"More Careful" or "Better Processes"?

NHS: 60,000 medication blunders in 18 months - Health News, Health & Wellbeing - The Independent

Trust me, I'm not picking on the NHS. There's a lot of good things happening here with Lean and I'll blog about some of that soon. This article from the Sunday Independent highlights some numbers on medical errors:

Medication blunders by NHS staff are killing patients at a rate of two a month and costing the health service £775m a year, a watchdog has revealed.

The National Patient Safety Agency (NPSA) has found that thousands of patients are being given the wrong drugs, too little or too much of their prescribed medication or miss doses altogether.

The study found 60,000 "medication incidents" were reported by hospitals, GPs, pharmacists and community health centres over 18 months up to June 2006. Thirty-eight patients died as a result of these mistakes and a further 54 were dangerously harmed. Experts believe that fewer than one in 10 cases are reported, suggesting that there may have been as many as 708 deaths out of one million incidents.

When you look at patient safety or medical error problems across the United States, Canada, and the U.K., they're roughly the same on a per-capita basis. It's not like any country is an order of magnitude better or worse than others. The operational processes tend to be the same across countries, leading to similar results, regardless of the payer system involved.

The response to these errors? We need more "Lean thinking" than what's demonstrated in the following quote:

These findings come a week after the NPSA Rapid Response Report which urged "extra care" when administering powerful drugs such as morphine, amid concerns incorrect dosing had caused several deaths since 2005.

As I've blogged about before (and write about in my book), "being careful" is not enough. Being careful is a good start, but bad processes and bad systems can defeat even the most careful of individuals. Urging staff members to be more careful, in my view, is unlikely to do much long-term good. Firing employees after the fact of an error doesn't do anything to improve the underlying processes.

If a process was error-prone, someone else is likely to make that same error again. If you could proactively identify which employees or physicians are likely to not be careful, those who going to cause an error, then just proactively fire those people. Problem solved right? Not really. We don't have that ability, so we'd better focus on processes and systems... not just "being careful."

The Lean approach urges us to create "error proofed" processes. Toyota and Lexus don't have better quality because their people are "more careful." It's all about systems and processes.

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Surgical Checklists in the News!

WHO Proposes Checklist to Reduce Surgery Errors : NPR

A surgical revolution: checklist that could prevent thousands of deaths

Thanks to long-time readers Chet and Andrew for pointing out these similar stories, one from NPR in the U.S. and one from The Independent newspaper in the U.K. (front-page news!)

As a Lean thinker, I love the idea of checklists. They are the Lean concept of "standardized work" in a different wrapper. Standardized work helps ensure quality and consistency of processes - whether in a factory, an airplane cockpit, or a medical setting.

Checklists, when done properly, are written by the people who do the work (just as we would do with standardized work). This isn't about consultants, mangers, or a single expert dictating the process to others.

Checklists aren't intended to "turn people into robots." Checklists and standardized work are a foundation, they cover typical situations, but can't cover everything. When a truly unique situation comes up, people are expected to utilize their professional judgment - to use their brains. There's a Toyota expression that says standardized work allows you to avoid hundreds of little decisions so you can make the one major decision that matters.

Checklists aren't "carved in stone" practices that can never change. As new evidence or practices emerge, checklists and standardized work can be improved - that's the Lean concept of "kaizen."

All of these principles were seen back in the story of the cardiac surgeons at Geisinger Health System in Pennsylvania. The surgeons themselves credited the checklists and standardized process for elective bypass surgeries - before, during, and after. The surgeons were able to deviate from the standardized work IF they had a reason they could justify to their peers (not just "because I didn't want to follow it today"). They improved upon their standard over time... and outcomes for patients improved dramatically.

As I've also written about, the work of Dr. Peter Pronovost and Dr. Atul Gawande has proven that checklists are incredibly powerful - preventing infections another preventable patient harm. This probably should be a surprise to Lean thinkers.

So now the World Health Organization is looking to spread these simple, yet powerful, practices around the world.

From NPR:

Since the 1930s, airplane pilots have run through checklists before taking off. Now the World Health Organization wants surgeons all over the globe to use them, too.

Dr. E. Patchen Dellinger, a surgeon at the University of Washington Medical Center in Seattle, says people are surprised when he tells them about the project.

"One of the common reactions is, 'You mean you weren't doing that before? Good heavens!'" he says.

Yes, I can understand that reaction! For all of the medical and clinical brilliance in our hospitals, they often have a great deal of opportunity for operational improvements.

Of course there will be resistance to this - as with any change. Again, from NPR:

Gawande says there's been some resistance to the list. One London surgeon thought it was demeaning "Mickey Mouse stuff" until one day in the operating room.

"Right before the incision [the medical team] took a timeout," Gawande says, "and when it came to the nurse's turn to raise any concerns, the nurse asked: 'Are we really sure we have the right size knee replacement for this patient?'"

Turns out, they didn't — not anywhere in the hospital. That surgeon now swears by the surgical checklist.

The surgeon now sees the benefit of the checklists - to the patient and to themselves (avoiding a lawsuit -- although I don't know how the legal system treats that in the U.K., compared to here in the U.S.). We have to sell people on the benefits of checklists -- not just forcing the method on them and saying "here, do this." It's one of my truisms that "people don't like to be told what to do." That's true not only for doctors... but for practically any time of person or role.

From The Independent:

More than eight million operations were carried out in the UK last year, equivalent to one for every eight people in the population, and there were 129,000 reported incidents in which patients were put at risk, according to the National Patient Safety Agency.

An estimated 2,000 NHS patients die each year as a result of errors in treatment, and an inquiry by the National Audit Office in 2005 concluded that half of all incidents could have been avoided if staff had learnt the lessons of previous mistakes.

And more quotes from Gawande:

Atul Gawande, the US surgeon and columnist for the New Yorker who is leading the initiative for the World Health Organisation, said: "The complexity of medicine has increased to the point where no one person can ensure it is delivered reliably and accurately. We have been struggling for a tool that can help people reliably deliver safe care. The checklist is turning out to be as important to successful care as the stethoscope. I think you could make the case that it is the biggest innovation since the stethoscope."

...

Dr Gawande said: "At the start of the pilot in the eight hospitals, 64 per cent of patients missed at least one check. Putting in the checklist cut the failure rate by half and has reduced deaths and complications, though it is too early to put a figure on it. The remarkable thing was we couldn't tell the first world countries from the developing world countries. This has shown we can do something we have never seen before – improve the safety of surgery on a population basis."

I'm surprised that the error rate was only cut in half. Having the checklist is one thing -- we need a management system and culture that ensures that the checklist is used the right way. Zero errors needs to be the goal with checklists.

Worldwide, the WHO aims to have the checklist operating in 2,500 hospitals in the most populous countries (with 75 per cent of the world's population) by the end of next year.

If you're reading this and you're not a hospital employee or leader -- if you're a patient -- it's time to push your local community hospitals to implement this proven method. If not before YOUR surgery, then before the surgery of a neighbor or a loved one. As Pronovost said before, the only thing stopping us from spreading the use of checklists is a lack of desire to do so.

The method is cheap, it's relatively easy, and it works!

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Everyday Lean: Aluminum Foil

snopes.com: Aluminum Foil Locking Tabs

Here's an interesting example of "Everyday Lean" that I never knew about. Have you ever been frustrated by pulling on a roll of aluminum foil (or plastic wrap) and having the roll pop out of the container?

The boxes for these are actually designed with a little method for keeping the roll in the box - a physical method is more effective than "being careful."

Click on the link above for some further explanation and a few photos. It's not rocket science - that's why I love this example. This is designed into the product, but we can use this to think about opportunities to error proof our processes - at work, not just in our kitchens at home.

Does saying "be careful" really work? If this were a workplace and the roll popping out of the box were a serious problem, would we post signs, cautions, and exhortations for our employees, or would we error proof it?

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The USPS Should Error Proof This

Express Mail: USPS Says Guaranteed Overnight Isn't Guaranteed. What?

Saw this post on The Consumerist blog about how the United States Postal Service does NOT guarantee overnight delivery of "guaranteed" overnight documents.... IF you place the package in a drop box instead of handing it to an agent at the counter.

What?

According to the blog report:

Dorothy found out that the USPS's guaranteed overnight delivery doesn't apply if you use their Express Mail boxes, because "Letters get stuck up in the top of the box all the time. Sometimes, it takes days or even a week before we find them." Hey post office, maybe you should try to check the top of the box every day. Problem solved!

Checking the box every day would be a form of inspection -- that's waste.

It would be better if the USPS could design a drop box that prevents letters from getting stuck. It's called "error proofing" (or "poka yoke" if you insist on the Japanese term). It's not really a new concept. How hard is it to design a box that works perfectly?

Again, from the Consumerist:

...nowhere on the website, while purchasing the Express Mail option did it state that items needed to be taken to the window/desk in order for the guarantee to apply.

I asked her, "Where on the box does it say that?" She then told me she had handed my form over to her supervisor.

I was given my full refund without any further discussion, but we did have to wait for half an hour while all this occurred. Although the supervisor did not want to give me the refund. She actually explained, "Letters get stuck up in the top of the box all the time. Sometimes, it takes days or even a week before we find them."

Consider yourself warned. Does FedEx have this problem? Or DHL?

To top it all off, one commenter claims:

This is absolutely true. I worked as a USPS letter carrier and when I had to empty collection boxes at least half the time there would be a letter or two stuck against the side of the box or at the very top of the box. To combat this, the USPS has a company send out test letters to see how long it takes for them to reach their destination. They also do random checks after you leave to make sure you grabbed every single letter. People have been fired over this.

Step 1: Design a box that doesn't meet customer or employee needs
Step 2: Do inspections to see how badly it works
Step 3: Blame and fire people

If you believe that, it's not a very encouraging thought process they are following. Typical bad management, eh?

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Fire Fighting vs. Root Cause Problem Solving

Lean Hospitals Book Newsletter Archive

Below is some of the text from edition #3 of the newsletter from my upcoming book "Lean Hospitals: Improving Quality, Patient Safety, and Employee Satisfaction." Click on the archive link above for previous issues or to sign up for future editions, including results from the online survey I conducted for the book.

---------------------------------------

Hospitals are notorious for employing "workarounds" to respond to problems. For example, when supplies or medications are missing, the typical response is to run around, looking for what is needed. Once the missing item is found, the nurse might go back to their regular duties -- problem solved, right?

The workaround does nothing to prevent the problem from occurring again -- this ensures more wasted time and more potential problems in the future. It is not fair to blame individuals for this behavior, as workarounds and fire fighting are often encouraged by our organizational culture and reward systems.

In a Lean setting, we still "put the fire out," if you will. If a medication is missing, the first response is to make sure the patient has what they need -- get the med. But we then have to STOP and identify how to fix the process. Instead of blaming people or asking "who messed up?," we have to look at the process.

Two simple questions to ask:

1. How and why did this problem occur?
2. How can we prevent it from happening again?
   
   

For the first question, you might use the "5 Whys" method of continuing to ask why until you reach something that really is a "root cause" rather than being a symptom/result of a more fundamental problem.

With the second question, we focus on prevention. Use "error proofing" methods or ensure that a standardized process and method is in place.

This approach is all about the mind set. If you are a manager and employees come to you with a problem or complaint (or to report fire fighting), be sure to ask them about stopping to identify the root cause. Work together with them on preventative measures. Be sure to communicate changes with the rest of the team.

Many people complain, "That makes sense, but I don't have time for that." Have you gathered data on how much time is spent using workarounds and fighting with the current process? If you invest a bit of time on process improvement (even if it requires a few hours of overtime), you will likely find recurring time savings from improving the process instead of fighting the same fires over and over again.

One hospital pharmacy spent 11 hours a day processing medication that was returned from patient floors. Not all returns are the result of a process error, but many returns are the result of medications not being transferred to another unit along with the patient, for example. By dedicating some time to improving the process (delivering medications more frequently and working with nurses to prevent process errors), this time was significantly reduced. Those hours saved, time not spent processing returns, are saved each and every day.

As "fires" pop up during the day, there might not be time right then and there to stop and use the Lean problem solving approach. It can be useful to have a formal method of documenting problems that need solving as time allows. Sticky notes or note cards on a board can be a simple way of tracking these opportunities (don't hide the notes in a "suggestion box"). When slow times occur during the day, encourage team members to take a card off the board, spending some time on process improvement. Small improvements can often be made in a 20 or 30 minute window, as time allows. Almost all of us have some slack time in our day -- it's just often not identified or utilized properly.

Hospitals can break the cycle of fire fighting -- it requires dedication, some time investment, and continuous reinforcement from leadership until new habits are formed in the organization. When time is available in the day, are we chatting about "American Idol" or working on small process improvements (or "kaizen")?

Here is an outstanding article from Steve Spear and Mark Schmidhofer titled, "Ambiguity and Workarounds as Contributors to Medical Error."

Do you have examples of how you have struggled with breaking the fire fighting cycle? Have you been able to move toward root cause problem solving and prevention? Share your experiences on the message board or click comments to share your experiences here...

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LeanBlog Podcast #42 - Martin Hinckley, Mistake Proofing

This is LeanBlog Podcast episode #42 with Dr. C. Martin Hinckley, of the firm Assured Quality. He is the author of the book "Make No Mistake!: An Outcome-Based Approach to Mistake-Proofing," available through Productivity Press. We'll talk about his book and approaches for teaching people how to develop mistake proofing in processes.

For earlier episodes, visit the main Podcast page, which includes information on how to subscribe via RSS or via Apple iTunes.

You can use the player (use the VCR-type controls) below to listen to a "streaming" version of the podcast (or click here for the streaming audio and RSS subscription). The streaming link is faster for one-time listening (hardly any delay to start listening). Or you can use the download link to put it on your iPod or other MP3 player.

MP3 File Right-Click to "Save As"

LeanBlog Podcast #42 Key Points & Links

• Some mistake proofing examples from Dr. Hinckley's site


• Upcoming webinar on mistake proofing on May 15 (via http://www.visualworkplace.com/)

If you have feedback on the podcast, or any questions for me or my guests, you can email me at leanpodcast@gmail.com or you can call and leave a voicemail by calling the "Lean Line" at (817) 776-LEAN (817-776-5326) or contact me via Skype id "mgraban". Please give your location and your first name. Any comments (email or voicemail) might be used in follow ups to the podcast.

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Error Proofing Vs. "Be Careful"

Why do you need a "be careful" warning message when you've already error proofed something? For liability's sake?

I am going to be flying back and forth to the UK a lot this summer, so I needed an airplane power adapter/converter. The one I ordered had this packaging insert, pictured to the left (click on any picture for a larger view)

Why is the warning even needed? The product is designed with two types of error proofing in mind. First, there are colored lines that help visually indicate the correct orientation of the plug insert. Not the most effective error proofing, but it's something.

The second form of error proofing is much more effective -- the plug and port are asymmetrical. It seems pretty impossible to insert it the wrong way, even if you forced it. That's the smarter way of designing things -- make it truly impossible to do something the wrong way. So is the "IMPORTANT" reminder unnecessary? Seems like it.

This reminded me of a similar situation I saw in a hospital laboratory. They had two pieces of testing instrumentation, both from the same vendor. The one instrument (ironically, the newer one) had no error proofing. It was possible to load a rack of test tubes (pictured left) backward, which would have jammed up the instrument.

So, there was a warning sign, exhorting the technologists to be careful. How effective was this? Somebody managed to load it backward about once a week, they told me. You see, even if people are trained and they are "careful", human error is exactly that -- we make mistakes because we are human. Error proofing would have been a better approach

The loading chute for the older instrument (again, this manufacturer had taken a step BACKWARD in the new generation) was error proofed brilliantly. See the angled corner in the lower left side of the slot? It's shaped perfectly so the rack cannot be loaded backward. Just like my DC power adapter. No need for a warning or a caution or a "Be Careful!" It's not as "pretty" as the new instrument, but it's more effective. More "elegant," you might say.

I see far too many "Be Careful" signs in hospitals. I have quite a collection of photos of them. Maybe I can share them in some format, maybe a monograph on not exhorting people to "be careful"??

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Dennis Quaid on 60 Minutes

Dennis Quaid Recounts Twins' Drug Ordeal, Actor Tells 60 Minutes' Steve Kroft Medical Errors Kill Thousands - CBS News

Did you see the actor Dennis Quaid on 60 Minutes last week? He talked about the sad case where his twin babies were mistakenly overdosed TWICE at Cedar-Sinai Hospital in Los Angeles.

His babies are recovered now, thankfully. The silver lining on the sad case is that Quaid, as an actor and celebrity can become a powerful voice and advocate for patient safety and preventing systemic errors - highlighting the problem AND suggesting countermeasures and systemic fixes.

As Quaid recounted the story, he first seemed to blame the nurse: "The nurse didn't bother to look" at the dose (the correct dose, on the right, and the incorrect dose are both pictured here). Later, he mentioned, correctly, that a series of errors had occurred. As I've said before, it's too simplistic to just blame or punish a single person when an error like this occurs. That approach certainly doesn't help prevent other such errors.

He said the babies had been given TWO massive overdoses in an 8-hour period "that we know of," he said -- again, the signs that there's suspicion of a cover-up. It also highlights what a systemic error this is, that it could happen twice in the same hospital. It was a chain of errors that occurred. First, someone in the pharmacy picked the wrong dose. Secondly, a pharmacist is supposed to double-check any medications that leave the pharmacy (an inspection step). That's two people who are supposed to "bother" to look at the label. Then, there's the person who delivers the medication to the ICU. Finally, the nurse is the last in that chain. But, the nurse isn't expecting that the adult dose of Heparin is even there in a neonatal unit. So, pretty easy to let your guard down, right? I don't think that's an excuse, that's just reality.

Quaid was right to say the errors were "avoidable" -- pointing out it was the same avoidable errors as the case where three babies died at Methodist in Indianapolis.

Quaid has become pretty obsessed with researching the topic (he was shown on the computer, maybe he's been on this blog?) and discovered the errors happen "everywhere." He cited the "100,000 deaths a year" number (which comes from the late 90's study from the Institute of Medicine. Quaid said, "This is bigger than AIDS, bigger than breast cancer... yet nobody seems to be really aware of the problem." I'm glad Quaid is trying to spread the word and to help others.

There was a lot of talking about the old labeling being too similar across the two bottles. The new label (pictured on the right) is better because it's not just a different shade of blue and it requires a different motion (tearing off a paper cover) that is not required for the smaller Hep-Lock dose that is intended for babies.

The old stock (the old, more mistakable labels) was NOT recalled. Cedar-Sinai was using up their old stock first (sure, it was "FIFO" or First-In-First-Out, something Lean folks generally like), but that shouldn't have been the case when safety was at risk. What responsibility does hospital administration take for this materials decision?

The maker of the drugs, Baxter, had a spokesperson on 60 Minutes who reminded us that people were supposed to read the label (again, casting blame), even though the labels had been mistaken many times before by other nurses in other hospitals. But they redesigned the labels after earlier incidents. It was not necessary to recall, 60 Minutes asked? The Baxter spokesperson said "No, the drugs were safe" and that it was due to preventable errors in the hospital's system.

The CEO of Cedar-Sinai admits it was human error, preventable error. The CEO said "you need backup systems" and CBS's Steve Kroft asked, "but you had backup systems, you had three people." How many more backups can you add? More inspections and more backups isn't necessarily more effective due to, here it is again, "human error" in inspection. When many people are checking something, it's human nature to let your guard down because the "other person" will get it.

So what is my advice? Hospitals need to bee proactive, with this and other known risks. Leaders need to manage the process, not just reacting after bad results. If you're in a similar hospital setting, are YOUR people double-checking the medications? Are you spot checking this to see if it's really the case? There was "standardized work" (the Lean term, the hospital probably called it "policy") in place to double check the medications, but administration took their eye off the ball (if it was ever on there). We need to move from "policies" (which are never "policed") to a "standardized work system" where supervisors and leaders are working WITH their employees, checking to see if key processes are being followed, BEFORE harm occurs.

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Another Pathology Mishap

L.I. Hospital Scrutinized After Deaths of Patients - New York Times

It wasn't the same laboratory this time, but it's more than likely a similar root cause. I wrote before about pathology specimen labeling errors, how they're preventable human error. Labs need to get away from batching multiple specimens (working with multiple patient specimens at the same time) and they need to stop blaming individuals when errors happen. We have to look at the system. We have to be proactive. We have to try to prevent errors from occurring.

You might recall an incident from last year, where a private NY pathology lab mixed up two patient specimens ("This Will Happen Again, Unless...")

In this most recent case (at a hospital):

"Last spring, doctors at Mercy Medical Center on Long Island gave a patient the news she had feared: Cancer had been detected in her left breast. She was only in her 30s, but she decided to act swiftly because breast cancer ran in her family. On May 25, she had a double mastectomy. The next day, she died of complications from the surgery. As it turned out, the woman did not have cancer. According to the State Department of Health, the pathology report from the woman’s surgery had found no tumors in her breasts. The hospital’s lab had mixed up her test with another woman’s."

Why the woman died after the surgery is a altogether different story and there aren't many details about that. The lab error was more clearly preventable.

Every pathology lab should be using Lean methods to identify "standardized work" methods that allow work to be done in a single-piece flow manner, reducing the opportunity for error. This should be done pro-actively, before an error occurs in your lab. I heard a lab manager say once, after being asked about error proofing that process, "But my people are careful." I'm sure they were generally "careful" in Long Island also, but being careful is not enough.

How many times does something like this need to occur? For all of the truly complicated things in a hospital, this is NOT one of them. These processes are all pretty manual -- put the right patient specimen onto the correct, properly labeled "cassette" or slide. These errors can be prevented.

In this article, a doctor who is speaking out very publicly about the problems at the hospital says:

"That mix-up was a simple procedure," Dr. Anthony Colantonio said. "The simple thing of placing a label on a specimen container. That sort of mistake should not happen."

Thinking about this more, I might not be completely accurate in calling it a "pathology error." It *is* possible that the specimen container was improperly labeled in the operating room, before it ever got to the lab.

Update: Here' s an overview of the anatomic pathology and "histology" process steps, including a photo of the cassettes and slides that get labeled.

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An Example of Vehicle Error Proofing

Urban Legends Reference Pages: Cruise Control on Wet Roads Hazard

This is sort of an old urban legend that has been making the rounds again, but there's some truth to it in that we shouldn't use cruise control in our vehicles when it's wet or icy outside.

One thing reminded me of Lean principles and the idea of preventing errors from occurring, a mention in the one email version of this story that's making the rounds that pointed out how certain Toyota models prevent you from using the cruise control when the wipers are on, something mentioned here on the Popular Mechanics site.

Pretty good example of error proofing, don't you think? Are there other cars with that safety protection, or just those with new "adaptive cruise control?"

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Quaid Case Update: Whose Responsibility is Standardized Work?

If you're a regular reader, you might recall the Cedar-Sinai medical error that harmed Dennis Quad's twins (and others).

Quaid and his wife are now suing the maker of the drug, Baxter, claiming the company is negligent for not designing packaging with good visual distinctions between the two doses (photo there on the linked TMZ.com page).

This week, Baxter announced an initiative to redesign the packaging of their "high risk" medications.

Considering this problem has happened before, I'm sure that effort isn't just a direct response to the Cedar-Sinai incident. It sounds like Baxter tried to get some "voice of the customer" input:

Baxter conducted multiple interviews with more than 100 pharmacists, physicians and nurses to identify areas for improvement . The feedback received from health care professionals guided the design of the new vial packaging.

In research conducted after the three-phase development program, clinicians indicated that the new packaging design enhancements addressed the current clinical needs for safer injectable drug administration and could help reduce medication errors.

“Health care professionals played a vital role in the design of the new label and we look forward to their continued input to gain key insights that will help in the development of future design enhancements, ” said Bonderud.

Baxter had already done some redesign, but Cedar-Sinai may have tried to save a few bucks by using up the old medication (in the old packaging) first. Normally "FIFO" would be a good thing, but not if the old product leads to a greater patient safety risk. In hindsight, would have been cheaper to throw the old stuff out, right?

I'm also not impressed that Cedar-Sinai leadership is apparently throwing their employees under the bus. In a statement, they said:

The medical center's investigation found that preventable errors made by pharmacy and nursing staff caused the wrong concentration of heparin to be used.

A pharmacy technician failed to follow hospital policy of having another pharmacy technician verify the medication and concentration prior to removing it from main pharmacy inventory. As a result, the technician mistakenly retrieved a higher concentration of heparin (10,000 units per milliliter) instead of the lower-concentration heparin (10 units per milliliter) used for flushing IV catheters.

The higher concentration heparin was delivered to the satellite pharmacy that serves the pediatrics unit. A second pharmacy technician, working in the satellite pharmacy, did not verify the concentration of the delivery from the main pharmacy, as required by hospital policy.

As a result, the higher-concentration heparin was placed in a location in the pediatrics unit where the lower-concentration heparin is kept. The nurses who subsequently administered the heparin to the patients also did not follow hospital policy of verifying the correct medication and dose prior to flushing the intravenous site.

The error was identified later that day by Cedars-Sinai staff, who immediately performed blood tests on the patients to measure blood clotting function. In one of the three patients, the clotting tests returned quickly to normal. The other two patients were given protamine sulfate, a drug that reverses the effects of heparin and helps restore blood clotting function to normal. Additional medical tests and clinical evaluation conducted on the two patients found no adverse effects from the heparin or from the temporary abnormal clotting function.

"Although this was a rare event, and attributable to human error, it is also an important opportunity for the entire institution to explore any and all ways we can further improve medication safety," said Michael L. Langberg, M.D., chief medical officer at Cedars-Sinai Medical Center.

"On behalf of the medical center, I extend my deepest apologies to the families who were affected by this situation, and we will continue to work with them on any concerns or questions they may have. This was a preventable error, involving a failure to follow our standard policies and procedures, and there is no excuse for that to occur at Cedars-Sinai," Langberg said.

Whose responsibility is it for the Standardized Work to be followed? Doesn't management have a responsibility to be proactively checking and looking to see if policies and procedures are being followed? It's not enough to wait and react when an incident occurs. I'd guess those same policy violations were happening every day and it finally caught up to them. Are employees responsible for following processes? Sure, but it's also management's responsibility to manage the process and the people. Does Toyota say, "well, our policy says people don't build defective vehicles"? Of course not.

Does management taking responsibility mean that we constantly hound and watch employees? No, but we have a responsibility to check to see if there are violations of policies BEFORE an injury or death occurs. Proper training and re-training should happen BEFORE problems occur. The employees directly involved in the Quaid incident are suspended. What about the managers and leaders?

To be fair, Cedar-Sinai is making a number of systemic changes (including moving from using heparin to saline, which is much safer, they say). But, they've also added MORE double checks (adding more of a method, relying on inspection and "be careful," that didn't work 100%).

I hope other hospitals, where the same risk factors exists, will be more proactive. We need to make "preventable" errors into "prevented" errors.

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Follow Ups to BIDMC

If you've been following any of the posts about healthcare, here are a few interesting follow ups.

Following up on this post about Boston's Beth Israel Deaconess Medical Center, CEO Paul Levy posted many interesting employee responses to his email about the systemic waste that people have to fight every day in your typical hospital (and there).

After the medical mistake with Dennis Quaid's twins in L.A., I had asked Paul what BIDMC was doing to proactively protect against that same error from happening at their hospital. Paul asked some of staff and posted a lengthy response here.

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My At-Home Medical Mistake

I'm a bit mad at myself for inflicting some preventable human error on myself last night. It's OK, I didn't harm myself, but let me tell the story.

I've been battling what's either severe allergies or a mild cold for three or four days. I've alternated a bit between the daytime and nighttime formulas of a major branded OTC cold/congestion pill. Last night, I was in bed and couldn't sleep, I was wired. I thought, uh-oh, got up to check and, sure enough, I had given myself non-drowsy daytime formula.

The upside is that I went out to the home office and got a lot of work done, but I'm dragging this morning.

What has me kicking myself... I didn't practice what I preach in the Lean methodology!!

I had a "near miss" the night before. I had made the exact same mistake the night before. I had caught the error right after popping the pills in my mouth, I spit them out and took the nighttime formula. I'm mad at myself for not fixing the root cause of the problem. I didn't move the daytime formula off the bathroom counter, making it harder to mistakenly grab the wrong on while getting ready for bed. I did what so many people do in healthcare, because of time pressures, fatigue, or because of just human fallibility. I didn't take the time to really prevent the problem from occurring again. Obviously, the stakes aren't very high in the case of OTC cold medicine.

I'm doubly human. 1) I took the wrong pill and 2) I didn't think to take preventative measures!!

That said, looking at the packaging of the two formulas, there's some room for confusion (again, the "severity" score for the FMEA calculation of the RPN would be low for this one). The outer box of the daytime formula used to be primarily yellow (somewhat indicating "day") and the nighttime formula used to be primarily blue (indicating "night"). But the packaging changed to be more consistent, and that color coding is less prominent in the corner of the box. The backs of the blister packs are all white, being basically identical, except for some small text.

There *was* some color coding of the pills themselves, which should have been a tip off. The daytime pills are white, the night time cold/head congestion pills are blue. But, the color coding is NOT consistent among different products in that brand family. The "sinus congestion/pain" formula is green for day, white for night, when they come in the dual-boxed pack that includes day and night formulas. Strangely, when you buy daytime "sinus congestion/pain" on its own (without night), the pill is a green/white caplet. Why would they manufacture two different forms of the same pill?" The "sinus congestion/pain SEVERE" formula has white pills for daytime.

Seems like an opportunity for some standardization. Or time for me to quit obsessing about it, time to get to work!

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Update on Medical Mistakes

Here are some follow up articles, quotes, and data following up the news from the other day that Dennis Quaid's twins were impacted by a medication error at L.A.'s Cedar-Sinai hospital.

This article points out that seven children were impacted by this error at Cedar-Sinai, three showed signs of overdose. Some of the data on how pervasive this problem is:

U.S. Pharmacopeia is the national leader in tracking hospital mistakes and they say there are a lot of them.

"People need to know that medication errors are frequent," John P. Santell, of U.S. Pharmacopeia, said.

There are an estimated 1.5 million adverse drug events each year according to the Institute of Medicine. In particular, accidents with heparin are so common and so potentially harmful, it is on the "high alert" list posted by the Institute for Safe Medication Practices.

"Over a six year period from 2001 through 2006 we had over 20,000 error reports involving the drug heparin, reported to USP. Of those, about 3.6 percent were categorized as harmful," Santell said.

U.S. Pharmacopeia says the figures are derived from what hospitals report voluntarily even anonymously -- the actual number of errors they believe is much higher.

When data on problems like this rely on self reporting, it's understandable how the actual numbers would be much higher.

This article, from Indianapolis, follows up with parents of those killed by the same error last year. A dad is quoted as saying:

"It was inexcusable the first time it happened, so there should be no reason something like that happened again," said James Daniel Soots, whose son survived a heparin overdose at Methodist in 2006.

The families took action to try to help prevent future occurrences

Afterward, local families and caregivers worked to get the word out that the Baxter Healthcare vials were similar and that all medical centers should be on alert, and have prevention plans in place.

I wonder how that is going? We need more awareness and more prevention.

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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.

Look 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.

"Heightened Vigilance" is Not Enough

The Sun Chronicle Online - Opinion

A medical error was in the news this week, a teacher was mistakenly given an insulin shot instead of a flu vaccine. Thankfully for the teacher, it's not even something they had to be taken to the hospital for.

We're human, we make mistakes. In the Lean mindset, we recognize that and try to design systems that make it harder for errors to occur.

But what happened here? Reading the opinion piece I linked to, the response was predictable:

• Nurse placed on administrative leave (we must punish someone to show we, as management, have control of the situation)
• People are told to "be careful."

The newspaper that wrote the opinion column expresses a few unfortunate nuggets of conventional wisdom -- that errors are "bound to happen" (no, we can work to prevent them) and we should "be careful" (no, we should work to prevent them through systems improvement).

I'm sure the nurse feels horrible. He (yes, it was a he) didn't mean to make that mistake, I'm sure. How would things turn out differently if, instead of placing the nurse on leave, he was involved in the identification of the root cause of the error. The vials look alike -- how can we error proof the process? What if the nurse were involved in solving the problem, to prevent it from happening again? Even if the nurse is fired, are other nurses likely to do a better job at "being careful?" The next nurse hired is human, too.

Instead, we blame, we punish, and we say "be careful." No wonder we have such problems. Being careful helps, but it is not enough. I wish the U.S. Department of Health and Human Services had better recommendations than to be careful and to constantly inspect the work being done on you in healthcare.

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Bad Systems in the News: Not the Worst "Oops" Possible with Nukes

The Lean Thinker » What Nukes?

I had been mulling over trying to do a post on this story since the original story broke in August that some nuclear-armed cruise missiles were "accidentally" or "mistakenly" moved from one base in North Dakota to another in Louisiana.

I've read a number of stories, and there doesn't seem to be a clear story about what happened. The most recent stories are more about punishment and blame. I'm more interested in "root causes." There are different theories:

1. A mistake occurred. Procedures got lax, airmen weren't following procedures and leaders didn't notice or didn't take action. The system didn't have enough controls or oversight.
   
2. A mistake like this couldn't possibly have happened. The systems are too air tight and there are too many controls in place.

So which is it? I'm not sure. If you read too far into possibility #2, Google search results quickly get you to conspiracy theories worthy of the show "24." The systems are too tight for this to have happened unless someone was trying to send a message to a foreign country or somebody was trying to steal a nuke. I'm not endorsing those theories and I quit reading when I realized I was getting close to the lunatic paranoid fringe.

There are some really interesting underlying issues here, related to Lean concepts of standardized work, error proofing, and the role of leadership. Heck, if Air Force personnel were really coming up with their own unauthorized process, there's a horribly astray attempt at "kaizen," perhaps.

I've linked to a lengthy post from the new "Lean Thinker" blog. Check it out. Who has some insight into this? This story makes my head spin.

How (One) CEO Works, or "How I Selfishly Endanger Others"

In the October 29, 2007 issue of FORTUNE, there is their weekly "How I Work" segment that profiles and/or glorifies an executive. This time it is Bobby Kotick, CEO of videogame maker Activision. They've evolved from Atari 2600 "tapes," to a modern game maker.

Anyway, the part that jumped out at me was this (and I can't find this online), after talking about all of the gadgets and phones he uses:

"I have an Audi W12. I'm a distracted driver, so I wanted the most airbags."

Yikes. I hope he was trying to be funny. It's not really "ha ha" funny. Did executives make jokes back in the 1970's about how they needed to drive big American cars because they drank a lot and needed protection in a likely DUI wreck?

Does this Audi W12? have external airbags to help protect the less fortunate who he might smash into?

At the least, here's an example we can use of very poor preventative problem solving, eh? It's better to NOT be distracted, thus avoiding an accident, right? Maybe he should hire a driver or put his distracting gadgets in the trunk? To his credit, I'm sure he's not planning on getting in a wreck, but he's counting on "being careful" with his unsafe practices -- not a good strategy in any environment.

Maybe we can, without naming names, use this in our Lean training -- how buying a very expensive, large car with lots of air bags is poor error proofing.

Just a note to the Activision board about your CEO's judgment, or lack thereof, on public display. There are a lot of laws being proposed about banning 16 and 17 year olds from "distracting driving." Does that ne