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By November 21, 2007 16 Comments Read More →

Updated: How Often Must the Same Mistake Be Repeated?

Dennis Quaid’s newborns reportedly harmed by medical mix-up – Los Angeles Times

(Updated 4:57 PM, again at 9:51 PM, see bottom of post)

If this story sounds familiar, it’s because it is the exact same error as one that killed three babies in Indianapolis last year. This time, the error has harmed the twin babies of actor Dennis Quaid. The babies are reportedly in stable condition at L.A.’s Cedars-Sinai hospital and will hopefully pull through. My thoughts and prayers go out to the Quaid family.

“Dr. Michael L. Langberg, Cedars-Sinai’s chief medical officer, confirmed in a statement late Tuesday that “as a result of a preventable error,” three patients had their intravenous catheters flushed Sunday with a concentration of heparin 1,000 times higher than the normal protocol. Staff members used vials containing a concentration of 10,000 units per milliliter instead of similar vials containing a concentration of 10 units per milliliter.”

This was truly a preventable error and something that should have never occurred. So what is the response? Do we ask “who did this?” or “why did this occur?” Those are two very different questions.

First off, let’s give the hospital credit for their public response:

“Cedars-Sinai spokesman Elbaum said no employees had yet been disciplined because “our focus tonight is on quickly determining what needs to be done to make sure it doesn’t happen again.” For instance, all 1,800 nurses coming on duty beginning Tuesday night will be retrained on medication safety practices before they begin seeing patients. Other steps also will be taken.”

It says “had yet been” disciplined, meaning I guess they are leaving that door open. Focusing on why it happened and making sure it doesn’t happen again are good problem solving responses. With Lean, we first want to ask “why did this happen?” instead of “who screwed up?” The chief medical officer was quoted on the news as saying it was a “preventable error” but he also said that procedures and standards were not followed. That sounds like a precursor to throwing someone under the bus for not being careful.

In the Lean approach, management has a responsibility to ensure that “Standardized Work” is being followed. If the standardized work (or procedures) say that nurses are supposed to double-check the labels, how often does management spot check that the right process is being followed? A Toyota plant does not just assume that the work is being done properly, the managers and supervisors are constantly auditing and checking that procedures are being followed. They are not waiting for a defect or customer injury to occur first.

Blaming an individual might feel good, but who do we blame? The nurse who administered the wrong dose? In the Indianapolis case, the nurse never expected that an adult dose of heparin would be in a neonatal I.C.U. Do we blame the pharmacy technician who likely delivered the wrong dose to the unit? Do we blame the pharmacist who was supposed to confirm the medications that were being delivered? Do we blame the person who possibly put the wrong vial into to the wrong bin in the pharmacy? If the pharmacy technician scanned a bar code on the bin (and assumed that the medication also matched), do we blame them? Or do we blame the purchasing agent who buys different dose vials that look similar? Or do we blame the manufacturer of the heparin?

People were blamed in Indianapolis. But that didn’t prevent the problem from happening in L.A.?

Cedars-Sinai is now taking reactive measures to train and raise awareness. Why was that not happening already? Does every single hospital have to make the same mistake before they take preventative measures? How about being proactive? How about we not rely on asking people to “be careful?”

In Indianapolis, they have “double checks” which is like a “double be careful.”

“Nurses at Methodist didn’t check the label and administered the wrong dosage. After the incident, the hospital required a minimum of two nurses to verify any dose of blood thinner used in the newborn and pediatric critical-care units, among other steps.”

That’s just another form of inspection. It doesn’t prevent the root cause of the problem. We can’t rely on people to be careful, especially when nurses often work 12 hour shifts. People get tired, we’re human, we make errors. That’s why the Lean philosophy of error proofing is so powerful. It recognizes that people make mistakes, so we design systems that make it less likely for errors to occur. And don’t call it “dummy proofing.” The nurses who make these mistakes aren’t dummies. This might have been the only mistake they’ve made — they were careful every other time, but here was one mixup that can have fatal consequences.

A professor of pharmacy in San Francisco was quoted as saying:

“This is not an unheard-of error,” Kayser said.

It sure is. The FDA and Baxter issued a warning in February 2007. And we’re going to keep hearing about it until every hospital takes proactive and preventative measures to keep this from happening. Reacting after an incident shouldn’t be looked upon favorably.

Baxter’s recommendation, for now, was to “be careful” basically:

Both products use blue as the primary background color on their labels, though in different shades.Baxter is looking for ways to vary the packaging to prevent future errors. In the meantime, it suggests that healthcare workers check their inventory to ensure no mix-up has occurred; notify staff of the problem; be sure not to rely solely on package color to identify a product; and always read the label and verify that the correct dose and product are being used.

heparin Updated: How Often Must the Same Mistake Be Repeated? leanLook at the packaging. Sure, they don’t look identical, but imagine you’re in a somewhat dark patient room at 3 a.m. Why isn’t the stronger dose in a larger form factor bottle?? Or a different shape? Or maybe the adult dose bottle can have sharp jagged edges to poke the nurse to make sure they are being careful? We need error proofing devices, not “being careful.”

If I ever have children, and they’re in a hospital, I’m going to be a nervous wreck. My advice to others would be to have someone monitoring your child and their care 24 hours a day. You can’t trust the system to protect them for you, unfortunately.

There is a surprisingly intelligent and informed comment on the E! Online website, discussing this problem (scroll down to the 4:27 comment). The comment actually comes from this blog posting, written by a nurse. Surprisingly, she primarily blames the nurses!

Yes, nurses in this day and age are very rushed to get everything done for their patients, and there is definitely not enough time in the day to get it all done. Nurses are overworked, underpaid, and stressed to the max. We are assigned to too many patients at times, creating unsafe situations for the very people we are here to help. But by skipping the very foundations of safety, we are putting each and every one of our patients at risk for medication errors, injury and potential death.”

Can you really hold people solely accountable when they are overworked, stressed, or tired? I’m not saying people have zero responsibility, but merely blaming someone for firing a nurse won’t prevent this from happening again. Training will help, at that hospital. But what about the others? I wish the media would go to the OTHER hospitals in L.A. and ask, “So what are YOU also doing to prevent this?”

Maybe this story will get the right kind of coverage since it’s a celebrity’s babies?

Update: This blog says the error was a result of a technician storing the drug in the wrong location.

Update: This site (lawyer alert) says that Methodist had made the same mistake five years before killing the three babies last year. The news article he links to says:

“The parents of one of the children overdosed five years ago were assured by the hospital that steps were being taken to ensure the mistake was not repeated, but those steps didn’t stop it from happening again.”

That’s why being careful or even saying “we have procedures and policies” doesn’t work. At some point, hospital leadership should be held accountable, not just individual workers.

The lawyer has it wrong when he says:

“Administering an adult dose of Heparin to an infant is the type of error that should only happen once in the history of a hospital.”

No, it should never happen. Hospitals need to be proactive and NOT wait until a mistake is made. We need Lean and Toyota Production System methods to spread within health care.

Update (9:51 PM): This blogger (another lawyer!) reports that the celebrity site tmz.com is reporting:

We’re told one dose was given on Sunday morning, another on Sunday evening.

We’re told as many as thirteen patients at Cedars were mistakenly given the overdose of Heparin, but the effects are more critical because of the age and weight of the twins.

Wow, that is one hell of a systemic problem. It’s not as simple as one nurse being careless one time if the Quaid twins were overdosed TWICE and it happened with other patients. Yikes, how is someone “not careful” that many times??

The lawyer then, predictably, goes on to rant that problems like this happen because hospitals aren’t as afraid of being sued anymore, thanks to tort reform. Ah, the fear of lawsuits, the best path to quality! Not really. He also confuses the heparin dosing error with the “heparin and insulin confusion” error, which the FDA also gave a warning about and also happens all over the place.


mark graban lean blog Updated: How Often Must the Same Mistake Be Repeated? leanAbout LeanBlog.org: Mark Graban is a consultant, author, and speaker in the “lean healthcare” methodology. Mark is author of the Shingo Award-winning books Lean Hospitals and Healthcare Kaizen, as well as the new Executive Guide to Healthcare Kaizen. Mark is also the VP of Customer Success for the technology company KaiNexus.

book mark graban Updated: How Often Must the Same Mistake Be Repeated? lean mark graban consulting Updated: How Often Must the Same Mistake Be Repeated? lean

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16 Comments on "Updated: How Often Must the Same Mistake Be Repeated?"

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  1. Phillip says:

    This article describes a horrible incident, and my sympathies go to the victims. But this incident was not an accident; it was preventable.

    The article inidcates that this incident had happened before, perhaps at other institutions. A good quality system would have raised a red flag much earlier, and developed systems to fix it.

    The double-nurse check, as you said, is just more inspection. It actually makes the problem worse, by requiring even more nurse-time, when that resource is most valuable and in short supply.

    A lean solution would be to create a system that prevents the problem from being able to occur in the first place (poka-yoke, or mistake proofing). A different connection adapter (interface) is one obvious solution. The bottle with the higher concentration ought to be impossible to connect to the syringe used to flush the catheter.

    Systems should not have to rely on people to work correctly. This principle is basic to lean practices.

  2. Mark Graban says:

    Thanks for your excellent comments, Phil and for the links. Yes, it certainly is something people need to be proactive about. I like your error proofing device idea. Something like that would be much more effective at preventing the error than saying “Be careful in the future.”

  3. Mark Graban says:

    I’m also reminded of the quote from Gary Convis, formerly of Toyota:

    “You respect people, you listen to them, you work together. You don’t blame them. Maybe the process was not set up well, so it was easy to make a mistake.”

    That’s the key to real quality and real problem solving. Toyota and the Lean approach recognize that we’re human and fallible and we design systems accordingly. It’s not fair to design systems that require a superhuman ability to always be alert or always be careful.

  4. Ralf Lippold says:

    Checking is just the “easy” solution;-(

    But this will never be sustainable as people change, work conditions change and you can forget what you have been told to do (when there is a stressy time).

    Never take checking as a Poka Yoke solution – it will definitely not work especially when it is a MUST.

    So long

    Ralf

  5. andrewmc says:

    A couple of observations.

    The last Toyota Plant I was in had a final inspection area where the vehicles were tested and gone over by a final inspection team before being signed off. If a defect was found the team leaders, were called over, signed to acknowledge that it was a problem and have until the start of the following shift to put in place a means of preventing them.

    Three of the same defects were grounds for dismisal.

    This was a US plant.

    There are a number of issues here, the ease of packing in the pharmaceutical company, the cost, both of which are clearly designed to keep costs to a minimum not improve safety.

    If you want to address issues like this it has to be at the root cause and that is not the nurses, doctors or other professionals but at the manufacturing level.

    In the last few years every major automotive manufacturer has moved to different size holes for diesal and petrol. (You can make the mistake one way but not the other)

    Whilst this is not ideal it’s an issue that has been addressed industry wide and it is far easier to do that, than to train millions and millions of clinical staff world wide on how to use account for all of the variances between equipment.

    One example of this that Atul Gawande refers to is the manufacture and standardisation of Anaesthetic equipment.

    These things can be done, I agree its not about punishing the person (although sometimes disciplinary action is clearly warranted), but about putting in place systems that prevent these errors from occuring.

    As to the comments about TPS or Lean being the way to go, Bob Wachter at Wachters world has written a brilliant blog on this very subject and as a Lean practioner I tend to agree with his own thoughts on the matter. (google wachtersworld)

  6. Mark Graban says:

    This LA Times article has some more details:

    “But last month, in the wake of the Indiana deaths, Baxter began repackaging heparin to make the different doses more distinct, including adding a large “red alert” symbol on the more concentrated dose.

    Even with the change, many hospitals are still working through the last of the old vials — and in some cases have not yet received the new ones. A source close to the matter, who spoke on the condition of anonymity, told The Times on Wednesday that Cedars-Sinai was still using the old vials.”

    The Baxter spokesperson said:

    “Last month, the company altered the label on its dose with a concentration of 10,000 units per milliliter, changing the background color from blue to black, increasing the font size by 20% and adding a large “red alert” symbol on the vial, Gardiner said. Such changes, however, don’t “replace the value of clinicians carefully reviewing and reading a drug name and dose,” she said.”

    It’s good they made some systemic redesign changes, but they are still telling clinicians to be careful. That didn’t work before, did it?

    “Cedars-Sinai has long used a “double-check system” requiring two licensed healthcare professionals to verify independently any medication before administering it, Elbaum said.”

    So much for the doublechecks. When you have rare or unexpected errors, complacency can result. It’s a normal human reaction, so we have to design systems to account for that.

    You can install bar code systems, as the article suggests, but there are many workarounds and ways that nurses are able to avoid the time involved in using those systems. The nurses are often overworked, so we have to get waste out of the processes to free up more time for them to do things the right way.

  7. Anonymous says:

    “…We need error proofing devices, not “being careful.”
    …”

    Yes, the solution should *never* be to excercise personal responsibility. After all, if we can have somebody else take the blame for our every mistake, why in the world would we bother to be careful about anything?

    How horrible that the manufacturer didn’t consider every single, obscure way to idiot-proof their product from people who don’t think they should have to be careful!

  8. Mark Graban says:

    “Being careful” is necessary, but not sufficient for safety and quality.

    Using the term “idiot proofing” is insulting. The people who make these errors are often good people who make a mistake.

    Are you, anonymous commenter, a superhuman who never has a distracted moment or never makes an error under stressful conditions?

    That’s why we need “error-proofing” not “idiot proofing” or “dummy proofing.”

    This isn’t about making excuses, it’s about doing what’s most effective.

    The healthcare industry has preached “be careful” for decades. We see how well that’s working.

  9. Neutron Jerk says:

    Hey Anonymous:

    So if people need to be careful, but we (as a human race) have a track record of often NOT being careful, what do you do?

    Get all people out of the healthcare system (not likely)?

    Proactively fire those who are not careful?

    Fire those who are likely to not be careful in the future?

    Can you see the futility in the “people should be careful” argument? We are NOT careful. We have to protect patients through systems and engineering. Not hope.

  10. Tosk59 says:

    Color coding vials is a horrible idea, which encourages the bad habit of using color/shape/etc. of the vial as a proxy rather than checking drug and dose. It is not the answer, even were it possible…

    http://www.ph2dot1.com/2008/02/color-coding-is-this-good-idea.html

  11. Tosk59 says:

    A good part of the hospitals’ responses is to be seen to be doing something. After this happened in Indianapolis the COO was on TV and I saw him say that they would discontinue carrying the very high concentration (10,000u/ml and/or 20,000u/ml) sizes.

    This was really silly, the reason these sizes exist and are carried is because there is a need/indication for that strength for a certain patient population and indication. I’m sure they ended up having to “walk that decision back.”

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