Medical Mistake in In-Vitro Fertilization: Blaming Process vs. People
This was front-page news in one of the UK papers that I read coming back from The Netherlands on Sunday. Coincidentally, I briefly saw an in-vitro fertilization lab in The Netherlands last week (look for upcoming blog posts about lean healthcare in that country). Part of our discussion was around process error proofing and the need to avoid giving the wrong embryo to the wrong couple.
So, the timing was interesting to see that this exact type of error occurred in England. A couple's last embryo had been given to the wrong couple, ruining their chances at a sibling to their only child (born years ago after their initial IVF efforts).
Early in the article, my Lean eyes started “seeing” (imagining) the opportunity for Lean thinking in a process like this (emphasis mine):
The error was made by an overworked trainee doctor who failed to carry out strict checks that require all fertility procedures to be witnessed and verified.
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Uh oh, I know what happens when people are “overworked” — they are under time pressure and they end up often cutting corners… and this is when errors occur. Whose fault is it that the doctor was overworked? Pointing out that they are a “trainee” — whose responsibility is it to make sure people are being trained properly? The “Training Within Industry” methodology points out that it is the instructor's responsibility and I'll add that Dr. Deming would have said that top leadership is ultimately responsible for all of the above questions.
Whose responsibility is it to make sure standardized work is being followed? Again, that's management's job. Especially with a trainee involved, shouldn't management be paying closer attention…. especially if they are overworked? This seems like a disaster waiting to happen… and the waiting is over.
I wonder how long these conditions were in place before an error actually occurred (or was actually detected)?
This scenario should emphasize the importance of focusing on PROCESS and not just waiting for a bad RESULT.
The story describes an investigation by an oversight group:
An urgent HFEA investigation into the incident found that vital safety checks were not being carried out at the clinic and that overworked staff were being placed under too much pressure to clear a backlog of cases.
But there are now fresh questions over the HFEA's effectiveness as a watchdog as it had previously been told of two other ‘near-misses' at the clinic – also understood to involve failures in ensuring procedures were properly witnessed by other staff – just months before the latest incident.
So this had been going on for sometime. I'd expect it's rare to be burned by the one and only time somebody didn't follow procedures. You could question the role of the watchdog, but we should also question the role of local management. I guess you need a watchdog because they weren't managing the process and quality effectively…
A few more details emerged if you read the story, including:
The embryo was also taken from an incubator that was carrying embryos for other patients, which goes against good-practice guidelines because of the possibility of making an error.
The process was very reliant on having a second person making double checks, which didn't happen in this case. But, the inspection and double checks would be less necessary if you had an environment where people couldn't disregard the standard process of not keeping embryos from multiple patients in the same location.
So we had someone not following the standard process and management wasn't detecting that process problem. They were relying on inspections that didn't happen. That should also illustrate the problem with relying on double checks. If double checks are good, wouldn't triple checks or quadruple checks be better? Maybe not, even if they actually occurred.. (oops, the triple checks were also skipped, or they would be if they were that pressed for time).
It is understood that staff at the clinic – based in the University Hospital of Wales, Cardiff – had been under enormous pressure because of an increased workload as the clinic accepted a higher volume of cases.
It sounds like they accepted more workload and didn't properly analyze staffing levels? If work is very manual, adding work volume means you would likely have to add staff (very generally speaking).
The one and only somewhat bright spot is that the organization is not necessarily blaming or punishing the “trainee” (who probably already feels bad enough):
The clinic has not named the trainee and will not confirm whether she is still working for the clinic or whether disciplinary action was taken.
It is understood that the clinic has a ‘no-blame' policy and that the HFEA highlighted systemic failings rather than individual human error for the mistake.
It certainly sounds systemic to me. Will the clinic learn? Will leaders be held responsible? If it's the “system's” fault, the people responsible for the design and management of the system should be held accountable, right?
However, the HFEA has decided the clinic has made improvements. IVF Wales will not face any disciplinary action or restrictions on its licence.
I'd be curious to hear what those “improvements” are…
Click here for related posts and errors on pathology mixups… similar thinking and scenarios. This is a general healthcare problem, not just for IVF labs.
As always, the reader comments are interesting, including:
“It is understood that the clinic has a ‘no-blame' policy” that's the problem with the Public Sector right there. if no one is to blame for msitakes then who cares if they are made or not?
“No-blame”, as practiced by many hospitals, probably just doesn't sound right to the general public. Maybe we need a different term like “system blame” because what they're really not blaming is the individual. To the commenter, I'd ask if blaming and even punishing the trainee (and doing nothing else) would really help anything?
Another commenter gets it half correct:
What has worried me is the sentence “…the clinic has a ‘no-blame' policy”. The staff; medical, managerial and administrative will never learn from their mistakes if there is an attitude of “mistakes happen” throughout the clinic. The managers are to blame for not employing sufficient staff, and the traineee is to blame for not following the safeguard procedures. Admit that and they are halfway to ensuring that the same mistake will not recur.
Funny that all of these comments about mistakes have a spelling error or two. Yes, the managers are to blame if they didn't have enough staff, but management also has a role in making sure people follow procedures and standardized work.