I Guess These Couples Should Worry – We Need Lean, not More Regulation


Embryo mix-up worries couples | detnews.com | The Detroit News

I've seen a lot of news stories about couples who suffer through errors caused by in-vitro fertization labs. A Toledo woman recently gave birth to a baby that was actually from another married couple — laboratory mixup and preventable error. Stories often talk about how IVF clinic staff members failed to follow basic processes. This is not a problem of a technology that's not ready for prime time — these seem to be basic fundamental operations issues.

When I was in the UK this year, there were major news stories about the rash of such errors. A new report said there were 182 errors or near misses in 52,000 cases in the UK. That's nowhere near Six Sigma quality levels, yet alone being error-proofed perfection.

When mistakes like this hit the media, the reaction of many is to say “well, we must need more regulation.”

“…errors are rare in reproductive technologies, which help thousands of couples become parents, and more regulation won't eliminate all mistakes.

“We aren't a bunch of cowboys running around the West making our own rules,” said Ronald Strickler, a reproductive endocrinologist with Henry Ford Health System. “We've been given license to look largely after ourselves. You can write all the regulations you want but you can't deal with human greed or human stupidity.”

By “stupidity,” I hope Dr. Stricker doesn't mean the individuals who make these errors. I hope he means the leaders that aren't ensuring that processes are error proofed. That's stupidity. If you're not managing the process every day to make sure standardized work is being followed (instead of just reacting and blaming someone when there's a bad result), that's stupidity.

At a presentation yesterday, I recounted cases (like Darrie Eason's, from two years ago) where individuals were blamed AFTER the fact, when management should have known that short cuts were being taken habitually. If your employees are cutting corners, that's YOUR responsibility to make sure that isn't happening.

I'll give the UK community for taking a constructive approach:

“We wanted to build trust, to assure centres that our aim was to learn and to promote higher standards, not to punish human error.

“But we now have a solid foundation on which we can continue to build a culture of learning and improvement throughout the sector.

Learning and improvement — not punishment. But let's speed up the learning!

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Mark Graban
Mark Graban is an internationally-recognized consultant, author, and professional speaker, and podcaster with experience in healthcare, manufacturing, and startups. Mark's new book is The Mistakes That Make Us: Cultivating a Culture of Learning and Innovation. He is also the author of Measures of Success: React Less, Lead Better, Improve More, the Shingo Award-winning books Lean Hospitals and Healthcare Kaizen, and the anthology Practicing Lean. Mark is also a Senior Advisor to the technology company KaiNexus.


  1. Mark
    Thanks for picking up this crucial topic of error proofing (poka yoke) in Healthcare. Especially for highlighting the fact that ultimate responsibility remains with management.
    I find it interesting that many (most?) examples of error-proofing that we see in hospitals today are driven from external by manufacturers of equipment (alarms, fail-safe mechanisms – e.g. for defibrillators, etc.) and medication.
    These are usualy expensive ways of error proofing and also can be seen as waiting for "someone else to take care of our problem".
    Fortunately, it also means that suppliers are seeing error-proofing as important enough to get a competitive advantage … that is great.
    Now hospital managers only need to empower and support everyone at the coal face to also focus on low-cost ways to achieve that 100% inspection, obtain immediate feedback and continuously tackle root causes of reasons for making mistakes.
    Danie Vermeulen


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