During this “let's try to get people vaccinated” phase of the Covid-19 pandemic, almost every article that I've seen about the vaccine and its distribution mentions the need to not waste precious doses.
There are many opportunities for error with the different vaccines. If some of them aren't stored properly at the correct temperature, the vaccine degrades and gets wasted (or worse, gets injected and gives a false promise of effectiveness).
Hear Mark read this post:
Good process design (lessons I learned as an engineer) means being proactive and thinking about what could go wrong — and then designing the process in a way that prevents errors or mistakes. The ideal would be “error proofing” that makes it impossible to make a mistake.
Or, we could make it more apparent that a mistake has been made (for example, a temperature-sensitive label on a vaccine bottle that would let you know if it's been out of the correct storage temperature too long). A countermeasure like this might prevent the mistake of using expired vaccine.
But how can we prevent the storage problem (and the waste of the vaccine) to begin with?
I wasn't planning on blogging over the holidays, but this article caught my attention:
Wisconsin hospital tosses 500 doses of COVID-19 vaccine due to ‘human error'
Updated: It was intentional, says the hospital. They have terminated the employee, which is appropriate if it wasn't “error.”
Further Update: Wisconsin hospital worker [pharmacist] arrested for spoiled vaccine doses
Note: This blog post was written when this was being reported to be “human error.” For more updates, see the comments…
Before getting into the article, my instinct and experience immediately prompted me to respond by thinking, “I don't like blaming ‘human error' as a root cause.” Yes, we are fallible… the first version of my tweet here demonstrated this (inadvertently) as I had typed “infallible” — I had to delete and repost the tweet with the correct sentiment:
BECAUSE we are imperfect, we should be driven to design a process that makes it harder (or impossible) for us to make a mistake. In the absence of that, perhaps a headline could read as follows:
Wisconsin hospital tosses 500 doses of COVID-19 vaccine due to ‘bad process'
or
Wisconsin hospital tosses 500 doses of COVID-19 vaccine due to ‘poor planning'
or
Wisconsin hospital tosses 500 doses of COVID-19 vaccine due to ‘bad management'
Do those headlines make you cringe? Do they seem harsh? Well, that was my reaction to the original headline.
OK, so digging into the story a bit (and there's not a ton of detail):
“Advocate Aurora Health said 50 vials, containing 500 doses, of the Moderna vaccine were removed from a pharmacy refrigerator overnight Saturday, Dec. 26 at the Aurora Medical Center in Grafton.”
Being “removed” wasn't necessarily the problem (although that most certainly could have been avoided).
“Officials say as a result of “unintended human error”, the vials were not placed in the refrigerator after temporarily being removed to access other items.”
Not placed back into the refrigerator.
By definition, “human error” cases are “unintended,” so I'm not sure that modifier is needed. If it were “intentional,” then that would be “sabotage” not “error.”
The scenario begs a number of questions, with the benefit of hindsight (although I'd argue these things could have been anticipated):
- Was education and communication good enough regarding the need to keep the vaccine cold?
- Was this training given to everybody who could have accessed the refrigerator?
- Could the vaccine have been kept in its own dedicated cold storage?
- Could the refrigerator have been better organized (or properly sized) so that other needed items could be accessed without needing to remove the vaccine?
- Was there a proper checklist or standardized work in place to help ensure that the vaccine was put back, if it had to be moved?
- Was there proper and effective supervision in place?
Hayat pharmacy CEO Hashim Zaibak said:
…this is the kind of error that can happen regardless of the size of the operation.
You can have good process (or bad process) in an organization of any size, large, medium, or small. Good process doesn't cost anything, really, other than time and effort. I don't understand what the size of the operation has to do with the error.
“Human error, which is going to happen in any process,” Zaibak said. “Any time there is a human involved, things like that can happen.”
Saying that human error “… is going to happen” is self-defeating, self-fulfilling prophesy.
“Things like that can happen” doesn't mean they must happen.
When leaders shrug off human error instead of looking in the mirror and thinking about systems and processes, errors like this don't get resolved, they don't get prevented for the future.
If human error is not preventable, does that mean we have to remove all humans from the work? Hogwash. Unlikely.
How can other hospitals and pharmacies LEARN from this so the problem isn't repeated elsewhere? Does everybody really have to learn from their own mistakes?
This article says:
In a statement to WISN 12 News, an Aurora spokesman said, “This was the result of unintended human error, and we have used it as an opportunity to review and remind team members about our process.”
As I've written about a lot before, putting up a warning sign that says “Don't forget to put the vaccine back in the fridge” is probably not an effective countermeasure. Healthcare loves “be more careful” type signs, but we need more than that.
“Should all hospitals be reviewing their own procedures for the vaccine after seeing how a mistake like this can happen?” [the reporter] Wainscot asked [Milwaukee County Medical Services Director Ben] Weston.
“Absolutely, all hospitals should be reviewing their policies and practices and health departments and anybody else receiving the vaccine. It's a complicated process,” Weston said.
I hope that all hospitals will be proactive… how could this mistake happen in your organization? What can you do to prevent it? If you're reading this and you work in healthcare, what can you do today to prevent a similar mishap?
On a more positive note, here is a story about a hospital being proactive:
Deaconess officials make sure COVID-19 vaccines aren't wasted
“So we really have to look at the schedule for the following day to make sure that we are pulling the right amount, we're labeling it with the correct expiration. We have to, obviously, do it very quickly,” shared Brian Spencer, pharmacy service line manager. “So we have a whole team in pharmacy that is taking care of that.”
Up to this point, Spencer tells us that no doses have gone to waste, and he is very pleased with how his team has managed the vaccine storage.
There's a “whole team” and hopefully they have a well-defined process… and I hope they keep up that perfect track record of not wasting doses.
Here is story about a different type of vaccine error in Germany:
JAB BLUNDER: Care home workers rushed to hospital after being ‘overdosed' with Pfizer Covid vaccine five times the recommended dose
“Each vial contains five doses of the vaccine – and are supposed to be diluted before use.”
It doesn't say directly, but I guess we can infer that people were given the full vial, undiluted?
At least this isn't likely to be a deadly error… just more wasted vaccine.
An administrator is quoted as saying,
“This individual case is due to individual errors.”
There they go again, blaming individuals instead of process… “but they should have known better!” somebody might reply. Again, how effective was the training? How good was the supervision? How could this have been allowed to occur?
Questions like that help us get beyond just shrugging and feeling bad and saying, “Human error was to blame.”
Final thought: If you're doing root cause analysis, and part of that includes asking “why?” repeatedly… if you get to the point where an answer to “why?” is “human error,” then keep asking why. Why was the human error possible? Why was the process susceptible to human error?
And then ask, “What can we do to prevent it in the future?”
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As I updated the post, there is a claim now of intentionality…. one headline reads:
“Employee intentionally removed COVID-19 vaccine from fridge”
https://www.usatoday.com/story/news/nation/2020/12/31/wisconsin-covid-19-vaccine-ruined-aurora-employee/4097416001/
Earlier reports said it was basically intentionally removed… taken out so that other items could be found.
The problem is *not putting it back* — was THAT intentional?
I can’t tell if a person really intended to damage the vaccines or if the organization hasn’t found a way to throw an individual under the bus…
Even if this IS proven to be a truly fully intentional act, there is still a systems question to be answered.
“How was one person able to do this without it being noticed?”
There are still systematic questions about supervision and security that the system could answer (and hopefully improve upon).
Other systems could learn from this.
Here is another egregious, but different, error:
West Virginia clinic gave 42 people an antibody treatment instead of the coronavirus vaccine
For one, if you’re expected to get a vaccine (which is a needle injection into your upper arm), you’d think that being hooked up to an IV drip would be a red flag that an error was occurring.
I’m not blaming patients for not speaking up about it… but I certainly would have, since I know enough that an IV prep would have seemed very strange.
“The moment that we were notified of what happened, we acted right away to correct it, and we immediately reviewed and strengthened our protocols to enhance our distribution process to prevent this from happening again,” said Maj. Gen. James Hoyer, Adjutant General of the West Virginia National Guard.
Update: Wisconsin hospital worker [pharmacist] arrested for spoiled vaccine doses
https://apnews.com/article/us-news-milwaukee-wisconsin-coronavirus-pandemic-3d6db7b839be9276734088cb9d93a52d
According to reports, the pharmacist was intentionally trying to make the vaccine ineffective… not so it couldn’t be used, but so it would be injected and not work… awful, if true:
So, how will hospitals step up security around this vaccine? When I worked at Dell 25 years ago, they were concerned that small, valuable items (like memory chips) would be stolen from the assembly line (and it probably happened at one point). They had locked cabinets and security… hospitals should do the same, right?
“He not only took them out overnight Friday as first thought but had also done so Thursday – returning them to the fridge the next morning before anyone noticed
A pharmacist technician discovered the vials out of the fridge Saturday morning
Because hospital officials were unaware they had been left out the night before, some of the doses were given to 57 people ”
https://www.dailymail.co.uk/news/article-9103981/PICTURED-Milwaukee-pharmacist-deliberately-spoiled-57-vials-Moderna-vaccine.html
In this article:
https://www.jsonline.com/story/news/2020/12/31/500-doses-covid-19-vaccine-thrown-out-hospital-worker-aurora-removed-from-fridge-on-purpose-grafton/4098837001/
The health system President is quoted as saying it was a “bad actor” not a “bad process.” It could be BOTH.
Why were these best practices not followed? What could still be improved?
Here’s the first article I’ve seen about motive…
https://www.nytimes.com/2021/01/04/us/pharmacist-accused-of-tampering-with-vaccine-was-conspiracy-theorist-police-say.html
As with many situations like this, did co-workers feel unsafe in speaking up? Did managers ignore behavioral warning signs for one reason or another? From the article: “he expressed that he was under great stress because of marital problems.” He said that according to co-workers, Mr. Brandenburg had brought a gun to work on two prior occasions.”
Is there any perspective on New York state where the state government rules seemed to result in doses expiring?
Hi Don – I guess I don’t know the particulars, but I’ve read how some doses have gone to waste because enough of the “right” people weren’t available. It’s better to vaccinate somebody (not in the currently prioritize group) than it is to let it go to waste. But, this points to a need to improve the planning and communication process (and possibly the transportation process) to get the right people to the right needle at the right time… I hate to see doses go to waste, but I also hate to see the elderly and other priority groups being delayed in getting it. I can wait. I’ll continue staying home most of the time and will personally keep riding this out until I can get one.
Here is another case from Wisconsin that’s being blamed on “human error” and it might not be an intentional act this time:
More than 2,300 COVID-19 vaccines wasted across Wisconsin
Let’s be proactive… what types of “human error” are possible in your vaccination process?? What can be done to prevent it, to make it more difficult or even possible for a human error to occur? I hope they really are able to “improve processes and put additional measures in place…”