Life-saving program BANNED by the Feds!

Life-saving program BANNED by the Feds!

Summary: Pardon me while I bang my head on my deskLess 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.

TOPICS: Health

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.

Topic: Health

Kick off your day with ZDNet's daily email newsletter. It's the freshest tech news and opinion, served hot. Get it.


Log in or register to join the discussion
  • (nt)Thanks for helping to bring this to everyone's attention

  • Are you a doctor? Do you work in ICU?

    Yeah.. let's all go and teach doctors how to work in ICU because we know better.
    • Say what?

      [i]Are you a doctor?[/i]

      The people who set up the checklists are.

      [i]Do you work in ICU?[/i]

      The people who set up the checklists do.

      As it happens, I do volunteer EMS work as a first responder, and the MDs who oversee us most emphatically [u]do[/u] believe in checklists -- at least for us, if not for themselves. Speculation as to why is left to the reader.
      Yagotta B. Kidding
    • To: pauliusp

      Hey pauliusp, I'm not a medical professional, but I am a pilot and I can tell you no pilot would dream of performing life-critical procedures, such as flying aircraft, without using checklists, so why wouldn't the same apply in the medical field? Come on -- it's common sense!
    • I am a doctor, and I have worked in ICUs

      Any doctor with half a brain wants these checklists. Nobody exercises their
      professional judgement by skipping a step in a procedure. Usually, they're rushed and
      forget. If they don't forget, but choose to skip a step that has been shown to save
      lives (as have those on the lists), it would probably be ruled malpractice in any court.
    • Are you a doctor?

      If you are a doctor, you need to reverse the lens on your telescope and take a look at what the patient experiences in the ICU. I just saw a man almost die of infection because of an improperly handled IV insertion. When people are in a hurry, check lists not only give proper reminders, they slightly slow things so that they are done properly instead of haphazardly. The good thing is that after they have used the checklist a few dozen times, they will have the best practice memorized. One of the problems with our whole medical establishment is that doctors are expected to have perfect memories rather than good decision making capabilities. With a few check lists, maybe the mechanics can become less important, and diagnostics and decision making can move forward.
    • I have worked as an ICU doctor...

      Checklists are fine, as long as the damn lawyers do not get to use them. Unfortunately, some doctors perform a procedure, like a central venous catheter insertion, ten times a year, whereas I have installed ten in a single day. Checklists can allow bleagured ICU nurses to weed out the poorest performers. Who do you want to do your procedure? I was the go to guy for babies requiring arterial lines and central lines for harvesting. The public does not appreciate that these procedures earn big money in a short period of time. I've had mercenary doctors consult me after they nailed the $$$. Always and everywhere, follow the money. John Hopkins 99 times out of 100 does smart things. Like DUH!
    • Yeah, Why have Traceable Accountability?

      Yep, must be an old school doctors are "god".

      *Real* Doctors are humans... Humans make mistakes!

      Would you want to fly on an airliner with pilots who failed to use thier pre-flight, or pre-landing checklists???

      No, of course not! My own step dad landed once without the wheels being down. After thousands of landings... Why? He was distracted from THE CHECKLIST!!!!

      In this case the checklists would, of course (duh!), be written by medical professionals.

      But, I've proof-read a few checklists and procedures by professionals outside my "ken" and found obvious errors...

      So, maybe, having *both* medical professionals and non-medical oversight isn't such a bad idea...

      BTW, IMHO, there is ONLY ONE GOD and doctors aren't them.

      Mike Sr.
    • You must be unemployed...

      because just about every job has a checklist of some sort even McDonald's has a check list!., ALL jobs that are critical (i.e. death, injury or loss of a whole lotta $$$) do have checklists. I know for a fact that in the Navy we have checklists out that backside, for EVERYTHING! If you are a doctor, I feel sorry for your patients. ]:)
      Linux User 147560
    • I am an R.N.

      Yea, your right, let's teach Doctor's about proper patient care, might shock them into being effective and reducing, not only deaths, but also wasted time, money and last, and maybe least, LIVES. Just in case you weren't thinking at time of posting, I would never hand that to a patient in ICU or surgery. Patient's deserve the best care humanly possible. Yes even from Dr's.
      pepperminnt patti
  • RE: Life-saving program BANNED by the Feds!

    Your tax dollars at work! I would not have expected
    anything less from the clueless, inept, brain-dead bozos
    in the Federal Government. I'm sure she paid her political
    dues to get her position, though, so how dare we mere
    citizens question her judgement?
  • RE: Life-saving program BANNED by the Feds!

    These people want to manage National Health Care?
    • actually....

      No, they don't. If they wanted national health care, we'd have it by now. In fact, the very LAST thing they want is to manage a health care system. The politicos receive far too much money in campaign contributions from the insurance companies.
  • This bears repeating...

    When it comes to technology, the Feds would not know their arses from a hole in the ground.
    Mr. Roboto
  • This is bureaucracy at it's extreme version

    How's her name? Kristina C. <b>Horror</b>? Even the known CPR procedure is a checklist based on consensus upon best practices and scientific evidence. No one ask an unconscious person what their preference is; you do the best you can.
    pablo Dante
    • I meant

      I meant in an emergency. Oh, and I am a physician (if someone asks).
      pablo Dante
  • RE: Life-saving program BANNED by the Feds!

    if each goverment employee,from the janintor to pres of the usa can't make money off the deal it's banned. goverment today is to make money not to save lifes or anyhting else.
    mr fish
  • Where is my List?

    Yea for paperwork!! Where is my checklist on how to do my job, yeah that job I do every single day. Oh what will I do without my checklist??? wait wait, my checklist says to hit enter when I'm finished...arrrrhhhh there is no enter, its an ADD widget box, what will I do... I'm crashing, help
  • RE: Life saving program banned

    Typical bureaucrat, suffering from SFB (s--- for brains) syndrome.

    Quick!!! Put her on a ventilator; she is [b]brain dead.[/b]
  • not as bad as it seems...

    what she's really saying is that the lists need to go though the IRB (institutional review board) for each institution to be approved before they can be posted. that's all. everything is "research", even when it's not really.