January 22, 2008 | Mark Paradies

Why Healthcare Safety Doesn’t Improve

Sometimes you read stories, and you just can’t believe what you are reading.

For example, a New York Times story explained that a government office – the Office for Human Research Protection – shut down a John Hopkins University research project.

The project was using a checklist to reduce post-operative infections. Using a 5-step checklist cut the rate of bloodstream infections acquired in the I.C.U by two-thirds. Over 18 months, the program saved 1,500 lives and $200 million dollars.

So why did the government shut it down? The study was breaking the rules. What rules? The NY Times article said that:

“…by introducing a checklist and tracking the results without written, informed consent from each patient and health-care provider, they had violated scientific ethics regulations.”

Here is the logic for the finding reported by the NY Times:

“A checklist is an alteration in medical care no less than an experimental drug is. Studying an experimental drug in people without federal monitoring and explicit written permission from each patient is unethical and illegal. Therefore, it is no less unethical and illegal to do the same with a checklist. Indeed, a checklist may require even more stringent oversight, the administration ruled, because the data gathered in testing it could put not only the patients but also the doctors at risk — by exposing how poorly some of them follow basic infection-prevention procedures.”

By this tortured logic, I’m surprised that any study or improvement efforts are allowed in the medical field. No wonder improvement in the medical industry progresses so slowly.

Root Cause Analysis
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