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Tuesday, May 06, 2008

A Pharmacy's Long Turnaround Time?

Star-Telegram.com: | 05/06/2008 | LETTERS

OK, so we're piling on JPS Hospital at this point.. but this letter to the editor caught my eye today:

One glaring omission in your series was failure to critique the pharmacy. It's one of the worst parts of the JPS system.

One example: The pharmacy won't let us order refills until five days before our medications run out. But it often takes seven days or more to get the refills. Some patients need a continuous supply of life-or-death medications. The pharmacy seems to operate independently, with an air of indifference, as if it's not part of a patient-care facility.

I hope your series will prompt those officials in charge to act aggressively to fix the hospital's problems so you'll have plenty of material for your series on JPS's positive aspects.

Yikes. That's one anecdotal story, but still. A pharmacy's "value added" time (filling a prescription and having a pharmacist review) should really be measured in minutes, if not seconds. It shouldn't take one day, let alone seven, to get a prescription filled.

A standard Lean measure is the percentage of "Value Added" time to the total "cycle time" or "turnaround time." As with many non-Lean processes (whether in manufacturing or healthcare), the percentage of VA time is very low according to that story about JPS. The non-value added time is waste -- waiting due to not having enough capacity to get the work done or waiting due to batching and other systemic delays.

I certainly do hope there are JPS success stories in the future. Lean methods could certainly be used to improve processes, reducing turnaround time in the pharmacy.If there isn't enough capacity (people or equipment) to get each day's work done, Lean would focus on reducing wasted time so people can be more effective. Lean isn't about cutting corners or doing work too fast -- that might introduce more errors, something you don't want to do in a pharmacy, yet alone any process.

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Saturday, December 01, 2007

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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Wednesday, November 21, 2007

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.

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Friday, September 28, 2007

Waste in Philly Pharmacies

Phila. health agency in disarray | Philadelphia Inquirer | 09/26/2007

I saw this in the news as I was leaving Philly earlier this week. Would you run your manufacturing warehouse like this? Dell keeps better track of computer parts than these pharmacies track medications, sadly.
"The Philadelphia Health Department does not keep track of prescription-drug deliveries, fails to remove expired medication from the shelves of its pharmacies, and can't account for more than 2,000 pieces of equipment, the city controller said yesterday."
Just a basic lack of processes and controls:
"...the department does no accounting of its $7.6 million in prescription-drug orders each year. It has no way of knowing whether drugs are delivered as ordered, whether the correct price was charged, or whether supplies have been depleted by theft."
Reading on:

The audit also found six expired bottles of prescription medicine in one health center. Domzalski called that a "dangerous" practice that would end.

Butkovitz noted that city pharmacists, who fill three times the number of prescriptions of their commercial peers, were often too busy to properly keep track of their stocks. Domzalski said that before July, when salaries were raised, city pharmacists were paid about half what their private-sector counterparts earn.

I'm tired of the "too busy" excuse. It's not a good excuse, particularly in healthcare. If tasks are important, we MUST make time to do those tasks. We have to eliminate waste to free up time and we need a Standardized Work system to make sure key tasks get done. No more excuses.

And we can't just blame the pharmacists. Lean isn't about making people work harder. If they're already 3x more productive than commercial peers, they're probably already working hard. But, I bet there's still waste in their process that can be reduced, freeing up time to more carefully keep track of expired meds.

Next week, I'm attending a pharmacy supply chain expo, will be interesting to hear more about current issues in that area. I've seen quite a few hospital pharmacies and there are some fairly systemic process design issues -- pharmacies tend to be like other pharmacies (although not all of them have waste to the same extent as those mentioned in the article here).

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Sunday, April 01, 2007

Say "No" to Bad Drug Stores

The Blotter: ABC Report on Pharmacy Errors

I first stumbled across this 20/20 report when I saw a preview on the ABC investigative reports video podcast. Pharmacy errors are a major problem (see this story):
There are as many as 7,000 deaths annually in the United States from incorrect prescriptions, according to Carmen Catizone of the National Association of Boards of Pharmacy. He told The Washington Post that as many as 5 percent of the 3 billion prescriptions filled each year are incorrect.
In the ABC piece, they focus on Walgreens, although I'd suppose the conditions and processes are the same at other major chain pharmacies.

One former pharmacist was interviewed, talking about how he was fired for being too slow, the implication being that other employees rushed through their work to meet some sort of quotas and that he refused to work in a way that would have jeopardized patient/customer safety.

I think that leads us to a reminder about Lean and Standard Work. For one, nobody has accused Walgreens of using lean practices. The pressure that the former pharmacist described was probably an old Taylorist mass production approach of pressuring workers to work faster because management wanted better results.

With lean, Standard Work includes the steps in a process and the standard time required to do each step SAFETY and with high QUALITY. Sure, there might be variation in that time person to person. If someone is an extreme outlier, you would look at the Standard Work -- are they following it? In a lean setting, you don't pressure people to work faster "just because" and you don't pressure people to work faster than they are able to safely.

The story also highlights how many Pharmacy Technicians are 16 year olds without any sort of degree. I've never seen this in the hospital pharmacies I've worked with, the Pharmacy Techs are always trained, experienced adults.
A high school-aged pharmacy technician at a Walgreens in Lakeland, Fla., made a typing error and dispensed a dose of the blood thinner Coumadin that was 10 times what the doctor had prescribed.

She was in high school. Her prior job had been cleaning a movie theater and serving popcorn," said Karen Terry, a lawyer representing the patient's family.

The patient, Beth Hippely, suffered a massive stroke after taking the medicine she was incorrectly given, forcing her to stop chemotherapy for a treatable, stage II breast cancer. She died earlier this year.
That's a tragic story. There is some incredibly sad video of Ms. Hippely before she passed away. I don't think the problem would necessarily be a "young" employee, but isn't it likely Walgreens had a bad process with poor quality controls built in? The young tech dispensed the wrong dosage, but that happens a lot (unfortunately) at many pharmacies, which, to me, points to a systemic problem. Systemic problems are rarely solved completely by telling people to "be careful." Is a 16 year old less likely of "being careful?" Maybe, but there's a higher responsibility on Walgreens: the supervising pharmacist as well as the leaders who are responsible for creating a solid, lean, error proofed process.

More on Walgreens management's role:

The high school student who made the error with Beth Hippely testified she had watched a video and was taking classes in school to learn about the pharmacy job.

Testimony in the Hippely case also revealed that stock boys and photo shop workers were also pressed into service behind the pharmacy counter when the store became very busy.

"They know mis-fills and errors are bound to occur because they're giving huge responsibility and important responsibility to people that aren't trained to perform those duties," said Terry.

"This is an intentional, system drive for profits, for money. If it wasn't about that, they would hire more pharmacists," the lawyer said.

Or they would spend more money on training their pharmacy techs better. We can try to throw a nurse into jail for making ONE error, yet the executives who oversee failed systemic processes are left to collect huge paychecks. I think the focus on "oh how shocking, it's irresponsible teenagers filling your prescriptions!!!" is misplaced. The shocking things are the lack of training and lack of standard work.

The industry seems to want to cover up the problem (2nd ABC page). 46 out of 50 states have no requirement for reporting pharmacy errors, even those that are fatal.

While some fear there is an unreported epidemic of pharmacy errors, there are no reliable figures to gauge the scope of the problem. And that's the way the industry seems to like it.

"I don't think it should be publicized," said Mary Ann Wagner, the senior vice president of the National Association of Chain Drug Stores, in an interview to be broadcast Friday on "20/20."

She says the industry fears the public won't understand the difference between minor and major errors, and that the figures could be used to punish drug stores.

We won't understand?? Of course the figures should be used to punish drug stores. We, as consumers, should be able to choose a pharmacy based on their safety record. Customers should run away, in droves, from those pharmacies that refuse to do a better job with patient safety. Notice I said "refuse to." I don't think "can't" is the problem, I think it's a problem with "won't" fix.

One pharmacist who was deemed responsible for an error in another case:
The pharmacist who admitted responsibility for the error, William Zaeske, continues to work at Walgreens and is now a pharmacy manager at another store near the one where the prescription error happened.
This might actually be the right approach, in a way. Should the pharmacist be fired for something that happened under his watch that was a systemic problem that's occurring in other pharmacies? Again, what about management? Why aren't we outraged that a VP or CEO wasn't fired? I guess $21m lawsuits aren't waking up Walgreens.

Final thought, Walgreens says:

In a statement, Walgreens said, "We deeply regret the few errors that have occurred among the more than 500 million prescriptions we fill each year at our 5,600 pharmacies."

Instead of a sincere apology, we get a sales pitch from Walgreens about how big and popular they are. That's inappropriate. I guess they are saying that errors are inevitable because they're such a large company? That's an inappropriate attitude also. "Zero defects" really and truly needs to be the goal. We can't tolerate anything less, it's a matter of expectations. Put in error proofing methods and proper management oversight -- that's how you work toward zero defects. A "Six Sigma" level in that industry is going to kill people. That's why we need zero defects.

It says it has invested nearly $1 billion in "redundant pharmacy safety systems" and training over the last 10 years.

And I wonder how much of this $1B investment was in "siren song" technology instead of investing in people and process??

So what can you do?
  • Insist on better oversight and reporting mechanisms for pharmacy errors
  • Ask your pharmacist what THEY are doing to prevent errors from occurring
  • DOUBLE CHECK each and every prescription you bring home to make sure you have the RIGHT PILL and the RIGHT DOSAGE
ABC Video Link #1 "Prescription Errors"

ABC Video Link #2 "What Your Pharmacist Doesn't Tell You."

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Saturday, February 03, 2007

More Education or a Better Process??

Fatal Dose: Ohio Girl is Killed By Medical Mistake

Here is a sad story of a girl's death due to a hospital pharmacy mistake. Pharmacies oftentimes just repackage and dispense "off the shelf" drugs (such as pills), but they often mix and formulate their own drugs, things that are bought in bulk and mixed to the proper dosage or delivery instrument (a drip bag, a syringe, etc.).

This article is pretty much blaming a lack of education for the death:
"...you may be shocked to learn that the people compounding your medication need only a high school diploma to do their job.

They're called Pharmacy Technicians, and while they do go to school to learn the field, most programs are no longer than eight or nine months."
My first response is to disagree that there is a correlation between education level and mistakes. Highly educated and highly trained physicians and nurses are involved in errors all of the time. When we have errors, we have to look for systemic causes rather than just assigning blame. Blaming lack of education sort of implies that someone was too stupid or not educated enough, probably not the right root cause in most cases.

From the case:
Emily's chemotherapy drug was supposed be mixed in a standard bag of saline that has less than one percent of sodium chloride.

For some unknown reason, the Pharmacy Technician mixed the drug with a 23 percent concentration of sodium chloride.

Her work was supposed to be reviewed by the Pharmacist but apparently that didn't happen and the fatal dose was delivered to Emily's room.
I'm inclined to think it's also NOT a case of the pharmacy techs "not being careful." Sure, "being careful" is one component of quality. But I've also seen many hospital pharmacies that were disorganized and had bad processes. Most pharmacies rely heavily on inspection (by pharmacists) to ensure quality. This hospital had a process in place that wasn't followed. The "standard work" wasn't being managed properly and something fell through the cracks of a badly designed system. Why not set up the process so things can be done right the first time? This shows how inspection isn't effective for ensuring quality. If you're inspecting something 1000 times and an error is never made, you might tend to slack off and assume everything is perfect. Then, an error is made and it wasn't caught because someone assumed quality would continue to be perfect.

I've seen pharmacy techs making up large batches of drugs and then labeling all of the syringes in a batch after the fact. Different pharmacy techs were making different drug batches at the same table and they were pilling the unlabeled syringes into tubs. I observed (and pointed out) that this batching and lack of process control could easily lead to an error of Tech A accidentally grabbed a syringe that Tech B was making and labeled Drug B as Drug A. If this happened, is the fault of someone "not being careful" or was it a systemic error that was just waiting to happen? An error that could have been foreseen and "error proofed?"

Increasing the education level of pharmacy techs, without improving the processes they work in, might likely do very little to improve quality.

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Wednesday, January 24, 2007

A Hospital Death in Florida

Kevin, M.D. - Medical Weblog: A woman dies after receiving 8 grams of Dilantin

I read about this on the blog linked above and the source article is here.

A nurse administered an incorrect dose to a patient, TEN TIMES the normal dose and well above an amount that would have been fatal, so of course it was a fatal incident (or "sentinal event") as hospitals would call it.
Rohart, an ER specialist for eight years and a doctor since 1989, said he ran tests and prescribed 800 milligrams of the anti-seizure drug Dilantin.

But Cooper [the RN] instead administered 8000 mg (eight grams), quickly stopping Plass' heart, hospital officials said. The fatal dosage is two to five grams.
The article doesn't say what the error was that led to 800 becoming 8000. I can't imagine it was a decimal place error. How could this have happened?

I'm normally quick to place blame on the system, but this one comes close to really seeming like the mistake of an individual:
The correct dose required 3.2 vials of the drug. Cooper gave Plass 32 vials, hospital administrator Joe Scott said. To get that many, she had to search the halls and take every vial from three computerized drug-dispensing machines, he said. "That would be a big red flag," Scott said.

All the Dilantin didn't fit in one intravenous bag, so Cooper hooked up two, one in each arm, Scott said. "That would be another big red flag," he said.

Cooper never double-checked or questioned the amount, Scott said. Nor did she explain her error to hospital officials, he said.
It would be a big red flag, I guess, but nurses are often scrounging for drugs in the hospital due to stock shortages and poor replenishment processes. But still.... yeah, it seems like she should have at least asked somebody. That's part of the problem with hospitals -- the culture of workarounds and "just getting the job done" instead of stopping to proactively fix problems. In a better hospital culture, the RN would have had someone to ask or at least make the suggestion, "We should stock more of this drug, I've had to look all over." A supervisor could have or should have caught it or questioned the action. The culture of workarounds and heroic measures means that, even in less fatal situations, that RN's are constantly fighting the same fires and battles every day, without root cause problem solving.

After the tragic death, the hospital took some systemic steps beyond firing the RN:
The death exposed gaps in safety procedures, Scott said, mainly that the drug-dispensing system did not detect such a huge dosage being prepared for one patient.

The machines have been reset to flag large withdrawals and to stock only small amounts of Dilantin and other high-risk drugs, forcing nurses to go to the hospital pharmacy in person, he said. After the death, the hospital retrained nurses and tested them on calculating dosages.

"I have a sense of comfort that they have taken all the steps necessary," Levine said.
OK, why wasn't that systemic fix put in place BEFORE? Will OTHER hospitals learn from this error and make sure similar protections are in place?

Also, RN's already struggle through enough systemic waste and non-value-added activity each day without forcing them to take a long trip to the pharmacy, taking them away from their patients.

There's a whole other subplot in the story about how the hospital warned the doctor to not ask questions about the death, which smells like a cover up attempt... that's a post for a different blog.

A call to all hospitals: Be proactive about preventing mistakes, don't wait for a death to respond. Learn from the mistakes of others so you can prevent this particular type of error from happening ever again, anywhere. Establish a culture where people don't have to be heroes, where they can ask questions and question things or ask for help without being viewed as lame or weak or incapable.

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Friday, September 29, 2006

"Lookalike" Drug Packaging

Drug makers must think about different packaging | IndyStar.com

Here's a picture of the two drugs that were mixed up when the three babies were killed at the hospital in Indianapolis last week.

As the MD wrote in the letter-to-the-editor that I've linked to above, the deaths were absolutely preventable. We can't just blame the drug maker. This was a systemic problem. The "system" killed the babies.

The packages, to me, are hardly "identical." Similar yes, but not identical. The MD recommends that the manufacturer put the drugs in different sized bottles. That might be a decent step, and the extra cost to the manufacturer (stocking and producing different sized bottles) would be worth it.

Maybe stronger dosed drugs/pills should always be in larger bottles/packages, denoting "stronger." That might increase the inventory costs throughout the supply chain (more space taken up by larger packaging), but pharmacies I've seen typically have their shelves somewhat lightly utilized, at least in one direction (e.g., the shelves are packed from left to right, but they're not using vertical space well, or the shelves aren't close enough together). Pharmacies are hardly efficiently "cubing out" their stock space the way a lean manufacturer might tweak their warehouse or truck utilization. If they were really concerned about that, they would use SQUARE or rectangular bottles (ala Fiji Water -- look at how these bottles "cube out" nicely in boxes and shipping containers).

Anyway, this was a systemic problem with many root causes, all of which can be fixed using lean methods. The manufacturer -- change the packaging (an error proofing method). The hospital needs to take steps -- error proofing and standard work among the pharmacy techs and nurses to truly prevent the problems, not just to catch the problems in time or at the last minute before drugs are given to a patient.

I've read about how the hospital is putting in more "double checks." This is just more inspection. We need more prevention. 100% inspection isn't 100% effective. Having TWO people inspect anything (an engine built n a factory or drugs dispensed in a hospital) is sometimes WORSE than having one person inspect. Basic human psychology says we slack off if we think someone else will catch our mistake. Two inspectors might each think "well, the other person will catch it" and then nobody catches the problems.

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Sunday, September 24, 2006

Lack of Error Proofing Kills 3 Babies

This is an incredibly sad, and completely preventable, situation. Three babies are dead, and three more injured, because the wrong drug was administered to them at an Indianapolis hospital.

Let's keep in mind, first, this quote from the World Health Organization:

“Human error is inevitable. We can never eliminate it. We can eliminate problems in the system that make it more likely to happen.”

This quote could easily come from Toyota leadership. This is why they error proof. You want to prevent good people from making mistakes. My point is to look at this situation by NOT pointing fingers of blame at an individual.

The situation and the news stories:

Initial story about the first two deaths from a local news station

CBN story, again after the first two deaths

"At the newborn intensive care unit of Methodist Hospital, the staff is blaming the newborn deaths on human error. Somehow the wrong dose of a blood-thinner medication, Heparin, was stocked in a hospital drug cabinet.

President and CEO of Methodist Hospital, Sam Odle, said, "They're both one-milliliter vials. One has 10,000 units of heparin, one has 10 units of heparin...so the nurses -- knowing they only carry one dose on the unit -- took the vial out and administered it to the patients."The mistake proved deadly.In all, six premature babies were given adult doses of the drug. Three babies are in stable condition. Another is in critical condition. Two babies died."

A lot of the initial response was focused on "a nurse made a mistake." Situations like this are far more systemic and wide spread than to think a single person and a single mistake led to this.

A nurse said:
"I have always been confident that the drug that I'm looking at is the drug that's in the drawer," said a nurse. "But, of course, it's still my responsibility to assure it's the right drug."
Since this was a CHILDREN's ICU, you would wonder why an adult-dose drug was ever there. The nurse is saying that it should NOT have been there. But still, a nurse did not read the label, she ASSUMED. That's just one mistake. A better process would be to ALWAYS double-check the drug name and dosage. The drug should have been labeled "Heplock" but it was actually "Heparin" that was loaded into the cabinet. Heparin has been in the news before when adults are killed because "Heparin" was confused with "Insulin" (same vial, clear liquid, etc.).

Looking at future PREVENTION, the CBN article says:
"Under new guidelines, the hospital staff will double-check drug labels and remove certain doses of the blood-thinning drug, heparin, from their unit."
Now the second part sounds like an error-proofing step.... but removing the drug that already shouldn't have been there is very reactive. How do you prevent the adult-dose drug from getting there? What process was responsible for that?

The Washington Post news story, after the third death
has some more details:
"According to hospital officials' account, a pharmacy technician had loaded the cabinet with heparin, at 10,000 units per milliliter, instead of hep-lock, at 10 units per milliliter."
So we had one mistake, a tech from a different department loading the wrong drug. The nurses, far too trusting of the system, didn't double check the label and assumed, incorrectly, that they have the wrong drug -- partially lulled to sleep by the technology that you might expect to prevent this. There is a cabinet in the ICU that requires a nurse to enter their ID code and a patient code -- it prevents the wrong DRAWER from being opened. But, it doesn't address the issue of a pharmacy tech loading the wrong drug. How is that error-proofed?

Everyone is pointing fingers, some of it system related (how does the drug maker help make the packages more distinct, so Heparin and Heplock aren't confused?)

The mother, and we can't possibly have enough sympathy and empathy for her pain and suffering, she says:
"The nurses is what I'm blaming. They need to lose their licenses is what I am saying so it won't happen again to the other babies," Jeffers said.
I'm sorry, but that's not going to prevent other deaths. Everybody in the system, particularly the nurses, were probably trying their best. We need to improve the SYSTEM to prevent it from happening at Methodist and at other hospitals. Was this a one-time error?
"Methodist has acknowledged two other heparin mix-ups involving babies in 2001, and said both infants recovered."If this was an isolated incident I would say that it would be solely the responsibility of the person at the hospital," Lee said. "But this is not an isolated incident.""

The five nurses and pharmacy technician involved are on leave and receiving support and counseling, and are expected to return to work, Odle said.
I'm sure all of the hospital employees feel sick over what happened. I know I would. Hell, I read about this yesterday and I had basically a nightmare where I was working with a pharmacy and trying to get them to improve, mistakes were still being made and I was yelling at people (and I'm not normally a yeller). This kind of situation really bothers me and reinforces my mission to work in lean healthcare.

When I'm back to work at my client tomorrow, I'm going to talk with a pharmacy tech I know and get her perspectives on this, what procedures would be in place at their hospital to prevent this kind of situation.

People need to "be careful" but that isn't enough. As the quote up top says, people are human. Blaming "human error," as the hospital did doesn't mean "what individual screwed up?" It means, humans designed a fallible system. We need to try harder to design error-proofed systems, whether in healthcare, aviation
, etc. In the current situation,d either in it takes MULTIPLE errors for a death to occur, but it still happens too often.

There are over 5,000 hospitals in the U.S. This kind of error could happen (and probably does) at any of them. My question is this --- what kind of network is in place to share situations like this? EVERY hospital in America (and the world) should be looking at their own processes today to prevent THIS problem. With the internet and modern communications, each hospital shouldn't be operating in a vacuum. One mistake ANYWHERE should be enough to drive change and process improvement EVERYWHERE. We don't need to make the mistake at each hospital before each hospital fixes the process.

Do we have any Intel readers who could share how "Copy Exact" communication among the fabs takes place? Sure, a network of 5,000 hospitals under different ownership is one thing compared to a smaller number of fabs all run by one company, but I'm sure lessons can be learned.

One lesson for me -- if I had a baby in the ICU (or any loved one in the hospital), I would be there and would monitor each and every drug that was ever administered. If a nurse is offended, so be it.

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Tuesday, May 30, 2006

That Pill Again

what is the peach drug that says 7253 - Google Search

Back in April, I wrote about a generic allergy pill I got from Walgreens. This blog has been getting hits every week from people who have that same question. They're expecting Allegra and, instead, they get a generic pill with cryptic markings. So people are going to "Dr. Google" and searching things like "round pill 7253 93" and "what is the peach drug that says 7253."

This blog comes up high in many such google searches. It seems like a real problem that people aren't getting good communication from their doctors or pharmacists. Not very lean. At least some people aren't just taking a mystery pill without doing some research first.

Other related searches: pill 93 and 7253, 93 7253 pill, 93 round pill, round pill 7253.

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Monday, April 10, 2006

Pharmacy Error Proofing Example

Here is a great example of error proofing that I've never seen before. It's springtime, so my allergies have been killing me, especially after mowing the lawn on Saturday. I went and got a prescription for Allegra and received the new generic equivalent.

Walgreens put a diagram on the information sheet that allows you to confirm that you have the right pills, which is especially helpful here because the generic doesn't have an Allegra logo on there.

Walgreens should almost draw more attention to the purpose of the diagram. I can confirm that I was given a round peach colored pill of that size. I can also confirm that it says "93" on one side and "7253" on the other. I know I have the right pill.

It's not ultimate error proofing. That would be on the pharmacy side, anything they would have in place to make sure the pharmacist couldn't give me the wrong pill. Maybe they have standard work that says they have to confirm the pills against this printout.

It's scary, but there are some medical expert estimates that say about 3% of all prescriptions are wrong (at hospitals or drugstores), which includes wrong pill or wrong dosage.

Walgreens should really have a huge page that says "HEY CUSTOMER! Double check that we gave you the right pill!!!" That would probaby be bad for business though.

A good tip for everyone.... double check anything you get from the drug store. They aren't perfect... they're human after all.

Update: May 30

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