Tuesday, October 03, 2006

Just Plain Wrong, or at least Wrong-Sided

So it appears that LA Lakers coach Phil Jackson is scheduled to undergo surgery today --- a total hip arthroplasty, or hip replacement, is on today's game plan instead of opening day of training camp. He seems like a nice enough guy, though a bit too "Zen masterish" for me, and I hope all goes well and he recovers nicely.

But. But. But......what if everything doesn't go well? What if he becomes one of the (fortunately reasonably rare) cases of wrong-sided surgery? What, then, will pundits say (OMINOUS TONE) went wrong?

There is a study that has been published in the September issue of Archives of Surgery that, like many that have preceded it, tries to address that very question. Entitled "Wrong-Side/Wrong-Site, Wrong-Procedure, and Wrong-Patient Adverse Events: Are They Preventable?," it is authored by a pediatrician at the University of Chicago Comer Children's Hospital and an anesthesiologist at the University of Miami School of Medicine. One of the obvious difficulties they encountered is a lack of consistent data; they tried to collect as much data as possible from sources such as

(1) the National Practitioner Data Bank (NPDB), (2) the Florida Code 15 mandatory reporting system, (3) the American Society of Anesthesiologists (ASA) Closed Claims Project database, and (4) a novel Web-based system for collecting WSPE cases (http://www.wrong-side.org).
I guess I should not be surprised by two things about this report that jump out and grab me. First of all, there is a very difficult to substantiate OMINOUS CLAIM (from the abstract; full text requires subscription):
Based on these findings, we estimate that there are 1300 to 2700 WSPEs annually in the United States. Despite a significant number of cases, reporting of WSPEs is virtually nonexistent, with reports in the lay press far more common than reports in the medical literature.
That's a pretty big number, particularly when the National Practitioner Data Bank has evidence for only 5,940 such incidences --- in 13 years. Now, I will grant the authors some latitude, as there is no consistent, mandated method for reporting such incidents. But to throw out these kinds of unsubstantiated WAG numbers is irresponsible.....why, I haven't seen such irresponsibility since, let's see, oh yeah! The Institute of Medicine's report on deaths attributable to hospital errors!

Sorry. That bit of statistical voodoo still sticks in my craw.

Now comes the second thing that may not seem so obvious but is clearly linked with the OMINOUS FINDINGS of the report. The authors of this study, Samuel Seiden, M.D., and Paul Barach, M.D., MPH, just so happen to be the guys in charge of (guessed it yet?) www.wrong-side.org! Well, isn't that special! Kind of like publishing a study that "finds" that carpet dirt can cause acne while at the same peddling a "new" vacuum cleaner.

OK. Please do not misread my aggravation. I do not think wrong-site/wrong-side surgery is over-reported, and it certainly deserves a much clearer, probably mandated, reporting system. But this type of "academic study" appears, at least to me, an attempt to get funding for one proposed solution --- the one being proposed by the study's authors ---- rather than a clear look at the problem.

For me, there are some fundamental issues that are at the heart of the wrong-side/wrong-site surgery problem, and they differ to some degree from the non-surgical wrong-treatment/wrong-procedure problem. First and foremost is the importance of a good old-fashioned doctor-patient relationship. This means in my practice not seeing the patient and scheduling them for surgery some weeks away without a preop appointment soon before the operation is to take place. That allows at least two occasions for the patient and I to interact, and the visit within a few days of surgery keeps me well aware of what I am doing to that particular patient. I think I lose a "feel" for the patient, their history, and their surgical problem if I don't see them a day or so ahead of time.

On the day of surgery, I always see the patient before they are carted off to the OR. I just have always felt that was common courtesy, at a minimum, and it gives me a chance to make sure there are no unanswered questions from the patient or their family. Because it is mandated by JCAHO, that also gives me the opportunity to mark the patient when I am doing surgery on one side or the other (such as a hernia repair). I'm also a stickler for making sure the patient is not prepped until I am in the room, so that I don't arrive with the wrong side already prepped, draped and begging for an incision.

It's not all left up to me, however. There are guidelines that have been established to ensure a multiple-step process to try to prevent the wrong procedure from being done. Everyone involved with the procedure is involved, from the preop nurses to the anesthesiologist to the scrub techs. Essentially every specialty society has policy statements about how to prevent wrong-side/site surgery --- the American College of Surgeons, the American Academy of Orthopedic Surgeons, the American Academy of Ophthalmology, etc. --- all following the basic outline of the JCAHO protocol. For example, here are the ACS guidelines:

The American College of Surgeons (ACS) recognizes patient safety as being an item of the highest priority and strongly urges individual hospitals and health organizations to develop guidelines to ensure correct patient, correct site, and correct procedure surgery. The ACS offers the following guidelines to eliminate wrong site surgery:
  1. Verify that the correct patient is being taken to the operating room. This verification can be made with the patient or the patient's designated representative if the patient is under age or unable to answer for him/herself.
  2. Verify that the correct procedure is on the operating room schedule.
  3. Verify with the patient or the patient's designated representative the procedure that is expected to be performed, as well as the location of the operation.
  4. Confirm the consent form with the patient or the patient's designated representative.
  5. In the case of a bilateral organ, limb, or anatomic site (for example, hernia), the surgeon and patient should agree and the operating surgeon should mark the site prior to giving the patient narcotics, sedation, or anesthesia.
  6. If the patient is scheduled for multiple procedures that will be performed by multiple surgeons, all the items on the checklist must be verified for each procedure that is planned to be performed.
  7. Conduct a final verification process with members of the surgical team to confirm the correct patient, procedure, and surgical site.
  8. Ensure that all relevant records and imaging studies are in the operating room.
  9. If any verification process fails to identify the correct site, all activities should be halted until verification is accurate.
  10. In the event of a life- or limb-threatening situation, not all of these steps may be followed.
Call me old fashioned. Call me a curmudgeon. Call me an arrogant bastard. Just don't call me Shirley. The problem with this type of policy is that it leaves sufficient wiggle room for laziness. Most hospitals have policies that allow a physician extender to take the place of the surgeon in the steps above --- so it's the orthopedic PA that says "hi" to the patient and marks them preop (and the orthopedic PA that dictates the preop history and physical, and obtains the surgical consent,...I pick on orthopods because [1] they are responsible for most of these incidents, as they do "sided" surgery all the time; [2] they all seem to have a PA attached to their hip; and [3] because I can, and it's fun).

In fact, JCAHO guidelines even state the operating surgeon "should," rather than "must," mark the patient, and even the OR nurse --- who has never even met the patient --- is considered an adequate substitute for the surgeon in marking the patient. That's just plain wrong.

Look, I'm not full of sour milk here -- I agree with the study authors that wrong-side/site surgery is likely underreported, and I agree that we need a better system to report and monitor such events. As much as I might hate to admit it, I think that JCAHO is on the right track in trying to ensure a system-based approach to prevention of this 100% preventable problem. But I also believe that the "best defense is a good offense," and in this case, the best offense is good communication between patient and surgeon.