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.

8 replies »

  1. I have been concerned about the potential for wrong site surgery during my entire tenure in orthopaedic practice. 20 years ago when I began marking limbs it was thought of as an eccentricity. Relying on only a time out is clearly not sufficient to prevent such errors (or other areas of concern such as wrong patient, unavailable but necessary instruments, unavailable but necessary implants, unavailable essential team member, etc.).
    Our current protocols include:
    1. The surgical site is marked in ink on the patient by the surgeon.
    2. There is a preoperative briefing by the attending surgeon in the operating room which must include a member of the anesthesia team and the surgical nurse, and which occurs before the patient is brought into the operating room and before anesthesia is begun. During the briefing we check for availability of equipment, implants, instruments, blood availability, anesthetic requirements and confirm the procedure, approach, and laterality, etc.. We use a surgical safety checklist similar to the World Health Organization list discussed.
    3. There is a timeout procedure once the patient arrives in the room. We check the surgical consent form and schedule against the ID bracelet, Social Security number, and date of birth of the patient, and check for agreement with the laterality, marked the surgical site, and procedure type.
    4. There is a postoperative de-briefing led by the attending surgeon at or near the end of surgery but including the anesthesia team and OR staff. We discuss any issues or problems that arose during the case, ways to improve future performance, and postoperative management of the patient.
    Yes, this has slowed us down somewhat and has been the source of frustration for surgeons, leading to an apparent lower daily productivity. It was implemented largely through the force of will of the department of surgery and chiefs of each surgical subspecialty service. Unfortunately, another incentive for its adoption was an actual incident of wrong site surgery. These policies are accompanied by a policy encouraging full disclosure and analysis of both occurrences and near misses. One of my former teachers, Dr. Augustus White, has admonished us to “make only original mistakes”. I agree with your comment that it would be interesting to learn whether they had been using a checklist or other procedures to prevent this error.

  2. I think Bob makes some good points but like many is afraid to reveal the real truth about what happens in every hospitals all over the country. I have been chief safety officer for three different hospitals over the past 10 years from very small to a large tertiary care center. One consistent theme in all is the medical staff’s constant refusal to properly police themselves where safety and quality are concerned. There are the few to very few who are concerned but their voices are drowned out and over ruled by the majority who continue to think this safety stuff is just more bureaucracy and “rules for fools”. When safety rules and procedures are skipped and there is a bad result or near miss then it is feel sorry for the doctor and blame the staff time.
    I know this sounds cynical but after 10 years of fighting this battle and still seeing these mistakes happening, it is time to take the gloves off and confront the problem. Administrators can spend all the time and money and training and developing they want on all the safety processes possible but the physicians are still in charge, as they demand and as they should be, so until they decide it is a problem and they want to fix it, we are all just spinning our wheels. Airlines can have all the safety procedures they want but if pilots don’t follow them, they are worthless and in fact may add to the risk. What would happen if a pilot decided to land on whichever runway they wanted and “control tower be damned”. My guess is that would be either one of their last or their last flight. I see physicians ignoring the procedures every day and the medical staff or med exec committe won’t even consider it an issue.
    Physicians are unbelievably smart and incredible problem solvers. They can transplant hearts, beat cancer, reverse strokes, and fetch people from the jaws of death without working up a sweat. Do you really think they can’t fix this problem? The real issue is they are stuck in a good ole boy system of circling the wagons.

  3. Production pressure may be a realistic concept, but time-outs might add 30 seconds, so I’m not buying that concept in surgery. It is more relevant to the family practitioner who needs to see 25+ patients per day to make a living.

  4. I wonder how much just being tired contributes to this kind of thing, and other errors that happen. From what I have heard from friends that are doctors, some are expected to work over 60 hours a week, with long shifts. Some think they are jazzed by doing this, but I am not convinced.
    No one is immune to sleep deprivation problems, no matter how tough they think they are. Pushing doctors and other health care providers to work long hours is a recipe for disaster for patients. There should be regulations of some kind to limit this practice, especially if it’s pushed by trying to get more profit.

  5. Insightful and persuasive points – but will surgeons and OR teams take heed?
    Unfortunately many will not, emphasizing the need to use forcing functions, technology, and having the funding to implement them. Until then, organizations need to monitor for compliance so that Time Outs become so hard wired that they are viewed as basic as scrubbing.

  6. These flaws don’t become public only when hospitals disclose them. In the normal course of events, the patient and his attorney will disclose them to a court.
    And, typically, as a condition for a prompt settlement, the hospital and doctor will require a confidentiality agreement, to affirmatively HIDE their errors.
    The ultimate responsibility therefore lies with the judges who approve such gag clauses and the legislatures which give them the power to do so.

  7. So, John Stuart Mill died in 1873; is there a message here? The only reason you are wondering about safety processes at Beth Israel is because Beth Israel is one of the only ones disclosing flaws in its safety processes.
    In this case, what you don’t know WILL hurt you.

  8. Your comments are eloquent and incisive; razor-sharp, as Paul Levy might say. I found the e-mail from Beth Israel management a little too self-complimentary. I think the dissenting board member hit it on the head when he said the management’s explanations were embarrassing.
    Only a few weeks before, Paul Levey described a near-disaster in his hospital’s labor and delivery rooms. He said instead of Oxytocin, a drug called
    Zemplar, generic name Paracalcitol, was placed in each room. Zemplar is a drug that suppresses the production of the thyroid hormone in a person. That error was caught in time but it makes me wonder about safety processes at Beth Israel hospital.