Tag: Bob Wachter

Overregulating patient safey

In responding to dysfunctional systems, America instinctively turns to “more regulation” (Exhibit A: today’s Wall Street). But regulation can, and often does, go too far, and – in patient safety – I believe that it now has.

Note that this comes from someone who believes that health care was under-regulated
until recently, not a popular viewpoint (just more mavericky behavior,
I guess). But you must admit that it was rather odd that until 5 years
ago, I was more likely to have my order read back when I called my
Chinese takeout restaurant than when I called my hospital ward with a
complex medication order. (Parenthetically, the reason for this
disconnect is that my takeout restaurant has a more powerful business
case to avoid screw-ups – they lose a customer – than does my
hospital). So now there is a Joint Commission requirement to perform
“read-backs” of important verbal communications. And it’s hard to
question the need for regulation when a prescription that said, “Inject
10U Insulin,” could be followed without question, despite the fact that
such orders have been mistaken for “100 Insulin” thousands of times,
leading to scores of patient deaths.

I reviewed the first 5 years of the patient safety field a few years ago. In an article in Health Affairs,
I opined that increased regulatory/accreditation pressure had been the
most potent force for change in the first years of the safety

Because physicians remain highly
individualistic (which causes them to resist regulatory solutions and
standardization), and hospitals continue to lack a robust set of
incentives to drive patient safety, regulatory solutions have arguably
been the most important early step, particularly when it comes to
procedural safety (creating safe systems, standardization, and
redundancies) in hospitals.

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Shout out to Adam Singer, physician entrepreneur of the year


Modern Physician just named Adam Singer, the founder of IPC — The Hospitalist Company, its first annual Physician Entrepreneur of the Year. Adam and I don’t always see eye to eye, but I want to congratulate him and highlight some of his contributions.

When the hospitalist field launched in the mid-1990s, Adam was there – I recall seeing him at virtually every hospitalist-related meeting during the early years. He struck me as a bit awkward – maybe a tad insecure – but he was brimming with passion and a near-religious fervor for the hospitalist concept. He had just started his company, whose business was to organize hospitalist programs and place them in hospitals, first in So Cal, and later in other regions. In essence, IPC was really the first “rent” (vs. buy) hospitalist solution, and it quickly found a market niche.

Adam’s vision was unique and deeply held. He frequently scolded me for what he called an overly traditional and “academic” view of what a “real hospitalist” should be. To his way of thinking, hospitalists should be relentless managers of the inpatient stay, less about traditional views of physicianship and more about driving teams and technology to make hospitalizations more efficient and increase adherence to practice standards.

The use of technology was critical to Adam’s ability to bring his vision to fruition. Adam had a fundamental problem to solve: he needed data to run his business, but getting information from all of his client hospitals was nearly impossible. As Adam once told me, “if I need to get clinical and billing data from each hospital, I’d be spending all my time in hospital IT meetings.” So he built IPC’s infrastructure around home-grown handheld devices that allowed his hospitalists to collect detailed patient data; the devices synced up with a central data repository daily. Not only did this give IPC the ability to measure and articulate their value to client hospitals, but it gave Adam – a self-described control freak – a detailed window into the daily practice of dozens, later hundreds, of his hospitalists without having to leave his North Hollywood office. I remember him demonstrating the system to me one day, including the tough, sometimes boorish notes he would tear off to those docs who seemed to be underperforming. It wasn’t my idea of an attractive management style, but one couldn’t doubt his commitment to his vision and his ability to disseminate this vision across an increasingly vast enterprise.

Perhaps most impressively, Adam focused like a laser on post-discharge care, well before it was fashionable. At a time when few saw the business case to do this, Adam developed a sophisticated (and expensive) system of post-discharge follow-up phone calls, aided by his handheld technology system. He found that, by calling every patient soon after discharge, his nurses were often able to troubleshoot and avoid unnecessary re-hospitalizations or harm. “All part of our value equation,” he told me when I asked him how he could afford to do this, and there was no doubt that it was a marketplace differentiator for IPC. Today, everybody is thinking about readmission rates and filling the post-discharge black hole. Adam was all over it a decade ago.

I’ve had my disagreements with Adam over the years, and continue to harbor concerns about some aspects of IPC’s clinical and business model. I also wondered whether he would suffer “Founder’s Syndrome” – he has the kind of high energy, confrontational personality that is perfect for the early, free-wheeling days of a start-up, but sometimes gets shoved aside when the company matures, replaced by a smoother consensus-builder. To Adam’s credit, that hasn’t happened, in part because he is a great judge of talent, bringing in others who have played Robert Gates to Adam’s Rumsfeld.

And you can’t argue with success. IPC’s net revenue now exceeds $200M/year. And last year his company became the first hospitalist enterprise to go public, earning he and his shareholders considerable wealth (which they have retained, despite the market conditions). Others will doubtless follow, but this event was external validation of Adam’s leadership and, more broadly, the hospitalist idea.

So hats off to Dr. Adam Singer, Physician Entrepreneur of the Year. Whatever one thinks of his unusual style, there is little doubt that Adam has been as responsible for the growth of the hospitalist field as anyone.

Big administrator is watching you

Last week, came the announcement that Suzanne Delbanco, founding director of the Leapfrog Group, has assumed the presidency of a company that tracks compliance with safety and quality practices via remote video. Big Brother, meet the Joint Commission.

The report, in Modern Healthcare, describes the process this way:

Video auditing refers to a system in which cameras are mounted in targeted locations to continuously capture specific clinical processes, such as observing handwashing and hand-sanitizing stations. [Using video] fed through a Web-based link, independent, third-party observers audit the recordings and provider reports on safety incidents.

Did you ever doubt this was coming? Virtually every other industry with compliance standards has long used video to monitor compliance and to goose workers into following the rules. If video surveillance is good enough for Vegas croupiers and Kansas meat packers, why wouldn’t it be good enough for neonatal nurses and ER docs?

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Medicare hospital quality reporting steps up in sophistication

Medicare is now reporting actual risk-adjusted mortality rates for pneumonia, MI, and heart failure. The topic must be important because NPR’s "Talk of the Nation" spent 30 minutes interviewing Don Berwick and me about it — on the day of Hillary’s speech nonetheless!

To listen to the show, click here. Also, here’s an article from USA Today that got the ball rolling, as well as Avery Comarow’s thoughtful blog on these new reports.

Here are a few observations about the new Centers for Medicare & Medicaid Services initiative, some of which I made on the NPR broadcast:

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Health care in the YouTube era

August 11th was the 2nd anniversary of the epic implosion of George Allen’s presidential campaign, the first defeat at the hands of YouTube. Two recent videos of unattended patients dying in ER waiting rooms leave me wondering whether health care has also entered the YouTube era.

Remember the George Allen fiasco? A 20-year-old Indian-American named S.R. Sidarth, working for Allen’s opponent Jim Webb, was filming an Allen campaign stop in Breaks, Virginia. Twice, Allen pointed to him and called him “Macaca,” a racial slur meaning “monkey.” Once the video hit YouTube, it went completely viral (this clip, one of many, has been viewed 350,000 times) and Allen’s promising political career was toast.

What does this have to do with health care? In the past 18 months, two powerful, highly troubling videos have surfaced of patients being left to die in ER waiting rooms. The first, in May 2007, involved a woman named Edith Rodriguez. Rodriguez began vomiting blood while waiting outside the King-Drew ER, and soon collapsed. Rodriguez’s husband called Los Angeles’s 911 system, but got nowhere. Then someone else in the waiting room called:

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Knol and web publishing challenge medical journals’ stronghold

Yesterday, Google launched Knol, immediately branded as Google’s answer to Wikipedia. As health care adviser to the project, I’ll say a few words about Knol, but focus on how it – and other forms of electronic self-publishing – may signal the end of medical publishing as we have known it.

First, a word about Knol (the name is short for “a unit of knowledge”). Google’s vision is that providing a tool for people to write about “things that they know” will make the world a better place. Unlike Wikipedia’s anonymous, collaborative writing/editing process, Knols have authors, with names, faces, and reputations. (Authors can choose to have their identity verified, through a cross-check on their credit card or phone records.) Google provides Knolers a tool; authors enter their content and click “publish.” And poof, there it is, on the Web. Users can rate and comment on Knols, send them to friends, and suggest changes. But the author remains the sole owner of the content, able to update and modify it (or remove it) at any time.


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Another case of wrong-site surgery: are we averting our eyes from the root causes?

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.

How preventing infections rose to the forefront of the patient safety movement

The Joint Commission just released its 2009 National Patient Safety Goals, and –- no surprise –- they focus on infection prevention. While this seems natural today, it wasn’t always so. In fact, the conflation of infection control and patient safety is one of the most surprising twists of the patient safety revolution.

The inclusion – make that dominance – of infection prevention in the safety field was anything but preordained. The IOM Report on medical errors, which sparked the modern patient safety movement, mentions the word “infections” 8 times and the word “medications” 234 times. In other words, the Founding Fathers of patient safety didn’t appear to have preventing infections in mind when they articulated the scope of the endeavor.

So how did it come to pass that infection prevention became one of, if not the, central focus of the patient safety enterprise? The first step was recognition of the importance of measurement. Without measurable rates of adverse events, there could be no public reporting, no research demonstrating improvements, no pay for performance (or, more au currant, “no pay for errors” – note that more than half of the “no pay” entities on CMS’s present and proposed list are infections), and ultimately no one who could be held accountable for progress in safety.

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Readers respond to Google Health launch

By Google’s recent launch of its Health Beta personalized health records provoked great commentary from THCB’s expert contributors and thoughtful comments from readers. Generally, readers acknowledge Google’s system is not flawless, they are enthusiastic something tangible finally exists.

But the privacy concerns persist.

In response to Matthew’s "Serious test drive," E-patient Dave wrote,"The privacy issue is simply huge. I don’t know why the advocates don’t get it. The lay people I talk to *all* express concern about it; some flat-out say "No WAY I’m giving them my data."

He continued,"I’d feel a lot better if all the enterprises that want to get into this great opportunity (and it is one) would work to get HIPAA updated to cover their case."

Keith Schorsch’s post on whether consumers care about Google Health also generated a lot of comments — mostly from people who shared his skepticism.

"While I agree that there certainly is and can be value in a PHR for
consumers, I think this is the right discussion. Do consumers even know
what a PHR is and that it is an option for them? I think Forrester’s
data shows that something like 75% of consumers don’t," George Van Antwerp wrote

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Why diagnostic errors don’t get any respect and what can be done about it

I gave a keynote yesterday to the first-ever meeting on "Diagnostic Error in Medicine." I hope the confab helps put diagnostic errors on the safety map. But, as Ricky Ricardo said, the experts and advocates in the audience have some ‘splainin’ to do.

I date the origin of the patient safety field to the publication of the IOM report on medical errors (To Err is Human). It is the field’s equivalent of the Birth of Christ (as in, there was before, and there is after). But from the get-go, diagnostic errors were the ugly stepchild of the safety family. I searched the text of To Err… and found that the term “medication errors” is mentioned 70 times, while “diagnostic errors” appears twice. This is interesting because diagnostic errors comprised 17 percent of the adverse events in the Harvard Medical Practice Study (from which the IOM’s 44,000 to 98,000 deaths numbers were drawn), and account for twice as many malpractice suits as medication errors.

What I call “Diagnostic Errors Exceptionalism” has persisted ever since. Think about the patient safety issues that are on today’s public radar screen (i.e., they are subject to public reporting, included in “no pay for errors,” examined during Joint Commission visits, etc.). It’s a pretty diverse group, including medication mistakes, falls, decubitus ulcers, wrong-site surgery, and hospital-acquired infections. But not diagnostic errors. Funny, huh?

There are lots of reasons for this. Here are just a few:

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