Friday, July 11, 2008

Wrong side surgery

Reading CEO Paul Levy’s post about the recent episode of wrong side surgery at his institution and Bob Wachter’s reaction I’m left wondering. This evokes all kinds of questions and reactions, a few of which I want to share here. Lest I come across as insensitive or cynical I first want to say that judging from Levy’s post and the comments of some of the people who work with him, it’s clear the folks at Beth Israel Deaconess Medical Center (BIDMC) take safety very seriously. I can only imagine what they and the patient must be going through.

Wachter deals with two dimensions of safety, starting with the notion that our obsession with “throughput” (Wachter also refers to it as “production pressure”) may threaten patient safety. The OR crew at BIDMC was having a hectic day, full of distractions. But today’s culture of production pressure makes every day hectic. Some see throughput itself as a safety goal because of its ultimate impact on ER crowding. That goal may come into conflict with other safety and quality concerns as I observed in Wednesday’s post on early goal directed therapy in which I quoted a rant from an academic leader in emergency medicine (italics mine):

The crowded ED is a blatant patient safety issue, much more so than medication reviews by pharmacists, medication reconciliation, time-outs, or two patient

A time out, omitted in this case, would have averted the error. Wachter goes on to address the issue of blame surrounding the failure to observe the time out. While boosters of today’s patient safety movement purport to deemphasize blame their efforts have had the opposite effect as I noted here, here and here. Wachter asks whether this is a situation where we should go beyond our systems approach and actually assign blame. Not if it’s a case of human error, he concludes, but perhaps so if individuals are found to have flouted established safety measures. We don’t have enough information about this case to make the call.

What surgical procedure was actually done? We aren’t told, but given that it was characterized as wrong side we know it involved a structure of bilateral symmetry. And, from White Coat Notes (linked from Levy’s post) we learn that it was not an organ removal and did not result in permanent harm. Was it a biopsy, an arthroscopic procedure or carpal tunnel release?

Whatever it was the hospital is apparently not threatened with huge financial loss. Levy’s candor, laudable as it is, must be viewed in that context. After the OR staff disclosed the error to the patient Levy emailed the entire hospital staff, the Boston Globe and other media about the incident! But what if the patient had renal cell carcinoma and had the wrong kidney removed, sentencing him/her to long term hemodialysis? Would Levy have responded in the same way? I doubt it. If he shared such an incident with the media Beth Israel’s attorneys would have concerns and the malpractice carrier would arguably be within its rights to refuse coverage. One of Levy's commenters said:

Because the team of doctors are working so hard for everything to be perfect, they need assistance from a protocol ambassador that will check final review before any procedure starts. The ambassador will then give the green light to go ahead with the procedure. This would eliminate a number of errors.

Not a bad idea. The ambassador, an outsider not in a hurry and not distracted by other details of the case, would have added a layer of safety and likely have averted the error. So I was a little disappointed in Levy’s response:

I have to respectfully disagree.In my view, you have the right sentiment, but the wrong cure. Nobody should need to be appointed to go in to the OR to make sure a time out is done. That is the responsibility of the surgeon, first, and everybody else, too. That happens in the overwhelming majority of cases. It did not here. The goal is to make sure it does. But, if you take away the responsibility from those who should own it, you don't ever get to the result that is needed.

The exchange highlights a fundamental question. In response to an incident such as this should we look for someone to blame or should we look to improve system design? Design is the first principle of today’s patient safety movement. Adding a final check point in the form of a protocol ambassador is a design enhancement. It adds a safety net; it doesn’t remove responsibility from anyone.

Some might ask how many more safety nets we need in a system already designed with redundancies. A review of wrong site surgery in the Annals of Surgery (reproduced in Medscape) suggests that the time outs and check points now in place are not enough; wrong site surgery still occurs at an alarming rate. Suggestions for design improvement were made in the discussion at the end of the article: Withhold instruments from the surgeon until the time out is done; hold a briefing among OR personnel before entering the OR (in addition to the last minute time out in the OR); require documentation of the time out in the op note.

Donald Berwick, safety expert and leader of the Institute for Healthcare Improvement (IHI) addressed this issue in his talk at SMH 2008. Berwick is a big advocate for system design. He believes asking individual doctors to be more vigilant and take more “ownership” of patient safety is 180 degrees wrong. Doctors in general are conscientious and work at top speed, he said. If the surgeon at BIDMC is an exception to this rule it will be revealed in the root cause analysis and can be addressed appropriately.


Paul Levy said...

Pls read my latest post on this topic:

To your intitial point, I believe we would have handled this exactly the same way if it had been a more serious error. I'm hoping never to have a chance to test that proposition, though.

R. W. Donnell said...

Paul, you said:
"To your intitial point, I believe we would have handled this exactly the same way if it had been a more serious error. I'm hoping never to have a chance to test that proposition, though."

I hope so, too, but I also hope you've anticipated the consequences of such a proposition. What would your risk management people and malpractice carrier think?

I'll go read your latest post.