians and residency programs to the ACGME, indicating both that widespread under-reporting exists, and that the ACGME’s enforcement has been ineffective.

According to the petition, these numbers of hours are among the highest in the professional world and negatively affect personal health and safety.  Despite the previous rejection of a similar petition in 2002, the petitioners have changed their strategy in appealing to OSHA:  “Whereas previous appeals to limit resident physicians’ work hours have focused on the well-documented risks patients face due to tired physicians, this petition concentrates on the often-overlooked health risks faced by the resident physicians who endure those long hours.”  These risks include:

• Motor Vehicle Accidents — In addition to anecdotal evidence that resident fatigue after long work hours has resulted in physical injury and death, the petition offered the following research:
  • A Journal of the American Medical Association (JAMA) informal survey found that “[o]f seven surgical residents in our hospitals who we interviewed, six fell asleep while driving to or from workduring their internships and three were involved in motor vehicle accidents.”
  • A New England Journal of Medicine (NEJM) study found that “risk of a motor vehicle crash was increased significantly following awork shift of 24 hours or greater,” as well as the risk of a near miss.
  • Sleep deprivation researchers at John Hopkins Hospital found that “[f]orty-nine percent of resident physicians [questioned] reported falling asleep at the wheel (not necessarily at a stop light), and 90% of these events occurred after the resident physicians had worked an extended duration (> 24-hour) shift.”
  • An Anesthesiology abstract reported that 17% of survey respondents reported post-call automobile accidents and 72% reported near misses.
• Mental Health
  • One study described “house officer stress syndrome.” Caused in large part by sleep-deprivation and excessive work load, physicians-in-training may suffer from (1) episodic cognitive impairment, (2) chronic low-grade anger with outbursts, (3) pervasive cynicism, (4) family discord, (5) depression, (6) suicidal ideation and suicide, and (7) substance abuse.
  • Four studies demonstrated that residents are unhappy, face high levels of stress, and suffer “major problems” in their personal relationships with others.
  • Three studies demonstrated that on-call residents reported greater mood disturbance and increased negative mood than those who were rested.
  • One study found that as many as 30% of residents experience depression during their residencies.
  • A study published in the Archives of Internal Medicine found that 21% of residents reported depressed scores on the Center for Epidemiological Studies-Depression (CES-D) scale and that depressed responses increased with longer work weeks. Two other studies also found increased rates of depression among residents that correlated with high work hours.
• Pregnancy
  • A NEJM study reported that premature labor and preeclampsia or eclampsia was twice as common among pregnant residents as the wives of male residents and that residents working more than 100hours per week in the third trimester were twice as much at risk for preterm delivery than those that worked fewer than 100 hours.
  • The pre-term labor and preeclampsia risk was validated by a study published in Obstetrics and Gynecology.
  • One study found that infants born during residency significantly more likely to be born with intrauterine growth restriction.
• Percutaneous Injuries (such as needlestick injuries)
  • A JAMA study of self-reported percutaneous injuries in residents found that substantially increased risk during day shifts after overnight call as compared with day shifts not preceded by overnight call.
  • “An Annals of Surgery study from 2005 found that 20 to 38% of all procedures in one urban academic teaching hospital involved exposure to HIV, HBV or HCV.”
  • A NEJM study found that 99% of all residents had suffered a needlestick injury by their final year of study. Fatigue was the second most common reason given for the injury.

Additionally, this petition has more public support than the one submitted in 2002.  Petitioners include:

• Public Citizen, a consumer and health advocacy group with 150,000 members and supporters;
• the Committee of Interns and Residents/SEIU Healthcare (CIR/SEIU), a housestaff union, part of SEIU, representing over 13,000 resident physicians;
• the American Medical Student Association (AMSA), a national organization representing over 33,000 physicians-in-training;
• Bertrand Bell, M.D., Professor of Medicine at Albert Einstein College of Medicine and author of New York State Health Code 405 restricting resident physician work hours;
• Charles A. Czeisler, Ph.D., M.D., Baldino Professor of Sleep Medicine, Harvard Medical School;
• Christopher P. Landrigan, M.D., M.P.H., Assistant Professor of Pediatrics and Medicine, Harvard Medical School;
• Plus forty-five health-related organization and over 1,000 individuals.

Response to the Petition

In order to fulfill OSHA’s mission “to send every worker home whole and healthy every day,” the petition argues that OSHA must “act now to address the dangers that extreme work hours pose for resident physicians and subspecialty resident physicians.”

In a statement released the same day, Assistant Secretary Dr. David Michaels recognized the concerns raised by the petition:

We are very concerned about medical residents working extremely long hours, and we know of evidence linking sleep deprivation with an increased risk of needle sticks, puncture wounds, lacerations, medical errors and motor vehicle accidents. We will review and consider the petition on this subject submitted by Public Citizen and others.

The relationship of long hours, worker fatigue and safety is a concern beyond medical residents, since there is extensive evidence linking fatigue with operator error… All employers must recognize and prevent workplace hazards. That is the law. Hospitals and medical training programs are not exempt from ensuring that their employees’ health and safety are protected.

However, ACGME believes that the revised rules under development are adequate.  According to medpagetoday.com, the ACGME said the following in a prepared statement:

As the Occupational Safety and Health Administration reviews a petition from three special interest groups requesting federal regulation of resident duty hours, the Accreditation Council for Graduate Medical Education stands ready to share with OSHA the many studies, evidence, and documentation that substantiate the standards proposed by the ACGME Task Force on Quality Care and Professionalism.

This article originally appeared on Health Reform Watch, the web log of Seton Hall University School of Law, Health Law, & Public Policy Program.

Katherine Matos is a 3rd year student at Seton Hall Law and a regular blogger atHealth Reform Watch.. She is the principle inventor on a patent application in the field of medical imaging, resulting from her research as a student at Stevens Institute of Technology. After graduating with degrees in biomedical engineering and history in 2008, she volunteered with the Irish government in the Health Services Executive. At Seton Hall Law, Katherine has researched federal oversight of nanotechnology with Professor Jordan Paradise and non-profit governance with Professor Melanie DiPietro. She worked as a summer associate at Fitzpatrick, Cella, Harper & Scinto in 2009 and at Robinson & Cole in 2010.