The Unlikely Saga of a Medical Checklist
Wednesday, January 02, 2008
Joshua Schwimmer, MD, FACP, FASN
In the New Yorker, Atul Gawande describes a study designed by Dr Peter Pronovost of Johns Hopkins to prevent a frequent problem in the ICU -- intravenous catheter infections. The intervention was a checklist:
On a sheet of plain paper, he plotted out the steps to take in order to avoid infections when putting a line in. Doctors are supposed to (1) wash their hands with soap, (2) clean the patient’s skin with chlorhexidine antiseptic, (3) put sterile drapes over the entire patient, (4) wear a sterile mask, hat, gown, and gloves, and (5) put a sterile dressing over the catheter site once the line is in. Check, check, check, check, check. These steps are no-brainers; they have been known and taught for years. So it seemed silly to make a checklist just for them.The results were astounding. In 103 intensive care units in Michigan that adopted the checklist, the rate of catheter related bloodstream infections dropped 66%. (The paper, published in the New England Journal of Medicine, is here.)
Naturally, you'd expect an intervention this simple, successful, and lifesaving to have government support . But unexpectedly, the checklist program has now been shut down by the Office for Human Research Protections. Gawande provides an update in the Op-Ed page of the New York Times:
The agency issued notice to the researchers and the Michigan Health and Hospital Association 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. Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island.Apparently, the program and the government regulators are now at an impasse. The requirement that informed consent be obtained from every patient and physician is unworkable, and further research on checklists cannot continue. The only solution, according to Gawande's Op-Ed, is to have Congress step in.
Labels: atul gawande, checklists
4 Comments:
At Sat Jan 05, 08:35:00 AM 2008,
JKMD said…
Another great example of a system meant to protect patients that actually causes harm. We as physicians need to continue to advocate for better patient safety as a top priority.
Thanks for bringing this to our attention, Dr. Schwimmer. Great article as usual.
At Mon Jun 30, 09:19:00 AM 2008,
Kevin said…
You cannot conduct a research study w/o IRB approval and either a local IRB determination that informed consent can be waived or is not required, or a consent form. When you try to avoid the onerous process of multiple IRB approval and the ill-conceived HIPAA regulations regarding research as apposed to commercial use (which it pretty much gives payers and hospital's carte blanch) you get into trouble.
This is simple a case of a government agency doing what we want it to: prohibiting unregulated/uncontrolled medical research. While it seems like an over zealous application of the rules, the rules are essential.
The fault is with the study authors for skipping a step (i.e. getting a waiver for consent from the local IRBs).
As far as I know, there is no prohibition from using the checklists--only from conducting research on the patients about their use w/o proper consent/IRB approval or waiver. The guys from Hopkins should have known better, or perhaps they just need to retake their institution mandated curriculum on human subjects research protections.
At Sat Oct 25, 05:48:00 AM 2008,
John Faben said…
I'm not sure I understand - the physicians would have been perfectly within their rights to introduce checklists as part of normal operating procedure - but this automatically became illegal when they also try to gather data to see if it was a good idea? Or is innovation in general illegal?
At Thu Nov 13, 11:13:00 AM 2008,
Anonymous said…
It wasn't the system. It was the failure of the institution to follow the process--one they should have known well, but ignored.
See: Service by the Scoop ... SRAInternational 2008 Symposium Porceedings, p 33.
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