This will happen again, unless the process is fixed. Lean can help. Please read on…
I heard about this story this morning, this horrible tragedy where a 35-year old woman, Darrie Eason (pictured), from New York was told she had cancer and had a double mastectomy done on her, only to find out she really didn't have cancer. The lab had switched two patient specimens. So the woman who really had cancer didn't find out right away. The results were read properly by the pathologists, but they were mixed up due to what amounts to an administrative error.
Incidents like this are rare, but it happens regularly enough where I've heard about and read about cases like this before. I've been in about a dozen anatomic pathology labs where work exactly like what is described in that article takes place. I've seen “the gemba“ — not the exact lab where the mistake was made, but others.
I've thought about this a lot today… gotten angry… calmed down… gotten frustrated… went to the gym… thought about it some more. I thought about how and what to blog about this. There are probably 20 different things I could write, as there are many “Lean” aspects we could consider. I'm trying to be careful because I could share many more details, I will try to keep the story general based on what's standard industry practice. Other than the lab in this incident, I'm not referring to any specific laboratories.
First, the MSNBC story here was basically the same content that was on the Today Show (check out the video on the MSNBC site), from what I was told. I was struck how the discussion wasn't full of individual blame, there were comments about systemic problems.
The one victim's attorney probably has it right when he says:
“It may be one person, but personally I doubt it. One of the things we may learn is ‘Was there a system failure, and if so, what can be done to improve the system?' Personally, I doubt this is a one-time event by someone who was careless for one time in his or her life,” he said.
He must inadvertently be a “Lean thinker” because that is the exact Toyota Way thought process — what failed in the system? That's the same thought process Deming would have brought to this situation.
The MSNBC article mentioned the practice of “batching” specimens:
The state report said “the most likely source of the error” was the technician engaging in a practice called “batching,” which involves handling more than one specimen at a time.
Now, if you're a manufacturing person, you recognize the term “batching.” It happens all the time in factories. When you implement Lean, you try to reduce your batch sizes to help improve flow. Batching interferes with flow. Batching also harms quality, in a number of ways.
Unfortunately, the same is true in a medical laboratory. “Batching” is the “conventional wisdom” method in EVERY anatomic pathology lab I have ever been in. That's how they do it — at least that's how they do it before implementing Lean.
Let's assume you were on the table in an O.R. and had a biopsy specimen take out of you. Your specimen, that little piece of you they took out is special, right? Here's what typically happens. Draw a value stream map if the urge hits you.
- Your specimen is put in a container, in a preservative solution, and it waits for other specimens to accumulate. A batch. It's not “efficient” (in a traditional sense) to take one specimen to the lab.
- Your specimen is “grossed,” often by a pathologist. It is examined and cut into small pieces and is placed into a plastic cassette. This cassette might be labeled as they go, or the casettes may have been labeled in advance — batched — either done manually or by a piece of automation. There is a risk, here, that the specimen is put into the wrong specimen. The pathologist usually does “one at a time,” reducing the risk somewhat.
- As the cassettes are made, they usually accumulate in a tray, another batch.
- The batch is moved and loaded into a “tissue processor.” Now this is inherently a batch process. Think of loading dishes into a dishwasher. Not a perfect analogy, but you don't load one dish and hit “start.” Not if the dishwasher runs for 12 hours overnight.
Now let's stop and think about this for a minute. We see the exact same mentality in manufacturing. If you have a factory process that is batch oriented, we tend to use that same mindset and batch everywhere. With Lean in a factory, we move toward flowing up to the batch process and flowing after the batch process — for quality purposes and other reasons. The same thing can be done in a lab.
- The tissue then goes through a few more operations. None of which is a batch process. It's a lot of manual work. But, batching is still the primary mindset. We do a lot of work and let specimens accumulate in a tray until we move them, as a batch, to the next step.
In the New York case, the slides were mislabeled or switched. Ideally, you should be handling and working with one patient specimen at a time. But, you have a batch of specimens (“work in process” in manufacturing terms”) that you are working from. You cut a thin slice of specimen and you put it on a slide. Sometimes, the slide gets labeled (by hand) by the technologist right before the specimen slice is put on there. That's probably the least risky way to do it.
Sometimes, though, the technologist will “batch up” and hand label a whole batch of slides because it's “more efficient” to keep doing the same thing over and over. At least it seems that way if you're not a Lean Thinker.
Sometimes, the slides are all made, as a batch, the night before by automation.
So here's the risk. If you have ONE patient specimen and a whole BATCH of labeled slides, we are depending on the individual to “be careful.” If you're a Lean thinker, that should set off fireworks and red flags. We're human, we make errors. Being careful isn't good enough, whether you're in a Toyota factory or a hospital. If you grab the wrong pre-labeled slide… you're going to have a mismatch. And that leads to often tragic results.
Again, batching is the “normal” non-Lean process. That's why this type of error happens again and again in different hospitals. It happens so rarely that we might think, “that shouldn't happen… that doesn't happen normally…. who screwed up?”
So we blame.
Stories other than the MSNBC story started to place blame.
This article said:
A state health department report said Eason's tissue sample was mislabeled at the CBLPath lab in Rye Brook because a technician “cut corners.”
The laboratory management also blamed the employee in some articles.
Another article spelled out the “corner cutting” in two ways. First by batching and secondly by not double checking their work.
A CBLPath technician who handled Eason's test admitted to his supervisors that he “occasionally cut corners by batching,” or handling more than one tissue specimen at a time, and did not always verify patients' initials when labeling them, according to a state Health Department report issued last August.
Unless the lab had implemented Lean methods (and it's a small percentage that actually have), batching was the normal process. It's not “cutting corners” if you are following the same normal process that everyone else is using. The normal process that sets people up to make errors. Not often, but it will happen. It's a perverse lottery where you have a 1 in 47 million chance of losing. Losing big time. The worker and the patient both.
The step of verifying initials — that's an inspection step. To a Lean thinker, the fact that you NEED inspection is a sign that your process is prone to errors. To say someone forgot to do the inspection once, it's conceivable. We're human. We need to design a BETTER PROCESS where inspection isn't necessary. The lawyer had it right, for pete's sake.
Now, don't get me wrong — the patient has suffered immensely, I don't mean to forget about her for a second.
But, the employee who was involved in the error. Don't you think they are suffering? I've read other stories about nurses who were involved in a medical error (a systemic series of errors they were a part of) and they feel horrible. Many leave the profession. Some get convicted, for crying out loud. Not is not helpful for preventing future errors. That does not help create a construction “blame-free environment” as some hospitals are doing. Not blaming doesn't mean we aren't holding people accountable. But we have to look and see if the error or problem was systemic or if it was likely to happen, given the design of the system. In this case, I think it clearly was.
The other stories highlighted that the employee who made the error is gone. Under what circumstances, we don't know.
“[The CEO] said the technician responsible for the mixup also no longer works there.“
What does that do, other than making sure that same person won't make that same mistake. What about all of the other people working in that lab? What about all of the other labs around the world that work using similar processes? This same error pops up all over:
Back in 2003, CBS News reported that Linda McDougal, 46, learned that the lab had mixed up specimens. Unfortunately, she had undergone a mastectomy only days before based on the inaccurate lab report. In 2005, Molly Akers had her right breast removed only to discover — thanks to a biopsy — that she didn't have cancer, according to UPI, which says the 33-year-old filed a lawsuit alleging that the lab mislabeled specimens.
Are you convinced yet that this is a systemic problem?
The NY State Board of Health isn't helping. I don't think they get it at all.
Claire Pospisil, a spokeswoman for the state health department, said mistakes like Eason's are “very rare” in New York. She said the state's investigation ended with its report.
“Very rare?” One mistake is one too many. Having identified “batching” as a risk factor and a failure mode, why aren't they looking for batching in other labs? You'll find it. Do we all need to call our local hospital to ask the CEO, “Are you batching anatomic pathology specimens in your lab?” Unless they have implemented Lean and/or “single piece flow,” chances are they do. And it's potentially putting people in your community at risk.
The state also claimed
The state health department determined that CBLPath's error was isolated and found “no systemic problems and no deficiencies” at the lab.
Sigh. Let's just blame the person. Problem solved. Go back to trusting your health system.
There is some good news out there: many laboratories are making systemic improvements using methods from Lean Manufacturing and the Toyota Production System. They are reducing the use of batching, improving the flow of patient specimens, while using “error proofing” methods to prevent errors, rather than relying on people to “be careful.” Again, It's called “human error” for a reason – we are human and we make mistakes. Smart system design recognizes that and makes it harder for errors to occur. A company like Toyota, unfortunately, has better methods in place to prevent the wrong steering wheel from being installed in the wrong vehicle than a typical laboratory has in place to make sure the wrong patient specimen doesn't get on the wrong patient slide.
If you read the whole thing, thanks for hanging in there. I'm going to relax, watching my Thursday night NBC shows, including my favorite bad bosses — Michael Scott (The Office) and Jack Donaghey (30 Rock). Watch the 30 Rock clip in this blog post if you need a laugh. I sure do.
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