In my ever-changing, annotated "Implementation" Presentation, version 0119, at Slides 137-145 you will find a riff on the power of "simple" checklists in reducing hospital errors. My presentation drew this incredible—ever so credible!—Comment by Manoj Pawar, M.D.:
The next chapter in this story is extremely important, as described in the NY Times Op-Ed piece by Dr. Gawande.
I urge you to read the Op-Ed piece.
The gist: A simple checklist, similar to pre-flight checklists used by pilots, has been proven to reduce ICU deaths. People die less ... much less ... as a result of this. Plans to spread this nationally in the US were underway. Simple. Elegant. And primed for implementation on a broad scale, BUT ...
The Office for Human Research Protections (OHRP), upon learning of this, stopped the project immediately.
Why? The OHRP treats this as research (despite the fact that results are proven). Because they see it as research, they feel that it was unethical that patients were not informed that a checklist was being used, and that its use was being measured. In essence, they treated this in the same way that they would a study in which patients were being given a medication with unknown efficacy.
Can they really do this? Sure. And in fact, they can cut off all federal funding to groups (hospitals, researchers, etc.) that fail to obey.
Since that 12/30/07 decision, health care institutions and quality improvement specialists across the country have been running scared, fearing the wrath of the OHRP and the subsequent loss of funding. They've asked their quality improvement folks to stop doing what they're doing immediately, based on these legal and regulatory concerns.
A number of prominent healthcare bloggers share their concerns. Check out healthbeatblog.org to see Maggie Mahar's blog.
We all are left asking, "WHY?"
With such great results, who would want to stop this work? Maybe it's the folks who fear exposure of how truly bad our hospitals currently are. Imagine the loss in market share for those that don't use the checklist! Maybe it's about money.
Analogy: We've done process improvement work to look at and improve compliance with ideal handwashing guidelines (yes ... not all doctors wash their hands as much as they should). But imagine if we had to get informed consent for patients to participate in this work! "You may be subject to an intervention ... your doctor may actually wash his/her hands, and, as such, you may be exposed to something that isn't consistently done."
Innovation isn't common when it comes to healthcare operations and processes. When it happens, (even if it's something simple like a checklist), do we really want to squelch it? The lesson for implementation: Watch out for the barriers to implementation. And when barriers sometimes seem insurmountable, there are times when radical action is necessary. When our Denver-based healthcare think tank met last night, I suggested civil disobedience as one approach. Do it anyway, and worry about the consequences later. Be radical ... be remarkable!
Manoj Pawar, MD, MMM
Posted by Manoj Pawar at January 19, 2008 12:13 AM