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:
Updated: It was intentional, says the hospital. They have terminated the employee, which is appropriate if it wasn't “error.”
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'
Wisconsin hospital tosses 500 doses of COVID-19 vaccine due to ‘poor planning'
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:
“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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