Monday's announcement by Methodist Hospital that a surgeon on staff mistakenly removed a patient's healthy kidney proves once again that a hospital, even a really good hospital, can be a dangerous place.

According to Park Nicollet's chief medical officer, Dr. Samuel Carlson, the patient underwent surgery to remove a kidney that was believed to have a malignant tumor. Unfortunately, the patient's healthy kidney was removed, and the cancerous kidney was left in place.

Responses from the public and the St. Louis Park hospital were similar: profound empathy for the patient, and a resounding "How in the world could this have happened" and "Don't we have systems in place to prevent this kind of thing?"

There are systems in place, the primary one being the "Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery," produced by The Joint Commission, the nation's predominant standards-setting and accrediting body in health care. Every hospital accredited by The Joint Commission has been expected to be in compliance with this surgical safety protocol since 2004. The current protocol is meant to be applied to every surgery, and to any other invasive procedure that entails more than minimal risk to the patient.

According to Judith Napier, vice president of quality for Allina Health System, "The whole Universal Protocol came out of a movement based here in the Twin Cities called 'Safest in America.' " (PDF) The initiative, a collaboration of 10 Twin Cities and Rochester hospital systems and the Institute for Clinical Systems Improvement (ICSI), began calling for mandatory marking of the surgical site.

"That idea was eventually picked up by The Joint Commission and incorporated into what we know as the Universal Protocol," Napier says.

How the Universal Protocol works
As it stands today, the protocol calls for three separate steps. The first is implemented in the pre-operative area, where the patient is interviewed and "all relevant documents and studies" (PDF) are used to confirm that the patient is who they say they are (using date of birth or medical record number); and that the anticipated procedure is consistently documented in various areas of the chart.

Ideally the patient is asked to confirm the above: "I'm Fred Kablunschki, and I'm here to have Dr. Meniscus replace my left knee." This confirmation is typically repeated by several different staff members, including a pre-op nurse and someone from anesthesia. Patients can sometimes misinterpret this repeated questioning as incompetence. "A patient who isn't aware of the protocol, or what we're trying to do, might say, 'You're the sixth person who's asked me that question. Don't you know what's going on?' " Napier told me.

Before entering the operating room, Dr. Meniscus is required to meet with the patient, reconfirm the surgery and site, and then write his or her initials on Mr. Kalblunschki's left knee. This marking of the surgical site is the second step, and the third step occurs in the operating room, where a "time-out" is held immediately before the procedure. The entire team steps back and reconfirms that this is the right patient, and the right procedure, on the correct site.

Looking for the loophole
Where was the loophole in the Universal Protocol that allowed the tragic error to occur at Methodist Hospital? Apparently a mistake was made in the chart several weeks earlier, and somewhere along the line that wrong information became accepted as accurate.

Perhaps the radiologist reading the CT scan saw the tumor in the right kidney but simply misspoke and said the left. Or the radiologist had it correct but the transcriptionist entering the radiologist's reading just mistyped. Or perhaps one of the physicians taking care of the patient mistakenly documented the affected kidney side, which then got promulgated in the chart. No misjudgment really — just a simple error that somehow came to be accepted as fact. Presumably even the patient was misinformed, as he or she would likely have been queried several times as to which kidney was to be removed.

Interestingly, a Joint Commission document clarifying the "Wrong Site, Wrong Procedure... Protocol" notes, "It is the process that is important, not the documentation." But that didn't prove to be true in this case, where the right process was applied to the wrong (but consistently wrong) documentation, and bad things happened.

Park Nicollet's response to this incident was to mandate that surgical teams review diagnostic images (X-rays, computerized tomography scans, magnetic resonance imaging scans) to confirm the surgical site before surgery.

A radiologist colleague of mine jokingly refers to the CT scanner as "The Tube of Truth" for its diagnostic prowess, but in a case like this he might well be right. One can potentially mislabel a plain X-ray, but a CT or MRI scan has a right and a left, and there's no turning it around. A CT or an MRI does not misspeak or mislabel. In the Methodist case, a last-minute review of the film would have shown that the "healthy" kidney had a tumor in it, and vice versa.

Clarifying the protocol
What's unclear is whether Park Nicollet's new mandate for corroborating the surgical site with radiographic images like CT scans is really something that's already required by The Joint Commission's Universal Protocol. The "pre-op verification process" portion of the document states that all "relevant documents and studies" should be available to confirm the details of the surgery, and that "relevant images" should be properly labeled and displayed. (PDF) But The Joint Commission doesn't specify what "relevant" is, and that determination has been left up to individual hospitals and health care systems.

According to Napier, that's because the Universal Protocol is a work in progress. "The Universal Protocol was never as robust as it is now," she noted, and there will certainly be more changes. "That's often what happens with cases like this. As you learn new pieces, people put new patches in."

Meanwhile, from an Allina perspective, the Universal Protocol doesn't specifically mandate that CT or MRI scans be reviewed by the surgical team. "It hasn't gone to that point," she said. "They should be available for the surgeon, but whether they're posted on a view box [or computer screen] in the operating room is still up to the surgeon's discretion."

Methodist's mistake hits home in every hospital
As a physician working full time in the hospital, may I take a moment to editorialize? A case like this puts a shiver down the spine of every hospital employee who has anything to do with patient care. The work we do is complicated, hectic, emotional and often highly technical. We are awed by the simultaneously transformative and potentially destructive power of modern medicine.

While cases like what happened at Methodist are rare (although too frequent whenever they occur), anyone involved in a case where a mistake was made, be it big or small, carries that around with them like a stethoscope around their neck — a very heavy stethoscope. It's an ugly feeling. We're in this to heal and give comfort, and to "first, do no harm."