On November 4th, 2004, Mary McClinton entered the Virginia Mason Medical Center (VMMC) for an elective procedure involving a nonsurgical treatment for an incidentally discovered cerebral aneurysm. Almost three weeks later, Ms. McClintock was dead, after suffering massive intravascular damage caused by the inadvertent injection of a disinfectant. After reading all 160 news reports on the Web, portions of a "memo" released to the Seattle Times, and the VMMC website, I have laid out the bizarre circumstances of this occurrence, and, in the process raised many question -- and many doubts -- about the explanation for this disaster.These are questions yet to be answered, and doubts yet to be addressed. My analysis follows.
n.b. A synopsis is contained in Part I, if you don't have the time for the whole post; Part II is a more detailed evaluation; Part III is opinion, excoriation, and questions.
HAT TIP TO KEVIN, M.D. FOR THE LINK
PART I: Minimalism
The Nutshell:
Otherwise healthy 69 year old Mary McClinton was incidentally found to have an unruptured cerebral aneurysm (an abnormal outpouching of an arterial blood vessel in the brain -- these can bleed).
Ms. McClinton went to Virginia Mason Medical Center (VMMC), in Washington, to have the aneurysm fixed by a nonsurgical, minimally invasive procedure called transcatheter embolization (done in the radiology department usually by an interventional neuroradiologist)
How It's Done: The groin is washed off, draped, and anesthetized. A scalpel wound is made and a needle is stuck into the femoral artery. A wire is then passed through the needle, the needle is removed, and a catheter is passed over the wire, threaded up to the aneurysm, in the brain, and small coils are passed through the catheter and dropped into the aneurysm until the anurysm clots off. The catheter is then pulled back to the level of the neck and iodinated contrast ("dye") is injected in order to view the result.
While on the table, we are told that towards the end of the exam, McClinton was injected with cleaning fluid instead of contrast medium, and she died as a result.
The Nut:
The story of how this catastrophic error was made -- reconstructed through reports in the media and from a memo released by VMMC -- makes no sense. VMMC’s rationale of why and how this catastrophic error occurred is vague, contrived, and full of holes. Furthermore, VMMC makes a shameless PR play as champions against medical errors in the face of this momentous mistake, and this despite their poor record of safety in the past.
Here are the available excerpts of the memo from The Seattle Times:
PART II: Pointillism
According to the memo issued by VMMC: (italics mine)
1. at some time during the procedure a bowl of colorless disinfectant (used to clean the skin before needle puncture) was put on the doctor’s procedure table right next to an identical bowl containing colorless iodinated contrast material (injected into blood vessels during the exam rendering them visible by X-ray)
2. the disinfectant was confused with the contrast and was inadvertently injected instead of the contrast
*3. a technologist purportedly injected the iodinated contrast.material
*4. this mistake was made at the end of McClinton's procedure as physicians wanted to check the status of the thrombosed aneurysm
5. The antiseptic was injected into a main artery carrying blood to the leg
6. the antiseptic caused profound injury and swelling of the leg; and, kidney failure, a sudden drop in blood pressure and a stroke followed.
7. VMMC publicly admits that this constitutes a deadly medical error, part of a stunning American statistical group of 98,000 purported to occur every year
8. However, this particular medical error was actually due to a systems problem and no individual is responsible
9. In fact, VMMC has actually made a firm commitment to eliminate errors from its system entirely -- by establishing processes that bring errors to the forefront for examination
*These points were made in news reports but not quoted as being from the memo per se
Point by Point, Here Is What’s Rotten in the State of Virginia Mason:
1. …during the procedure:
the disinfectant is used to clean the groin before the patient is draped and before the femoral artery is penetrated. Most of the disinfectant should have been used at that point, making the liquid volume in the bowls notably disproportionate…why does VMMC keep making the point that the disinfectant was put on the table “at some point during the procedure”?
2. …confused with the contrast
although during this type of procedure I can postulate how the two clear fluids became juxtaposed; most times, experienced professional angiographers should be able to tell (sight, smell, feel, viscosity, behavior) the difference between iodinated contrast and cleaning fluid
3. …a technologist…injected
All the news reports indicate that a technologist was supposed to or actually did inject the cleaning fluid instead of the contrast
I find this hard/impossible to believe. Catheters in place to study the brain are always injected by the physician, and if the technologist did do this injection, then this is another “systems problem” at VMMC
4. …this mistake was made at the end of McClinton's procedure
a key point
at the end of this type of procedure the catheter is retracted to the level of the carotid artery (in the neck) and the catheter is injected in order to opacify the distal carotid circulation to check the status of the now thrombosed aneurysm
if disinfectant were injected at this point, as they indicate, it wouldn’t be her leg that melted, it would have been her brain
5. … injected the leg
as per # 4, it is not the leg (meaning a direct injection of the common femoral artery at the level of the groin) that is injected at the end of this procedure, it is the carotid artery in the neck. There is nothing, in any report or in the excerpts from the memo that would justify injecting her leg
6. …a stroke followed
all the reports and the memo excerpts report that Mary McClinton had a stroke (a cerebral infarction) and everything written makes it seem as if the stroke occured as a result of the chlorhexime injection; however, how did she stroke if they actually did inject her leg; and, how bad was the stroke if she were able to call her son two hours later to complain of pain, and likewise receive her son as a visitor that night to again complain of pain and swelling? So, chronologiocally, when did the stroke occur, what caused it, and how bad was it?
7. …a stunning statistic
This really angers me. VMMC makes a catastrophic, inexcusable error of the highest magnitude and then they spin themselves as some kind of champions against medical errors who are stunned at the number of deaths from medical errors each year in America (numbers that are wildly overblown, I might add, from an IOM study that, I think, had a lot of problems...download here)
8. a systems problem…no individual is responsible
a systems problem? I should really roast them for this, but they are already so deep in black duff, it would be like kicking a dead animal. That is patent nonsense and insulting to everyone who reads it. There certainly is an individual responsible here and if you would like, I can think of precisely three people who should step forward and take responsibility for this.
9. …a firm commitment to eliminate errors...bringing them to the forefront for examination
PART III: POST MODERNISM
VMMC got high marks from the knee-jerk press for owning up to injecting cleaning products into a patient. And their medical director of quality, Robert Caplan M.D. -- with cogliones as big as stuffed veal chops– actually had the nerve to start lecturing, on the hospital’s website, about the “medical error” problem in America (I guess it STARTS in Seattle)! Caplan cites that outrageous Institute of Medicine (download it here) article (the one that confabulates unreal numbers for deaths from medical errors and is now all but taken as fact) and then, in a stunningly bold, almost Clintonesque move, he suddenly takes the stance of a champion for eliminating errors! Wait! I thought this was an apology? From the VMMC website apology for Mary McClinton's death:
Virginia Mason has made a firm commitment to eliminate errors from our system entirely -- by establishing processes that bring errors to the forefront for examination, and by developing systems to prevent such errors in the future.
Sounds like a very retrospective approach to me…I’d rather go at it from the other end of the process, but nonetheless, the whole “Bless me father for I have sinned” routine has come off smashingly well in the press and also with the victim’s family (just wait though, Bob, till the Torters come a callin’), and I have to say, job well done, Dr. Caplan. It must have cost a fortune in consultant’s fees to come up with that.
Well, I think we will not let Dr. Caplan or Virginia Mason off that easy, eh? After all, in the same paragraph on the hospital’s website the medical director says:
Open discussion of medical errors is essential, because it provides the best opportunity to understand what actually happened and to teach others the important lessons that have been learned.
Okay, I’m ready for some open discussion.
WHICH SYSTEMS ARE WHICH?
First, let’s just get one thing out of the way: this tragic error isn’t any nonsensical VMMC “systems problem,” and the transparency of that dodge will probably show up like beefsteak tomatoes on the salad of a litigator soon. Then to boldly go on by saying that “no individual is responsible,” makes me really suspicious. I mean, it sounds as if the hospital administration is throwing itself on a grenade here…but you know, hospital administrators are not usually the most altruistic of people. Hmmm….
First Bottom Line:
Whoever dipped the syringe into the bowl, sucked up the chlorhexine, and passed it off as contrast is responsible. Period. Yes, I understand that it’s a bad coincidence and these things happen, but I would want to know the experience of the person who drew up that contrast and how much supervision was involved. That is information that needs to be exposed.
In any event, I am going to get a bowl of chlohexidine and place it next to a bowl of contrast and see for myself if there isn't any noticeable difference in the texture, viscocity, feel and smell between the two substances.
I'm not saying I don'tunderstand how, after hours of tedious work in the angio suite someone could accidentally suck up the wrong colorless fluid and inject it into the catheter. I do. But that does not mean that the individual is not responsible for this action.
Second Bottom Line:
According to the Seattle Times, the Washington state Department of Health, says that Virginia Mason:
had reported more "adverse events" over the past three years than three other Seattle hospitals —
Since the start of 2002, Virginia Mason, with 280 beds (licensed for 336), has reported nine adverse events, including four that resulted in the patient dying or being left in a permanent vegetative state,
During the same period, Swedish Medical Center, with 1,400 beds, reported four incidents and no deaths. Harborview Medical Center, licensed for 413 beds, reported five incidents including three that were catastrophic.
The University of Washington Medical Center, with 450 beds, reported seven incidents including three that were catastrophic
I can see why VMMC "has made a firm commitment to eliminate errors from our system entirely"
After Such Knowledge, What Forgiveness?
If VMMC really is serious about reducing their medical errors, coming clean, apologizing, and atoning for the death of Mary McClinton, here are the questions they need to answer NOW:
What did the original CT scan show?
Why was it decided to embolize Ms.McClinton's aneurysm?
Was the chlorhexine present on the procedure table from the beginning of procedure?
Was chlohexine used to wash off the groin before the original puncture?
Was chlohexine used to prep any other areas?
Was the bowl with chlohexine refilled during the arteriogram?
What volume bowls were used for the contrast and the chlorhexime?
What other bowls were on the table?
Were the embolization materials on a separate table from the contrast and disinfectant?
Who injected the contrast?
Was it a technologist?
Where was the catheter when the chlorhexime was injected?
Was chlorhexime injected into the leg (femoral artery) at the end of the exam? If so, why?
STAY TUNED
The solution used to clean skin before and after procedures was recently changed from a brown iodine-based solution to a colorless antiseptic, which looks exactly the same as the dye,
At some time during the procedure, the clear antiseptic solution was placed in an unlabeled cup identical to that used to hold the marker dye ... that is injected into blood vessels to make them visible on x-rays."
The antiseptic then was injected into a main artery carrying blood to the leg,
The antiseptic solution is highly toxic when injected into a blood vessel. Acute and severe chemical injury to the blood vessels of the leg blocked blood flow to muscles, causing profound injury and swelling of the leg...Kidney failure, a sudden drop in blood pressure and a stroke followed.
The memo went on to describe the medical error as a "systems problem," where " no individual is responsible"
I know a lot of opinions have been put forth in the Blogosphere recently rearding Viktor Yushchenko's facial transmogrification. Wizbang set off the fireworks and diagnoses were running rampant on the net thereafter. Highly respectable Blogs like Interested-Participant and Medpundit took a stab at a diagnosis (Leprosy -- that was titillating and awesome to imagine) while Flit found someone ready to diagnose cutaneous T-cell Lymphoma (look out for that!) and thereafter spurring several of my readers to write me asking for my take... 
Name your Poison
So all I can do is evaluate what we are all presented with and give the MOST LIKELY SINGLE DIAGNOSIS to explain it all. That's what my professors DRILLED into my head. First: the patient gets one diagnosis. Second, likely things are likely (or, when you hear hoofbeats don't expect to see Zebras come around the corner--it's going to be a HORSE).
Take this photograph to any Betty Ford Treatment Center Kiosk in the country and ask them what they think this guy does every night other than sleep. 
It's the Bell's Palsy which causes him to wipe his eye -- his eyelid is paralyzed and doesn't blink. 
Well, to get to THIS final face, of the three faces of Yushchenko, we have to make one final stop on the diagnostic railroad: Rosacea (parenthetical remaks are my translations):
So, as much as we all want our leaders to be involved in the glamor of poisonings and radiation burns and mutants from another galaxy, most often they are afflicted simply with foibles -- and those are worse than pimples, but better than Leprosy.
