Tag: Patient Safety

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.

A message you hope to never send

First, an email sent out on Thursday morning. My commentary follows.

Dear BIDMC Community,

This week at BIDMC, a patient was harmed when something happened that never should happen: A procedure was performed on the wrong body part. With the support of all our chiefs of service, we are sharing this information with the whole organization because there are lessons here for all of us.

While respecting the confidentiality of both the patient and caregivers, here are the key facts: It was an elective procedure, involving an excellent team of providers. 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. In the midst of all this, 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. The error was not detected until after the procedure was completed. When it was, our patient safety division was notified immediately, and they in turn took all appropriate steps including investigation, reporting and corrective action. The physician discussed the error with the patient at the first opportunity, and made a full apology. The patient is now recovering at home from the injury, which is not life-threatening.

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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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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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Dennis Quaid takes on hospital errors

Oie_800px_dennis_quaid_dn_sc_04_1_2Hospital patient safety has a new celebrity advocate in Dennis Quaid, whose twin newborns received a massive overdose of a blood thinner last year at Cedars-Sinai Medical Center while being treated for infections.

While his twins bled profusely, Quaid and his wife, Kimberly, were met by a hospital risk management team, who instead of offering an apology and explanation, provided half-truths and excuses, Quaid told hundreds of journalists Thursday at the annual Association of Healthcare Journalists Conference in Washington D.C.

The Quaids’ experience has been widely covered in the press, and he and his wife recently started The Quaid Foundation to shine a spotlight on the 100,000 people who the Institute of Medicine estimates die annually from preventable hospital errors.

"Unfortunately this tragic secret in the medical industry will continue until the medical community overwhelms a conspiracy of silence and demands public accountability,” Quaid said. "I do realize that because I’m a known person, we have an opportunity to get the word out."

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Lessons From a Sad Error

I think many people have seen this sad story of a wrong-sided kidney removal in Minnesota. We all feel the pain for this poor patient. It is difficult for us non-physicians to understand how this happens, for the pathway to the error seems remarkably clear after the fact. But, we have to understand that the actual delivery of medical care contains multiple opportunities for mistakes, and even extremely competent and well meaning doctors and nurses can find themselves in shock afterwards when this kind of thing occurs.

Here are two emails I have received on the topic which both offer useful perspectives on the matter.

First, my buddy E-patient Dave writes:

I’ve caught a couple of errors on my radiology reports, and have had them corrected. Both VERY minor compared to this. Can there be any doubt that patients need to have access to their records, as PatientSite allows, and need to be aware of their need (and ability) to read them?

Second, from one of our senior surgeons to his colleagues:

As copied below, another high profile event, to remind us how easily error can occur. In this case the consent was wrong when done in the office, and it was the only document used to confirm sidedness at the time out. As you read the article, you will note this tragedy extends not only to the patient but to the entire team, as well as the institution.

I would remind you that we had our own "near miss" here at BIDMC, which was caught by the attending surgeon, and confirmed on reviewing the images. In our case, the patient had confirmed the wrong site to the nurses, residents and fellows involved, so patients are not infallible. To best avoid this we (multiple providers) must use multiple sources of information (including the patient, exam, imaging and documentation), and we must have all OR participants agree actively that the patient ID, procedure, side and site are correct. Also as highlighted by this case, the episode of surgical care and opportunity to err starts the first time we see the patient.

Loving Our Children

Among its many less-noticed accomplishments, this Administration has strangled funding for comprehensive sex education. Instead, it has thrown the immense weight of the US government behind abstinence-based education, an impractical ideological approach rooted in religious zealotry and a romantic notion of social mores that no longer exists for most young Americans. In 2005 and 2006, the Bush Administration spent $170 and $178 million, respectively, more than double the 2004 expenditure, much of it allocated to mostly conservative Christian organizations, to encourage children to refrain from sex without explaining the fundamentals of contraception and sexually-transmitted disease (STD). In 2004, a Minority Staff Special Investigations report prepared at the request of Rep. Henry Waxman (D-CA) found that more than 80 percent of federally funded abstinence programs contain false
or misleading information about sex and reproductive health.

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Four Big Trends – Brian Klepper

BrianSeveral events and trends emerged over the last year that will reverberate throughout the health care
marketplace in 2008 and going forward. While none of these dominated the trade press like some other issues – electronic and personal health records, RHIOs, the evolving labor shortage, pay-for-performance reimbursement – these manifestations of change are occurring in the marketplace as well as through policy, and are moving health care forward in fundamentally positive and far-reaching ways.

Health 2.0The most significant for the long term in terms of its capacity to change how health care works is the Health 2.0 movement, which Matthew Holt and Indu Sabaiya have played a central role in facilitating and explaining. In some ways, Health 2.0 is simply a continuation of what has come before: companies creating new value through information and connecting with customers over the Web. Health 2.0 takes this approach into every area of health care data, often driven by companies outside of or at the margins of health care, who have no financial stake in perpetuating inappropriateness and waste, and who see an opportunity to make money by rationalizing the system.

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Look at How Safe [Fill in the Blank] Is by Bob Wachter

But is it as simple as that really?  Perhaps not. In the commentary that follows, Bob Wachter has a very different take on the airline analogy. Analogies are useful things, true, he argues. But perhaps not as useful as the cure-healthcare-by-adopting-model-posed-by- [ insert industry / EU member state here ] might have us believe. Who should you believe? That’s up to you. You’ll find more of Bob’s excellent commentary on quality and patient safety in the THCB archives and on his blog, Wachter’s World.

The rate of fatal domestic airline crashes has fallen by 65% in the past decade – from an amazingly low rate of one fatal accident in about 2 million departures in 1997, to a breathtakingly low rate of one in 4.5 million departures this year. Flying just keeps getting safer and safer.

Beginning with the 1999 Institute of Medicine report on medical errors, aviation has become the poster child for patient safety. In fact, it was an aviation analogy – the translation of the 44,000-98,000 deaths per year from medical errors into “the equivalent of a jumbo jet a day crashing” – that jumpstarted the patient safety field in the first place.

On the whole, I like the aviation analogy, because it energizes us and helps illustrate the need for certain safety-oriented practices, such as standardization, simplification, simulation, teamwork training, and effective reporting systems and regulations. It is also uniquely accessible: who would ever fly electively if a big plane went down every day in the U.S.? Yet hundreds of thousands of people check into hospitals and clinics electively daily.

But lately, I’ve sensed gathering pushback against the aviation analogy – as well as against analogies from other industries. “This has nothing to do with us,” I hear from colleagues sometimes. “Healthcare is so different.” And they’re partly right. For example, we have learned that dampening down authority gradients on a med-surg ward is orders of magnitude harder than doing so in a cockpit. Here’s why: to prevent another Tenerife disaster (the horrific 1977 runway incursion/collision of two 747s, ostensibly caused when the flight engineer – who suspected there was a large airplane blocking the way – felt uncomfortable speaking up to his boss, the pilot), aviation had to transform its culture.

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HOSPITALS: Dennis Quaid’s Kids – Are VIPs Safer? By Bob Wachter

Robert_wachterRobert Wachter is widely regarded as a leading figure in the modern patient safety movement. Together with Dr. Robert Goldman, he coined the term "hospitalist" in an 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."
The Entertainment Blogosphere was atwitter this week with the story
of actor Dennis Quaid’s twin
newborns, who reportedly received a
1000-fold heparin overdose at Cedars-Sinai Medical Center in La La
Land. Cedars’ Chief Medical Officer Michael Langberg may win this
year’s Oscar for fastest public apology – having learned the lesson
from the 2003 Duke transplant error, where the hospital stonewalled for a week or so, adding chum to the media feeding frenzy.

error came during heparin line flushes, when a 10,000 units/ml solution
of heparin was mistakenly substituted for the intended 10 units/ml
solution. Although the cases required pharmacologic reversal of the
anticoagulant effect, thankfully there were no bleeding complications.

These cases come on the heels of last week’s report
out of Dallas that the state-supported UT-Southwestern kept an “A-list”
of potential donors and assorted bigwigs. Apparently, when these folks
come to the hospital or clinic, they may get a personal greeting, a
preferential parking spot, perhaps even an escort to their appointment.
My friends at Health Care Renewal, who chronicle and condemn healthcare’s corporate influences, were shocked. Shocked!

not. 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.

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