By Bob Wachter

The Institute of Medicine just released its long-awaited report on trainee duty hours. It is well researched and balanced, and its recommendations appropriately reflect what we know vs. what we believe. Now the fun begins.

Let’s start with a little background, some of it drawn from my book Understanding Patient Safety:

Let’s be honest. Traditional resident schedules – on call every third night, staying up for 48 hours in a row, and working 120 hours per week – were both inhumane and immoral.

The “Days of the Giants” view that such training was needed to “turn boys into men” (before women became the majority of medical students) was machismo garbage. This was a hazing ritual formed when people believed that one should sacrifice one’s life on the Altar of Medicine, perpetuated because all of our egos are such that we said, “Well, that was brutal, but just look how great I turned out – so that must have been a good system!”

And, because housestaff labor is easily the cheapest in the building (what intern hasn’t done this math – my own 1983 internship salary of $17,600 translated into about $4.50/hour, less than I made caddying), what began as a rite of passage quickly morphed into an economic imperative. Having fallen asleep at the wheel once or twice driving home during my internship, I have little sympathy for those who wistfully long for the Days of Yore.

Beginning with the famous Libby Zion case at New York Hospital in 1984, the public and media have pressured “the system” to fix the problem of long trainee hours. A 1989 New York State regulation limiting duty hours to 80 per week was largely ignored, and no other state followed suit for over a decade. But the overarching pressure to improve patient safety, which began with the IOM’s 1999 report, To Err is Human, was enough to give the Accreditation Council for Graduate Medical Education (ACGME) the courage to gore this particular sacred cow, and to withstand the subsequent mooing.

In 2003, the ACGME, which accredits the nation’s 7,800 training programs, decreed that residents’ hours would be limited to 80 a week, with no shifts longer than 30 hours. Both numbers were completely arbitrary – there is no research that helps tell us the “right” number of hours per week or per shift. In fact, the research on sleep deprivation as it pertains to resident performance is surprisingly mixed. While it is well appreciated that 24 hours of sustained wakefulness results in performance equivalent to that of a person with a blood alcohol level of 0.1% – legally drunk in every state – studies have shown that tired radiology residents made no more mistakes reading x-rays than well-rested ones, and sleepy ER residents performed physical examinations and recorded patient histories with equal reliability in both tired and rested conditions.

That said, most folks find this to be one of those issues in which common sense trumps evidence-based medicine – pointing to the tongue-in-cheek BMJ piece challenging EBM zealots to participate in a randomized trial of jumping out of an airplane with and without parachutes (since the value of parachutes has never been subjected to evidence-based scrutiny). On this one, I agree: given the substantial evidence of the harms of sleep deprivation, the burden of proof should be on those defending the old schedules, not on those proposing more humane variations.

Several studies have examined the impact of the 2003 ACGME regs. It is fair to say that the jury remains out. The studies generally show no real effect on clinical outcomes or patient safety, and significant concerns have been voiced by both faculty and residents regarding unintended consequences. But the pressure to do more from a wary public remains, and there have been studies that have convincingly demonstrated that shorter shifts in the ICU environment lead to fewer errors.

When the ACGME regulations first came out, programs did what they always do with regulations they don’t like – they tried to skirt them. The ACGME did something clever in response – it fired two shots over the academic bow, placing two of the most prestigious programs in the country (Yale Surgery and Hopkins Medicine) on probation. The message was clear: we’re not screwing around. That said, this week’s IOM report was critical of what it deemed lax enforcement of the existing standards, calling for unannounced surveys, periodic audits, and stronger protections for whistleblowers. I think they were right to do so.

Programs responded to the 2003 duty hours regulations in a number of ways. When the rules hit, I was virtually certain that our residency at UCSF would go to a Night Float-on-Steroids system, sending the on-call team home at 10pm, having the nights covered by a fresh crew, and handing those patients back to a new team in the morning. But that’s not how it turned out.

One of the great things about UCSF is that our residents rotate through three separate hospitals, so we tried three different strategies to see what worked best. And the Night Float/Send The Primary Team Home idea proved to be a disaster – we couldn’t get housestaff to leave the hospital soon after admitting a desperately ill patient (that damn professionalism), so they were getting home in the wee hours of the morning, leaving them well over the hours limits and exhausted the next afternoon.

Surprisingly, the favored system was a robust Day Float system. In it, our teams continue to stay overnight, admitting all patients till about 2 am, after which a night float takes new non-ICU admissions. When I arrive for attending rounds in the morning, my team is there along with a freshly scrubbed day float resident. We hear about all the patients together, and then the team rushes for the doors, the goal being to be out by noon. The day float resident and the attending then spend the post-call afternoon finishing up the plan, notes, etc. It works pretty well.

With that background, let’s turn to this week’s IOM report. Although there was considerable trepidation that the IOM would recommend severe additional limits in duty hours (most other industrialized countries limit resident hours to 50-60 per week), the report recommends relatively mild modifications to the existing regulations (they’re summarized here). The biggest one is a requirement for a minimum sleep period of 5 hours in any 24-hour work period, with a maximum shift length of 16 hours. If we keep the scaffolding of our present UCSF system, this will mandate that the on-call team takes no new admissions and doesn’t cross-cover its own patients overnight; instead they’ll have to have a complete hand-off and a beeper-less interlude from about 2am-7am. That seems pretty do-able, especially considering the fact that we were girding for much more radical restrictions on hours.

What may prove to be a bigger deal is the new requirement that housestaff have “immediate access to an in-house supervising physician” – which I interpret to mean 24-hour in-house attending coverage, most likely by hospitalists. Although we have some moonlighters in the house overnight, we don’t yet have faculty hospitalists. But the tea leaves are clear: It is time to start planning for around-the-clock hospitalist coverage at teaching hospitals.

Efforts to cut duty hours raise a number of questions and concerns, which I’ll separate into five buckets: 1) handoffs, 2) costs, 3) do people really sleep when they’re off?, 4) practice makes perfect, and 5) the culture of medicine. Let’s tackle them each briefly.

First, handoffs. Until 2003, our handoffs were haphazard, on the fly, and completely unsystematized. Early on, we recognized that the 80-hour workweek was markedly increasing the number of handoffs – our own Arpana Vidyarthi found that resident handoffs increased by 40% after the 2003 regulations. Like so many other aspects of the safety field, we essentially had a squeezing balloon phenomenon: one fix (better rested residents) was traded for a new safety hazard (more handoffs).

In my own judgment, patient safety worsened in the first couple of years after the 2003 rules because the handoff hazards trumped the advantages of rested trainees. It was only after we developed standardized sign-out systems that the balance became more favorable, and the new IOM report calls for even more attention to such systems. That said, there are few days when I don’t hear our nurses complain about paging the resident and hearing, “I really don’t know that patient very well. I’m just covering.” (That’s assuming that they can figure out which resident is covering at that particular moment, an immense challenge unto itself.)

The second issue is cost. The new IOM report estimates that the cost of implementing the new standards will be $1.7 billion nationally – including the hiring of about 6000 mid-level providers (NPs, PAs) and 5000 hospitalists. I don’t doubt it. The 2003 regs were the Hospitalist Full Employment Act. At UCSF, while early efforts to deal with duty hour reductions focused on residents covering for themselves coming off non-call electives (didn’t work and was wildly unpopular), they soon shifted to using NPs and PAs (worked sometimes, but some patients were simply too complex and some providers were too expensive and inefficient) and ultimately to using hospitalists.

Of our 42 faculty hospitalists, I’d estimate that about 12 FTEs are here because of the need to replace resident bandwidth on a variety of services. The new restrictions are likely to increase the need for additional coverage, and thus the costs. The reason that the IOM blinked when it came to cutting the hours down to 60 must have been partly due to these cost considerations, especially in an era in which many teaching hospitals are struggling to break even.

The third concern is whether housestaff really sleep when they’re off. Remember, these are young people with significant others, hobbies, laundry, and debts. Not surprisingly, there is some evidence that they don’t use the time out of the hospital to sleep, and the IOM weighed this in choosing to keep the weekly hours at 80. As John Iglehart observes in his excellent editorial in this week’s NEJM, “Although some might propose further reductions in total duty hours, the report notes, ‘evidence suggests it is an indirect and inefficient approach given the moderate correlation that exists between resident duty hours and sleep time.’”

The fourth is Practice Makes Perfect. Particularly in surgery and other procedural specialties, there is real concern that trainees may not be handling enough cases to become fully competent. There are few data to support this concern, and one has to believe that some of the work that residents put in during hours 80-110 in the old days were not highly educational (not to mention safe). But I’ve met many surgical program directors who are quite convinced that their graduating trainees are not prepared to operate independently – both because trainees are doing fewer cases and because of the enhanced supervision that is chipping away at the trainee autonomy necessary to develop clinical instincts and judgment.

Which brings us to the final concern (and my greatest worry): the culture of training. When the 2003 ACGME regulations came out, New England Journal editor Jeff Drazen and Harvard policy maven Arnie Epstein wrote that that traditional residency schedules,

. . . have come with a cost, but they have allowed trainees to learn how the disease process modifies patients’ lives and how they cope with illness. Long hours have also taught a central professional lesson about personal responsibility to one’s patients, above and beyond work schedules and personal plans. Whether this method arose by design or was the fortuitous byproduct of an arduous training program designed primarily for economic reasons is not the point. Limits on hours on call will disrupt one of the ways we’ve taught young physicians these critical values . . . We risk exchanging our sleep-deprived healers for a cadre of wide-awake technicians.

Therein lies the tension: legitimate concerns that medical professionalism might be degraded by “shift work” and that excellence requires lots of practice and the ability to follow many patients from clinical presentation through work-up to denouement, balanced against concerns about the effects of fatigue on performance and morale. Getting this balance right will be the central challenge of medical education over the next decade.

In my view, the IOM is to be commended for thoughtfully reviewing the issues and developing a set of recommendations (likely to be embraced by the ACGME) that seem quite sensible and balanced.

So let us old fogies cast aside the warm afterglow of our residency experiences and admit that we’ve blocked out the memories of the bone-crushing fatigue, the errors caused by the immoral mantra of “see one, do one, teach one”, and the all-consuming fear that we would crash and burn, with nary a safety net in sight. Once we get over romanticizing the past, we can start figuring out how to work within these sensible limits on hours and supervision requirements to create a more perfect system for both our trainees and our patients.

Robert Wachter is widely regarded as a leading figure in the modern patient safety movement. Together with Dr. Lee Goldman, he coined the term “hospitalist” in an influential 1996 essay in The New England Journal of Medicine. His most recent book, Understanding Patient Safety, (McGraw-Hill, 2008) examines the factors that have contributed to what is often described as “an epidemic” facing American hospitals. His posts appear semi-regularly on THCB and on his own blog “Wachter’s World.”

By Bob Wachter

Yet another case of wrong-side surgery, this one at Boston’s Beth-Israel Deaconess Hospital. Though CEO Paul Levy does a nice job discussing the case on his blog, I’ll focus on two aspects Paul neglects: the role of production pressures in errors, and the tension between “no blame” and accountability.

First, I hope you’ll read Paul’s piece, which includes a courageous memo he and BI-D’s chief of quality Kenneth Sands sent to the entire community describing the case (within the boundaries created by HIPAA). In laying out the “how could this happen,” they say this:

It was a hectic day, as many are. Just beforehand, the physician was distracted by thoughts of how best to approach the case, and the team was busily addressing last-minute details.

Surprised? Hardly. How many days in my and your hospitals don’t look like that?

The concept of “production pressure” is an important one in safety. In a nutshell, every industry – whether it produces CABGs or widgets – has to deal with the tension between safety and throughput. The issue is not whether they experience this tension – that would be like asking if they operate under the Laws of Gravity. Rather, it is how they balance these twin demands.

When my kids were little, they loved going to the International House of Pancakes (IHOP), particularly the one about 15 minutes from my house and a few minutes from San Francisco International Airport (SFO). I personally find the food at IHOP a bit gross, but being a dutiful dad, we would trudge to the IHOP nearly every weekend.

Unfortunately, on most weekend mornings, the line extended 50 feet into the parking lot. Seeing that, I’d push the kids to move on to a decent place for a civilized breakfast. “No, dad, we wanna stay. And the line really moves fast!”

They were right. No matter how long the line, it seemed like we were seated in a matter of minutes, barely enough time to watch more than a couple of 747s fly overhead on their way to Hawaii. How did they manage this kind of throughput?

Once we sat down in the booth, the answer became clear. We were handed our menus within a few seconds. Less than a minute later, a waitress asked for our order. The food was delivered within 6 or 7 minutes. When I paused to catch my breath, the waitress was there. “Is there anything else I can get you this morning?”, she asked helpfully. Any hesitation… and the check instantly appeared, to be settled at the front register. Another family was seated the nanosecond we rose from our seats.

In other words, a business like IHOP – with its relatively low profit margin per customer – is all about production: everything is designed to get you in and out promptly. But production carries a cost: with haste sometimes come mistakes. I remember many times when our cute little syrup well was filled with four boysenberry syrups, rather than the appropriate assortment (maple, strawberry, blueberry, and boysenberry). But that seemed a small price to pay for speed.

In other words, in the ever-present battle between production and reliably getting it right, production wins at the IHOP.

As I mentioned, the South San Francisco IHOP is on the flight path of San Francisco International Airport. The tension between production and safety is particularly acute at SFO, since its two main runways are 738 feet apart (the picture at left is an actual SFO landing, with a bit of an optical illusion. But not much of one – the runways are really close).

The FAA has inviolable rules about throughput, designed to ensure that safety is defended at all costs. For example, when the fog rolls in and the cloud cover falls to 3000 feet (which happens all the time during the summer), one of the two runways is closed, not only gumming up SFO’s works but those of the entire US air traffic control system. And, whatever the weather, planes cannot land more often than one per minute.

In other words, in the aviation industry, in the battle between production and safety, safety wins. And aviation’s remarkable safety record is the result.

I’ve used this IHOP/SFO metaphor many times in speeches to hospital staff and leaders over the past few years, and usually end it by asking audiences: “In its approach to production and safety, does your hospital look more like the IHOP or SFO?” Although things have gotten a bit better over the last couple of years, the answers still run about 10:1 in favor of the IHOP.

So the fact that is was “a hectic day” is a latent error. I’m not naïve – fixing it involves setting limits on production, which slows down the works. And that costs money! Turns out, so does closing a runway. But in aviation, this is a price people are willing to pay for safety.

Will Paul, or any other bold and visionary CEO, commit to paying that price in his or her organization? Will the docs, who can care for more patients (oh yeah, and make more money) from each case? Probably not. But until we all make different choices, it is important to see the “hectic day” at Beth Israel not as a random Act of God but as a conscious choice that prioritizes production over safety. Every day. Virtually everywhere.

The other issue I found fascinating about the Beth Israel case was the discussion about the lack of safety procedures that allowed this error to occur. Again, quoting from the Levy/Sands letter,

In the midst of all this [frenzy], two things happened: First, no one noticed that the wrong side was being prepared for the procedure. Second, the procedure began without performing a “time out,” that last-minute check when the whole team confirms “right patient, right procedure, right side.” The procedure went ahead.

I’ve discussed the tension between “no blame” and accountability in a previous posting – I continue to find it one of the most interesting and difficult issues in the patient safety field. It would be good to know the context here. Was everybody (surgeon, anesthesiologist, OR nurses) distracted? Was this was the first time any of them had forgotten to perform the time out? If so, this would strike me as a “slip”, an honest mistake deserving no blame and an emphasis on designing a more reliable system.

But what if this was a surgeon who always seemed to “forget” the time out? (Believe me, they’re out there, and all of them think wrong-site surgery only happens to those other, more careless, surgeons.) To me, willfully ignoring a sensible safety rule (as I believe the time out to be, perhaps embedded the more robust WHO-style checklist, as demonstrated here) is not a “no blame” event, but rather one that screams out for accountability.

At some point, systems are people. In the old days – before the modern patient safety movement – nobody thought this way, and the fundamental problem was blaming individuals when bad systems were at fault. That was wrong, and got us nowhere in our quest to keep patients safe.

But this is now a decade later, and we do have some pretty good systems for preventing errors, systems that can always be subverted by recalcitrant providers. In such circumstances, the failure is not that of the system but that of the individual, and I believe they should be handled accordingly. This is tricky stuff, as some of the dozens of comments in response to the Levy blog, and the Boston Globe article on the case, illustrate.

Paul Levy ends his post with an eloquent and passionate bit of feedback from one of his Beth Israel-Deaconess board members:

“Protocols are meant to make procedures insensitive to distraction and busy days. These are inadequate and embarrassing excuses. The ‘culture of safety’ has not permeated the front lines. Culture of safety training, and application of advances in safety science, I believe, are critical to preventing the type of complex harm that occurs in hospitals. Not just for new staff. For everyone who wears a BIDMC badge, or is affiliated as a physician to the hospital. I know that this is a new science, and a new way of doing business, but this event might just give that leverage needed for change.

While we explore lots of ideas, one already in my mind and that of this Board member would be to make a video with the actual people – doctors, nurses, surgical techs – who were in the OR at the time to explain what they saw and felt and what they learned from the experience. While they might be in too much distress to do this right now, they might agree over time, and their doing so would create a powerful message at every orientation, at nurses and departmental meetings, and conferences… Transparency as opportunity, social marketing. It would get people talking, and thinking.”

I know the arguments against being punitive, but if this was a surgeon who habitually ignored the regulatory and ethical obligation to perform a time out, I would go ahead and produce the video as the board member suggests. The difference is that the surgeon would not only be discussing how badly he feels about the error, but also describing what he did during his one-month suspension from the OR. I’m guessing that this small addition would make the video even more memorable.

At some point, these safety rules will need teeth or they’re not rules, only suggestions. And, in many cases, suggestions won’t prevent devastating medical errors.

This is tough stuff, and I’d welcome your thoughts.