Backers of the limits, however, respond that common sense dictates that humans are more prone to errors when they are sleep-deprived. And as patient-safety pioneer Dr. Lucian Leape has said, randomized, double-blind studies were not needed to prove the effectiveness of parachutes.
ACGME CEO Dr. Thomas Nasca acknowledges that patient hand-offs will increase under the new rules, and because each institution handles those differently, the ACGME didn't have a standardized protocol to offer hospitals to help them ease into the transition. “There is no silver bullet,” he said.
“Whether we do 16 or we do six, it doesn't matter,” Nasca said. “We have to make them better.”
Nasca was dubious of some of the other responses to the rules. A Rand Corp. study priced the total nationwide implementation costs for the new rules at $380 million (in 2008 dollars) and at $330 million (or $32 per admission) for subsequent years. Also, he said, if a hospital reduces adverse events by 2.4%, the cost would be neutral.
Rand was selected to perform the study because it conducted an analysis of resident work rules recommended in 2008 by the Institute of Medicine—which included limiting shifts for all residents to no more than 16 consecutive hours (Dec. 8, 2008, p. 6). That figure was about $1.6 billion.
The new ACGME rules reflect the input from almost 3,000 written comments and, Nasca said, didn't lower the 80-hour work limit so the new standards don't reduce educational opportunities or lower clinical staffing “by one minute.”
Yet Dr. Bradley Sharpe, an associate clinical professor at the University of California at San Francisco division of hospital medicine, said his department recently spent $4 million to hire 20 hospitalists at UCSF's three affiliated hospitals. About 15 of the new hires were needed to perform “backfill work” normally performed by residents, said Sharpe, who serves as associate director for the UCSF internal medicine residency program.
Sharpe added that UCSF and programs across the country have done a good job of transferring the responsibility for nonphysician tasks, often called “scutwork,” away from residents. These jobs include filling out forms, drawing blood, pushing patients to radiology and scheduling follow-up appointments for patients being discharged—a task that required long periods spent waiting on hold listening to classical music over the phone.
“Now we joke about that they're missing out on the cultural experience of listening to Beethoven by not spending so much time waiting on hold,” Sharpe said. This exercise was a waste of time, he said, but until 2003—when the ACGME first set work-hour limits—it didn't matter: Residents could work as long as they needed to get the job done.
On the other hand, Sharpe said, physicians are now finding themselves performing more basic physician tasks that used to be handled by residents, causing something of a professional identity crisis. Physicians will finish their training, get a job and then find themselves doing the same tasks they were doing just a few weeks earlier as residents, he said.
“You're getting paid more—but still,” Sharpe said, adding that the cutback in resident hours created a big demand for senior residents in his specialty. “It was quite a year to be an internal-medicine resident who wanted to be a hospitalist,” he said. “You had a lot of options.”
The ACGME's Nasca questions whether expenditures such as those Sharpe describes were really necessary or born out of the new work-hour limits. “I'd like to see a justification of why these standards forced that issue,” he said of UCSF's hospitalist hiring spree.
Dr. James Korndorffer, assistant dean for GME at the Tulane University School of Medicine in New Orleans and director of the school's general surgery program, said his 24 residents used to work in three-person teams but now must work in pairs to be in compliance with the new rules. As a result, residents have shorter and more-intense shifts.
Korndorffer said the new schedule was tested in May, before the new class of residents came in July 1. “We wanted to know what the issues were before we even started,” he said. “We found it does work, but there is more work for them to do when they're here.”
Hiring more staff does not seem to be an option at Tulane. “We did not hire new physician extenders as of yet because, quite frankly, where would the money come from?” he said. “What we would need to have them for would be night call, and that would be a challenge itself.”
The new rules and the schedule juggling they created have led to a situation where residents will not be able to attend some education conferences, Korndorffer said.
“If they come in at 4 p.m. for a 16-hour shift that ends at 8 the next morning, they have to be out of the hospital,” he said. They have to exit once their shift ends, regardless of what else might be going on at the hospital. He said this would occur only every four weeks or so, but it would add up to residents' missing about 5% of the year's conferences.
“You've also decreased the amount of interaction between faculty and residents,” Korndorffer said. “Of the residents we have, they don't want to do it this way. They are greatly concerned about their education.”
Korndorffer said one surgery resident has discussed suing ACGME out of fear that the hour restrictions will limit the variety of cases he'll see and that that will hurt his chances of getting hired—or create the need to go into some sort of apprenticeship when his residency is over.
Another possibility starting to be discussed, he said, is lengthening the surgical residency program from five years to 10. “But will people want to do it?” he asked. “Will the government be willing to pay for it? I'd say no.”
Dr. Henry Dove, the associate head of clinical services for the psychiatry department at the University of Illinois College of Medicine, is responsible for making sure the college's 125 programs (in which 860 doctors are being trained) are ACGME-compliant.
Dove said an exact figure has not been calculated but that implementing the rules has contributed to higher expenses. One way to cover for residents working shorter hours and having more time off is to get more residents. So the school recruited medical students heavily in March, he said, to maximize its residency slots, worked with other hospitals where the residents rotate to find shared savings and went after other funding sources, such as grants. “Based on the fact that I haven't heard any hue and cry from the residents or from faculty, it's working well,” Dove said of the UIC plan.
Just as residents and staff at the hospital are encouraged to report medical errors and near misses, Dove said a reporting system has been set up for residents to report any work-limit violations they either witness or experience. Dove added that the university—and the industry as a whole—has fought the perception that, if a resident calls a supervising physician, it's a sign of weakness. But some doctors and residents may still hold to that notion, he said, and so it's up to the attending doctors to combat it.
“We tell attending: If you haven't heard from a resident, it's your responsibility to call them; don't wait for them to call you,” Dove said. “You may be dealing with an individual driven to display their confidence, so the onus is on the attending physician to interject themselves into that dynamic.”
Dove said the discussion of whether to make programs longer will be a big part of GME discussion for years to come. “I doubt it will happen any time soon,” he said.
If the new rules do lead to longer residency programs, so be it, said Helen Haskell, founder of Mothers Against Medical Error. (Sept. 7, 2009, p. 6) Haskell's healthy 15-year-old son died in 2000 following elective surgery after his pain caused by internal bleeding was dismissed as gas by the weekend staff at the Medical University of South Carolina Medical Center. The story is retold in the award-winning documentary “From Tears to Transparency ... The Faces of Medical Error: The Story of Lewis Blackman,” a film designed to help teach patient safety lessons to medical students.
“I don't think that would be a terrible thing,” she said. “I think you do what you need to do. It's better than people doing their residency in a fog.”
Haskell applauded the ACGME's new rules.
“Human beings are human beings, and there are limits to what they can do and do well and do what's good for the patient,” she said. “Fatigue is most obvious to the person who is fatigued. But lack of supervision is apparent to the public and it has certainly led to many tragedies—including my own.”
Dr. Robert Wigton, associate dean for GME at University of Nebraska Medical Center College of Medicine in Omaha, is in his 40th year at Nebraska and his 35th as the leader of the school's residents and fellows as the department institutional officer for his college's 39 residency programs. He has witnessed a multitude of changes affecting inpatient care, so the new rules didn't faze him, he said. “I've seen it evolve over time.”
Wigton reports a smooth implementation of the new regulations. Departments were asked to have implementation plans in place by last December for the school's 525 doctors-in-training. “That helped people think and plan ahead,” Wigton said, adding that residents in specialties such as pathology and radiology rarely come close to an 80-hour workweek anyway and were not affected to the degree that residents in surgical specialties were.
The challenge with surgical residents, he said, was getting night shifts fully staffed. “Most of the work fell upon the people who schedule,” Wigton said. “For them it was a just a big complicated job with less flexibility than before.” Although Wigton said the new scheduling “is like shift work in a factory,” he supports the new rules. “There's very little question in my mind that this is the right time to do this and that it's necessary,” he said. “Even if you can't measure a difference, it's so logical.”