Tag: Patient Safety

Op-Ed: Healthcare Reform Lessons From Mayo Clinic

Mayo_MN_Gonda_3884cp Three goals underscore our nation’s ongoing healthcare reform debate:1) insurance for the uninsured, 2) improved quality, and 3) reduced cost.  Mayo Clinic serves as a model for higher quality healthcare at a lower cost.President Obama, after referencing Mayo Clinic and Cleveland Clinic, advised, “We should learn from their successes and promote the best practices, not the most expensive ones.”

Atul Gawande writes in The New Yorker, “Rochester, Minnesota, where the Mayo Clinic dominates the scene, has fantastically high levels of technological capability and quality, but its Medicare spending is in the lowest fifteen per cent of the country-$6,688 per enrollee in 2006.”Two pivotal lessons from our recent in-depth study of Mayo Clinic demonstrate cost efficiency and clinical effectiveness.

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Should the FDA relax in the search for new cures?

Over at DiabetesMine #1 health blogger Amy Tenderich has very important post. She and several fellow travelers are appealing to the FDA to strike a balance between safety and progress in allowing new diabetes treatments.

The FDA of course has been beaten to a pulp these last few years because it’s played footsie with the drug industry and ignored several potentially damning studies, with the result that the number of drugs withdrawn from the market has been much higher than in previous years.(Vioxx, Phen-Fen, Baycol, et al).

I’ve always felt that the FDA’s role should not to be a black/white (dangerous/safe) stamp of approval, but instead it should be the honest broker of getting all the data out there. As Amy and her crew point out, some diabetics may be prepared to take a risk of higher long-term cardiac complications in return for a medium term gain from a new medication. Something similar is certainly true in terms of hormone replacement therapy.

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A new year’s resolution for greater hospital transparency

Just thinking, along the lines of a New Year’s resolution. What if all
of the hospitals in the Boston metropolitan area — academic medical
centers and community hospitals — decided as a group to eliminate
certain kinds of hospital-acquired infections and other kinds of
preventable harm? And what if they all committed to share their best
practices with one another and to engage in joint training and case
reviews in these arena? And what if they all agreed to publicly post
their progress on a single website for the world to see?

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Low tech ways to improve patient care: sleep and manners

A few recent reports point to ways for improving the quality of physician delivered care that has little to do with technology or complex interventions.  The first involves how physicians interact with patients, and the second examines the work hours for physicians in training.

Etiquette in Medicine
The first article, by Dr. Michael Kahn in the New York Times, describes six recommended actions for physician to create a good rapport with hospitalized patients. Dr. Kahn collectively calls these actions “etiquette-based medicine”:

  1. Ask permission to enter the room; wait for an answer
  2. Introduce yourself; show your ID badge
  3. Shake hands
  4. Sit down. Smile if appropriate
  5. Explain your role on the health care team
  6. Ask how the patient feels about being in the hospital

Clearly these actions are all directed towards creating a stronger person-to-person connection between the physician and the patient as a step toward improved communications – which is the foundation for developing and effectively delivering a treatment plan to and for the patient.

Physicians Getting Rest
Another challenge physicians have in this process is being awake and aware enough to actually engage in those 6 steps. (Having enough energy also would effect their ability to engage patients empathetically – something I’ve written about before.)  [Also see the previous posting about napping being better than caffeine for improving verbal and physical memory and learning.]

How much sleep physicians need to act appropriately – and avoid making errors – is the subject of a recent Institute of Medicine report, (“Resident Duty Hours: Enhancing Sleep, Supervision and Safety”), that makes new recommendations for limits to the work hours for physicians in training:

  • Duty hours should not exceed 16 hours per shift; For 30 hour shifts there should be an uninterrupted five hour break for sleep
  • Residents should have variable off-duty periods between shifts based on the timing and duration of shifts to increase residents’ opportunities for sleep each day, as well as regular days off that enable residents to recover from chronic sleep deprivation.
  • Medical moonlighting, (additional paid healthcare work), should be restricted
    [A chart comparing the current and new recommendations is available here.]

While all these changes would certainly make for more aware and awake residents, the IOM also estimates that recruiting and paying professional staff to substitute for the work hours the residents would have been (over)working, would cost about $1.7 billion.

Besides figuring out how to pay for these new staff hours, one policy question for implementing these recommendations is how to find the clinicians to actually work these hours considering there is such a shortage of non-physician clinicians.

Anther policy question these recommendations raise, is why they should they only apply to physicians in training?  Why shouldn’t they also apply to physicians who’ve finished their training and are supervising, teaching, and mentoring residents and medical students – and of course are directly responsible for patients?  While it might be argued that most physicians don’t work these long hours, for some that may not be the case – particularly in hospitals without many residents.

Considering that many quality improvements for medicine have been taken from the airline industry – such as the pre-flight/pre-surgery checklist – then why shouldn’t the limits on pilot shifts and hours also be applied to fully licensed physicians?  [I suspect that this will not make me popular with some physicians, but I wonder how they will defend their right to treat patients round-the-clock without sleep?]

Perhaps work hours and etiquette should be other aspects of quality improvement and patient safety that are considered as part of health reform discussions at the Federal and State levels. Certainly well-rested, empathetic physicians trained to interact with their patients with etiquette should improve the quality of healthcare by reducing errors and making physician-patient communications more effective.

How to integrate all these “innovations” into physician training and practice will be a significant challenge, because teaching such skills and promoting their use is not very exciting or technological, and it will be hard for such behaviors to be tied to economic incentives – which are often the carrot or stick for quality improvement initiatives.  Hopefully, as health reform ideas move forward and become crafted into comprehensive packages and plans, they will expand beyond direct economic incentives for improving clinical processes, to include non-economic inducements to promote quality enhancing actions and attitudes for clinicians as well as patients.

Dr. Michael Miller started HealthPolCom Consulting in 2000 after 12 years in health policy positions in Washington, DC.  He works with an extensive network of policy and communications consultants. He blogs regularly at Health Policy & Communications, where this post first appeared.

Dispatches from IHI’s quality forum

Don Berwick is one of the leading lights of the health care quality world; an
oft-quoted and published visionary who founded the Institute for Healthcare Improvement to spread the gospel of transformation and improvement around the world. Sometimes, however, he can come across as messianic, especially when preaching to the choir in a setting like the IHI Forum, which took place last week in Nashville.

Some criticize Berwick and IHI for a lack of measurable outcomes for the interventions they preach. The most recent complaint like this concerns IHI’s 5 Million Lives campaign, which recommended that hospitals adopt a series of interventions to improve patient safety, promising that if they did so, 5 million patients would be saved. 

The campaign officially ended at this week’s conference, and no one at IHI can show data on the number of lives saved. It’s true that Berwick has a powerful voice and a broad platform, and he could use it to structure the work that needs to be done, rather than sticking to a combination of inspirational cheerleading and emotional appeal. But back when no one was thinking about quality, Berwick was championing it; and for some community hospital quality leaders who feel like they are the lone voice in the wilderness, his words keep them going all throughout the year.

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Transforming medicine and saving lives

This week, Don Berwick will announce the results of the 5 Million Lives Campaign
before thousands of people in Nashville attending the National Forum on Quality Improvement in Health Care.

Twenty years ago, it was almost heretical to question the quality of American health care. The common refrain being that it was unarguably the best in the world.

Decades of work by Berwick and others, however, have dispelled that myth, and the underlying belief that medical errors and hospital acquired infections are simply an artifact of the business. These quality champions deem it unacceptable that as many as 98,000 Americans die annually from preventable medical errors, and that most Americans receive the recommended care only half the time. They’ve spent years building their case, and in turn created a social movement around their cause.

In the book, "The Best Practice," Charles Kenney chronicles this long march toward a culture within American health care that demands continuous quality improvement.

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Resident Duty Hours and Patient Safety: Did The IOM Get It Right?

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.”

Battling MRSA with transparency

Two weeks ago, I made an emergency trip home to Minnesota because my grandmother fell ill. She went to the emergency room on a Sunday night, complaining of fatigue and shortness of breath.

The emergency physician diagnosed her with pneumonia and admitted her for the night. Two days later, she was transferred to the intensive care unit and put on a ventilator. My grandma is only 74, healthy and energetic. Her rapid decline shocked my family.

My grandma, however, had not been taking good care of herself since her husband died three weeks earlier. He had many health issues, but at the end, died of MRSA pneumonia. My grandmother slept by his side, caring for him daily during his last days.

No one from the nursing home hospice program or the hospital warned my grandma about the seriousness of this drug-resistent staph infection. No one suggested she take precautions to protect herself or that she be tested as a carrier.

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Can a Hospital Afford to Share Its Warts with the Public?


Paul Levy, the blogging CEO at Boston’s Beth Israel Deaconess Medical Center, has staked his – and his hospital’s – reputation on a culture of transparency. Although no doubt partly driven by Paul’s ethical compass, he must also hope that his unique brand of openness will be good for business.

But will it be?

An article in last week’s Boston Globe left me unsure. In it, reporter Patricia Wen describes Levy’s culture of openness (which has included a unilateral decision to lay bare data on hospital-acquired infections – making him the skunk in the room at Boston hospital CEO cocktail parties – and rapid and forthright mea culpas after serious errors), juxtaposing it against several recent reports of high profile mistakes and tragedies at BI-D, including a wrong-site surgery case and the death of a young woman during childbirth. Although the article raises the possibility that Levy’s openness is enhancing safety, I think most readers will come away with the impression that these high profile errors illustrate that Beth Israel might well be riskier than other hospitals.

I can’t prove it, but my guess is that this impression would be dead wrong. Knowing about the groundbreaking work BI-Deaconess has done in simulation, teamwork training, quality improvement, patient-centeredness, developing one of the nation’s first procedure services and a high quality hospitalist program, and educating trainees in quality and safety science – as well as knowing what I know about the strength of the faculty and housestaff – I find it nearly inconceivable that the hospital is less safe than the average facility, and likely that it’s safer. Plus they have a boffo information technology system, led by their indefatigable (and blogging) CIO, Dr. John Halamka.

The problem, as usual, boils down to the core challenge of measuring patient safety. Until we can figure out how to determine whether a hospital is safe using standardized data and definitions, we remain dependent on self-reports of errors. So a hospital that has convinced its nurses and docs to fess up to mistakes and chosen to be open about these errors to promote organizational change may appear to be riskier than others with fewer reports, while actually being far safer. This is how a hospital like BI-D, which is doing all of these things to an unprecedented degree, can look like an Error Hot-Spot to the media and public while possibly being the safest show in town.

Is this fair? Of course not. Is it predictable? Absolutely. What should we do about it? We must educate the media about this fact: if you are not hearing about serious errors from other hospitals, trust me – it is because you’re not hearing about them, not because they’re not happening. This is a case in which the obvious (I just heard about another bad error from Hospital A – it must be less safe than Hospital B) might well be dead wrong.

As Levy concludes in his blog posting today,

…in today’s electronic environment, it is virtually impossible to keep data ‘private’ if it is sufficiently distributed to the hospital’s staff. So, if you don’t want the public to know, don’t even tell your own people!

If media coverage convinces the Paul Levys of the world that the better, safer course is to play the old game of “hide the ball” – or convinces hospital boards that they shouldn’t hire CEOs who favor transparency – then this type of reportorial error will cost lives, just as surely as medical errors do.

Robert Wachter, MD, 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.

Pitfalls of VIP Syndrome

Slate has an article today by two doctors discussing VIP syndrome in health care and how it can lead to worse care for the rich and powerful, such as Sen. Ted Kennedy, who following a diagnosis of cancer convened his own tumor board.

The authors lay out the pitfalls of VIP syndrome here:

VIP syndrome affects not only treatment but also testing decisions. If
Joe the Plumber requests a CT scan he doesn’t need, doctors simply say,
"No, Mr. Plumber." But Joe Biden can get any CT he wants. Some health
care programs
for corporate executives even involve routine full-body CT scans as
screening tests as part of the "chairman’s physical." The problem is
that these expensive and detailed tests may actually increase the risk
of cancer from radiation exposure
and have never really been shown to improve anyone’s health. And if
there is an incidental finding, as there often is, more tests might be
ordered, which may lead to unnecessary biopsies. And doctors perform
heroic procedures on VIPs not just when there is clear benefit but when there is any question of benefit.

Bob Wachter wrote a few months ago about VIP Syndrome, noting there is a sizable medical literature documenting this shift in practice for the rich and powerful.

Wachter writes, "Every hospital I know keeps some sort of a VIP list, a tripwire to
alert the organization of the arrival of a dignitary or billionaire.
Even when there isn’t a formal list, you can be sure that a single call
to the CEO’s office is more than enough to lift the velvet rope. That’s
a simple fact of life, and to me, not worthy of a big fuss. Unless,
of course, they’re getting better care than Joe and Jane Average. But
are they? Believe it or not, I really doubt it."

Something interesting that both articles point out is that the top researcher or surgeon often directs the care or operates on the VIPs. Often, these top doctors haven’t been in the OR for a long time.