Sunday, April 17, 2011

A ‘Never Event’ in Alabama: Did Nine People Have to Die?

Recently, nine patients died in Alabama when they received intravenous nutrition that was contaminated with deadly bacteria. This type of nutrition is called total parenteral nutrition, or TPN, and is used to nourish patients by vein when their digestive systems are not functioning properly. It is a milestone achievement in medicine and saves and maintains lives every day.

What went wrong? How did an instrument of healing become death by lethal injection? What is the lesson that can emerge from this unimaginable horror?

This tragedy represents that most feared ‘never event’ that can ever occur – death by friendly fire. No survivors. Contrast this with many other medical ‘never events’ as defined by the Centers for Medicare and Medicaid Services, such as post-operative infections, development of bed sores in the hospital or wrong-site surgery. Under the ‘never events’ program, hospitals will be financially penalized if a listed event occurs. Many physicians and hospitals are concerned that there will be a ‘never events’ mission creep with new outcomes added to the list that don’t belong there. Medical complications, which are unavoidable, may soon be defined as ‘never events’.

Do we need a new category of ‘never ever ever events’ to include those that lead to fatal outcomes?

The facts of the Alabama deaths have started to emerge.  Apparently, a water faucet in the pharmacy was contaminated. Protocols and processes are violated every day in all spheres of professional life; and we usually get away with them. The absence of serious consequences breeds complacency, which is shattered by an occasional tragedy. Isn’t it after a horrible traffic accident that a local government decides to erect street lights that were requested by local residents for years? I read earlier today that the Federal Aviation Administration is requiring extensive inspections of a few hundred airplanes when small cracks were discovered in a few of them. This followed a near disaster when a 5 foot hole burst open in the roof of an airplane during flight. The plane landed and all survived. Of course, a very different outcome was possible.

A few weeks back, an airline pilot was puzzled and perturbed when he couldn’t make contact with an air traffic controller at Ronald Reagan Washington International Airport. This wasn’t a mechanical failure but was a matter of zzzz’s. The controller simply nodded off. I suppose it’s preferable for the controller to take a catnap than for the pilot, but there is a process defect in the tower. Afterwards, the Secretary of Transportation announced a new policy that middle school kids could have devised. Air traffic controllers shouldn’t be manning the fort solo. Wow! Real genius advice here from our government. Are these the same brainiacs that make me take off my sneakers before I board an airplane?  (No, these Mensa folks are Department of Homeland Security experts.)

In past years, several people have contracted hepatitis C after undergoing medicine’s most elegant medical procedure – a colonoscopy. These events were not Acts of God but were Acts of Man. They occurred when established procedures were breached for various reasons, none of which are defensible.

While we often cut corners with impunity, on occasion a small and seemingly innocuous deviation can result in unforgiving consequences. The concept of Universal Precautions means what it says. It means do what you are supposed to do every time without exception. Here’s what a list of Partial Precautions might include:

  • Wear seat belts on long car trips only.
  • Physicians should wash their hands only before seeing ICU patients.
  • Do not leave infants alone in the bath on odd numbered days.
  • Give your children two-thirds of recommended vaccinations.
  • Never drive under the influence of alcohol during daylight.
So, the water faucet was dirty.My kitchen faucet isn't sterile either. However, while I'm no TPN expert, should tap water be used to clean a container that would be used for preparing TPN, which must be 100% germ free?  Similar mistakes are made daily throughout society without causing harm. Lighting a match won’t lead to havoc and destruction. But, when the same match lights a fuse, then the world can go dark.

Any corner cutters out there who want to come clean?

14 comments:

A. Bailey said...

Son, you've taken a very bold stance by coming out firmly opposed to medical errors, especially fatal ones. Are you running for office?

Very few people are willing to take on the important question: WHY did it happen, really?

James Reason has extensively researched this issue. His conclusions are often counterintuitive. Breakdowns are more often the result, not of the breakdown of an individual, but the breakdown of a system.

Of course, it's much easier to blame an individual, and more fun, too, as long as you're not the individual in question.

The assumption these days is that sloppiness is the result of evil capitalists taking shortcuts, but there is ample evidence that government regulations play a surprising role in making the situation worse, not better.

Edmund Hayes, R.Ph, M.S., Pharm.D., ACCP said...

I am sort of an expert in TPN (Parenteral Nutrition) and USP 797 (USP 797 are the standards that clean rooms MUST abide with). Every regulatory agency including the Joint Commission surveys pharmacies making sure that these standards for the preparation of sterile products are followed.
I can not fathom a reason why anyone would be cleaning a container in the sink that will eventually be used to make any sort of sterile solution. Sink contamination, especially the aerator on the end of the faucet used to prevent splashing, is very well documented in the literature.
As a matter of fact, USP 797 forbids sinks from being in a clean room.
The Director of Pharmacy and the pharmacist responsible for making those parenteral nutrition solutions should absolutely know better and should be held responsible for these deaths.

Toni Brayer, MD said...

This is an example of protocols (ie:rules) that are there but are not followed. A culture of patient safety and quality in an organization comes from the top. But many times, A. Bailey,the "top" doesn't pay attention until regulations and fines force the issue. It would be wonderful if we could all just depend upon leaders to do the right thing. In medicine we have turned a blind eye for too long.

A. Bailey said...

I doubt it. Health care providers have had the threat of lawsuits hanging over their heads for decades. You know it, I know it, the pharmacy people know it. We all know there's a price to be paid for negligence.

I suspect there were pressures on the pharmacy team in question that have not come to light. I suspect it will not be something as simple as "cutting corners to save money".

Michael Kirsch, M.D. said...

I also doubt that the breach was to save money. Perhaps, a piece of equipment broke and a tech simply went to the tap. Don't know yet. Keep in mind that we do not know all of the facts yet.

Anonymous said...

I've noticed several of my posts have been ignored here. Its amazing how this writer is in favor of 'free markets' for everyone else, ie teacher unions bad etc etc, but the doctors are free to limit the numbers to keep themselves on the gravy train.

Michael Kirsch, M.D. said...

Gravy train? Are we both in the same country? Have a chat with your doctor, or any doctor, for a view from Ground Zero.

Anonymous said...

No comment then about the closed shop the doctors run - keeping numbers down to keep their incomes high?

Michael Kirsch, M.D. said...

What 'closed shop' are you referring to? In addition, medicine doesn't operate according to supply and demand, as you suggest. Remember, we do not set or control our prices. If there is more demand for colonoscopy, for example, my 'price' doesn't increase. In fact, reimbursement for this procedure is steadily declining in the face of higher demand for it.

Anonymous said...

The control of the LCME which keeps the numbers of medical schools and students down.

A. Bailey said...

1. Hey, anonymous! Why don't you use your name? Everyone else here does.

2. If our profession lowered our standards and opened the floodgates, you'd probably be the first to whine that the profession doesn't "police it's own".

3. Just do away with licensure, or even better, make an M.D. a political appointment. That will drive prices down. Who knows, maybe if we did that we'd actually get tort reform then.

Anonymous said...

So in other words, you do control the numbers. Doctors keep the numbers down to keep their incomes up. Free markets for everyone else but themselves.

Michael Kirsch, M.D. said...

I wish we 'controlled' the numbers better in Cleveland where I practice. This region is exploding with doctors and medical services.

Anonymous said...

Just address the question, does the LCME keep doctor numbers down? Stop the doctors labor union keeping numbers down to steal from the public!

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