Pardon me while I bang my head on my desk Less than 3 weeks ago I wrote about a simple storage device that saved 1500+ lives and over $175,000,000 in just a couple of hundred hospitals out of 3700 nationwide.
Now the Feds have ordered the program halted. Read on to learn what you can do to help.
The technology: printed paper checklists of the proper steps for common intensive care unit (ICU) procedures like inserting catheters. Nationwide some 4% of ICU catheters get infected resulting in tens of thousands of deaths and billions in added expenses for heroic care efforts. The checklists reduced infection rates to 0%.
Bureaucracy inaction In a mind-numbing display of bureaucratic reasoning, Kristina C. Borror, Ph.D., Director, Division of Compliance Oversight in the Office for Human Research Protections of the Department of Health & Human Services, ordered the life-saving practices halted.
Why, you ask? According to Ms. Borror and the OHRP asking doctors to perform procedures according to best practices
. . . represented non-exempt human subjects research that was conducted without appropriate IRB [institutional review board] review and approval . . . .
Informed consent in the ICU Human subject research requires the patient's informed consent for good reason. But once a "best practice" is defined, asking patients if they want it is, in effect, giving them the option to accept substandard care.
How would this work in the ICU? I can see it now:
Researcher: "Ms. At-Death's-Door? I need your informed consent for some human subject research. Yes, in this research, we're requiring doctors to perform procedures correctly by using checklists. You can also opt for our standard level of ineptitude."
Patient: "Uh-h-h, don't want to, uh, die. Help. . . ."
Researcher: "You've rejected the experimental treatment. Doctor! Prep them any way you want! If they die, don't tell me!"
Whiskey! Tango!! Foxtrot!!! Performing common procedures incorrectly is not "human subjects research" since nobody keeps track of the dead. But using the checklists to perform procedures correctly AND tracking results IS human research because uh, well, him-m-m . . . .
Maybe you can explain it. I'm at a loss for words.
What you can do. Right now! I've sent off letters to US Senators, McCain and Kyl, as well as the Chairman of the House Oversight Committee, Henry Waxman, the House Science Committee and the Chairman of the Senate Committee on Health, Education, Labor and Pensions Ted Kennedy.
Here's suggested text:
On Nov. 7, 2007 DHHS's Office of Human Research Protections shut down a Johns Hopkins University program to use checklists for common medical procedures. Research published in the New England Journal of Medicine found that checklists dramatically reduced deaths and costs in common medical procedures.
The OHRP has misconstrued Congressional intent. Programs to ensure best medical practice cannot and should not be considered "human subject research". Patients expect "best practices" from medical professionals and should not be asked to consent to anything less.
As a technology professional I know the proper application of technology is just as important as the technology itself. American medicine has the best technology in the world, but health organizations aren't applying that technology consistently for maximum benefit.
I urge your committee to hold hearings on the OHRP's actions in the Johns Hopkins case and on the larger question of how we can systematize medical best practice throughout America.
The Storage Bits take Write today! The life you save may be that of someone you love.
Comments welcome, of course. Happy New Year to all.