Wednesday, July 16, 2008

Our learning process

Now, I want you to see something that is so illustrative of the very points Tom Botts makes below. What follows is an email from one of our best surgeons to his Chief making suggestions on how to avoid the kind of wrong-side surgery we recently had. This surgeon is a wonderful person as well as a fine clinician, and his intentions are noble and thoughtful.

But, read the email and compare it point-to-point with the lessons learned by Tom. I don't in any way mean to be disrespectful of the surgeon's thoughts or efforts, but I have become sensitized to the fact that good intentions can lead us into several organizational and learning traps. This is no reflection on him personally: We are all learning a lot about how teams function and can improve in high-stress and unpredictable environments. This area of expertise is not usually part of our training, whether we studied medicine, economics, history, or art. So, we have to learn it now, on the job.

See how many organizational and learning traps you can detect in this note. At the end, I'll give you a couple that I noticed. See if you agree with mine, and please add your own comments.

I've given some thought to the issue of wrong-side surgery since you presented the matter at last week's meeting, and I have some suggestions. I believe we can strengthen our approach to the problem with only modest extra effort in the OR. I would consider the following changes:

1. "Time Out" is now an oral exercise. I'd add written confirmation. Below is a draft of a form that would be initialed or signed and then kept in the patient's medical record. Most people pay closer attention when required to write something that would be available for subsequent review in the event of a problem.

2. It would be a requirement that the surgeon have his/her patient's medical record in the OR. The surgeon would affirm (in writing) that the operative site marked earlier in the pre-op holding area agrees concerning site and side with (1) the surgeon's office record and (2) the patient's signed consent form.

3. I'd consider making the anesthetist a more involved party. The anesthetist would confirm (in writing) that the site and side affirmed by the surgeon agree with the information in the anesthetist's pre-op records.

New guidelines for managing this sort of problem might best come out of a committee comprised of representatives of key stakeholders in the process: surgeons, nurses, anesthetists, administrators, maybe a trustee, maybe a representative of the public. The committee's chair should be an experienced surgeon. A surgeon would be the person most familiar with how the diverse components of the problem interrelate. Also, the product of the committee's work would have more credibility in the minds of surgeons if they felt this were a surgeon-led effort.

Please forward this to Ken Sands and Paul Levy.


I affirm:
a) the patient in this operating room is the patient identified by the label on this page;
b) the procedure I will perform is:
c) the SIDE for the procedure is (box) LEFT (box) RIGHT;
d) the procedure and side noted in b) and c) above agree with (1) my pre-operative record and (2) the patient's operative consent form, copies of which are in this room. SITE and SIDE as noted in these records agree with my pre-operative marking on the patient's skin.
Affirmed: (signature or initials, name printed)


I confirm:
a) the patient for whom I am administering anesthesia is the patient identified by the label on this page;
b) the procedure to be performed as recorded on the CONSENT FOR ANESTHESIA is:
c) the SIDE for the procedure recorded on the CONSENT FOR ANESTHESIA is (box) LEFT (box) RIGHT.
Confirmed: (signature, name printed)


I confirm:
a) the patient in this operating room is the patient identified by the label on this page;

b) the procedure to be performed is:

c) the SIDE for the procedure is (box) LEFT (box) RIGHT.

Confirmed: (Signature, name printed)

Date: ________________ Time: ____________

OK, here are my comments. First, note the "bolt-on" nature of the solution, i.e., an add-on type of approach. Replacing single-point failure with dual-point failure might be an improvement, but in our recent event no one exercised their prerogative and obligation to ask about the timeout. We know from other settings that filling out a form does not ensure compliance with underlying safety requirements. Forms tend to get signed even when the action to have been taken was not. We need a solution that creates an expectation of compliance from everyone in the room, and freedom to point out a lack of compliance by any other member of the team.

How about this? "The committee's chair should be an experienced surgeon. A surgeon would be the person most familiar with how the diverse components of the problem interrelate." I think this could lead us awry. Every person in (and indeed outside of) the operating room has an important and unique view of how things interrelate. Instead of establishing a surgeon as chair of the committee, perhaps there should be a more neutral facilitator, part of whose job is to make sure that all those viewpoints are taken into account. Also, I wonder if a committee or task-force approach to this kind of issue is the way to go or whether a more broadly based community of people should be involved.

Your turn! Teach me and this surgeon what you have learned.


Anonymous said...

What about involving the patient? On the day of pre-op and H&P give the patient a permanent marker and tell them to write YES on the site of surgery and NO on the opposite side and then have it verified by the physician. Having had to remove permanent marker from a twenty something son who was unknowingly given body art while passed out at a party, it is VERY difficult to remove. Or someone could invent a new body marking device read by a scanner like a bar code. Just a thought...

Anonymous said...

Certainly having the patient involved is a good step -- in many ways. I leave to others whether s/he should write things or not, as the actual mark to be used needs to be correctly done, but perhaps they could be asked to initial it.

I don't see a need for a technical fix like a scanner. This should not be a difficult mark for all to see. Other comments welcome.

By the way, in our case, the correct side was marked, and the patient had concurred.

Anonymous said...

And note this story, for a related, but different kind of error.

"A local orthopedic surgeon operated on the wrong knee of a patient who went to Heywood Hospital last month for arthroscopic surgery, hospital officials have confirmed.... Although doctors and staff performed a “time out,” by reviewing important details before the surgery, it was not enough to prevent the error, according to the release."

Anonymous said...

I think it's great but problematic that the surgeon is willing to chair, to affirm, etc. Quis custodiet ipsos custodes? It seems to me that the three big players have to be equals in the moment of the first cut. You have a Time Out system that really ought to work, without adding paper to the process. But all three players have to feel equally responsible for it to work. They can't get caught up in the surgeon's forward motion -- or his or her competence.

Surgeons have a complex non-relationship with everyone in the room. They have an extraordinary and rare skill and everybody knows it. The person who actually cares the most is asleep. The staff often has a certain awe, fear, or adoration. It's a situation ready-made for mistakes, yet mistakes are rare. I think it's the time out that works, but three people need to take it, quickly but one at a time. It's a beautiful solution, really -- simple, efficient, but entirely dependent on equality of responsibility. I would say it's like the Holy Trinity!

Anonymous said...

I have had surgery twice. Both times the anesthetist introduced himself and spoke reassuringly to me just before the surgery. This is not only a comfort to the patient, it is an additional opportunity for the patient to orally confirm the side and the reason for surgery, and to voice any last minute worries. (In my case, I felt better for having the opportunity to ask for the lightest possible meds, and in the case of my elbow surgery, the anesthetist said that I liked, he could do a shoulder block. That made sense to me.)


Anonymous said...

The comment from the anesthesiologist at another major hospital, stating that error rates had not declined since establishment of the JC's Universal Protocol, prompted me to do a brief google search on the subject. Hopefully, this link will transmit:

Briefly, it contains an analysis of the factors associated with near-misses of wrong site surgery as opposed to actual wrong site surgeries. The factors of "someone raising a concern", and "the surgeon responding to a concern" were both associated with more near misses and fewer actual wrong surgeries.

Other articles indicated that the Joint Commission had re-evaluated its protocol in light of the non-decline in errors and concluded, at least partially, that error was associated with not successfully carrying out its protocol. Apparently some hospitals make the protocol so onerous to carry out that harried staff begin skipping steps.
And, of course, some errors are established way upstream and would not be prevented by a time out.

ps I applaud the surgeon who wrote in with his thoughts, whether they are good ones or not. At least he is engaged. Now may be a golden opportunity to appear at some surgery dept. meetings and educate all of them about this issue and national efforts to solve it, with real data from the literature, while the incident is fresh in their minds.


Anonymous said...

Everyone on a team has their own set of "no exception" policies which others may not quite comprehend. That's why we have specialists. A task force could incorporate these, plus any others from indirect team members, into a working "no exceptions" protocol. This must have the respect of all team members. Each individual must be heard and supported by their managers, chief, CEO, etc. If not, then speaking up under any circumstance is not going to make a difference. This would also help instill the concept of a team having indirect members that care and want what's best for the patient. A neutral facilitator makes sense- takes the emotion out of it.
It seems to me this starts the minute a potential employee comes for an interview. What attitude is going to be "in the air" when s/he walks inside our doors?

Is the right-side check performed prior to draping the patient?

There is a white board in the OR with patient information. What is written there and is this part of time-out?

Anonymous said...

The patient safety movement is a somewhat recent phenomenon (IOM To Err is Human 1999; Crossing the Chasm 2001). Key, often common sense, steps have been put in place in every hospital to avoid errors such as this one. Yet, care providers continue to disregard these measures. Taking a time out and doing it properly works to avoid this type of mistake. The time out is your safety mechanism to prevent a human error. It is set up to not allow the holes in the swiss cheese to line up (Reason). However, there is a general disregard for the process and since bad outcomes are relatively rare in a given hospital, the perception is that the process put in place is overkill. I am confident that this is not the only time a “time out” did not take place in the OR that day. The process put in place is fine. The culture needs to change, the process needs to be taken seriously, and there needs to be accountability (perhaps “Just Culture”). These are rare events for any hospital but they add up. In Minnesota, in a one year period ending in October 2007, they had 24 wrong site surgeries (

-not brave enough to leave my name!

Anonymous said...

This is the first I've heard that the correct site was actually marked ahead of time. So I take it the surgeon simply didn't check before cutting, or had someone else do the marking?

Ownership, ownership, ownership. Everyone who's part of the surgical team has to own the process. No exceptions.

I have no clue how to make this happen. Maybe it starts with the leadership philosophy of "this is how we do things here." Maybe it's part of the hiring process. Maybe it's a built-in value of the environment that's reinforced over and over.

As someone who sustained a medical injury several years ago and later discovered the medical record had been falsified to cover up the sequence of events, I am not in favor of forms. But I agree with the surgeon's concept of some kind of "prompt" that reminds people, "OK, this is what we need to do." Not "what we're *supposed* to do," but "what we *need* to do."

My perception is that safety still isn't taken seriously enough by many of the people on the front lines. Not that they're willfully careless, but they don't adequately perceive the risk or see it as something that might happen at their own hospital. And over time, hospitals have learned to tolerate a certain level of error as just the cost of doing business.

The public has already been saying this is unacceptable. And too often the reaction is to kill the messenger.

It's all well and good to talk about blame-free culture, but I think the pendulum needs to swing back to the center. Some mistakes (not all, probably not most) are just no-holds-barred what-the-hell-were-you-thinking screwups, and you have to be brave enough to recognize when those happen and to call them what they are.

Get some members of the public onto your committee. I think they will bring a perspective that's really important. You will all learn from each other.

- Anna

Anonymous said...

I think the oral time out process should be adequate as long as everyone below the rank of surgeon feels empowered to speak up if something is wrong and not keep quiet because they feel intimidated by the surgeon.

I also wonder if it might be helpful to audio record every surgery. If something goes wrong, there would be an actual record of what happened, similar to the cockpit voice recorder and flight data recorder on aircraft or the tape recording of trades on Wall Street trading desks or call center conversations. A video recording could, in theory, be even more informative, but it could also make the surgical team sufficiently uncomfortable to more than offset the potential benefits.

Anonymous said...

Audio recordings might help reconstruct events after the fact, but I seriously doubt they would actually prevent errors from happening.

Oftentimes the error takes place upstream, before the patient arrives in surgery and in some cases before the patient is even admitted to the hospital (e.g. wrong site is identified in the patient's chart during a pre-surgery consultation). It's hard to see how audio tape would help with this.

The Happy Hospitalist said...

The correct site of surgery should be painted in an obscence florescent pink. If there is no paint under the incision site, there is no surgery.

Marie said...

Thank you, Paul, for allowing us to be part of your learning. Please share, too, the processes you are using to arrive at solutions.

If the time out is the right step, the required step and it's embedded in a specific and defined process, I would ask what your leaders can do, in word and deed, to create an environment where it would be unthinkable not to do it. There are lots of steps that are unthinkable not to do does that come about at BIDMC?

Then, if the step doesn't happen, what "chain" can be pulled to stop the it can be done? Creating the safety and the procedure to do this empowers all, protects the patient and allows for the capture of "near misses" which can be studied to reduce variance.


Anonymous said...

To Paul Levy, thank you for opening up to us all the issues that recently occured. As a nurse and now a pt with a unexpected event my only goal through this experience is that change will occur and hopefully what I went through will bring changes that were needed. All persons involved I am sure started the day with the silent prayer may I take good care of my pt and all go well. None of us start our day thinking anything but does happen. I hope all involved the staff and pt are getting the needed support they all need. I find your note about MITSS to be so appropriate they have supported all through my event and aftermath.

Anonymous said...

is it truly possible to make something a never event?
the solution to this problem is unlikely to be found by futher burdening already overworked people with even more paperwork, even if those people buy in to the importance.
my thoughts would be to look at how much time they are already wasting (with mandated redundant paperwork perhaps)and where more time could be created for them to do this critical element of the job.
perhaps less time spent making sure they were jcaho compliant would be one start. evaluating what regulations are truly required by jcaho and which some hospital administrator claims are jcaho mandated might yield some interesting results.

Unknown said...

As the head of Research and Development for a company building patient safety solutions for operating rooms I applaud you for speaking so openly about this thorny problem. I've been visiting and observing operating rooms at some great institutions lately and would add the following observations.

1) The timeout is often documented as complete before the patient or surgeon is even in the room. This doesn't mean the timeout doesn't get done, just that the documentation is not an indication of whether or not it has been completed. The same is commonly true for instrument count documentation.

2) The volume of similar cases done at major healthcare institutions makes errors more likely than most people would imagine. This is compounded by the fact that staff in the operating room are sometimes not easy to understand. It is a noisy environment and many nurses and doctors are soft-spoken or have difficult accents. I have witnessed a near miss where the soft-spoken nurse in a busy room was misunderstood and the Timeout approved for the wrong patient with a similar name and procedure.

3) Whiteboards seem a great answer for visual confirmation, until you see them in use. One OR manager in a major hospital told me that a walkthrough of the rooms showed 50% of the whiteboards had information about a previous case, often from a previous day. In a spot check in one of the nation's leading hospitals the other day, a number of rooms didn't even have white board markers.

4) I'm convinced that the only reason wrong-side surgeries don't happen with even greater frequency in today's high volume medicine is the competence and dedication of the medical professionals. We owe it to them and to the patients to make it easier to get this right every time - in spite of room schedule changes, cancellations, long hours, staff changes, and the other realities of modern medicine.

Although this is clearly a people and process problem, I believe that technology can help teams transform the process. The company I work for builds an electronic OR-Dashboard that goes on a large screen LCD on the wall of the operating room. The system watches data from schedules, documentation, and patient physiological monitors. The Dashboard knows when the patient is in the room and presents critical patient information (name, procedure, allergies, pathology results, vital sign trends etc) to the staff, prompting them to do the timeout at the right time in the surgical workflow, and warning the staff if the case is proceeding without the timeout, or if the documentation systems disagree on the identification of the patient. Though not a perfect solution, it beats the heck out of all the current alternatives.

Our challenge is prioritizing hospital investment in safety systems over the latest surgical robot or intraoperative imaging system, tools which can also save lives and improve outcomes. There are many things competing for the hospital's funding and it is difficult to quantify the return on investment of preventing a infrequent event, especially one which the staff is understandably reluctant to admit can happen. Nonetheless, I think it is an investment worth fighting for and worth making.

I am obviously not an impartial observer, I have a commercial interest in the success of our product, but I strongly believe in what we are doing, and that it can and does make a difference in patient safety.

Again, thanks for your willingness to engage on this difficult subject.

John Hotchkiss
VP Research and Development
LiveData Inc.
Cambridge MA

Andy Olson said...

This is an especially interesting topic to me. I read of this incident before I went into an operating room to observe a left nephrectomy. During prep before the surgery, I wanted to make any observations on how mistakes, such as this one, do not occur in my hospitals OR. Fortunately, I noticed that everyone involved - the CNA, the techs, the RNs, the anesthetist, the PA, and the surgeon - participated in the timeout. The CNA said, loud enough for everyone in the room to hear, the patient's name and the operation. Then, in almost a choir-like unison, they repeated what was said. In addition to verbal announcements, the whiteboard in the room was large enough to be seen and in a proper place that named the patient, allergies, and in BIG BOLD LETTERS, the surgery being performed.

Now, all this said, I still don't feel that we have perfected the system. There were other mistakes that could have been made given different circumstances. Measuring the process and consistently looking for opportunities to improve is the goal.

As for plausibility of making this a "never event," I have and will continue to believe that success in this area is attainable. As a participant in the Keystone Project in Michigan, after implementing processes and procedures, we have NOT had an IV infection in our hospital for over two years. Achieving such success that was once thought unattainable has given me hope that other areas, that some accept with a certain degree of allowance for errors, will soon follow.

Hey, You said...

I wonder what changes Duke University Medical Center made after they had a patient receive the wrong blood type organs during a heart-lung transplant in 2003. I did some searching, and all I could find were contemporaneous articles. At that time, DUMC immediately implemented a triple check procedure or something. At least three different people had to check the paperwork for blood type.

I wonder if that's all they did.

I also wonder how they identify success of new procedures. It is easier to detect failure than success.

Suppose everyone is hypersensitive to the problem because a mistake lead to devastating results. That's probably enough, for a while, to make sure the mistake isn't repeated. So how do you know that the other changes matter? Maybe the (temporary) heightened awareness and tension is really doing the trick.